Clinical effectiveness and cost-effectiveness of a brief accessible cognitive behavioural therapy programme for stress in school-aged adolescents (BESST): a cluster randomised controlled trial in the UK.

BACKGROUND: Depression and anxiety are increasingly prevalent in adolescents. The Brief Educational Workshops in Secondary Schools Trial investigated the effectiveness of a brief accessible stress workshop programme for 16-18-year-olds. We aimed to investigate the clinical effectiveness and cost-effectiveness of the DISCOVER cognitive behavioural therapy (CBT) workshop on symptoms of depression in 16-18-year-olds at 6 months compared with treatment-as-usual. METHODS: We conducted a multicentre, cluster randomised controlled trial in UK schools or colleges with sixth forms to evaluate clinical effectiveness and cost-effectiveness of a brief CBT workshop (DISCOVER) compared with treatment-as-usual. We planned to enrol 60 schools and 900 adolescents, using a self-referral system to recruit participants. Schools were randomised in a 1:1 ratio for participants to receive either the DISCOVER workshop or treatment-as-usual, stratified by site and balanced on school size and index of multiple deprivation. Participants were included if they were 16-18 years old, attending for the full school year, seeking help for stress, and fluent in English and able to provide written informed consent. The outcome assessors, senior health economist, senior statistician, and chief investigator were masked. People with lived experience were involved in the study. The primary outcome was depression symptoms measured with the Mood and Feelings Questionnaire (MFQ) at 6-month follow-up, in the intention-to-treat population of all participants with full covariate data. The trial was registered with the ISRCTN registry (ISRCTN90912799). FINDINGS: 111 schools were invited to participate in the study, seven were deemed ineligible, and 47 did not provide consent. Between Oct 4, 2021, and Nov 10, 2022, 933 students at 57 schools were screened for eligibility, seven were not eligible for inclusion, and 26 did not attend the baseline meeting and assessment, resulting in 900 adolescents participating in the study. The DISCOVER group included 443 participants (295 [67%] female and 136 [31%] male) and the treatment-as-usual group included 457 participants (346 [76%] female and 92 [20%] male). 468 (52%) of the 900 participants were White, and the overall age of the participants was 17·2 years (SD 0·6). 873 (97%) adolescents were followed up in the intention-to-treat population. The primary intention-to-treat analysis (n=854) found an adjusted mean difference in MFQ of -2·06 (95% CI -3·35 to -0·76; Cohen's d=-0·17; p=0·0019) at the 6-month follow-up, indicating a clinical improvement in the DISCOVER group. The probability that DISCOVER is cost- effective compared with treatment-as-usual ranged from 61% to 78% at a £20 000 to £30 000 per quality-adjusted life-year threshold. Nine adverse events (two of which were classified as serious) were reported in the DISCOVER group and 14 (two of which were classified as serious) were reported in the treatment-as-usual group. INTERPRETATION: Our findings indicate that the DISCOVER intervention is modestly clinically effective and economically viable and could be a promising early intervention in schools. Given the importance of addressing mental health needs early in this adolescent population, additional research is warranted to explore this intervention. FUNDING: National Institute for Health and Care Research Health Technology Assessment Programme.

Brief Educational Workshops in Secondary Schools Trial (BESST trial), a school-based cluster randomised controlled trial of the DISCOVER workshop for 16-18-year-olds: recruitment and baseline characteristics.

BACKGROUND: The Brief Educational Workshops in Secondary Schools Trial (BESST) is an England-wide school-based cluster randomised controlled trial assessing the clinical and cost-effectiveness of an open-access psychological workshop programme (DISCOVER) for 16-18-year-olds. This baseline paper describes the self-referral and other recruitment processes used in this study and the baseline characteristics of the enrolled schools and participants. METHOD: We enrolled 900 participants from 57 Secondary schools across England from 4th October 2021 to 10th November 2022. Schools were randomised to receive either the DISCOVER day-long Stress workshop or treatment as usual which included signposting information. Participants will be followed up for 6 months with outcome data collection at baseline, 3-month, and 6-month post randomisation. RESULTS: Schools were recruited from a geographically and ethnically diverse sample across England. To reduce stigma, students were invited to self-refer into the study if they wanted help for stress. Their mean age was 17.2 (SD = 0.6), 641 (71%) were female and 411 (45.6%) were from ethnic minority groups. The general wellbeing of our sample measured using the Mood and Feelings Questionnaire (MFQ) found 314 (35%) of students exhibited symptoms of depression at baseline. Eighty percent of students reported low wellbeing on the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) suggesting that although the overall sample mean is below the cut-off for depression, the self-referral approach used in this study supports distressed students in coming forward. CONCLUSION: The BESST study will continue to follow up participants to collect outcome data and results will be analysed once all the data have been collected. TRIAL REGISTRATION: ISRCTN registry ISRCTN90912799. Registered on 28 May 2020.

The Effectiveness and Cost-Effectiveness of a Universal Digital Parenting Intervention Designed and Implemented During the COVID-19 Pandemic: Evidence From a Rapid-Implementation Randomized Controlled Trial Within a Cohort.

BACKGROUND: Children's conduct and emotional problems increased during the COVID-19 pandemic. OBJECTIVE: We tested whether a smartphone parenting support app, Parent Positive, developed specifically for this purpose, reversed these effects in a cost-effective way. Parent Positive includes 3 zones. Parenting Boosters (zone 1) provided content adapted from standard face-to-face parent training programs to tackle 8 specific challenges identified by parents and parenting experts as particularly relevant for parents during the pandemic. The Parenting Exchange (zone 2) was a parent-to-parent and parent-to-expert communication forum. Parenting Resources (zone 3) provided access to existing high-quality web-based resources on a range of additional topics of value to parents (eg, neurodevelopmental problems, diet, and sleep). METHODS: Supporting Parents And Kids Through Lockdown Experiences (SPARKLE), a randomized controlled trial, was embedded in the UK-wide COVID-19: Supporting Parents, Adolescents and Children during Epidemics (Co-SPACE) longitudinal study on families' mental health during the pandemic. Parents of children aged 4 to 10 years were randomized 1:1 to Parent Positive or follow-up as usual (FAU) between May 19, 2021, and July 26, 2021. Parent Positive provided advice on common parenting challenges and evidence-based web-based resources and facilitated parent-to-parent and expert-to-parent support. Child conduct and emotional problems and family well-being were measured before randomization (T1) and at 1 (T2) and 2 (T3) months after randomization. Service use, costs, and adverse events were measured, along with app use and satisfaction. The primary outcome was T2 parent-reported child conduct problems, which were analyzed using linear mixed regression models. RESULTS: A total of 320 participants were randomized to Parent Positive, and 326 were randomized to FAU. The primary outcome analysis included 79.3% (512/646) of the participants (dropout: 84/320, 26% on Parent Positive and 50/326, 15% on FAU). There were no statistically significant intervention effects on conduct problems at either T2 (standardized effect=-0.01) or T3 (secondary outcome; standardized effect=-0.09) and no moderation by baseline conduct problems. Significant intervention-related reductions in emotional problems were observed at T2 and T3 (secondary outcomes; standardized effect=-0.13 in both cases). Parent Positive, relative to FAU, was associated with more parental worries at T3 (standardized effect=0.14). Few intervention-attributable adverse events were reported. Parent Positive was cost-effective once 4 outliers with extremely high health care costs were excluded. CONCLUSIONS: Parent Positive reduced child emotional problems and was cost-effective compared with FAU once outliers were removed. Although small when considered against targeted therapeutic interventions, the size of these effects was in line with trials of nontargeted universal mental health interventions. This highlights the public health potential of Parent Positive if implemented at the community level. Nevertheless, caution is required before making such an interpretation, and the findings need to be replicated in large-scale, whole-community studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT04786080; https://clinicaltrials.gov/ct2/show/NCT04786080.

Cross-cultural adaptability of parenting interventions designed for childhood behavior problems: A meta-analysis.

The dissemination of parenting interventions is one of the advised approaches to globally counteract childhood behavior problems, delinquency, and future criminal careers. Many of these interventions are developed in Anglosphere countries and transported to other contexts with distinct cultural backgrounds. However, there are no meta-analyses evaluating the overall effectiveness of these Anglosphere parenting programs in non-Anglosphere settings. This meta-analysis aimed to examine the effectiveness of parenting interventions developed in Anglosphere countries when transported to non-Anglosphere countries, as well as compare effectiveness levels between Anglosphere and non-Anglosphere trials; and analyze the impact of research and contextual factors in the dissemination of these interventions. Parenting interventions were included if they were: created in an Anglosphere setting; tested in non-Anglosphere countries; focused on reducing childhood behavioral problems; designed for children ranging from two to 12 years old; and tested in an experimental randomized trial. A random-effects model was selected for our meta-analysis. Standardized mean differences, confidence intervals and prediction intervals were also computed. Twenty studies were included, and results suggest that parenting interventions designed for childhood behavior problems can be transported to non-Anglosphere countries and potentially maintain effectiveness. This study is a relevant contribution to the evidence of cross-cultural transportability of parenting interventions.

Protocol for the Feasibility Randomised Controlled Trial of Being a Parent- Enjoying Family Life (BAP-EFL): A peer-led group intervention for parents and caregivers with significant emotional and interpersonal difficulties.

Group-format parenting interventions are well-established at reducing challenging child behavior and risk for psychopathology. However, there is significantly less evidence about the performance of these interventions for parents with significant emotional and interpersonal difficulties, including personality disorder. This protocol presents the rationale and design of a two-arm parallel group feasibility Randomised Controlled Trial and nested process evaluation of Being a Parent (BaP)- Enjoying Family Life, a novel peer-led intervention. The trial compares BaP-Enjoying Family Life to the well-established Empowering Parents Empowering Communities-Being a Parent (EPEC-Being a Parent) in a sample of parents who experience significant emotional and interpersonal difficulties and who are concerned about their child's, aged 2-11 years, behavior. 72 parents will be recruited and randomised to receive either BaP-Enjoying Family Life or EPEC-Being a Parent group-format interventions. The primary aim of this study is to examine the feasibility and acceptability of BaP-Enjoying Family Life and the proposed trial methods. Secondary clinical outcomes include child behavioral difficulties, parenting, parental reflective function, parent wellbeing, satisfaction and self-efficacy. An observational assessment of parent and index child will also assess changes in the home environment. Outcome measures will be collected pre-intervention, post-intervention and at 6-month follow up. A parallel process evaluation will use qualitative data from interviews to assess parents' experience of the intervention delivery and trial methods. Findings will be evaluated against pre-determined feasibility criteria. The results will be used to determine the planning of a definitive clinical trial. The wider methodological and clinical implications are also discussed.

First-time Mothers' Understanding and Use of a Pregnancy and Parenting Mobile App (The Baby Buddy App): Qualitative Study Using Appreciative Inquiry.

BACKGROUND: Internationally, there is increasing emphasis on early support for pregnant women to optimize the health and development of mothers and newborns. To increase intervention reach, digital and app-based interventions have been advocated. There are growing numbers of pregnancy health care apps with great variation in style, function, and objectives, but evidence about impact on pregnancy well-being and behavior change following app interaction is lacking. This paper reports on the qualitative arm of the independent multicomponent study exploring the use and outcomes of first-time mothers using the Baby Buddy app, a pregnancy and parenting support app, available in the National Health Service App Library and developed by a UK child health and well-being charity, Best Beginnings. OBJECTIVE: This study aims to understand when, why, and how first-time mothers use the Baby Buddy app and the perceived benefits and challenges. METHODS: This paper reports on the qualitative arm of an independent, longitudinal, mixed methods study. An Appreciative Inquiry qualitative approach was used with semistructured interviews (17/60, 28%) conducted with new mothers, either by telephone or in a focus group setting. First-time mothers were recruited from 3 study sites from across the United Kingdom. Consistent with the Appreciative Inquiry approach, mothers were prompted to discuss what worked well and what could have been better regarding their interactions with the app during pregnancy. Thematic analysis was used, and findings are presented as themes with perceived benefits and challenges. RESULTS: The main benefit, or what worked well, for first-time mothers when using the app was being able to access new information, which they felt was reliable and easy to find. This led to a feeling of increased confidence in the information they accessed, thus supporting family and professional communication. The main challenge was the preference for face-to-face information with a health care professional, particularly around specific issues that they wished to discuss in depth. What could have been improved included that there were some topics that some mothers would have preferred in more detail, but in other areas, they felt well-informed and thus did not feel a need to seek additional information via an app. CONCLUSIONS: Although this study included a small sample, it elicited rich data and insights into first-time mothers' app interactions. The findings suggest that easily accessible pregnancy information, which is perceived as reliable, can support first-time mothers in communicating with health care professionals. Face-to-face contact with professionals was preferred, particularly to discuss specific and personalized needs. Further studies on maternal and professional digital support preferences after the COVID-19 global pandemic and how they facilitate antenatal education and informed decision-making are recommended, particularly because digital solutions remain as a key element in pregnancy and early parenting care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1017/S1463423618000294.

Brief Educational Workshops in Secondary Schools Trial (BESST): protocol for a school-based cluster randomised controlled trial of open-access psychological workshop programme for 16-18-year-olds.

Anxiety and depression are increasingly prevalent in adolescents, often causing daily distress and negative long-term outcomes. Despite the significant and growing burden, less than 25% of those with probable diagnosis of anxiety and depression are receiving help in England. Significant barriers to help-seeking exist in this population, with a scarcity of easily accessible, effective, and cost-effective interventions tailored specially for this age group. One intervention that has been shown to be feasible to deliver and with the promise of reducing stress in this age group is a school-based stress workshop programme for 16-18-year-olds (herein called DISCOVER). The next step is to rigorously assess the effectiveness, and cost-effectiveness, of the DISCOVER intervention in a fully powered cluster randomised controlled trial (cRCT). If found to be clinically and cost-effective, DISCOVER could be scaled up as a service model UK-wide and have a meaningful impact on the mental health of adolescents across the country.Trial registration: ISRCTN registry ISRCTN90912799. Registered with ISRCTN 28 May 2020.

Baby and us: Community-based, Feasibility Trial of a Psychosocial Intervention for New Parents and their Infants.

Infancy is a critical period during which major developmental transformations occur. Early parenting is one of the strongest influences on infants' immediate and longer-term outcomes. The transition to parenting can be demanding and stressful for mothers and fathers. This paper reports results from a feasibility study of the Empowering Parents Empowering Communities Baby and Us programme, an 8-week, universal, peer-led parenting programme for new parents living in socially disadvantaged communities. This study is a quasi-experimental, one arm, no control group study, assessing the feasibility and acceptability of Baby and Us. Programme participants (n = 158) completed standardised self-report measures of parent goal attainment, self-efficacy, knowledge about parenting, mental wellbeing, parental confidence, and programme acceptability. We found that recruiting parents from disadvantaged backgrounds was feasible (96% of programmes recruited sufficient parents to proceed, mean = 6.6 parents per programme); parent goals closely matched the aims of the programme; programme completion was high (74%), and self-report measurement completion rates were in line with other large scale community delivered parenting programmes; parents rated the programme as highly satisfactory; and they reported significant improvements in their mental wellbeing, confidence, parenting skills, self-efficacy, and goal attainment. These results provide important data to conduct a full-scale trial of Baby and Us.

Impact of a peer-led, community-based parenting programme delivered at a national scale: an uncontrolled cohort design with benchmarking.

BACKGROUND: Childhood behavioural problems are the most common mental health disorder worldwide and represent a major public health concern, particularly in socially disadvantaged communities. Treatment barriers mean that up to 70% of children do not receive recommended parenting interventions. Innovative approaches, including evidence-based peer-led models, such as Empowering Parents Empowering Communities' (EPEC) Being a Parent (BAP) programme, have the potential to reduce childhood difficulties and improve parenting if replicable and successfully delivered at scale. METHOD: This real-world quasi-experimental study, with embedded RCT benchmarking, examined the population reach, attendance, acceptability and outcomes of 128 BAP groups (n = 930 parents) delivered by 15 newly established sites participating in a UK EPEC scaling programme. RESULTS: Scaling programme (SP) sites successfully reached parents living in areas of greater social deprivation (n = 476, 75.3%), experiencing significant disadvantage (45.0% left school by 16; 39.9% lived in rental accommodation; 36.9% lone parents). The only benchmarked demographic difference was ethnicity, reflecting the greater proportion of White British parents living in scaling site areas (SP 67.9%; RCT 22.4%). Benchmark comparisons showed scaling sites' parent group leaders achieved similar levels of satisfaction. Scaling site parent participants reported substantial levels of improvement in child concerns (ES 0.6), parenting (ES 0.9), parenting goals (ES 1.2) and parent wellbeing (ES 0.6) that were of similar magnitude to RCT benchmarked results. Though large, parents reported lower levels of parenting knowledge and confidence acquisition compared with the RCT benchmark. CONCLUSION: Despite common methodological limitations associated with real-world scaling evaluations, findings suggest that this peer-led, community-based, parenting approach may be capable of successful replication at scale and may have considerable potential to improve child and parenting difficulties, particularly for socially disadvantaged populations.

Supporting Parents & Kids Through Lockdown Experiences (SPARKLE): A digital parenting support app implemented in an ongoing general population cohort study during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The COVID-19 related lockdowns and distancing measures have presented families with unprecedented challenges. A UK-wide cohort study tracking changes in families' mental health since early lockdown (Co-SPACE) found a significant rise in primary school-aged children's behaviour problems and associated family-related stress. Three-quarters of parents in Co-SPACE also reported wanting extra support. In SPARKLE, we will examine whether providing Co-SPACE families with a smartphone application delivering information and parenting support, Parent Positive, can reverse the negative effects of the pandemic on children and parents. The efficacy on child and parent outcomes and cost-effectiveness of Parent Positive will be examined. We will also test whether the effects are moderated by pre-existing levels of child conduct problems and usage of Parent Positive. Exploratory analyses will examine whether other baseline characteristics or lockdown circumstances moderate the effects of Parent Positive. TRIAL DESIGN: SPARKLE is a two-arm superiority parallel group randomised controlled trial embedded in an existing large UK-wide self-selected community cohort - Co-SPACE. Those who consent to SPARKLE will be randomised 1:1 to either Parent Positive or Follow-up As Usual (FAU). PARTICIPANTS: Co-SPACE (a UK-wide longitudinal cohort study) parents aged ≥18 who have children aged 4-10 years will be eligible for SPARKLE. INTERVENTION AND COMPARATOR: Parent Positive: is a digital public health intervention that can be delivered rapidly at scale to support parents in managing their children's behaviour to reduce conduct problems and levels of family conflict, which were exacerbated during the first lockdown, and which may increase further in future months as families need to cope with continuous uncertainty and further disruption to their daily lives. Co-designed with parents and based on decades of parenting research, Parent Positive consists of three elements: (i) Parenting Boosters: where advice, delivered in the form of narrated animations, videos, graphics and text is provided to help parents with eight common parenting challenges; (ii) Parenting Exchange: a facilitated parent-to-parent communication and peer support platform and; (iii) Parent Resources: giving access to carefully selected high-quality, evidence-based online parenting resources. Follow-up as Usual: FAU was selected as a comparator because the public health nature meant that an active comparator was not appropriate due to the pragmatic, rapid implementation of the trial. Individuals randomised to FAU will receive no intervention for the first two months while the data for baseline (T1), T2 and T3 are collected. They will then be given full access to the app until 30th November 2021. MAIN OUTCOMES: Outcome measures will be collected remotely through Qualtrics according to the Co-SPACE schedule at baseline (T1), which will be the Co-SPACE survey data obtained immediately prior to randomisation, and then at one month (T2) and two months (T3) post-randomisation. Measures will be collected to assess group differences in child and parent outcomes, costs and service utilisation, and adverse events. Usage of Parent Positive will also be tracked. The primary outcome is parent-reported child conduct problems at one-month post-randomisation measured using the Strengths and Difficulties Questionnaire conduct problems subscale. RANDOMISATION: Enrolled participants will be allocated to Parent Positive or FAU at the ratio of 1:1 by simple randomisation using the Randomizer function within the Qualtrics programme. Neither blocking nor stratification will be used. BLINDING (MASKING): It is not possible to blind parents enrolled in the study and Qualtrics will automatically inform parents of their group allocation. Blinded members of the research team and the senior statistician will not be given access to the Qualtrics system or the data in order to remain blinded until after the analysis is complete. We do not anticipate any serious harms associated with taking part in the intervention, therefore there will be no need to unblind any blinded staff during the study. The junior statistician will be unblinded throughout. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 616 will be recruited into the trial with 308 consenting parents randomised to each treatment arm. TRIAL STATUS: V1.0; 15.03.2021. Not yet recruiting. Anticipated start date: 1st April 2021. Anticipated end date for recruitment: 31st July 2021. TRIAL REGISTRATION: Clinicaltrial.gov: NCT04786080 . The trial was prospectively registered on 8 March 2021. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

Feasibility of a psychoeducational group intervention to improve parental reflective functioning and bonding in pregnancy: a randomised trial.

OBJECTIVE: To develop and evaluate Baby CHAT, a single-session psychoeducational intervention for expectant parents. Baby CHAT aims to improve parental reflective functioning (RF) and bonding. BACKGROUND: The early years of a child's life, including pregnancy, are vital for healthy physical and emotional development. Caregivers who provide responsive parenting, enhanced through strong bonds and good RF, can aid healthy development.. However, limited interventions exist to enhance RF and bonding in expectant parents. METHODS: Feasibility of Baby CHAT was assessed using a mixed methods randomised controlled trial design. It evaluated uptake and retention of participants, effect size calculations, and acceptability and satisfaction with Baby CHAT. RESULTS: Participants (N = 20) were aged 30-39 years (n = 17) in their third trimester of pregnancy (n = 12). Nine males and 11 females were recruited. Content analysis of qualitative feedback after the intervention resulted in four themes; positive group aspects, group improvements, 4D scan footage and relating content to my baby. CONCLUSIONS: Baby CHAT can help expectant parents think about their baby as a separate person and has potential to improve prenatal RF and bonding. However, further research is required to assess the effectiveness of Baby CHAT to improve bonding and RF.

'Every day is hard, being outside, but you have to do it for your child': Mixed-methods formative evaluation of a peer-led parenting intervention for homeless families.

We conducted a mixed-methods, formative evaluation of a peer-led parenting intervention for homeless families. Participants were parents living in temporary accommodation with self-identified difficulties related to parenting an index child aged 2-11 years. An evidence-based programme ('Empowering Parents, Empowering Communities') was adapted for delivery with the target population in London, UK. We assessed feasibility in terms of session attendance rate, intervention completion rate and potential for impact on a range of parent-reported outcomes measures. Acceptability and appropriateness were examined by a user satisfaction measure and qualitative interviews. The intervention was delivered across three group cohorts (N = 15). Thirteen parents completed the programme (including one parent who required two attempts). We found improvements in child behavioural difficulties, parenting knowledge and practices, while parental well-being and social support were unchanged. Participants were highly satisfied overall, with indications that the peer-led model mitigated negative expectancies of services and normalized experiences of parenting in challenging conditions. Parental self-care and 'the good enough parent' were strongly endorsed topics, although some content (e.g. timeout) was deemed impractical. These promising findings warrant further testing under controlled conditions.

An intervention for parents with severe personality difficulties whose children have mental health problems: a feasibility RCT.

BACKGROUND: The children of parents with severe personality difficulties have greater risk of significant mental health problems. Existing care is poorly co-ordinated, with limited effectiveness. A specialised parenting intervention may improve child and parenting outcomes, reduce family morbidity and lower the service costs. OBJECTIVES: To develop a specialised parenting intervention for parents affected by severe personality difficulties who have children with mental health problems and to conduct a feasibility trial. DESIGN: A pragmatic, mixed-methods design to develop and pilot a specialised parenting intervention, Helping Families Programme-Modified, and to conduct a randomised feasibility trial with process evaluation. Initial cost-effectiveness was assessed using UK NHS/Personal Social Services and societal perspectives, generating quality-adjusted life-years. Researchers collecting quantitative data were masked to participant allocation. SETTING: Two NHS mental health trusts and concomitant children's social care services. PARTICIPANTS: Parents who met the following criteria: (1) the primary caregiver of the index child, (2) aged 18-65 years, (3) have severe personality difficulties, (4) proficient in English and (5) capable of providing informed consent. Index children who met the following criteria: (1) aged 3-11 years, (2) living with index parent and (3) have significant emotional/behavioural difficulties. Exclusion criteria were (1) having coexisting psychosis, (2) participating in another parenting intervention, (3) receiving inpatient care, (4) having insufficient language/cognitive abilities, (5) having child developmental disorder, (6) care proceedings and (7) index child not residing with index parent. INTERVENTION: The Helping Families Programme-Modified - a 16-session intervention using structured, goal-orientated strategies and collaborative therapeutic methods to improve parenting, and child and parent functioning. Usual care - standard care augmented by a single psychoeducational session. MAIN OUTCOME MEASURES: Trial feasibility - rates of recruitment, eligibility, allocation, retention, data completion and experience. Intervention acceptability - rates of acceptance, completion, alliance (Working Alliance Inventory-Short Revised) and experience. Outcomes - child (assessed via Concerns About My Child, Eyberg Child Behaviour Inventory, Child Behaviour Checklist-Internalising Scale), parenting (assessed via the Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale), parent (assessed via the Symptom Checklist-27), and health economics (assessed via the Client Service Receipt Inventory, EuroQol-5 Dimensions). RESULTS: The findings broadly supported trial feasibility using non-diagnostic screening criteria. Parents were mainly referred from one site (75.0%). Site and participant factors delayed recruitment. An estimate of eligible parents was not obtained. Of the 86 parents referred, 60 (69.7%) completed screening and 48 of these (80.0%) were recruited. Participants experienced significant disadvantage and multiple morbidity. The Helping Families Programme-Modified uptake (87.5%) was higher than usual-care uptake (62.5%). Trial retention (66.7%, 95% confidence interval 51.6% to 79.6%) exceeded the a priori rate. Process findings highlighted the impact of random allocation and the negative effects on retention. The Helping Families Programme-Modified was acceptable, with duration of delivery longer than planned, whereas the usual-care condition was less acceptable. At initial follow-up, effects on child and parenting outcomes were detected across both arms, with a potential outcome advantage for the Helping Families Programme-Modified (effect size range 0.0-1.3). For parental quality-adjusted life-years, the Helping Families Programme-Modified dominated usual care, and child quality-adjusted life-years resulted in higher costs and more quality-adjusted life-years. At second follow-up, the Helping Families Programme-Modified was associated with higher costs and more quality-adjusted life-years than usual care. For child quality-adjusted life-years, when controlled for baseline EuroQol-5 Dimensions, three-level version, usual care dominated the Helping Families Programme-Modified. No serious adverse events were reported. CONCLUSION: The Helping Families Programme-Modified is an acceptable specialised parenting intervention. Trial methods using non-diagnostic criteria were largely supported. For future work, a definitive efficacy trial should consider site selection, recruitment methods, intervention efficiency and revised comparator condition. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14573230. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 14. See the NIHR Journals Library website for further project information.

Parents affected by personality difficulties experience strong, overwhelming emotions and struggle in their personal and social relationships. These difficulties can interfere with their ability to provide stable, safe and warm parenting, which increases the risk of their children developing mental health problems. This research developed the Helping Families Programme-Modified, a new parenting intervention designed to help parents with severe personality difficulties who have children with mental health problems. Parents received 16 home-based appointments to learn new parenting skills and improve their children's difficulties. The research assessed how the Helping Families Programme-Modified worked in practice and the viability of evaluation methods. A short questionnaire assessing personality difficulties, rather than a lengthy diagnostic interview, was more effective and acceptable for identifying parents who may benefit from the Helping Families Programme-Modified. Parents taking part had high levels of personal, family and social problems. This slowed the rate at which parents agreed to take part in the evaluation and lengthened the intervention period. The research tested parent agreement to being randomly allocated to receive either the Helping Families Programme-Modified or usual care plus a specially designed parenting appointment. Although this random allocation was feasible, parents were disappointed when they did not receive the Helping Families Programme-Modified. They often felt overwhelmed by family difficulties and lacked other suitable services. These parents were less likely to take up the additional parenting appointment available or to provide subsequent research information, which affected the certainty of the research findings. Parents receiving the Helping Families Programme-Modified or usual care reported improvements, with a potentially greater impact on parents and children, and better acceptability, for the new intervention. Parents generally supported the tailored, home-based approach of the Helping Families Programme-Modified, and they valued its content, therapist skills and persistence. It was uncertain whether the new intervention increased or reduced service costs. These results will be used to plan the most suitable methods for a large-scale evaluation of the Helping Families Programme-Modified.

Randomised feasibility trial of the helping families programme-modified: an intensive parenting intervention for parents affected by severe personality difficulties.

BACKGROUND: Specialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties. OBJECTIVE: Conduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention. DESIGN: Pragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates. SETTINGS: Two National Health Service health trusts and local authority children's social care. PARTICIPANTS: Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties. INTERVENTION: HFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session. OUTCOMES: Primary feasibility outcome: participant retention rate. SECONDARY OUTCOMES: (i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory). SECONDARY OUTCOMES: child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation. RESULTS: Findings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95% CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3). CONCLUSION: HFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported. TRIAL REGISTRATION NUMBER: ISRCTN14573230.

The Bumps and BaBies Longitudinal Study (BaBBLeS): a multi-site cohort study of first-time mothers to evaluate the effectiveness of the Baby Buddy app.

BACKGROUND: Health mobile applications (apps) have become very popular, including apps specifically designed to support women during the ante- and post-natal periods. However, there is currently limited evidence for the effectiveness of such apps at improving pregnancy and parenting outcomes. This study aims to assess the effectiveness of a pregnancy and parenting app, Baby Buddy, in improving maternal self-efficacy at 3 months post-birth. METHODS: Participants were 16 years old or over, first-time mothers, 12-16 weeks gestation, recruited by midwives from five English study sites. The Tool to Measure Parenting Self-Efficacy (TOPSE) (primary outcome) was used to compare mothers at 3 months post-birth who had downloaded the Baby Buddy app with those who had not downloaded the app, controlling for confounding factors. RESULTS: Four hundred and eighty-eight participants provided valid data at baseline (12-16 weeks gestation), 296 participants provided valid data at 3 months post-birth, 114 (38.5%) of whom reported that they had used the Baby Buddy app. Baby Buddy app users were more likely to use pregnancy or parenting apps (80.7% vs. 69.6%, P=0.035), more likely to have been introduced to the app by a healthcare professional (P=0.005) and have a lower median score for perceived social support (81 vs. 83, P=0.034) than non-app users. The Baby Buddy app did not elicit a statistically significant change in TOPSE scores from baseline to 3 months post-birth [adjusted odds ratio (OR) 1.12, 95% confidence interval (CI): 0.59 to 2.13, P=0.730]. Finding out about the Baby Buddy app from a healthcare professional appeared to grant no additional benefit to app users compared to all other participants in terms of self-efficacy at 3 months post-birth (adjusted OR 1.16, 95% CI: 0.60 to 2.23, P=0.666). There were no statistically significant differences in the TOPSE scores for the in-app data, in terms of passive use of the app between high and low app users (adjusted OR 0.82, 95% CI: 0.21 to 3.12, P=0.766), nor in terms of active use (adjusted OR 0.47, 95% CI: 0.12 to 1.86, P=0.283). CONCLUSIONS: This study is one of few, to date, that has investigated the effectiveness of a pregnancy and early parenthood app. No evidence for the effectiveness of the Baby Buddy app was found. New technologies can enhance traditional healthcare services and empower users to take more control over their healthcare but app effectiveness needs to be assessed. Further work is needed to consider: (I) how we can best use this new technology to deliver better health outcomes for health service users and, (II) methodological issues of evaluating digital health interventions.

A study to evaluate the effectiveness of Best Beginnings' Baby Buddy phone app in England: a protocol paper.

IntroductionDevelopments in information and communication technologies have enabled electronic health and seen a huge expansion over the last decade. This has increased the possibility of self-management of health issues.PurposeTo assess the effectiveness of the Baby Buddy app on maternal self-efficacy and mental well-being three months post-birth in a sample of mothers recruited antenatally. In addition, to explore when, why and how mothers use the app and consider any benefits the app may offer them in relation to their parenting, health, relationships or communication with their child, friends, family members or health professionals. METHODS: We will use a mixed-methods approach, a cohort study, a qualitative element and analysis of in-app data. Participants will be first-time pregnant women, aged 16 years and over, between 12 and 16 weeks of gestation and recruited from five English study sites.Evaluation planWe will compare maternal self-efficacy and mental health at three months post-delivery in mothers who have downloaded the Baby Buddy app compared with those that have not downloaded the app, controlling for confounding factors. Women will be recruited antenatally between 12 and 16 weeks of gestation. Further follow-ups will take place at 35 weeks of gestation and three months post-birth. Data from the cohort study will be supplemented by in-app data that will include, for example, patterns of usage. Qualitative data will assess the impact of the app on the lives of pregnant women and health professionals using both focus groups and interviews.EthicsApproval from the West Midlands-South Birmingham Research Ethics Committee (NRES) (16/WM/0029) and the University of the West of England, Bristol, Research Ethics Committee (HAS.16.08.001).DisseminationFindings of the study will be published in peer reviewed and professional journals, presented locally, nationally and at international conferences. Participants will receive a summary of the findings and the results will be published on Best Beginnings' website.

Associations between social support, mental wellbeing, self-efficacy and technology use in first-time antenatal women: data from the BaBBLeS cohort study.

BACKGROUND: Information and communication technologies are used increasingly to facilitate social networks and support women during the perinatal period. This paper presents data on how technology use affects the association between women's social support and, (i) mental wellbeing and, (ii) self-efficacy in the antenatal period. METHODS: Data were collected as part of an ongoing study - the BaBBLeS study - exploring the effect of a pregnancy and maternity software application (app) on maternal wellbeing and self-efficacy. Between September 2016 and February 2017, we aimed to recruit first-time pregnant women at 12-16 gestation weeks in five maternity sites across England and asked them to complete questionnaires. Outcomes included maternal mental wellbeing (Warwick-Edinburgh Mental Wellbeing Scale), and antenatal self-efficacy (antenatal version of the Tool to Measure Parenting Self-Efficacy). Other variables assessed were perceived social support (Multidimensional Scale of Perceived Social Support), general technology use (adapted from Media and Technology Usage and Attitudes Scale). Potential confounders were age, ethnicity, education, socioeconomic deprivation, employment, relationship status and recruitment site. Linear regression models were developed to analyse the relationship between social support and the outcomes. RESULTS: Participants (n = 492, median age = 28 years) were predominantly white British (64.6%). Half of them had a degree or higher degree (49.3%), most were married/living with a partner (83.6%) and employed (86.2%). Median (LQ-UQ) overall scores were 81.0 (74.0-84.0) for social support (range 12-84), 5.1 (4.7-5.4) for technology use (range 1-6), 54.0 (48.0-60.0) for mental well-being (range 14-70), and 319.0 (295.5-340) for self-efficacy (range 0-360). Social support was significantly associated with antenatal mental well-being adjusting for confounders [adj R2 = 0.13, p < .001]. The addition of technology use did not alter this model [adj R2 = 0.13, p < .001]. Social support was also significantly associated with self-efficacy after adjustment [adj R2 = 0.14, p < .001]; technology had limited impact on this association [adj R2 = 0.13, p < .001]. CONCLUSIONS: Social support is associated with mental well-being and self-efficacy in antenatal first-time mothers. This association was not significantly affected by general technology use as measured in our survey. Future work should investigate whether pregnancy-specific technologies yield greater potential to enhance the perceived social support, wellbeing and self-efficacy of antenatal women.

Experiences of parenting and clinical intervention for mothers affected by personality disorder: a pilot qualitative study combining parent and clinician perspectives.

BACKGROUND: Evidence-based parenting programmes are recommended for the treatment of child mental health difficulties. Families with complex psychosocial needs show poorer retention and outcomes when participating in standard parenting programmes. The Helping Families Programme (HFP) is a 16-week community-based parenting intervention designed to meet the needs of these families, including families with parental personality disorder. This study aimed to explore the help seeking and participatory experiences of parents with a diagnosis of personality disorder. It further aimed to examine the acceptability of referral and intervention processes for the HFP from the perspectives of (i) clinicians referring into the programme; and (ii) referred parents. METHOD: Semi-structured interviews were conducted with parents recruited to receive HFP (n = 5) as part of a research case series and the referring NHS child and adolescent mental health service (CAMHS) clinicians (n = 5). Transcripts were analysed using Interpretive Phenomenological Analysis. RESULTS: Four themes were identified for parents: (i) the experience of parenthood, (ii) being a parent affected by personality disorder, (iii) experience of the intervention, and (iv) qualities of helping. Three themes emerged for clinicians: (i) challenges of addressing parental need, (ii) experience of engaging parents with personality disorders and (iii) limited involvement during HFP. Comparison of parent and clinician themes led to the identification of two key interlinked themes: (i) concerns prior to receiving the intervention, and (ii) the challenges of working together without a mutual understanding. CONCLUSIONS: This pilot study identifies potentially significant challenges of working with parents affected by personality disorder and engaging them in HFP and other similar interventions. Results have important wider clinical implications by highlighting potential barriers to engagement and participation and providing insights on how these barriers might be overcome. Findings have been used to inform the referral and intervention processes of a pilot RCT and further intervention development.

Feasibility trial of a psychoeducational intervention for parents with personality difficulties: The Helping Families Programme.

The Helping Families Programme is a psychoeducational parenting intervention that aims to improve outcomes and engagement for parents affected by clinically significant personality difficulties. This is achieved by working collaboratively with parents to explore ways in which their emotional and relational difficulties impact on parenting and child functioning, and to identify meaningful and realistic goals for change. The intervention is delivered via one-to-one sessions at weekly intervals over a period of 16 weeks. This protocol describes a two-arm parallel RCT in which consenting parents are randomly allocated in a 1:1 ratio to either the Helping Families Programme plus the usual services that the parent may be receiving from their mental health and/or social care providers, or to standard care (usual services plus a brief parenting advice session). The primary clinical outcome will be child behaviour. Secondary clinical outcomes will be child and parental mental health, parenting satisfaction, parenting behaviour and therapeutic alliance. Health economic measures will be collected on quality of life and service use. Outcome measures will be collected at the initial assessment stage, after the intervention is completed and at 6-month follow-up by research staff blind to group allocation. Trial feasibility will be assessed using rates of trial participation at the three time points and intervention uptake, attendance and retention. A parallel process evaluation will use qualitative interviews to ascertain key-workers' and parent participants' experiences of intervention delivery and trial participation. The results of this feasibility study will determine the appropriateness of proceeding to a full-scale trial.

Community organizing and community health: piloting an innovative approach to community engagement applied to an early intervention project in south London.

BACKGROUND: The importance of community engagement in health is widely recognized, and key themes in UK National Institute for Health and Clinical Excellence (NICE) recommendations for enhancing community engagement are co-production and community control. This study reports an innovative approach to community engagement using the community-organizing methodology, applied in an intervention of social support to increase social capital, reduce stress and improve well-being in mothers who were pregnant and/or with infants aged 0-2 years. METHODS: Professional community organizers in Citizens-UK worked with local member civic institutions in south London to facilitate social support to a group of 15 new mothers. Acceptability of the programme, adherence to principles of co-production and community control, and changes in the outcomes of interest were assessed quantitatively in a quasi-experimental design. RESULTS: The programme was found to be feasible and acceptable to participating mothers, and perceived by them to involve co-production and community control. There were no detected changes in subjective well-being, but there were important reductions in distress on a standard self-report measure (GHQ-12). There were increases in social capital of a circumscribed kind associated with the project. CONCLUSIONS: Community organizing provides a promising model and method of facilitating community engagement in health.