The Incredible Years® Teacher Classroom Management programme and its impact on teachers' professional self-efficacy, work-related stress, and general well-being: Results from the STARS randomized controlled trial.

BACKGROUND: Teaching is a stressful occupation with poor retention. The Incredible Years® Teacher Classroom Management (TCM) programme is a training programme that research has demonstrated may be an effective intervention for improving children's mental health, but little research has explored any impacts there may be on the teachers' own professional confidence and mental health. AIMS: In this paper, we evaluate whether TCM may lead to changes in teachers' well-being, namely a reduction in burnout and an improvement in self-efficacy and mental health. SAMPLE: Eighty schools across the South West of England were recruited between September 2012 and September 2014. Headteachers were asked to nominate one class teacher to take part. METHODS: Eighty teachers were randomized to either attend a TCM course (intervention) or not (control). TCM was delivered to groups of up to 12 teachers in six whole-day workshops that were evenly spread between October and April. At baseline and 9-month follow-up, we measured teachers' mental health using the Everyday Feelings Questionnaire (EFQ), burnout using the Maslach Burnout Inventory-General Survey (MBI-GS), and self-efficacy using the Teachers' Sense of Efficacy Scale-Short (TSES-Short). RESULTS: Using linear regression models, there was little evidence of differences at follow-up between the intervention and control teachers on the outcomes (the smallest p-value was .09). CONCLUSIONS: Our findings did not replicate previous research that TCM improved teachers' sense of efficacy. However, there were limitations with this study including low sample size.

The effectiveness and cost-effectiveness of the Incredible Years® Teacher Classroom Management programme in primary school children: results of the STARS cluster randomised controlled trial.

BACKGROUND: We evaluated the effectiveness and cost-effectiveness of the Incredible Years® Teacher Classroom Management (TCM) programme as a universal intervention, given schools' important influence on child mental health. METHODS: A two-arm, pragmatic, parallel group, superiority, cluster randomised controlled trial recruited three cohorts of schools (clusters) between 2012 and 2014, randomising them to TCM (intervention) or Teaching As Usual (TAU-control). TCM was delivered to teachers in six whole-day sessions, spread over 6 months. Schools and teachers were not masked to allocation. The primary outcome was teacher-reported Strengths and Difficulties Questionnaire (SDQ) Total Difficulties score. Random effects linear regression and marginal logistic regression models using Generalised Estimating Equations were used to analyse the outcomes. TRIAL REGISTRATION: ISRCTN84130388. RESULTS: Eighty schools (2075 children) were enrolled; 40 (1037 children) to TCM and 40 (1038 children) to TAU. Outcome data were collected at 9, 18, and 30-months for 96, 89, and 85% of children, respectively. The intervention reduced the SDQ-Total Difficulties score at 9 months (mean (s.d.):5.5 (5.4) in TCM v. 6.2 (6.2) in TAU; adjusted mean difference = -1.0; 95% CI-1.9 to -0.1; p = 0.03) but this did not persist at 18 or 30 months. Cost-effectiveness analysis suggested that TCM may be cost-effective compared with TAU at 30-months, but this result was associated with uncertainty so no firm conclusions can be drawn. A priori subgroup analyses suggested TCM is more effective for children with poor mental health. CONCLUSIONS: TCM provided a small, short-term improvement to children's mental health particularly for children who are already struggling.

'How I Feel About My School': The construction and validation of a measure of wellbeing at school for primary school children.

There is a growing focus on child wellbeing and happiness in schools, but we lack self-report measures for very young children. Three samples ( N = 2345) were combined to assess the psychometric properties of the How I Feel About My School (HIFAMS) questionnaire, which was designed for children aged 4-8 years. Test-retest reliability was moderate (intraclass correlation coefficient = .62). HIFAMS assessed a single concept and had moderate internal consistency (Cronbach's alpha values from .62 to .67). There were low correlations between scores on the child-reported HIFAMS and parent and teacher reports. Children at risk of exclusion had significantly lower HIFAMS scores than the community sample (mean difference = 2.4; 95% confidence interval (CI) = [1.6, 3.2]; p < .001). Schools contributed only 4.5% of the variability in HIFAMS score, the remaining 95.5% reflecting pupil differences within schools. Girls' scores were 0.37 units (95% CI = [0.16, 0.57]; p < .001) higher than boys, while year group and deprivation did not predict HIFAMS score. HIFAMS is a promising measure that demonstrates moderate reliability and discriminates between groups even among very young children.

Understanding influences on teachers' uptake and use of behaviour management strategies within the STARS trial: process evaluation protocol for a randomised controlled trial.

BACKGROUND: The 'Supporting Teachers And childRen in Schools' (STARS) study is a cluster randomised controlled trial evaluating the Incredible Years Teacher Classroom Management (TCM) programme as a public health intervention. TCM is a 6 day training course delivered to groups of 8-12 teachers. The STARS trial will investigate whether TCM can improve children's behaviour, attainment and wellbeing, reduce teachers' stress and improve their self-efficacy. This protocol describes the methodology of the process evaluation embedded within the main trial, which aims to examine the uptake and implementation of TCM strategies within the classroom plus the wider school environment and improve the understanding of outcomes. METHODS/DESIGN: The STARS trial will work with eighty teachers of children aged 4-9 years from eighty schools. Teachers will be randomised to attend the TCM course (intervention arm) or to "teach as normal" (control arm) and attend the course a year later. The process evaluation will use quantitative and qualitative approaches to assess fidelity to model, as well as explore headteachers' and teachers' experiences of TCM and investigate school factors that influence the translation of skills learnt to practice. Four of the eight groups of teachers (n = 40) will be invited to participate in focus groups within one month of completing the TCM course, and again a year later, while 45 of the 80 headteachers will be invited to take part in telephone interviews. Standardised checklists will be completed by group leaders and each training session will be videotaped to assess fidelity to model. Teachers will also complete standardised session evaluations. DISCUSSION: This study will provide important information about whether the Teacher Classroom Management course influences child and teacher mental health and well-being in both the short and long term. The process evaluation will provide valuable insights into factors that may facilitate or impede any impact. TRIAL REGISTRATION: The trial has been registered with ISCTRN (Controlled Trials Ltd) and assigned an ISRCTN number ISRCTN84130388 . Date assigned: 15 May 2012.

Parents' attitudes toward the use of complementary therapy by their children with moderate or severe cerebral palsy.

OBJECTIVE: To describe the use of, and attitudes toward, complementary therapy (CT) by parents of children with moderate to severe cerebral palsy. METHODS: Parents of 32 children with cerebral palsy (age 5-12 years) enrolled in a randomized trial of cranial osteopathy prospectively participated in semi-structured interviews in the home to explore the use of CT and views regarding access to and expectations of these therapies. Interview transcripts were analyzed thematically, and content analysis was used to determine the frequency of use of different therapies. RESULTS: Sixteen children (50%) had received one or more types of CT, although only three were currently receiving any CT. The primary reasons for trying CT were to reduce children's pain and improve physical function. Parents had limited knowledge of the range of, and possible indications for, CT and expressed concerns about CT safety and effectiveness. Practical considerations of time and cost were also identified. Some parents had strong beliefs about the benefits, and, overall, parents indicated a high level of commitment to finding any treatments, conventional or CT, to help their children. CONCLUSION: Parents of children with cerebral palsy want to help their child, but they need information, guidance, and practical support to facilitate their decision-making regarding the use of CT. A clearer understanding of factors predictive of optimal outcomes will enable resources to be targeted effectively.

Supporting teachers and children in schools: the effectiveness and cost-effectiveness of the Incredible Years teacher classroom management programme in primary school children: a cluster randomised controlled trial, with parallel economic and process evaluations.

BACKGROUND: Childhood antisocial behaviour has high immediate and long-term costs for society and the individual, particularly in relation to mental health and behaviours that jeopardise health. Managing challenging behaviour is a commonly reported source of stress and burn out among teachers, ultimately resulting in a substantial number leaving the profession. Interventions to improve parenting do not transfer easily to classroom-based problems and the most vulnerable parents may not be easily able to access them. Honing teachers' skills in proactive behaviour management and the promotion of socio-emotional regulation, therefore, has the potential to improve both child and teacher mental health and well-being and the advantage that it might potentially benefit all the children subsequently taught by any teacher that accesses the training. METHODS/DESIGN: Cluster randomised controlled trial (RCT) of the Incredible Years teacher classroom management (TCM) course with combined economic and process evaluations.One teacher of children aged 4-9 years, from 80 schools in the South West Peninsula will be randomised to attend the TCM (intervention arm) or to "teach as normal" (control arm). The primary outcome measure will be the total difficulties score from the Strengths and Difficulties Questionnaire (SDQ) completed by the current class teachers prior to randomisation, and at 9, 18 and 30 months follow-up, supplemented by parent SDQs. Secondary measures include academic attainment (teacher report supplemented by direct measurement in a sub-sample), children's enjoyment of school, and teacher reports of their professional self-efficacy, and levels of burn out and stress, supplemented by structured observations of teachers classroom management skills in a subsample. Cost data for the economic evaluation will be based on parental reports of services accessed. Cost-effectiveness, using the SDQ as the measure of effect, will be examined over the period of the RCT and over the longer term using decision analytic modelling. The process evaluation will use quantitative and qualitative approaches to assess fidelity to model, as well as explore Head teacher and teachers' experiences of TCM and investigate school factors that influence the translation of skills learnt to practice. DISCUSSION: This study will provide important information about whether the Teacher Classroom Management course influences child and teacher mental health and well-being in both the short and long term. It will also provide valuable insights into factors that may facilitate or impede any impact.The trial has been registered with ISCTRN (Controlled Trials Ltd) and assigned an ISRCTN number ISRCTN84130388. (http://www.controlled-trials.com/isrctn/search.html?srch=ISRCTN84130388&sort=3&dir=desc&max=10).

Cranial osteopathy for children with cerebral palsy: a randomised controlled trial.

OBJECTIVES: To estimate the effect of cranial osteopathy on the general health and wellbeing, including physical functioning, of children with cerebral palsy. DESIGN: Pragmatic randomised controlled trial. PARTICIPANTS: 142 children from Greater London and the South West of England, aged 5-12 years with cerebral palsy. INTERVENTION: Participants were randomised to six sessions of cranial osteopathy with a registered osteopath or a waiting list with partial attention control (parents invited to participate in two semistructured interviews). PRIMARY OUTCOME MEASURES: Blind assessment of motor function by physiotherapists using the Gross Motor Function Measure-66 (GMFM-66) and quality of life using the Child Health Questionnaire (CHQ) PF50 at 6 months. SECONDARY OUTCOME MEASURES: Parents' assessment of global health and sleep at 6 months, pain and sleep diaries at 10 weeks and 6 months, CHQ PF50 at 10 weeks and quality of life of main carer (Short Form 36) at 10 weeks and 6 months. RESULTS: Compared with children in the control group, children in the osteopathy group demonstrated no statistically significant differences in GMFM-66 (mean difference 4.9, 95% CI -4.4 to 14.1), CHQ Physical Summary Score (mean difference 2.2, 95% CI -3.5 to 8.0) or CHQ Psychological Summary Score (mean difference 3.4, 95% CI -0.8 to 7.7). There were no significant differences between groups with respect to pain; sleep (either 'time asleep' or 'time to sleep'); or main carer's quality of life. Compared with children in the control group, carers of children receiving cranial osteopathy were nearly twice as likely to report that their child's global health had 'improved' at 6 months rather than 'decreased' or 'remained the same' (38% vs 18%; odds ratio 2.8, 95% CI 1.1 to 6.9). CONCLUSIONS: This trial found no statistically significant evidence that cranial osteopathy leads to sustained improvement in motor function, pain, sleep or quality of life in children aged 5-12 years with cerebral palsy nor in quality of life of their carers.

Consulting parents about the design of a randomized controlled trial of osteopathy for children with cerebral palsy.

BACKGROUND: Although the UK Department of Health has advocated the involvement of service users and carers in health research for several years, there is little evidence about their contribution to the design of randomized controlled trials (RCTs). OBJECTIVE: To demonstrate how consulting parents about the design of a study, including which outcomes to use, led to the design and successful delivery of a RCT of osteopathy for children with cerebral palsy (CP). DESIGN: Semi-structured interviews were carried out with 20 parents of children with CP and other neurological conditions, asking them to choose between four different trial designs, to talk about noticeable changes in their child's condition and their views about payment for trial treatment. SETTING AND PARTICIPANTS: The parents interviewed were all members of Cerebra, a charity for 'brain-injured' children and young people. All interviews were carried out at the parents' homes. RESULTS: Parents had mixed views about possible trial designs; however, a waitlist design which allowed all children eventually to receive the treatment emerged as a clear favourite. Parents did not focus on isolated outcomes, but suggested a range of factors relevant to their child's quality of life. They expressed a clear preference for the costs of treatment to be funded by the trial. CONCLUSIONS: Involvement of parents helped design a trial which was acceptable to families and addressed outcomes that mattered to them. By consulting parents about the design of the research, the subsequent trial achieved excellent recruitment and retention rates.

Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial.

OBJECTIVES: To assess whether supplementation with antioxidants, folinic acid, or both improves the psychomotor and language development of children with Down's syndrome. DESIGN: Randomised controlled trial with two by two factorial design. SETTING: Children living in the Midlands, Greater London, and the south west of England. PARTICIPANTS: 156 infants aged under 7 months with trisomy 21. INTERVENTION: Daily oral supplementation with antioxidants (selenium 10 mug, zinc 5 mg, vitamin A 0.9 mg, vitamin E 100 mg, and vitamin C 50 mg), folinic acid (0.1 mg), antioxidants and folinic acid combined, or placebo. MAIN OUTCOME MEASURES: Griffiths developmental quotient and an adapted MacArthur communicative development inventory 18 months after starting supplementation; biochemical markers in blood and urine at age 12 months. RESULTS: Children randomised to antioxidant supplements attained similar developmental outcomes to those without antioxidants (mean Griffiths developmental quotient 57.3 v 56.1; adjusted mean difference 1.2 points, 95% confidence interval -2.2 to 4.6). Comparison of children randomised to folinic acid supplements or no folinic acid also showed no significant differences in Griffiths developmental quotient (mean 57.6 v 55.9; adjusted mean difference 1.7, -1.7 to 5.1). No between group differences were seen in the mean numbers of words said or signed: for antioxidants versus none the ratio of means was 0.85 (95% confidence interval 0.6 to 1.2), and for folinic acid versus none it was 1.24 (0.87 to 1.77). No significant differences were found between any of the groups in the biochemical outcomes measured. Adjustment for potential confounders did not appreciably change the results. CONCLUSIONS: This study provides no evidence to support the use of antioxidant or folinic acid supplements in children with Down's syndrome. TRIAL REGISTRATION: Clinical trials NCT00378456.

Inequalities in provision of the Disability Living Allowance for Down syndrome.

OBJECTIVES: To assess factors associated with granting of the Disability Living Allowance (DLA) for Down syndrome. DESIGN: Cross-sectional survey. SETTING: Families with a child with Down syndrome enrolled in a community-based trial of vitamin supplementation. PARTICIPANTS: 156 children with trisomy 21 (59% male, 20% non-white) were enrolled before 7 months of age and 138 completed follow-up. MAIN OUTCOME MEASURES: Before the child was 2 years old, we surveyed parents about applications for the DLA and socioeconomic factors, and assessed the child's development. RESULTS: Application for the DLA was not associated with ethnicity or speaking English. Significantly fewer ethnic minority parents (OR = 0.10; 95% CI 0.03 to 0.35; 69% vs 96%, risk difference 27%) and parents with English as a second language (OR = 0.15: 95% CI 0.04 to 0.62; 67% vs 93%, risk difference 26%) were granted the DLA. Amongst those granted the DLA, ethnic minority families were significantly less likely to be granted a higher monetary award (OR = 0.19; 95% CI 0.06 to 0.55). Severity of disability, reflected by quartile of Griffiths Developmental Quotient or the presence of severe cardiac disease requiring surgery, was not associated with application, granting or level of the DLA award. CONCLUSIONS: Although all children with Down syndrome meet some of the criteria for the DLA, only 80% were receiving this benefit. The decision to award the DLA and the monetary level of the award favoured white, English speaking parents and was not related to severity of disability. Routine monitoring of awards by ethnicity and language spoken is needed. TRIAL REGISTRATION NUMBER: NCT00378456.

Economic evaluation of a randomised controlled trial for anorexia nervosa in adolescents.

BACKGROUND: Young people with anorexia nervosa are often admitted to hospital for treatment. As well as being disruptive to school, family and social life, in-patient treatment is expensive, yet cost-effectiveness evidence is lacking. AIMS: Cost-effectiveness analysis of three treatment strategies for adolescents with anorexia nervosa. METHOD: UK multicentre randomised, controlled trial comparing in-patient psychiatric treatment, specialist out-patient treatment and general out-patient treatment. Outcomes and costs assessed at baseline, 1 and 2 years. RESULTS: There were 167 young people in the trial. There were no statistically significant differences in clinical outcome between the three groups at 2 years. The specialist out-patient group was less costly over the 2-year follow-up (mean total cost 26 738 UK pounds) than the in-patient (34 531 UK pounds) and general out-patient treatment (40 794 UK pounds) groups, but this result was not statistically significant. Exploration of the uncertainty associated with the costs and effects of the three treatments suggests that specialist out-patient treatment has the highest probability of being cost-effective. CONCLUSIONS: On the basis of cost-effectiveness, these results support the provision of specialist out-patient services for adolescents with anorexia nervosa.

Clinical effectiveness of treatments for anorexia nervosa in adolescents: randomised controlled trial.

BACKGROUND: Treatment guidelines identify few adequately powered trials to guide recommendations for anorexia nervosa. AIMS: To evaluate the effectiveness of three readily available National Health Service treatments for adolescents (aged 12-18 years) with anorexia nervosa. METHOD: Multicentre randomised controlled trial of 167 young people comparing in-patient, specialist out-patient and general child and adolescent mental health service (CAMHS) treatment. RESULTS: Each group made considerable progress at 1 year, with further improvement by 2 years. Full recovery rates were poor (33% at 2 years, 27% still with anorexia nervosa). Adherence to in-patient treatment was only 50%. Neither in-patient nor specialist out-patient therapy demonstrated advantages over general CAMHS treatment by intention to treat, although some CAMHS out-patients were subsequently admitted on clinical grounds. In-patient treatment (randomised or after out-patient transfer) predicted poor outcomes. CONCLUSIONS: First-line in-patient psychiatric treatment does not provide advantages over out-patient management. Out-patient treatment failures do very poorly on transfer to in-patient facilities.