A cross-sectional study of the association between physical activity and depressive symptoms among adolescents in southwest China stratified by parental absence: the mediating role of insomnia and the moderating role of resilience.

OBJECTIVES: This study explored the mechanisms by which physical activity was associated with depressive symptoms in multi-ethnic (Han, Yi and Tibetan) adolescents in southwest China. The mediating role of insomnia in the association of physical activity with depressive symptoms, the moderating role of resilience in this mediation model and the moderating role of parental absence in the moderated mediation model were also examined. DESIGN: A cross-sectional survey. SETTING: In southwest China (Sichuan Province and Tibet Autonomous Region). PARTICIPANTS: 3195 adolescents from a school-based survey conducted between April and October 2020. METHODS: There were 3143 valid samples in this study (47.2% males with mean age=12.88±1.68 years). Structural equation models were developed to estimate the direct and mediating effect, and the moderating effect. Multigroup comparison was performed to examine the differences and similarities of the moderated mediation model across three parental absence subgroups: (1) both parents present, (2) one parent absent and (3) both parents absent. RESULTS: As hypothesised, physical activity was significantly and positively associated with the reduction of depressive symptoms in adolescents. Insomnia partially mediated the effect of physical activity on depressive symptoms. In addition, resilience moderated the direct and indirect effects of physical activity (through insomnia) on depressive symptoms. Finally, the multigroup comparison indicated the moderating effect of parental absence on the moderated mediation model. CONCLUSIONS: Physical activity was associated with alleviating insomnia symptoms among adolescents, thus correlating with the improvement of their depressive symptoms. Resilience was associated with enhancing the beneficial effects of physical activity, further improving depressive symptoms among adolescents, especially those with both absent parents. It is evident that physical activity interventions should be further incorporated into public health programmes to foster the physical and mental health of left-behind adolescents in southwest China.

Preterm birth as a determinant of neurodevelopment and cognition in children (PRENCOG): protocol for an exposure-based cohort study in the UK.

INTRODUCTION: Preterm birth (PTB) is strongly associated with encephalopathy of prematurity (EoP) and neurocognitive impairment. The biological axes linking PTB with atypical brain development are uncertain. We aim to elucidate the roles of neuroendocrine stress activation and immune dysregulation in linking PTB with EoP. METHODS AND ANALYSIS: PRENCOG (PREterm birth as a determinant of Neurodevelopment and COGnition in children: mechanisms and causal evidence) is an exposure-based cohort study at the University of Edinburgh. Three hundred mother-infant dyads comprising 200 preterm births (gestational age, GA <32 weeks, exposed) and 100 term births (GA >37 weeks, non-exposed), will be recruited between January 2023 and December 2027. We will collect parental and infant medical, demographic, socioeconomic characteristics and biological data which include placental tissue, umbilical cord blood, maternal and infant hair, infant saliva, infant dried blood spots, faecal material, and structural and diffusion MRI. Infant biosamples will be collected between birth and 44 weeks GA.EoP will be characterised by MRI using morphometric similarity networks (MSNs), hierarchical complexity (HC) and magnetisation transfer saturation imaging (MTsat). We will conduct: first, multivariable regressions and statistical association assessments to test how PTB-associated risk factors (PTB-RFs) relate to MSNs, HC and or MTsat; second, structural equation modelling to investigate neuroendocrine stress activation and immune dysregulation as mediators of PTB-RFs on features of EoP. PTB-RF selection will be informed by the variables that predict real-world educational outcomes, ascertained by linking the UK National Neonatal Research Database with the National Pupil Database. ETHICS AND DISSEMINATION: A favourable ethical opinion has been given by the South East Scotland Research Ethics Committee 02 (23/SS/0067) and NHS Lothian Research and Development (2023/0150). Results will be reported to the Medical Research Council, in scientific media, via stakeholder partners and on a website in accessible language (https://www.ed.ac.uk/centre-reproductive-health/prencog).

Neurodiversity in the healthcare profession.

The term neurodiversity was coined in the 1990s to describe a diversity in thinking, learning, and processing the world around us, and is associated with strengths as well as challenges. Rates of diagnosis of neurodivergent conditions are rising rapidly amongst patients and healthcare professionals, largely due to a recent surge in awareness and understanding of neurodiverse conditions and more inclusive diagnostic criteria. Societal adaptation, however, has lagged, and likely explains some of the psychosocial comorbidities of neurodiversity, as individuals are forced to adapt their personality and how they display their emotions to fit societal norms. There remains a lack of awareness and understanding of neurodiversity amongst the healthcare professions. There is also very limited published literature on the challenges and strengths of this group in the clinical environment. Here, we use a case study, focusing on attention deficit hyperactivity disorder to explore the relationship between neurodiversity and work from the perspective of a neurodiverse health care professional. We challenge the notion that neurodiversity itself is a disability, but more likely a result of lack of societal awareness and adaption. We suggest accommodations and training in the clinical environment to raise awareness and support neurodiverse healthcare professionals in order that they flourish rather than struggle in the workplace.

Characteristics of effective parent-mediated interventions for parents of children with neurodevelopmental disorders in rural areas: a systematic review protocol.

INTRODUCTION: Parent-mediated interventions are therapeutic approaches that use parent training to enable parents to provide primary support and intervention to their child through the development of necessary skills, knowledge, and resources.Parent-mediated interventions can be broadly divided into two stages: (1) Clinicians educating, training and coaching parents in the implementation of an intervention and relevant information regarding their child's condition and (2) Parent(s) mediating and implementing the intervention based on the coaching and education received. These interventions can act as the primary intervention for children or supplement clinical interventions. This review will include both stages of the implementation process as well as both primary and supplementary interventions. Outcomes of parent-mediated interventions include long-term symptom reduction, improved prognosis for a wide range of behavioural and brain functions and enhanced parent-child dyadic social communication. METHODS AND ANALYSIS: This systematic review aims to synthesise existing evidence and identify the characteristics of effective parent-mediated intervention for parents of children with neurodevelopmental disorders residing in rural areas. Systematic searches of CINAHL, PsycINFO, ProQuest allied health and nursing database, Ebscohost Psych and Behavioural database and SocINDEX were conducted twice with the latest completed on 5 March 2024 using preidentified search terms. Citations will be imported into EndNote V.20.6 (Clarivate Analytics, Pennsylvania, USA) to organise and de-duplicate and then Covidence to complete screening and extraction. The articles will be screened and reviewed following the Joanna Briggs Institute (JBI) guidelines for systematic reviews of Mixed methods. The JBI appraisal tools for systematic reviews will be used to assess the trustworthiness, relevance and results of qualitative, quantitative and mixed-methods studies. The scope of the literature analysed will include articles published between 2013 and 2024 in English. Literature was limited to the last 10 years to ensure the relevance of results as the intention is to report on current evidence. The start date of the study was March 2023 and the planned completion date is October 2024. ETHICS AND DISSEMINATION: This study will neither involve human nor animal subjects and does not require ethics approval. Results will be disseminated to relevant groups in peer-reviewed journal(s) and at relevant children and parent health conferences or rural conferences. The key outcomes will also be shared on social media to support access for non-research audiences.

Barriers to and enablers of the transition from child and adolescent to adult mental health services for autistic young people and/or those with attention deficit hyperactivity disorder: protocol for a scoping review.

INTRODUCTION: Autistic young people and/or those with attention deficit hyperactivity disorder (ADHD) who have co-occurring mental health conditions experience significant challenges when transitioning from child and adolescent mental health services (CAMHS) to adult mental health services (AMHS). However, barriers and facilitators to this service transition are poorly understood for this population. This scoping review aims to synthesise the available evidence on barriers and enablers to the transition from CAMHS to AMHS for autistic young people and/or those with ADHD. METHODS AND ANALYSIS: Arksey and O'Malley's six-step framework for scoping reviews will be used. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist will guide the reporting of this review. Electronic databases of Medline, PsycINFO, CINAHL, Scopus, ProQuest Central and Google Scholar will be searched for relevant articles published in English with no date limitations. Title, abstract and full-text screening will be completed by two independent reviewers. Studies will be eligible for inclusion if the article focuses on (1) adolescents and/or young people (aged 18-24) with a primary diagnosis of autism spectrum disorder and/or ADHD (population) and (2) describes factors associated with service or care transitions (concept) (3) from CAMHS to AMHS (context). Study quality will be evaluated using the Standard Quality Assessment Criteria for Evaluating Primary Research Papers from a Variety of Fields. Data describing the factors that enable or inhibit the transition from CAMHS to AMHS will be extracted and synthesised using the Bronfenbrenner's social ecological model as a framework for organising and reporting results. ETHICS AND DISSEMINATION: Ethics approval is not required. Findings will be disseminated via peer-reviewed publications and presented at conferences. TRIAL REGISTRATION NUMBER: https://doi.org/10.17605/OSF.IO/BZPQF.

Professional perspectives on facilitators and barriers for high quality provision of health, education and social care services to disabled children in England during the COVID-19 pandemic: a qualitative study.

OBJECTIVES: To understand how health, education and social care services for disabled children changed during the COVID-19 pandemic, what did or did not work well and what the impacts of service changes were on both professionals and families. DESIGN: Qualitative study using semistructured interviews. SETTING: Telephone and video call interviews and focus groups with professionals working in one of five local authority areas in England. PARTICIPANTS: 78 health, education and social care professionals working with children in one of five local authority areas in England. RESULTS: There was a significant disruption to services and reduced contact with families during the early stages of the pandemic; nevertheless, professionals were able to reflect on innovative ways they interacted with and sought to support and maintain health, education and social care provision to disabled children and their families. As waitlists have substantially increased, this and the longevity of the pandemic were perceived to have had negative consequences for staff health and well-being, the health and psychosocial outcomes of children and young people, and their parent carers. CONCLUSIONS: Key learning from this study for service recovery and planning for future emergencies is the need to be able to identify disabled children, classify their level of need and risk, assess the impact of loss of services and maintain clear communication across services to meet the needs of disabled children. Finally, services need to work collaboratively with families to develop child-centred care to strengthen resilience during service disruption.

Exploring adults' recollections of growing up with childhood motor difficulties: a qualitative study using systematic text condensation.

OBJECTIVE: To explore the ramifications of childhood motor difficulties, providing insights into their impact and consequences over time. DESIGN: A qualitative study using semistructured individual interviews. Data were analysed using systematic text condensation. SETTING: Neonatal intensive care recipients born at Uppsala University Children's Hospital, Uppsala, Sweden, between 1986 and 1989, were enrolled in a longitudinal follow-up study and subsequently interviewed in 2019-2020. PARTICIPANTS: 13 individuals in their early 30s, who met the criteria for developmental coordination disorder or performed below the 5th percentile on motor tests at 6.5 years of age, were interviewed. Those with co-occurring deficits in attention or social behavioural at age 6.5 were excluded. RESULTS: Two themes emerged: (1) lifelong challenges and (2) navigating the journey of motor difficulties: support, awareness and confidence. Five participants reported persistent motor difficulties. They adapted and integrated these challenges into their daily lives without feeling constrained. Parental support was crucial to their success, whereas support from schools was limited. CONCLUSION: Adults who faced motor difficulties in childhood developed effective coping strategies, overcame challenges and now lead fulfilling lives. The findings stress the importance of parental support and understanding, addressing contextual factors and fostering positive attitudes and supportive environments to enhance well-being and participation.

Shared characteristics of intervention techniques for oral vocabulary and speech comprehensibility in preschool children with co-occurring features of developmental language disorder and speech sound disorder: a systematic review with narrative synthesis.

OBJECTIVES: To descriptively compare and contrast intervention techniques for preschool children with features of developmental language disorder (outcome: oral vocabulary) and speech sound disorder (outcome: speech comprehensibility) and analyse them in relation to effectiveness and theory. DESIGN: This is a systematic review with narrative synthesis. The process was supported by an expert steering group consisting of relevant professionals and people with lived experience. DATA SOURCES: Ovid Emcare, MEDLINE Complete, CINAHL, APA PsycINFO, ERIC, and Communication Source from January 2012 were searched. Relevant studies were obtained from an initial published review (up to January 2012). ELIGIBILITY CRITERIA: Interventions for preschool children (80% aged 2:0-5:11 years) with idiopathic speech or language needs; outcomes relating to either oral vocabulary or speech comprehensibility. DATA EXTRACTION AND SYNTHESIS: Searches were conducted on 27 January 2023. Two independent researchers screened at abstract and full-text levels. Data regarding intervention content (eg, techniques) and format/delivery (eg, dosage, location) were extracted. Data were synthesised narratively according to the methods of Campbell et al. RESULTS: 24 studies were included: 18 for oral vocabulary and 6 for speech comprehensibility. There were 11 randomised controlled trials, 2 cohort studies and 11 case series. Similarities included a focus on input-related techniques and similar therapy activities. Speech studies were more likely to be professional-led and clinic-led, rather than at home and through a parent. Analysis was restricted by heterogeneity in study design and terminology, as well as gaps within intervention reporting. Information deemed important to the expert steering group was missing. CONCLUSIONS: Similarities and differences between intervention techniques for oral vocabulary and speech comprehensibility have been identified and synthesised. However, analysis of effectiveness was limited due to issues with study design and heterogeneity within studies. This has implications for the progression of the evidence base within the field. PROSPERO REGISTRATION NUMBER: CRD42022373931.

Infant formula supplemented with milk fat globule membrane compared with standard infant formula for the cognitive development of healthy term-born formula-fed infants: protocol for a randomised controlled trial.

INTRODUCTION: Milk fat globule membrane (MFGM) is a complex lipid-protein structure in mammalian milk and human milk that is largely absent from breastmilk substitutes. The objective of this trial is to investigate whether providing infant formula enriched with MFGM versus standard infant formula improves cognitive development at 12 months of age in exclusively formula-fed full-term infants. METHODS AND ANALYSIS: This is a randomised, controlled, clinician-blinded, researcher-blinded and participant-blinded trial of two parallel formula-fed groups and a breastfed reference group that were recruited in the suburban Adelaide (Australia) community by a single study centre (a medical research institute). Healthy, exclusively formula-fed, singleton, term-born infants under 8 weeks of age were randomised to either an MFGM-supplemented formula (intervention) or standard infant formula (control) from enrolment until 12 months of age. The reference group was not provided with formula. The primary outcome is the Cognitive Scale of the Bayley Scales of Infant Development, Fourth Edition (Bayley-IV) at 12 months. Secondary outcomes are the Bayley-IV Cognitive Scale at 24 months, other Bayley-IV domains (language, motor, emotional and behavioural development) at 12 and 24 months of age, infant attention at 4 and 9 months of age, parent-rated language at 12 and 24 months of age, parent-rated development at 6 and 18 months of age as well as growth, tolerance and safety of the study formula. To ensure at least 80% power to detect a 5-point difference in the mean Bayley-IV cognitive score, >200 infants were recruited in each group. ETHICS AND DISSEMINATION: The Women's and Children Health Network Human Research Ethics Committee reviewed and approved the study (HREC/19/WCHN/140). Caregivers gave written informed consent prior to enrolling in the trial. Findings of this study will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12620000552987; Australian and New Zealand Clinical Trial Registry: anzctr.org.au.

Childhood neurodivergent traits, inflammation and chronic disabling fatigue in adolescence: a longitudinal case-control study.

OBJECTIVES: To test whether inflammatory processes link the expression of childhood neurodivergent traits to chronic disabling fatigue in adolescence. DESIGN: Longitudinal case-control study. SETTING: We analysed data from The Avon Longitudinal Study of Parents and Children (ALSPAC). PARTICIPANTS: 8115 and 8036 children of the ALSPAC cohort at ages 7 and 9 years, respectively, 4563 of whom also completed self-report measures at age 18 years. PRIMARY AND SECONDARY OUTCOME MEASURES: We assessed if children scoring above screening threshold for autism/attention deficit hyperactivity disorder (ADHD) at ages 7 and 9 years had increased risk of chronic disabling fatigue at age 18 years, computing ORs and CIs for effects using binary logistic regression. Mediation analyses were conducted to test if an inflammatory marker (interleukin 6 (IL-6)) at age 9 years linked neurodivergent traits to chronic disabling fatigue at age 18 years. RESULTS: Children with neurodivergent traits at ages 7 and 9 years were two times as likely to experience chronic disabling fatigue at age 18 years (likely ADHD OR=2.18 (95% CI=1.33 to 3.56); p=0.002; likely autism OR=1.78 (95% CI=1.17 to 2.72); p=0.004). Levels of IL-6 at age 9 were associated with chronic disabling fatigue at age 18 (OR=1.54 (95% CI=1.13 to 2.11); p=0.006). Inflammation at age 9 years mediated effects of neurodivergent traits on chronic disabling fatigue (indirect effect via IL-6: ADHD b=1.08 (95% CI=1.01 to 1.15); autism b=1.06; (95% CI=1.03 to 1.10)). All effects remained significant when controlling for the presence of depressive symptoms. CONCLUSIONS: Our results indicate higher risk of chronic disabling fatigue for children with neurodivergent traits, likely linked to higher levels of inflammation. The implementation of transdiagnostic screening criteria to inform support strategies to counteract risk early in life is recommended.

Associations of air pollution exposures in preconception and pregnancy with birth outcomes and infant neurocognitive development: analysis of the Complex Lipids in Mothers and Babies (CLIMB) prospective cohort in Chongqing, China.

OBJECTIVES: To investigate the associations of traffic-related air pollution exposures in early pregnancy with birth outcomes and infant neurocognitive development. DESIGN: Cohort study. SETTING: Eligible women attended six visits in the maternity clinics of two centres, the First Affiliated Hospital of Chongqing Medical University and Chongqing Health Centre for Women and Children. PARTICIPANTS: Women who were between 20 and 40 years of age and were at 11-14 weeks gestation with a singleton pregnancy were eligible for participation. Women were excluded if they had a history of premature delivery before 32 weeks of gestation, maternal milk allergy or aversion or severe lactose intolerance. 1273 pregnant women enrolled in 2015-2016 and 1174 live births were included in this analysis. EXPOSURES: Air pollution concentrations at their home addresses, including particulate matter with diameter ≤2.5 µm (PM2.5) and nitrogen dioxide (NO2), during pre-conception and each trimester period were estimated using land-use regression models. OUTCOME MEASURES: Birth outcomes (ie, birth weight, birth length, preterm birth, low birth weight, large for gestational age and small for gestational age (SGA) status) and neurodevelopment outcomes measured by the Chinese version of Bayley Scales of Infant Development. RESULTS: An association between SGA and per-IQR increases in NO2 was found in the first trimester (OR: 1.57, 95% CI: 1.06 to 2.32) and during the whole pregnancy (OR: 1.33, 99% CI: 1.01 to 1.75). Both PM2.5 and NO2 exposure in the 90 days prior to conception were associated with lower Psychomotor Development Index scores (ß: -6.15, 95% CI: -8.84 to -3.46; ß: -2.83, 95% CI: -4.27 to -1.39, respectively). Increased NO2 exposure was associated with an increased risk of psychomotor development delay during different trimesters of pregnancy. CONCLUSIONS: Increased exposures to NO2 during pregnancy were associated with increased risks of SGA and psychomotor development delay, while increased exposures to both PM2.5 and NO2 pre-conception were associated with adverse psychomotor development outcomes at 12 months of age. TRIAL REGISTRATION NUMBER: ChiCTR-IOR-16007700.

Prenatal and Postnatal Diagnosis and Genetic Background of Corpus Callosum Malformations and Neonatal Follow-Up.

INTRODUCTION: The corpus callosum is one of the five main cerebral commissures. It is key to combining sensory and motor functions. Its structure can be pathological (dysgenesis) or completely absent (agenesis). The corpus callosum dys- or agenesis is a rare disease (1:4000 live births), but it can have serious mental effects. METHODS: In our study, we processed the data of 64 pregnant women. They attended a prenatal diagnostic center and genetic counseling from 2005 to 2019 at the Department of Obstetrics and Gynecology at Semmelweis University. RESULTS: The pregnancies had the following outcomes: 52 ended in delivery, 1 in spontaneous abortion, and 11 in termination of pregnancy (TOP) cases (n = 64). The average time of detection with imaging tests was 25.24 gestational weeks. In 16 cases, prenatal magnetic resonance imaging (MRI) was performed. If the abnormality was detected before the 20th week, a genetic test was performed on an amniotic fluid sample obtained from a genetic amniocentesis. Karyotyping and cytogenetic tests were performed in 15 of the investigated cases. Karyotyping gave normal results in three cases (46,XX or XY). In one of these cases, postnatally chromosomal microarray (CMA) was later performed, which confirmed Aicardi syndrome (3q21.3-21.1 microdeletion). In one case, postnatally, the test found Wiedemann-Rautenstrauch syndrome. In other cases, it found X ring, Di George syndrome, 46,XY,del(13q)(q13q22) and 46,XX,del(5p)(p13) (Cri-du-chat syndrome). Edwards syndrome was diagnosed in six cases, and Patau syndrome in one case. CONCLUSIONS: We found that corpus callosum abnormalities are often linked to chromosomal problems. We recommend that a cytogenetic test be performed in all cases to rule out inherited diseases. Also, the long-term outcome does not just depend on the disease's severity and the associated other conditions, and hence proper follow-up and early development are also key. For this reason, close teamwork between neonatology, developmental neurology, and pediatric surgery is vital.

Realist process evaluation of occupational performance coaching: protocol.

INTRODUCTION: A cluster randomised controlled trial, the Meaning, Agency and Nurturing Autonomy (MANA) study, is underway comparing the effects of occupational performance coaching (OPC) and usual care on the social participation, health and well-being of children with neurodisability and their caregivers. This protocol presents the realist process evaluation which is occurring in parallel with the trial to allow testing and further refinement of OPC programme theory, as represented in its logic model. The aim of this realist evaluation is to examine what works, for whom, in the implementation of OPC with caregivers of children with neurodisability (in particular, Maori and Pasifika) in current service delivery contexts. METHODS AND ANALYSIS: Guided by OPC programme theory and realist evaluation processes, mixed-methods data collected from the MANA study OPC group will be analysed to elucidate when OPC works (outcomes), for whom, how (mechanisms) and under what circumstances (contexts). This will culminate in the synthesis of Intervention-Actor Context-Mechanism-Outcome configurations. Descriptive analyses will be reported for quantitative measures of treatment fidelity (OPC-Fidelity Measure), caregiver emotional response to OPC (Session Rating Scale) preintervention emotional state (Depression Stress and Anxiety Scale) and client outcomes (Canadian Occupational Performance Measure). Reflexive thematic analysis will be undertaken to analyse realist interviews with therapists who implemented OPC above and below fidelity thresholds and culturally focused interviews with clients of Maori or Pasifika ethnicity, informing understanding of the contexts influencing therapists' implementation of OPC with fidelity, and the mechanisms triggered within therapists or caregivers to elicit a response to the intervention. The MANA study trial outcomes will be reported separately. ETHICS AND DISSEMINATION: Ethical approval for this study was granted by the New Zealand Health and Disability Ethics Committee (20/STH/93). In all participating jurisdictions local area approval was obtained, involving a process of local Maori consultation. Results will be disseminated to all participants, and more broadly to clinicians and policy-makers through conference presentations and peer-reviewed journal publications, which will inform decision-making about resourcing and supporting effective delivery of OPC to optimise outcomes for children and caregivers. TRIAL REGISTRATION NUMBER: ACTRN12621000519853.

Shared symptomatology between atopic dermatitis, ADHD and autism spectrum disorder: a protocol for a systematic scoping review.

INTRODUCTION: Children with atopic dermatitis (AD) are more at risk for the neurodevelopmental disorders attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) with parallel increases in global prevalences. Children afflicted with these conditions appear to share similar problems in sensory modulation but investigational studies on the underlying aetiology are scarce. This scoping review aims to find knowledge gaps, collate hypotheses and to summarise available evidence on the shared pathophysiology of AD, ADHD and ASD in children. METHODS AND ANALYSIS: Our study will follow the methodological manual published by the Joanna Briggs Methodology for Scoping Reviews and will be reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses Extension for Scoping Reviews. The following electronic databases will be searched for studies focused on children with AD and symptoms of ADHD and/or ASD: Medline ALL via Ovid, Embase, Web of Science Core Collection and the Cochrane Central Register of Controlled Trials via Wiley. ETHICS AND DISSEMINATION: This review does not require ethics approval as it will not be conducted with human participants. We will only use published data. Our dissemination strategy includes peer review publication and conference reports.

Fetal alcohol spectrum disorder and attention deficit hyperactivity disorder stimulant trial in children: an N-of-1 pilot trial to compare stimulant to placebo (FASST): protocol.

INTRODUCTION: Fetal alcohol spectrum disorder (FASD) is a neurodevelopmental disorder caused by alcohol exposure during pregnancy. FASD is associated with neurodevelopmental deviations, and 50%-94% of children with FASD meet the Diagnostic and Statistical Manual of Mental Disorders-fifth edition diagnostic criteria for attention deficit hyperactivity disorder (ADHD). There is a paucity of evidence around medication efficacy for ADHD symptoms in children with FASD. This series of N-of-1 trials aims to provide pilot data on the feasibility of conducting N-of-1 trials in children with FASD and ADHD. METHODS AND ANALYSIS: A pilot N-of-1 randomised trial design with 20 cycles of stimulant and placebo (four cycles of 2-week duration) for each child will be conducted (n=20) in Melbourne, Australia.Feasibility and tolerability will be assessed using recruitment and retention rates, protocol adherence, adverse events and parent ratings of side effects. Each child's treatment effect will be determined by analysing teacher ADHD ratings across stimulant and placebo conditions (Wilcoxon rank). N-of-1 data will be aggregated to provide an estimate of the cohort treatment effect as well as individual-level treatment effects. We will assess the sample size and number of cycles required for a future trial. Potential mediating factors will be explored to identify variables that might be associated with treatment response variability. ETHICS AND DISSEMINATION: The study was approved by the Hospital and Health Service Human Research Ethics Committee (HREC/74678/MonH-2021-269029), Monash (protocol V6, 25 June 2023).Individual outcome data will be summarised and provided to participating carers and practitioners to enhance care. Group-level findings will be presented at a local workshop to engage stakeholders. Findings will be presented at national and international conferences and published in peer-reviewed journals. All results will be reported so that they can be used to inform prior information for future trials. TRIAL REGISTRATION NUMBER: NCT04968522.

The Pediatric Autism Research Cohort (PARC) Study: protocol for a patient-oriented prospective study examining trajectories of functioning in children with autism.

INTRODUCTION: The developmentally variable nature of autism poses challenges in providing timely services tailored to a child's needs. Despite a recent focus on longitudinal research, priority-setting initiatives with stakeholders highlighted the importance of studying a child's day-to-day functioning and social determinants of health to inform clinical care. To address this, we are conducting a pragmatic multi-site, patient-oriented longitudinal investigation: the Pediatric Autism Research Cohort (PARC) Study. In young children (<7 years of age) newly diagnosed with autism, we will: (1) examine variability in trajectories of adaptive functioning from the point of diagnosis into transition to school; and (2) identify factors associated with trajectories of adaptive functioning. METHODS AND ANALYSIS: We aim to recruit 1300 children under 7 years of age with a recent (within 12 months) diagnosis of autism from seven sites: six in Canada; one in Israel. Participants will be followed prospectively from diagnosis to age 8 years, with assessments at 6-month intervals. Parents/caregivers will complete questionnaires administered via a customized online research portal. Following each assessment timepoint, families will receive a research summary report describing their child's progress on adaptive functioning and related domains. Analysis of the longitudinal data will map trajectories and examine child, family and service characteristics associated with chronogeneity (interindividual and intraindividual heterogeneity over time) and possible trajectory turning points around sensitive periods like the transition to school. ETHICS AND DISSEMINATION: Ethics approvals have been received by all sites. All parents/respondents will provide informed consent when enrolling in the study. Using an integrated knowledge translation approach, where stakeholders are directly engaged in the research process, the PARC Study will identify factors associated with trajectories of functioning in children with autism. Resulting evidence will be shared with government policy makers to inform provincial and national programs. Findings will be disseminated at conferences and published in peer-reviewed journals.

Practices and outcomes of responsive caregiving on child neurodevelopment and mental health across diverse global populations: a scoping review protocol.

INTRODUCTION: Responsive caregiving (RC) leads to positive outcomes in children, including secure attachment with caregivers, emotional regulation, positive social interactions and cognitive development. Through our scoping review, we aim to summarise the practices and outcomes of RC in diverse caregiver and child populations from 0 to 8 years. METHODS AND ANALYSIS: We will use the Arksey and O'Malley framework and the Joanna Briggs Institute methodology for scoping reviews. We shall present our findings as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for scoping review. Only peer-reviewed, English-language articles from 1982 to 2022 will be included from PubMed, Web of Science, APA PsychInfo, APA PsycArticles, SocINDEX and Google Scholar databases. Reference lists of included articles will also be screened. The search strategy will be developed for each database, and search results will be imported into Rayyan. Screening will be done in two phases: (1) titles and abstracts will be screened by two authors and conflicts will be resolved by mutual discussion between both or by consulting with a senior author; and (2) full-texts of shortlisted studies from the first phase will then be screened using the same inclusion/exclusion criteria. A data extraction form will be developed to collate relevant information from the final list of included articles. This form will be pilot tested on the first 10 papers and iteratively refined prior to data extraction from the remaining articles. Results will be presented in figures, tables and a narrative summary. ETHICS AND DISSEMINATION: No ethics approval needed as the review shall only use already published data. We shall publish the review in an open-access, peer-reviewed journal and disseminate through newsletters, social media pages, and presentations to relevant audiences.

NeuroMotion smartphone application for remote General Movements Assessment: a feasibility study in Nepal.

OBJECTIVES: To evaluate the feasibility of using the NeuroMotion smartphone application for remote General Movements Assessment for screening infants for cerebral palsy in Kathmandu, Nepal. METHOD: Thirty-one term-born infants at risk of cerebral palsy due to birth asphyxia or neonatal seizures were recruited for the follow-up at Paropakar Maternity and Women's Hospital, 1 October 2021 to 7 January 2022. Parents filmed their children at home using the application at 3 months' age and the videos were assessed for technical quality using a standardised form and for fidgety movements by Prechtl's General Movements Assessment. The usability of the application was evaluated through a parental survey. RESULTS: Twenty families sent in altogether 46 videos out of which 35 had approved technical quality. Sixteen children had at least one video with approved technical quality. Three infants lacked fidgety movements. The level of agreement between assessors was acceptable (Krippendorf alpha 0.781). Parental answers to the usability survey were in general positive. INTERPRETATION: Engaging parents in screening of cerebral palsy with the help of a smartphone-aided remote General Movements Assessment is possible in the urban area of a South Asian lower middle-income country.

Evaluating the impact of movement tracking feedback on engagement with home exercise programmes of children with cerebral palsy using a new therapy app: a protocol for a mixed-methods single-case experimental design with alternating treatments.

INTRODUCTION: Children with cerebral palsy (CP) are prescribed home exercise programmes (HEPs) to increase the frequency of movement practice, yet adherence to HEPs can be low. This paper outlines the protocol for a single-case experimental design (SCED) with alternating treatments, using a new home therapy exercise application, Bootle Boot Camp (BBCamp), offered with and without movement tracking feedback. This study will explore the impact of feedback on engagement, movement quality, lower limb function and family experiences to help understand how technology-supported HEPs should be translated and the added value, if any, of movement tracking technology. METHODS AND ANALYSIS: In this explanatory sequential mixed-methods study using a SCED, 16 children with CP (aged 6-12 years, Gross Motor Function Classification System levels I-II) will set lower limb goals and be prescribed an individualised HEP by their physiotherapist to complete using BBCamp on their home television equipped with a three-dimensional camera-computer system. Children will complete four weekly exercise sessions over 6 weeks. Children will be randomised to 1 of 16 alternating treatment schedules where BBCamp will provide or withhold feedback during the first 4 weeks. The version of BBCamp that results in the most therapeutic benefit will be continued for 2 final weeks. Goals will be re-evaluated and families interviewed. The primary outcome is adherence (proportion of prescribed exercise repetitions attempted) as a measure of behavioural engagement. Secondary outcomes are affective and cognitive engagement (smiley face ratings), exercise fidelity, lower limb function, goal achievement and participant experiences. SCED data will be analysed using visual and statistical methods. Quantitative and qualitative data will be integrated using joint displays. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Research Ethics Boards at Bloorview Research Institute and the University of Toronto. Results will be distributed through peer-reviewed journals and scientific conferences. TRIAL REGISTRATION NUMBER: NCT05998239; pre-results.

Baby HABIT-ILE intervention: study protocol of a randomised controlled trial in infants aged 6-18 months with unilateral cerebral palsy.

INTRODUCTION: Research using animal models suggests that intensive motor skill training in infants under 2 years old with cerebral palsy (CP) may significantly reduce, or even prevent, maladaptive neuroplastic changes following brain injury. However, the effects of such interventions to tentatively prevent secondary neurological damages have never been assessed in infants with CP. This study aims to determine the effect of the baby Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (baby HABIT-ILE) in infants with unilateral CP, compared with a control intervention. METHODS AND ANALYSIS: This randomised controlled trial will include 48 infants with unilateral CP aged (corrected if preterm) 6-18 months at the first assessment. They will be paired by age and by aetiology of the CP, and randomised into two groups (immediate and delayed). Assessments will be performed at baseline and at 1 month, 3 months and 6 months after baseline. The immediate group will receive 50 hours of baby HABIT-ILE intervention over 2 weeks, between first and second assessment, while the delayed group will continue their usual activities. This last group will receive baby HABIT-ILE intervention after the 3-month assessment. Primary outcome will be the Mini-Assisting Hand Assessment. Secondary outcomes will include behavioural assessments for gross and fine motricity, visual-cognitive-language abilities as well as MRI and kinematics measures. Moreover, parents will determine and score child-relevant goals and fill out questionnaires of participation, daily activities and mobility. ETHICS AND DISSEMINATION: Full ethical approval has been obtained by the Comité d'éthique Hospitalo-Facultaire/Université catholique de Louvain, Brussels (2013/01MAR/069 B403201316810g). The recommendations of the ethical board and the Belgian law of 7 May 2004 concerning human experiments will be followed. Parents will sign a written informed consent ahead of participation. Findings will be published in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT04698395. Registered on the International Clinical Trials Registry Platform (ICTRP) on 2 December 2020 and NIH Clinical Trials Registry on 6 January 2021. URL of trial registry record: https://clinicaltrials.gov/ct2/show/NCT04698395?term=bleyenheuft&draw=1&rank=7.