Process evaluation of a Structured E-parenting Support (STEPS) in the OPTIMA randomised controlled trial: a protocol.

INTRODUCTION: Structured E-parenting Support (STEPS) is a digital application (app) designed to help parents manage behaviour of their children who are referred to mental health services and are waiting for an assessment or treatment. STEPS is currently being evaluated in the Online Parent Training for the Initial Management of Attention-Deficit/Hyperactivity Disorder randomised controlled trial. Alongside the examination of STEPS' clinical and cost-effectiveness, we are conducting a process evaluation to better understand the contextual factors that may influence study outcomes. The purpose of this protocol is to describe the aims, objectives and methodology of the process evaluation prior to it taking place to add to the fidelity and rigour of the trial process and outcomes. Our goal is to adapt STEPS to optimise its benefits in future applications. METHODS: In line with the Medical Research Council guidelines for evaluating complex interventions, the process evaluation will adopt a mixed method design using qualitative data collected from clinicians and parent interviews and app usage data from participants assigned to the intervention arm. ANALYSIS: Qualitative data from semistructured interviews and free text box responses included in trial questionnaires will be analysed thematically using framework analysis to better understand how parents use STEPS, how it works and key factors that could aid or hinder its effective implementation in routine clinical practice. ETHICS: The application for ethical approval for the study was submitted to the North West-Liverpool Central Research Ethics Committee and received a favourable opinion on further information on 26 November 2021, reference number 21/NW/0319. DISSEMINATION: The process evaluation aims to explore how a digital app might support parents in managing their child's behaviour. Implications for policy and research will be explored and the clinical implications of offering the app to a wider audience to address the lack of support to parents as highlighted in this paper. We plan to publish findings in international, peer-reviewed journals as well as present at conferences. TRIAL REGISTRATION NUMBER: The trial has been prospectively registered on 18 November 2021; ISRCTN816523503. https://www.isrctn.com/ISRCTN16523503.

Online remote behavioural intervention for tics in 9- to 17-year-olds: the ORBIT RCT with embedded process and economic evaluation.

Background: Behavioural therapy for tics is difficult to access, and little is known about its effectiveness when delivered online. Objective: To investigate the clinical and cost-effectiveness of an online-delivered, therapist- and parent-supported therapy for young people with tic disorders. Design: Single-blind, parallel-group, randomised controlled trial, with 3-month (primary end point) and 6-month post-randomisation follow-up. Participants were individually randomised (1 : 1), using on online system, with block randomisations, stratified by site. Naturalistic follow-up was conducted at 12 and 18 months post-randomisation when participants were free to access non-trial interventions. A subset of participants participated in a process evaluation. Setting: Two hospitals (London and Nottingham) in England also accepting referrals from patient identification centres and online self-referrals. Participants: Children aged 9-17 years (1) with Tourette syndrome or chronic tic disorder, (2) with a Yale Global Tic Severity Scale-total tic severity score of 15 or more (or > 10 with only motor or vocal tics) and (3) having not received behavioural therapy for tics in the past 12 months or started/stopped medication for tics within the past 2 months. Interventions: Either 10 weeks of online, remotely delivered, therapist-supported exposure and response prevention therapy (intervention group) or online psychoeducation (control). Outcome: Primary outcome: Yale Global Tic Severity Scale-total tic severity score 3 months post-randomisation; analysis done in all randomised patients for whom data were available. Secondary outcomes included low mood, anxiety, treatment satisfaction and health resource use. Quality-adjusted life-years are derived from parent-completed quality-of-life measures. All trial staff, statisticians and the chief investigator were masked to group allocation. Results: Two hundred and twenty-four participants were randomised to the intervention (n = 112) or control (n = 112) group. Participants were mostly male (n = 177; 79%), with a mean age of 12 years. At 3 months the estimated mean difference in Yale Global Tic Severity Scale-total tic severity score between the groups adjusted for baseline and site was -2.29 points (95% confidence interval -3.86 to -0.71) in favour of therapy (effect size -0.31, 95% confidence interval -0.52 to -0.10). This effect was sustained throughout to the final follow-up at 18 months (-2.01 points, 95% confidence interval -3.86 to -0.15; effect size -0.27, 95% confidence interval -0.52 to -0.02). At 18 months the mean incremental cost per participant of the intervention compared to the control was £662 (95% confidence interval -£59 to £1384), with a mean incremental quality-adjusted life-year of 0.040 (95% confidence interval -0.004 to 0.083) per participant. The mean incremental cost per quality-adjusted life-year gained was £16,708. The intervention was acceptable and delivered with high fidelity. Parental engagement predicted child engagement and more positive clinical outcomes. Harms: Two serious, unrelated adverse events occurred in the control group. Limitations: We cannot separate the effects of digital online delivery and the therapy itself. The sample was predominately white and British, limiting generalisability. The design did not compare to face-to-face services. Conclusion: Online, therapist-supported behavioural therapy for young people with tic disorders is clinically and cost-effective in reducing tics, with durable benefits extending up to 18 months. Future work: Future work should compare online to face-to-face therapy and explore how to embed the intervention in clinical practice. Trial registration: This trial is registered as ISRCTN70758207; ClinicalTrials.gov (NCT03483493). The trial is now complete. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Technology Assessment programme (project number 16/19/02) and will be published in full in Health and Technology Assessment; Vol. 27, No. 18. See the NIHR Journals Library website for further project information.

It can be difficult for children and young people with tics to access therapy. This is because there are not enough trained tic therapists. Online remote behavioural intervention for tics was a clinical trial to see whether an online platform that delivered two different types of interventions could help tics. One intervention focused on techniques to control tics; this type of therapy is called exposure and response prevention. The other intervention was psychoeducation, where participants learned about the nature of tics but not how to control them. The online remote behavioural intervention for tics interventions also involved help from a therapist and support from a parent. Participants were aged 9­17 years with Tourette syndrome/chronic tic disorder and were recruited from 16 clinics, two study sites (Nottingham and London) or via online self-referral. All individuals who were eligible for the online remote behavioural intervention for tics trial were randomised in a 50/50 split by researchers who were unaware of which treatment was being given. Participants received either 10 weeks of online exposure and response prevention or 10 weeks of online psychoeducation. A total of 224 children and young people participated: 112 allocated to exposure and response prevention and 112 to psychoeducation. Tics decreased more in the exposure and response prevention group (16% reduction) than in the psychoeducation group (6% reduction) 3 months after treatment. This difference is considered a clinically important difference in tic reduction. The treatment continued to have a positive effect on tic symptoms at 6, 12 and 18 months, showing that the effects are durable. This was achieved with minimal therapist involvement. The cost of online exposure and response prevention to treat young people with tics within this study was less when compared to the cost of face-to-face therapy. The results show that exposure and response prevention is an effective behavioural therapy for tics in this specific patient group. Delivering exposure and response prevention online with minimal therapist contact can be a successful and cost-effective treatment to improve access to behavioural therapy.

Remote Recruitment Strategy and Structured E-Parenting Support (STEPS) App: Feasibility and Usability Study.

BACKGROUND: The Structured E-Parenting Support (STEPS) app provides support for parents of children with elevated hyperactivity, impulsivity, inattention, and conduct problems who are awaiting clinical assessment. STEPS will be evaluated in a randomized controlled trial (RCT) within the Online Parent Training for the Initial Management of ADHD Referrals (OPTIMA) research program in the United Kingdom. Phase 1 of the OPTIMA tested the feasibility of participants' recruitment and the app's usability. OBJECTIVE: This study aimed to adapt a digital routine clinical monitoring system, myHealthE, for research purposes to facilitate waitlist recruitment; test using remote methods to screen and identify participants quickly and systematically; pilot the acceptability of the recruitment and assessment protocol; and explore the usability of STEPS. METHODS: myHealthE was adapted to screen patients' data. Parents' and clinicians' feedback on myHealthE was collected, and information governance reviews were conducted in clinical services planning to host the RCT. Potential participants for the observational feasibility study were identified from new referrals using myHealthE and non-myHealthE methods. Descriptive statistics were used to summarize the demographic and outcome variables. We estimated whether the recruitment rate would meet the planned RCT sample size requirement (n=352). In addition to the feasibility study participants, another group of parents was recruited to assess the STEPS usability. They completed the adapted System Usability Scale and responded to open-ended questions about the app, which were coded using the Enlight quality construct template. RESULTS: Overall, 124 potential participants were identified as eligible: 121 (97.6%) via myHealthE and 3 (2.4%) via non-myHealthE methods. In total, 107 parents were contacted, and 48 (44.9%) consented and were asked if, hypothetically, they would be willing to participate in the OPTIMA RCT. Of the 28 feasibility study participants who provided demographic data, 21 (75%) identified as White. Their children had an average age of 8.4 (SD 1.7) years and 65% (31/48) were male. During the primary recruitment period (June to July 2021) when 45 participants had consented, 38 (84%) participants agreed hypothetically to take part in the RCT (rate of 19/mo, 95% CI 13.5-26.1), meeting the stop-go criterion of 18 participants per month to proceed with the RCT. All parents were satisfied or very satisfied with the study procedures. Parents (n=12) recruited to assess STEPS' usability described it as easy to navigate and use and as having an attractive combination of colors and visual design. They described the content as useful, pitched at the right level, and sensitively presented. Suggested improvements included adding captions to videos or making the recorded reflections editable. CONCLUSIONS: Remote recruitment and study procedures for testing a parenting intervention app are feasible and acceptable for parents. The parents felt that STEPS was a useful and easy-to-use digital parenting support tool. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s40814-021-00959-0.

Development of cancer surveillance guidelines in ataxia telangiectasia: A Delphi-based consensus survey of international experts.

BACKGROUND/OBJECTIVES: Ataxia telangiectasia (A-T) is a multiorgan disorder with increased vulnerability to cancer. Despite this increased cancer risk, there are no widely accepted guidelines for cancer surveillance in people affected by A-T. We aimed to understand the current international practice regarding cancer surveillance in A-T and agreed-upon approaches to develop cancer surveillance in A-T. DESIGN/METHODS: We used a consensus development method, the e-Delphi technique, comprising three rounds. Round 1 consisted of a Delphi questionnaire and a survey that collected the details of respondents' professional background, experience, and current practice of cancer surveillance in A-T. Rounds 2 and 3 were designed based on previous rounds and modified according to the comments made by the panellists. The pre-specified consensus threshold was ≥75% agreement. RESULTS: Thirty-five expert panellists from 13 countries completed the study. The survey indicated that the current practice of cancer surveillance varies widely between experts and centres'. Consensus was reached that evidence-based guidelines are needed for cancer surveillance in people with A-T, with separate recommendations for adults and children. Statements relating to the tests that should be included, the age for starting and stopping cancer surveillance and the optimal surveillance interval were also agreed upon, although in some areas, the consensus was that further research is needed. CONCLUSION: The international expert consensus statement confirms the need for evidence-based cancer surveillance guidelines in A-T, highlights key features that the guidelines should include, and identifies areas of uncertainty in the expert community. This elucidates current knowledge gaps and will inform the design of future clinical trials.

Long-term clinical and cost-effectiveness of a therapist-supported online remote behavioural intervention for tics in children and adolescents: extended 12- and 18-month follow-up of a single-blind randomised controlled trial.

BACKGROUND: Little is known about the long-term effectiveness of behavioural therapy for tics. We aimed to assess the long-term clinical and cost-effectiveness of online therapist-supported exposure and response prevention (ERP) therapy for tics 12 and 18 months after treatment initiation. METHODS: ORBIT (online remote behavioural intervention for tics) was a two-arm (1:1 ratio), superiority, single-blind, multicentre randomised controlled trial comparing online ERP for tics with online psychoeducation. The trial was conducted across two Child and Adolescent Mental Health Services in England. Participants were recruited from these two sites, across other clinics in England, or by self-referral. This study was a naturalistic follow-up of participants at 12- and 18-month postrandomisation. Participants were permitted to use alternative treatments recommended by their clinician. The key outcome was the Yale Global Tic Severity Scale Total Tic Severity Score (YGTSS-TTSS). A full economic evaluation was conducted. Registrations are ISRCTN (ISRCTN70758207); ClinicalTrials.gov (NCT03483493). RESULTS: Two hundred and twenty-four participants were enrolled: 112 to ERP and 112 to psychoeducation. The sample was predominately male (177; 79%) and of white ethnicity (195; 87%). The ERP intervention reduced baseline YGTSS-TTSS by 2.64 points (95% CI: -4.48 to -0.79) with an effect size of -0.36 (95% CI: -0.61 to -0.11) after 12 months and by 2.01 points (95% CI: -3.86 to -0.15) with an effect size of -0.27 (95% CI -0.52 to -0.02) after 18 months, compared with psychoeducation. Very few participants (<10%) started new tic treatment during follow-up. The cost difference in ERP compared with psychoeducation was £304.94 (-139.41 to 749.29). At 18 months, the cost per QALY gained was £16,708 for ERP compared with psychoeducation. CONCLUSIONS: Remotely delivered online ERP is a clinical and cost-effective intervention with durable benefits extending for up to 18 months. This represents an efficient public mental health approach to increase access to behavioural therapy and improve outcomes for tics.

Online Parent Training for The Initial Management of ADHD referrals (OPTIMA): the protocol for a randomised controlled trial of a digital parenting intervention implemented to support parents and children on a treatment waitlist.

BACKGROUND: Children referred for attention-deficit/hyperactivity disorder (ADHD) often present with a broader pattern of conduct problems including oppositionality and defiance. This combination can be extremely stressful to parents, lower parents' self-esteem and negatively impact family life. The National Institute for Health and Care Excellence (NICE) recommends that families receive support as soon as possible after their referral. However, as clinical services are overstretched, and traditional in-person parenting intervention programmes are expensive, families often must wait times a long time prior to receiving this vital input. To address this, we have created a digital parenting programme called STEPS. It is delivered as a mobile phone app providing a set of tools and resources that can be easily accessed at parents' convenience. This study aims to evaluate the clinical and cost-effectiveness of STEPS in supporting parents of children with high levels of hyperactivity/impulsivity, inattention and conduct problems, who are waiting to be assessed by specialist children's clinical services. METHODS: Online Parent Training for The Initial Management of ADHD referrals (OPTIMA) is a two-arm superiority parallel randomised controlled trial with an internal pilot study. We aim to recruit 352 parents and their children, who have been accepted onto a waitlist in Child and Adolescent Mental Health Services or similar child health services. Parents who consent will be randomised 1:1 to either the STEPS or wait-as-usual (WAU) group. The trial will be conducted remotely (online and telephone) with measures taken at baseline and 3, 6, 9 and 12 months post-randomisation. The primary objective is to evaluate whether STEPS reduces the severity of children's oppositional and defiant behaviour, as rated by parents, measured at 3 months post-randomisation compared to WAU. DISCUSSION: Digital solutions, such as mobile phone apps, have potential for delivering psychological support for parents of children with clinical-level needs in a timely and inexpensive manner. This trial will provide data on the clinical and cost-effectiveness of the STEPS app, which could support the implementation of this scalable parenting intervention programme into standard clinical care and, ultimately, improve the outcomes for families of children referred to specialist child and adolescent health services. TRIAL REGISTRATION: ISRCTN 16523503. Prospectively registered on 18 November 2021. https://www.isrctn.com/ISRCTN16523503.

The feasibility of a strategy for the remote recruitment, consenting and assessment of recent referrals: a protocol for phase 1 of the On-Line Parent Training for the Initial Management of ADHD referrals (OPTIMA).

BACKGROUND: In the UK, children with high levels of hyperactivity, impulsivity and inattention referred to clinical services with possible attention-deficit/hyperactivity disorder (ADHD) often wait a long time for specialist diagnostic assessment. Parent training (PT) has the potential to support parents during this difficult period, especially regarding the management of challenging and disruptive behaviours that often accompany ADHD. However, traditional face-to-face PT is costly and difficult to organise in a timely way. We have created a low-cost, easily accessible PT programme delivered via a phone app, Structured E-Parenting Support (STEPS), to address this problem. The overall OPTIMA programme will evaluate the efficacy and cost-effectiveness of STEPS as a way of helping parents manage their children behaviour while on the waitlist. To ensure the timely and efficient evaluation of STEPS in OPTIMA, we have worked with children's health services to implement a remote strategy for recruitment, screening and assessment of recently referred families. Part of this strategy is incorporated into routine clinical practice and part is OPTIMA specific. Here, we present the protocol for Phase 1 of OPTIMA-a study of the feasibility of this remote strategy, as a basis for a large-scale STEPS randomised controlled trial (RCT). METHODS: This is a single arm observational feasibility study. Participants will be parents of up to 100 children aged 5-11 years with high levels of hyperactivity/impulsivity, inattention and challenging behaviour who are waiting for assessment in one of five UK child and adolescent mental health or behavioural services. Recruitment, consenting and data collection will occur remotely. The primary outcome will be the rate at which the families, who meet inclusion criteria, agree in principle to take part in a full STEPS RCT. Secondary outcomes include acceptability of remote consenting and online data collection procedures; the feasibility of collecting teacher data remotely within the required timeframe, and technical difficulties with completing online questionnaires. All parents in the study will receive access to STEPS. DISCUSSION: Establishing the feasibility of our remote recruitment, consenting and assessment strategy is a pre-requisite for the full trial of OPTIMA. It can also provide a model for future trials conducted remotely.

Therapist-supported online remote behavioural intervention for tics in children and adolescents in England (ORBIT): a multicentre, parallel group, single-blind, randomised controlled trial.

BACKGROUND: Exposure and Response Prevention (ERP) is a form of behavioural therapy for tics; however, its effectiveness remains uncertain. We aimed to evaluate the effectiveness of internet-delivered, therapist-supported, and parent-assisted ERP for treatment of tics in children and young people with Tourette syndrome or chronic tic disorder. METHODS: This multicentre, parallel group, single-blind, randomised controlled trial was conducted across two study sites in England. Participants were recruited via 16 patient identification centres, two study sites in England (Nottingham and London), or online self-referral. Eligible participants were aged 9-17 years, had Tourette syndrome or chronic tic disorder, had not received behavioural therapy for tics in the past 12 months or were about to start, and had a Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS) of more than 15 or more than 10 if they had only motor or vocal tics. Patients were excluded if they had started or stopped medication for tics within the past 2 months; had current alcohol or substance dependence, psychosis, suicidality, anorexia nervosa, or suspected moderate to severe intellectual disability; or presented an immediate risk to self or others; or the parent or carer was unable to speak, read, or write in English. Eligible patients were randomly assigned (1:1) by masked outcome assessors to receive 10 weeks of online, remotely delivered, therapist-supported ERP or psychoeducation (active control). Outcome assessors, statisticians, health economists, the trial manager, and the chief investigator were masked to group allocation. Patients were not directly informed of their allocation, but this could be established from the content once treatment commenced and the patients were not, therefore, considered masked to treatment. The primary outcome was YGTSS-TTSS 3 months after randomisation, and analysis was done in all randomised patients for whom data were available for each timepoint and outcome. Safety analysis was by intention to treat. Longer term follow-up is ongoing. This trial is registered with ISRCTN (ISRCTN70758207) and ClinicalTrials.gov (NCT03483493). FINDINGS: Between May 8, 2018, and Sept 30, 2019, we assessed 445 candidates for inclusion in the study. 221 potential participants were excluded (90 did not meet inclusion criteria, 84 declined to participate, and 47 unable to contact family). 224 participants were enrolled and randomly assigned to ERP (n=112) or psychoeducation (n=112). The enrolled patients were mostly male (n=177; 79%) and of White ethnicity (n=195; 87%). 11 patients were lost to follow-up 3 months after randomisation in the ERP group, compared with 12 patients in the psychoeducation group. Mean YGTSS-TTSS at 3 months after randomisation was 23·9 (SD 8·2) in the ERP group and 26·8 (7·3) in the psychoeducation group. The mean total decrease in YGTSS-TTSS at 3 months was 4·5 (16%, SD 1·1) in the ERP group versus 1·6 (6%, 1·0) in the psychoeducation group. The estimated mean difference in YGTSS-TTSS change between the groups adjusted for baseline and site was -2·29 points (95% CI -3·86 to -0·71) in favour of ERP, with an effect size of -0·31 (95% CI -0·52 to -0·10). Two serious adverse events occurred (one collapse and one tic attack), both in the psychoeducation group, neither of which were related to study treatment. INTERPRETATION: ERP is an effective behavioural therapy for tics. Remotely delivered, online ERP with minimal therapist contact time represents an efficient public mental health approach to improve access to behavioural therapy for tics in children and adolescents. FUNDING: National Institute for Health Research and Health and Technology Assessment.

Investigating a therapist-guided, parent-assisted remote digital behavioural intervention for tics in children and adolescents-'Online Remote Behavioural Intervention for Tics' (ORBIT) trial: protocol of an internal pilot study and single-blind randomised controlled trial.

INTRODUCTION: Tourette syndrome and chronic tic disorder are common, disabling childhood-onset conditions. Guidelines recommend that behavioural therapy should be offered as first-line treatment for children with tics. However, there are very few trained behaviour therapists for tics and many patients cannot access appropriate care. This trial investigates whether an internet-delivered intervention for tics can reduce severity of symptoms. METHODS AND ANALYSIS: This parallel-group, single-blind, randomised controlled superiority trial with an internal pilot will recruit children and young people (aged 9-17 years) with tic disorders. Participants will be randomised to receive 10 weeks of either online, remotely delivered, therapist-supported exposure response prevention behavioural therapy for tics, or online, remotely delivered, therapist-supported education about tics and co-occurring conditions. Participants will be followed up mid-treatment, and 3, 6, 12 and 18 months post randomisation.The primary outcome is reduction in tic severity as measured on the Yale Global Tic Severity Scale total tic severity score. Secondary outcomes include a cost-effectiveness analysis and estimate of the longer-term impact on patient outcomes and healthcare services. An integrated process evaluation will analyse quantitative and qualitative data in order to fully explore the implementation of the intervention and identify barriers and facilitators to implementation. The trial is funded by the National Institute of Health Research (NIHR), Health Technology Assessment (16/19/02). ETHICS AND DISSEMINATION: The findings from the study will inform clinicians, healthcare providers and policy makers about the clinical and cost-effectiveness of an internet delivered treatment for children and young people with tics. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval from North West Greater Manchester Research Ethics Committee (ref.: 18/NW/0079). TRIAL REGISTRATION NUMBERS: ISRCTN70758207 and NCT03483493; Pre-results.

Practitioner Review: Treatments for Tourette syndrome in children and young people - a systematic review.

BACKGROUND: Tourette syndrome (TS) and chronic tic disorder (CTD) affect 1-2% of children and young people, but the most effective treatment is unclear. To establish the current evidence base, we conducted a systematic review of interventions for children and young people. METHODS: Databases were searched from inception to 1 October 2014 for placebo-controlled trials of pharmacological, behavioural, physical or alternative interventions for tics in children and young people with TS or CTD. Certainty in the evidence was assessed with the GRADE approach. RESULTS: Forty trials were included [pharmacological (32), behavioural (5), physical (2), dietary (1)]. For tics/global score there was evidence favouring the intervention from four trials of α2-adrenergic receptor agonists [clonidine and guanfacine, standardised mean difference (SMD) = -0.71; 95% CI -1.03, -0.40; N = 164] and two trials of habit reversal training (HRT)/comprehensive behavioural intervention (CBIT) (SMD = -0.64; 95% CI -0.99, -0.29; N = 133). Certainty in the effect estimates was moderate. A post hoc analysis combining oral clonidine/guanfacine trials with a clonidine patch trial continued to demonstrate benefit (SMD = -0.54; 95% CI -0.92, -0.16), but statistical heterogeneity was high. Evidence from four trials suggested that antipsychotic drugs improved tic scores (SMD = -0.74; 95% CI -1.08, -0.40; N = 76), but certainty in the effect estimate was low. The evidence for other interventions was categorised as low or very low quality, or showed no conclusive benefit. CONCLUSIONS: When medication is considered appropriate for the treatment of tics, the balance of clinical benefits to harm favours α2-adrenergic receptor agonists (clonidine and guanfacine) as first-line agents. Antipsychotics are likely to be useful but carry the risk of harm and so should be reserved for when α2-adrenergic receptor agonists are either ineffective or poorly tolerated. There is evidence that HRT/CBIT is effective, but there is no evidence for HRT/CBIT alone relative to combining medication and HRT/CBIT. There is currently no evidence to suggest that the physical and dietary interventions reviewed are sufficiently effective and safe to be considered as treatments.

Systematic review and meta-analyses of risk factors for childhood overweight identifiable during infancy.

OBJECTIVE: To determine risk factors for childhood overweight that can be identified during the first year of life to facilitate early identification and targeted intervention. DESIGN: Systematic review and meta-analysis. SEARCH STRATEGY: Electronic database search of MEDLINE, EMBASE, PubMed and CAB Abstracts. ELIGIBILITY CRITERIA: Prospective observational studies following up children from birth for at least 2 years. RESULTS: Thirty prospective studies were identified. Significant and strong independent associations with childhood overweight were identified for maternal pre-pregnancy overweight, high infant birth weight and rapid weight gain during the first year of life. Meta-analysis comparing breastfed with non-breastfed infants found a 15% decrease (95% CI 0.74 to 0.99; I(2)=73.3%; n=10) in the odds of childhood overweight. For children of mothers smoking during pregnancy there was a 47% increase (95% CI 1.26 to 1.73; I(2)=47.5%; n=7) in the odds of childhood overweight. There was some evidence associating early introduction of solid foods and childhood overweight. There was conflicting evidence for duration of breastfeeding, socioeconomic status at birth, parity and maternal marital status at birth. No association with childhood overweight was found for maternal age or education at birth, maternal depression or infant ethnicity. There was inconclusive evidence for delivery type, gestational weight gain, maternal postpartum weight loss and 'fussy' infant temperament due to the limited number of studies. CONCLUSIONS: Several risk factors for both overweight and obesity in childhood are identifiable during infancy. Future research needs to focus on whether it is clinically feasible for healthcare professionals to identify infants at greatest risk.

The association between substance misuse and first-episode psychosis in a defined UK geographical area during the 1990s.

OBJECTIVE: The aim of this study was to examine the prevalence of all substance use disorders (SUD) and cannabis-specific SUDs reported in two first-episode epidemiological studies, conducted in the same catchment area, 5 years apart. METHODS: The prevalence of schizophrenia in Nottingham and Aetiology and Ethnicity of Schizophrenia and Other Psychoses studies included all people with a first-episode of psychosis between 1992 and 1994 and 1997 and 1999, respectively. Those individuals with a comorbid diagnosis of a SUD (ICD-10 harmful use or dependence) were identified. RESULTS: An upward (but not statistically significant) trend in all SUDs was found for the first-episode study population as a whole, between the two cohorts (11.9-18.2%). When analysed by age, a significant increase in cannabis-specific SUDs was observed for all first-episode cases aged 16-29 between cohorts (3.2-10.6%). When analysed by age and gender, a significant increase in all SUDs was apparent for female first-episode patients aged 16-29 between cohorts (6.1-24.2%), this same increase was not seen in male patients. CONCLUSIONS: Illegal drug misuse is common in patients with a first-episode of psychosis. However, most concerning is that when both age and gender are considered, females with a first-episode of psychosis aged 16-29 show a highly significant rise in the prevalence of all SUDs over the 1990s. More recent drug use data from England and Wales shows that the prevalence of drug use in the 21st century is declining; further epidemiological studies are required to determine whether this is also the case in young female first-episode psychosis populations.

Pregnant women's attitudes towards alcohol consumption.

BACKGROUND: There is uncertainty as to whether there is a safe threshold for drinking alcohol during pregnancy. We explored pregnant women's attitudes towards drinking alcohol in pregnancy and their attitudes towards sources of information about drinking in pregnancy following recent changes in UK government guidance. METHODS: A qualitative study involving individual, semi-structured interviews with 20 pregnant women recruited from community organisations in the UK. Interview transcripts were analysed qualitatively using thematic analysis. RESULTS: Most women found information and advice about safe levels of drinking in pregnancy confusing and lacking in evidence and detail. Although most women considered that there were risks involved with drinking in pregnancy and these perceptions influenced their behaviour, only six women reported abstinence. Women reported being influenced by advice from family and friends and their experiences of previous pregnancies. Many had received no individual advice from general practitioners or midwives relating to drinking during pregnancy. CONCLUSION: Pregnant women wished to take responsibility for their own health and make choices based on informed advice. In order to do so, they require clear and consistent advice about safe levels of drinking from policy makers and health professionals. This is an important issue as women might drink socially during their pregnancy.

International schizophrenia research and the concept of patient-centredness: an analysis over two decades.

BACKGROUND: Patient-centred medicine improves psychological and physiological functioning in chronic illnesses. AIMS: To determine to what extent the patient-centred ethos (as exemplified by research addressing subjective experiences) was incorporated into work presented at major international schizophrenia research forums between 1988 and 2004. METHOD: Whole population-based, retrospective cohort study using abstracts from the International Congress on Schizophrenia Research and the Biennial Winter Workshop on Schizophrenia (n = 9,284). Comparative analysis using abstracts from the International Society for the Psychological Treatment of Schizophrenia (n = 992). Patient-centredness was assessed by determining the number of abstracts that primarily addressed participants' subjective experiences. RESULTS: Research was presented from 50 countries globally. European and North American countries produced 8,573 (92%) of the total. Biological research was the main theme of 6,960 (75%) of the abstracts, with psychosocial research constituting less than 5%. One hundred and eighty three (2%) abstracts from the two main conferences addressed subjective experiences, as did 333 (34%) from the comparative analysis. CONCLUSIONS: Between 1988 and 2004 research emanating from North American and European countries, together with biologically orientated research, were the most prevalent perspectives on schizophrenia. It appears that research into the subjective experiences of participants has not been as prevalent as more objective accounts of the disorder, suggesting that this research effort has not been patient-centred.

Mental health and disclosure of HIV status in Zambian adolescents with HIV infection: implications for peer-support programs.

OBJECTIVES: To examine emotional and behavioural difficulties in HIV positive Zambian adolescents and to determine the relationship between disclosure of HIV status and mental health. DESIGN: A cross-sectional survey. METHODS: Participants were 127 HIV positive adolescents aged 11 to 15 years recruited through clinics in the Lusaka region. Mental health was assessed using the youth report version of the Strengths and Difficulties Questionnaire (SDQ). Caregivers completed the parent SDQ. Sixty-two participants were invited for a semi-structured interview which probed views on attending a peer support group. RESULTS: Compared to a British community sample participants had increased mental health problems (OR, 2.1), particularly emotional symptoms (OR = 3.6) and peer problems (OR = 7.1). The majority of children (n = 94) were receiving antiretroviral (ARV) treatment, but only 48 children (37.8%) had their HIV status disclosed. Those who had not had their HIV status disclosed were younger (P < 0.001) and less likely to be receiving ARV treatment (P < 0.001). Controlling for these factors they were also more likely to score in the abnormal range of the emotional difficulties subscale (OR = 2.63, 95% CI: 1.11 to 6.26). Of 38 interviews transcribed, content analysis showed that only 3 children were opposed to participation in a peer-group program, with the majority (23/38) expressing reasoned and positive responses, regardless of disclosure status. CONCLUSION: High rates of emotional and peer problems were found in this sample but disclosure of HIV status did not have a negative effect on mental health. Interventions to promote disclosure could facilitate access to emotional and peer support.

Asthma as a barrier to children's physical activity: implications for body mass index and mental health.

OBJECTIVES: The purpose of this work was to identify barriers to physical activity in children with asthma and to compare their customary activity levels, BMI and emotional well-being with that of children with other medical conditions. It was hypothesized that children with asthma would have higher BMI and lower levels of customary activity. PATIENTS AND METHODS: We studied children aged 7 to 14 years attending hospital outpatient clinics for either asthma (asthma group: n = 56) or for otorhinolaryngology or dermatological conditions (nonasthma group: n = 61). In this cross-sectional survey, children's weight and height were recorded and their BMI classified according to International Obesity Task Force classification of obesity. Child mental health was assessed by the parent-rated Strengths and Difficulties Questionnaire. The child-rated Physical Activity Questionnaire assessed total sedentary and physical activities during the previous 24 hours. RESULTS: The asthma group had a higher mean BMI (20.78 vs 18.82) and higher rates of obesity (21.4% vs 6.6%). Children with asthma reported fewer physical activities than the nonasthma group (median 4 per day vs 6 per day) but comparable levels of sedentary activities. Asthma was the strongest predictor of lower activity scores, followed by younger age. The asthma group had higher levels of emotional difficulties and, within this group, more active children had better mental health. More parents in the asthma group identified the child's health as a barrier to exercise (60.7% vs 11%). The same was true of children (66.1% vs 11.5%). CONCLUSIONS: We found that children attending a hospital clinic for asthma were more likely to be obese and were significantly less active than a comparison group with other medical conditions. Asthma was identified as a barrier to exercise by parents and children. Strategies to promote exercise within pediatric asthma care are needed to protect both mental and physical health.

A randomized, controlled trial of an interactive educational computer package for children with asthma.

OBJECTIVE: The purpose of this study was to evaluate the impact and acceptability of an educational multimedia program designed to promote self-management skills in children with asthma. METHODS: We conducted a randomized, controlled trial with measures at baseline and 1- and 6-month follow-up. The trial was conducted in pediatric outpatient respiratory clinics in 3 United Kingdom hospitals. Participants included 101 children aged 7 to 14 years under the care of hospital-based asthma services. The children were randomly assigned to receive an asthma information booklet alone or the booklet plus The Asthma Files, an interactive CD-ROM for children with asthma. Asthma knowledge was the primary outcome measure. Other measures included asthma locus of control, lung function, use of oral steroids, and school absence. RESULTS: At the 1-month follow-up (n = 99), children in the computer group had improved knowledge compared with the control group and a more internal locus of control. There were no differences in objective lung-function measures, hospitalizations, or oral steroid use. The study participants were positive in their evaluation of the intervention. At the 6-month follow-up (n = 90), significantly fewer children in the intervention group had required oral steroids and had had time off school for asthma in the previous 6 months. The difference did not reach statistical significance in the intention-to-treat analysis for both steroid use and school absence. CONCLUSION: The Asthma Files was found to be an effective and popular health education tool for promoting asthma self-management skills within pediatric care.

Impact of a multimedia intervention "Skinsafe" on patients' knowledge and protective behaviors.

BACKGROUND: Rates of malignant melanoma are rising, with those people with sun-sensitive skin most at risk. Health education interventions are needed to help people protect themselves by detecting early signs of melanoma and by protecting their skin from sunburn. This study aimed to evaluate the impact of an interactive multimedia intervention "Skinsafe" on patients' knowledge about melanoma and on their skin protective behaviors. METHODS: In this cluster-randomized, controlled trial conducted in Nottinghamshire, UK, doctors and nurses in 5 family practices prescribed Skinsafe to patients with higher risk skin characteristics. Measures of melanoma knowledge, perceived risk of melanoma and reported skin protective behaviors were obtained at baseline and at 6-month follow-up from 259 patients receiving the intervention and 330 patients with higher risk skin characteristics in 5 matched control practices. RESULTS AND DISCUSSION: Participants had low levels of melanoma knowledge at baseline. At follow-up, the intervention group had higher knowledge scores than control (3.71 vs. 3.03, P < or = 0.001), reported more protective skin behaviors (5.36 vs. 5.06, P = 0.007) and were more likely to report mole checking (odds ratio 1.67, 95% CI 1.04 to 2.70, P = 0.035). The Skinsafe intervention was evaluated positively by patients and could be used to support melanoma health education within clinical settings.

Educational interventions--computers for delivering education to children with respiratory illness and to their parents.

Educational interventions for children with asthma can result in both clinical and psychological improvements. However, traditional education programs have been hampered by lack of resources and doubts concerning long-term benefits. Researchers have looked to computer technology to overcome some of these obstacles and respiratory conditions have been the focus for a number of educational computer programs. Computer education packages should have a robust theoretical basis. Many programs aim to improve children's confidence, self-esteem and feelings of control, all of which are linked to compliance and positive health behaviours. The specific skills and knowledge needed for effective self-management also need to be taught in order to equip the child for future independent self-care. Programs tend to be either a stand-alone game, promoting self-regulation and practicing of skills, or an internet-enabled package, which may provide a link to their healthcare provider and/or other people with a similar condition. Computer technology is flexible, can be tailored to individuals' information needs, provides ongoing educational support and promotes active learning. However, there can be problems around accessibility, both in terms of computer ownership and technological literacy. Furthermore, internet sites are largely unregulated and of variable quality. It is essential that educational computer interventions are evidence-based and rigorously evaluated to identify who will benefit most from these packages.