BACKGROUND:Providing accessible CBT for young children identified as at risk for anxiety disorders through screening in schools could reduce later problems. This study aimed to evaluate the effectiveness of parent-led CBT delivered via online and telephone call support alongside usual school provision, compared to usual school provision only for young children identified through screening as having at least one risk. METHODS:We conducted a pragmatic, parallel group, superiority cluster randomised controlled trial in 95 primary/infant schools in England. Parents of children (aged 4-7) in sampled classes completed screening, and children who screened positive for one or more risks (anxiety symptoms/inhibition/parent anxiety) were eligible for the trial. Schools (clusters) were randomised (1:1) to intervention or usual school practice, stratified by school-level deprivation. Schools in both arms continued with usual provision, and parents in intervention schools were offered parent-led CBT via online and telephone support. The primary outcome was the presence of an anxiety disorder diagnosis at 12 months, assessed via the ADIS-P administered by independent assessors. Secondary clinical outcomes included parent-reported child anxiety symptoms, related interference, externalising symptoms, additional risks and intervention targets at 12 weeks and 12 months. Primary analyses were conducted on the full intention-to-treat population. The trial was prospectively registered with ISRCTN 82398107. RESULTS:In total, 2,328 children were screened; 1,172 were eligible; 865 enrolled. Forty-eight schools (434 children) were assigned to intervention and 47 schools (431 children) to usual school practice. At 12 months, the overall frequency of anxiety disorders was low, 6.8% (21/310) of children in the intervention arm compared to 11.5% (36/312) in the usual school practice arm; this difference was not statistically significant (adjusted odds ratio 0.67 [0.37 to 1.21], p = .19). However, the intervention was superior to usual school practice across all secondary outcomes (standardised mean difference: 0.15 to 0.47 at 12 weeks; 0.19 to 0.41 at 12 months). No serious adverse events were reported. CONCLUSIONS:Although the intervention did not significantly reduce anxiety disorders at 12 months, improvements across all other assessed outcomes indicate this approach brings wider immediate benefits and reduces known risks for future anxiety disorders. Future research needs to consider longer-term preventative effects.

BACKGROUND:Screening for anxiety problems in primary schools and offering parent-led cognitive behavioural therapy (CBT) via online and telephone support for those who screen positive could address key barriers to effective early intervention for some of the most prevalent child mental disorders. We aimed to evaluate outcomes from a screening-to-intervention pathway for child anxiety problems alongside usual school provision compared with assessment and usual school provision only. METHODS:iCATSi2i was a pragmatic, parallel-group, superiority, cluster-randomised, controlled trial in 84 primary and junior schools in England with at least two year-4 classes. Children aged 8-9 years in participating classes who were not opted out by their parent were eligible to participate. After baseline assessments, schools (clusters) were randomly assigned (1:1) to screening, feedback, and intervention, alongside usual school practice (intervention group) or assessment and usual school practice only (control group), stratified by school-level deprivation. Before allocation, schools were ordered by the number of children who screened positive for anxiety problems at baseline (target population). Block randomisation was used with block sizes of two and four. Trial statisticians were masked to group allocation until datasets were ready for final analysis. In schools in the intervention group all parents in sampled classes were invited to complete a two-item screening questionnaire (iCATS-2) at baseline and received feedback on the screening outcome (after randomisation); parents of children who screened positive for anxiety problems (target population) were offered parent-led CBT delivered via online and telephone support, using the Online Support and Intervention for Child Anxiety (OSI) platform (and this was available for other families on request); a single whole-class session on identifying and managing fears and worries was also provided. In both groups, assessments (including the screening questionnaire) were completed and schools continued with usual provision. The primary outcome was screen-negative for anxiety problems (score 0-2 on the parent-reported iCATS-2) versus screen-positive (score 3-6) in the target population at 12 months. Primary analyses were conducted in the intention-to-treat population, with missing data imputed. Adverse events were monitored and recorded throughout. The trial was registered with the ISRCTN registry, ISRCTN76119074, and the study is complete. The study management group included individuals with relevant lived experience. FINDINGS:We recruited participants and collected baseline assessments between Jan 6, and Nov 30, 2022. Parents of 1459 children (27% of 5335 children in participating classes) completed the screening questionnaire, and 409 screened positive (target population). On the basis of parent report, 222 (54%) of 408 children who screened positive were female, 185 (45%) were male, and one (<1%) preferred not to report child gender. 325 (85%) of 384 children were reported by the school as White. The mean age was 8·8 years (SD 0·3). 42 schools were randomly assigned to the intervention group (target population: 205 children) and 42 to the control group (target population: 204 children). In the target population at 12 months, more children screened negative for anxiety problems in the intervention group (89 [61%] of 145 children) than the control group (62 [38%] of 163 children), with an adjusted odds ratio of 2·32 (95% CI 1·41-3·81; p=0·0009) in the primary analysis based on imputed data. No serious adverse events related to trial procedures or the intervention or adverse events related to the intervention were reported. INTERPRETATION:An integrated screening-to-intervention pathway for child anxiety problems in primary schools reduced parent-reported child anxiety problems compared with assessment and usual provision only, providing a promising way to improve access to effective early intervention. FUNDING:National Institute for Health and Care Research Programme Grants for Applied Research.

BACKGROUND:Anxiety problems are extremely common and have an early age of onset. We previously found, in a study in England, that fewer than 3% of children with an anxiety disorder identified in the community had accessed an evidence-based treatment (Cognitive Behavioural Therapy; CBT). Key ways to increase access to CBT for primary school-aged children with anxiety problems include (a) proactive identification through screening in schools, (b) supporting parents and (c) the provision of brief, accessible interventions (and capitalising on technology to do this). METHOD:We provided a brief, therapist guided treatment called Online Support and Intervention (OSI) to parents/carers of children identified, through school-based screening, as likely to have anxiety problems. Fifty out of 131 children from 17 Year 4 classes in schools in England screened positive for 'possible anxiety problems' and 42 (84%) of these (and 7 who did not) took up the offer of OSI. We applied quantitative and qualitative approaches to assess children's outcomes and families' experiences of this approach. RESULTS:Inbuilt outcome monitoring indicated session on session improvements throughout the course of treatment, with substantial changes across measures by the final module (e.g. Child Outcome Rating Scale d = 0.84; Goal Based Outcomes d = 1.52). Parent engagement and satisfaction was high as indicated by quantitative and qualitative assessments, and intervention usage. CONCLUSIONS:We provide promising preliminary evidence for the use of OSI as an early intervention for children identified as having anxiety problems through school-based screening.

Background: Anxiety problems have a particularly early age of onset and are common among children. As we celebrate the anniversary of the BABCP, it is important to recognise the huge contribution that cognitive behavioural therapy (CBT) has made to the treatment of anxiety problems in children. CBT remains the only psychological intervention for child anxiety problems with a robust evidence base, but despite this, very few children with anxiety problems access CBT. Creative solutions are urgently needed to ensure that effective treatments can be delivered at scale. Here we focus on parent-led CBT as this offers a potential solution that is brief and can be delivered by clinicians without highly specialised training. Over the last decade there has been a substantial increase in randomised controlled trials evaluating this approach with consistent evidence of effectiveness. Nonetheless clinicians, and parents, often have concerns about trying the approach and can face challenges in its delivery. Method: We draw on empirical evidence and our clinical experience to address some of these common concerns and challenges, with particular emphasis on the key principles of empowering parents and working with them to provide opportunities for new learning for their children. Conclusions: We conclude by highlighting some important directions for future research and practice, including further evaluation of who does and does not currently benefit from the approach, determining how it should be adapted to optimise outcomes among groups that may not currently get maximum benefits and across cultures, and capitalising on recent technological developments to increase engagement and widen access.

Abstract Background Identifying and supporting young children who are at risk of developing anxiety disorders would benefit children, families, and wider society. Elevated anxiety symptoms, inhibited temperament, and high parental anxiety are established risk factors for later anxiety disorders, but it remains unclear who is most likely to benefit from prevention and early intervention programmes. Delivering an online intervention through schools to parents of young children who have one or more of these risks could maximise reach. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of delivering an online parent-led intervention, compared with usual school provision only, for children (aged 4–7) identified as at risk for anxiety disorders on the basis of at least one risk factor. We also aim to identify the characteristics of children who do and do not benefit from intervention and mechanisms of change from the intervention. Methods The design will be a parallel group, superiority cluster randomised controlled trial, with schools (clusters) randomised to intervention or usual school practice arms in a 1:1 ratio stratified according to level of deprivation within the school. The study will recruit and randomise at least 60 primary/infant schools in England, and on the basis of recruiting 60 schools, we will recruit 1080 trial participants (540 per arm). Parents of all children (aged 4–7) in sampled Reception, Year 1, and Year 2 classes will be invited to complete screening questionnaires. Children who screen positive on the basis of anxiety symptoms, and/or behavioural inhibition, and/or parent anxiety symptoms will be eligible for the trial. Parents/carers of children in schools allocated to the intervention arm will be offered a brief online intervention; schools in both arms will continue to provide any usual support for children and parents throughout the trial. Assessments will be completed at screening, baseline (before randomisation), 6 weeks, 12 weeks, and 12 months post-randomisation. The primary outcome will be the absence/presence of an anxiety disorder diagnosis at 12 months. Discussion The trial will determine if delivering an online intervention for parents of young children at risk of anxiety disorders identified through screening in schools is effective and cost-effective. Trial registration ISRCTN 82398107 . Prospectively registered on Jan. 14, 2021.

BACKGROUND:The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether 'screening and intervention', consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only - 'usual school practice', for children aged 8-9 years in the following: (1) the 'target population', who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire - iCATS-2, and (2) the 'total population', comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial. METHODS AND DESIGN:iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses. TRIAL REGISTRATION:ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022.