Background

Anxiety problems are common in children, yet few affected children access evidence-based treatment. Digitally augmented psychological therapies bring potential to increase availability of effective help for children with mental health problems. This study aimed to establish whether therapist-supported, digitally augmented, parent-led cognitive behavioural therapy (CBT) could increase the efficiency of treatment without compromising clinical effectiveness and acceptability.

Methods

We conducted a pragmatic, unblinded, two-arm, multisite, randomised controlled non-inferiority trial to evaluate the clinical effectiveness and cost-effectiveness of therapist-supported, parent-led CBT using the Online Support and Intervention (OSI) for child anxiety platform compared with treatment as usual for child (aged 5–12 years) anxiety problems in 34 Child and Adolescent Mental Health Services in England and Northern Ireland. We examined acceptability of OSI plus therapist support via qualitative interviews. Participants were randomly assigned (1:1) to OSI plus therapist support or treatment as usual, minimised by child age, gender, service type, and baseline child anxiety interference. Outcomes were assessed at week 14 and week 26 after randomisation. The primary clinical outcome was parent-reported interference caused by child anxiety at week 26 assessment, using the Child Anxiety Impact Scale–parent report (CAIS-P). The primary measure of health economic effect was quality-adjusted life-years (QALYs). Outcome analyses were conducted blind in the intention-to-treat (ITT) population with a standardised non-inferiority margin of 0·33 for clinical analyses. The trial was registered with ISRCTN, 12890382.

Findings

Between Dec 5, 2020, and Aug 3, 2022, 706 families (706 children and their parents or carers) were referred to the study information. 444 families were enrolled. Parents reported 255 (58%) child participants' gender to be female, 184 (41%) male, three (<1%) other, and one (<1%) preferred not to report their child's gender. 400 (90%) children were White and the mean age was 9·20 years (SD 1·79). 85% of families for whom clinicians provided information in the treatment as usual group received CBT. OSI plus therapist support was non-inferior for parent-reported anxiety interference on the CAIS-P (SMD 0·01, 95% CI –0·15 to 0·17; p<0·0001) and all secondary outcomes. The mean difference in QALYs across trial arms approximated to zero, and OSI plus therapist support was associated with lower costs than treatment as usual. OSI plus therapist support was likely to be cost effective under certain scenarios, but uncertainty was high. OSI plus therapist support acceptability was good. No serious adverse events were reported.

Interpretation

Digitally augmented intervention brought promising savings without compromising outcomes and as such presents a valuable tool for increasing access to psychological therapies and meeting the demand for treatment of child anxiety problems.

Funding

Department for Health and Social Care and United Kingdom Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, Oxford Health NIHR Biomedical Research Centre.

中文翻译：

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英格兰和北爱尔兰儿童心理健康服务中数字增强、家长主导的 CBT 与常规治疗儿童焦虑问题的比较：一项务实、非劣效、临床有效性和成本效益的随机对照试验

背景

焦虑问题在儿童中很常见，但很少有受影响的儿童获得循证治疗。数字增强心理疗法有可能为有心理健康问题的儿童提供更多有效帮助。本研究旨在确定治疗师支持的、数字增强的、家长主导的认知行为疗法 (CBT) 是否可以在不影响临床有效性和可接受性的情况下提高治疗效率。

方法

我们进行了一项务实、非盲、双臂、多中心、随机对照非劣效性试验，以评估使用儿童焦虑平台在线支持和干预 (OSI) 的治疗师支持、家长主导的 CBT 的临床有效性和成本效益与英格兰和北爱尔兰 34 个儿童和青少年心理健康服务中心针对儿童（5-12 岁）焦虑问题的常规治疗进行比较。我们通过定性访谈检查了 OSI 加上治疗师支持的可接受性。参与者被随机分配 (1:1) 接受 OSI 加治疗师支持或照常治疗，并尽量减少儿童年龄、性别、服务类型和基线儿童焦虑干扰。随机分组后第 14 周和第 26 周评估结果。主要临床结果是使用儿童焦虑影响量表-家长报告 (CAIS-P) 在第 26 周评估时家长报告的由儿童焦虑引起的干扰。健康经济影响的主要衡量标准是质量调整生命年（QALY）。在意向治疗 (ITT) 人群中盲法进行结果分析，临床分析的标准化非劣效界值为 0·33。该试验已在 ISRCTN 注册，编号为 12890382。

发现

2020年12月5日至2022年8月3日期间，共有706个家庭（706名儿童及其父母或照顾者）参考了该研究信息。444 个家庭参与其中。家长报告 255 名 (58%) 儿童参与者的性别为女性，184 名 (41%) 名儿童参与者为男性，三名 (<1%) 为其他儿童，一名 (<1%) 不愿报告孩子的性别。400 名 (90%) 儿童是白人，平均年龄为 9·20 岁 (SD 1·79)。在临床医生提供的常规治疗组信息中，85% 的家庭接受了 CBT。对于家长报告的 CAIS-P 焦虑干扰（SMD 0·01，95% CI –0·15 至 0·17；p<0·0001）和所有次要结果，OSI 加治疗师支持并不逊色。各试验组的 QALY 平均差异接近于零，并且 OSI 加治疗师支持与比通常治疗更低的成本相关。在某些情况下，OSI 加上治疗师支持可能具有成本效益，但不确定性很高。OSI 加上治疗师支持的可接受性良好。没有报告严重不良事件。

解释

数字增强干预在不影响结果的情况下带来了有希望的节省，因此为增加获得心理治疗的机会和满足儿童焦虑问题的治疗需求提供了宝贵的工具。

资金

卫生与社会保健部和英国研究与创新研究补助金、国家卫生与保健研究所 (NIHR) 研究政策研究计划、牛津和泰晤士河谷 NIHR 应用研究合作、牛津健康 NIHR 生物医学研究中心。