Skills for adolescent WELLbeing (SWELL): protocol for a preventive effectiveness randomised controlled trial for young people at high-familial risk of depression with treatment optimisation for parents with depression at study entry comparing online group cognitive behavioural therapy (CBT) with treatment as usual

青少年幸福感技能(SWELL):一项针对有抑郁症家族史的高危青少年,并针对入组时患有抑郁症的父母进行治疗优化的预防效果随机对照试验方案,比较在线团体认知行为疗法(CBT)与常规治疗的效果。

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Abstract

INTRODUCTION: Young people (YP) whose parents have depression are at elevated risk for developing depression themselves and could benefit from preventive interventions. However, when parents are in a depressive episode, this reduces the effects of psychological interventions for depression in YP. Moreover, parental depression is often managed suboptimally in usual care. There is, therefore, a case for identifying and optimising parental depression treatment to enhance the effectiveness of psychological preventive interventions for depression in YP. METHODS AND ANALYSIS: This is a randomised controlled trial (Skills for adolescent WELLbeing) to determine the effectiveness of a cognitive behavioural therapy (CBT) intervention compared with usual care in increasing the time to a major depressive episode in YP by 9-month follow-up (primary outcome). The intervention offers a 12-week treatment-optimisation phase for parents depressed at study entry, followed by randomisation of the young person to a small group manualised online CBT programme facilitated by a therapist. YP allocated to the intervention will receive eight weekly sessions plus three monthly continuation sessions. Secondary outcomes include the number of depression-free weeks, mental health symptoms and functioning. Mechanisms of intervention action will be assessed with mediation analysis of quantitative data and thematic analysis of qualitative interviews. Participants (parents/carers with depression and their children aged 13-19 years) will be identified through existing cohorts of adults with depression, from primary care through health boards in Wales and England, UK, schools and advertising including via social media. ETHICS AND DISSEMINATION: The trial has received ethical approval from Wales NHS Research Ethics Committee (REC) 5, the Health Research Authority and Health and Care Research Wales (IRAS 305331; REC 22/WA/0254). This manuscript is based on V.5.7 of the protocol (17 January 2025). Findings will be disseminated in peer-reviewed journals and conferences. Reports and social media messages will be used to disseminate findings to the wider public. TRIAL REGISTRATION NUMBER: ISRCTN13924193 (date registered: 15 March 2023).

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