The Effectiveness of a Low-intensity, Lay Counsellor-delivered, Problem-solving Intervention for Common Mental Health Problems in School-going Adolescents in New Delhi, India: the PRIDE Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Idiographic problems
研究概览
简要总结
We will conduct a two-arm individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health difficulties and associated impact. Participants will receive either a brief problem-solving intervention delivered by lay counsellors (intervention), or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health difficulties and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported impact of mental health difficulties, perceived stress, mental wellbeing and clinical remission, as well as parent-reported adolescent mental health difficulties and impact scores, will be assessed at 6 and 12 weeks post-randomization. Parallel process evaluation, including estimations of the costs of delivering the interventions, will be conducted.
详细描述
Background and rationale:
This study is part of a larger research program called PRIDE (PRemIum for aDolEscents) for which the goals are to:
- develop a trans-diagnostic, stepped-care intervention targeting common mental disorders in school-going adolescents in India; and
- evaluate its effectiveness in reducing symptom severity and improving recovery rates among adolescent participants
The components of the stepped-care intervention will be evaluated in separate, linked studies. The main aim of the current trial is to evaluate the effectiveness of a low-intensity problem-solving intervention (the first step of the PRIDE stepped-care intervention) delivered by school counsellors for adolescents with common mental health problems, when compared with enhanced usual care (EUC).
The primary hypothesis is that the intervention will be superior to the EUC control condition in reducing the severity of self-reported mental health symptoms and prioritized problems at six weeks post-randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The randomization list will be generated by an independent statistician. The randomization code will be concealed using sequentially numbered opaque sealed envelopes to maximize allocation concealment.
Baseline assessments will be carried out by field researchers prior to randomization. The six- and 12-week outcome assessments will be carried out by a team of field researchers who will be blind to allocation status.
入排标准
- 年龄范围
- 13 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility criteria:
- •For adolescent participants:
- •Enrolled as a student in Grades 9-12 (corresponding to 13-20 years of age)
- •Experiencing elevated mental health symptoms, based on response in the borderline or abnormal range (scores of 19 or higher for boys and 20 or higher for girls) on the self-reported SDQ Total Difficulties scale
- •Experiencing significant distress and/or functional impairment, based on response in the abnormal range (scores of 2 or higher) on the self-reported SDQ Impact Supplement
- •Experiencing difficulties for >1 month, based on response to the self-reported Chronicity item from the SDQ Impact Supplement
- •For adolescents under 18 years of age, able to provide informed assent to participate and supported by parental consent
- •For adolescents over 18 years of age, able to provide informed consent to participate
- •For parent participants:
- •A primary parental caregiver or guardian for the index adolescent
- •Able to provide informed consent to participate, and if adolescent age 18+ years, parental involvement is supported by the index adolescent
- •Proficient in spoken English or Hindi
排除标准
- •For adolescent participants:
- •Requiring urgent medical attention (defined as needing emergency treatment or in-patient admission)
- •Unable to communicate clearly (due to a speech or hearing disability or inability to comprehend one of the program's languages)
- •Already receiving intervention for mental health problems
- •Received PRIDE intervention in past six months during pilot study
- •Not providing assent
- •Adolescent whose parents are not providing consent
- •For parent participants:
- •Unable to communicate clearly (due to a speech or hearing disability or inability to comprehend one of the program's languages)
- •Intoxicated at the point of consent or assessment
研究组 & 干预措施
Control
Enhanced usual care (problem-solving booklets only).
干预措施: Enhanced usual care (Behavioral)
Intervention
PRIDE 'Step 1' problem-solving intervention.
干预措施: PRIDE 'Step 1' problem-solving intervention (Behavioral)
结局指标
主要结局
Idiographic problems
时间窗: 6 weeks
The Youth Top Problems (YTP) is a brief, idiographic measure which identifies, prioritizes and scores respondents' three main problems (Weisz et al., 2011). Each nominated problem is scored from 0 ('not a problem') to 10 ('huge problem'). A mean severity score is calculated by summing individual problem scores and then dividing by the number of nominated problems. The YTP will be used to assess problems that other scales might address generally or otherwise miss; while providing a sensitive measure of specific priorities of the participant within a larger array of problems.
Mental health symptoms
时间窗: 6 weeks
The Strengths and Difficulties Questionnaire (SDQ) is a 25-item self-report measure of youth mental health symptoms (Goodman et al., 2000). A Total Difficulties score is derived by summing items from four problem subscales (Emotional, Conduct, Hyperactivity/inattention and Peer problems). The measure is the most widely used clinical and research instrument in the field of child and adolescent mental health globally. The Hindi version will be used in complementary forms for self-report by adolescents and parents. The adolescent-reported SDQ Total Difficulties score (at 6-week end-point) will be a co-primary outcome, while the corresponding caregiver-reported SDQ Total Difficulties score will be an exploratory outcome.
次要结局
- Idiographic problems(12 weeks post-randomization)
- Mental health symptoms(12 weeks post-randomization)
- Impact of mental health problems(12 weeks post-randomization)
- Internalising symptoms(12 weeks post-randomization)
- Perceived stress(12 weeks post-randomization)
- Mental wellbeing(12 weeks post-randomization)
- Clinical remission(12 weeks post-randomization)
- Externalising symptoms(12 weeks post-randomization)
- Prosocial behaviour(12 weeks post-randomization)