Effects of a Classroom-based Sensitization Intervention on Demand for Mental Health Care Among School-going Adolescents in New Delhi, India: Study Protocol for a Stepped-wedge Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 835
- 试验地点
- 2
- 主要终点
- Referral rate into the host trial
研究概览
简要总结
The primary objective of this embedded stepped-wedge, cluster randomized controlled trial is to evaluate the impact of a classroom sensitization (intervention condition), over and above the school-level sensitization activities (control condition), on referrals to a host trial (examining the effectiveness of a problem-solving intervention delivered by lay counsellors). The primary hypothesis is that the classroom-level sensitization intervention will be associated with a higher overall referral rate into the host trial (i.e. the proportion of adolescents referred as a function of the total sampling frame in each condition). The secondary hypotheses are that, compared with the control condition, the intervention condition will be associated with a greater proportion of referred students who meet eligibility criteria for inclusion in the host trial and a greater proportion of students who self-refer. We will also explore whether there are any differences between conditions in terms of the severity of total symptoms and symptom subtypes presented by referred adolescents.
详细描述
Background and rationale:
Schools are recommended as strategically important platform for improving young people's access to mental health care, including in low and middle- income countries (Patton et al., 2016). Along with a limited supply of effective treatments, low awareness about mental health problems and their treatment often act as barriers to help seeking in schools. Interventions to increase mental health literacy have been shown to increase the demand for mental health care among young people in a number of studies conducted worldwide, including in low-resource settings. However, the evidence is not conclusive as many of the existing studies are associated with a high risk of bias (Wei et al., 2013; Wei et al., 2015; Kutcher et al., 2016).
Formative research in Government-run secondary schools in New Delhi, India indicated that mental health services were non-existent and adolescents had limited knowledge about mental health care. The investigators have therefore developed sensitization activities to promote referral to, and uptake of, a newly developed school counselling service. These sensitization activities have been designed for implementation at both whole school and classroom-levels, and are intended to be delivered by non-specialist counsellors. The additional resource investment in classroom-level sensitization activities may be justified if this component leads to significantly greater levels of demand. This trial therefore seeks to evaluate the additional impact of the classroom sensitization session on demand for school counselling in New Delhi.
This study is part of a larger research program called PRIDE (PRemIum for aDolEscents). The overall goal is to develop and evaluate a trans-diagnostic, stepped-care intervention targeting common mental disorders in school-going adolescents in India. The PRIDE intervention architecture involves two sequential psychological treatments of incremental intensity. The first step is a brief problem-solving intervention delivered by lay counsellors. Adolescents with enduring mental health problems are referred to a higher intensity trans-diagnostic treatment delivered by psychologists.
The trial described here is embedded within a host trial that is testing the effectiveness of the low-intensity problem-solving intervention. The embedded trial will evaluate the impact of the classroom sensitization activities over and above the school-level activities on referral rates generated for the host trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- 是
入选标准
- •CLASSROOM CLUSTERS
- •Inclusion criteria:
- •Classes from grades 9-12 in the six collaborating schools.
排除标准
- •Classes that have received classroom sensitization sessions during earlier pilot work.
- •ADOLESCENT PARTICIPANTS
- •Inclusion criteria:
- •Enrolled as a student in grades 9-12 (aged 13-20 years) at one of the collaborating schools
- •Adolescent willing and able to consent for participation in the research
- •Exclusion criteria:
- •Adolescent not proficient in written and spoken Hindi, as needed to participate fully in study procedures
- •Adolescent needing urgent medical or mental health care
研究组 & 干预措施
Intervention
Classroom sensitization session (plus school-level sensitization activities)
干预措施: Classroom sensitization session (Behavioral)
Intervention
Classroom sensitization session (plus school-level sensitization activities)
干预措施: School-level sensitization activities (Behavioral)
Control
School-level sensitization activities only
干预措施: School-level sensitization activities (Behavioral)
结局指标
主要结局
Referral rate into the host trial
时间窗: 4 weeks
The referral rate will be calculated as the number of referred students from a given condition divided by the total number of students in corresponding classes. This will be calculated from researchers' referral logs. Referrals will be recorded continuously and reported for each 4 weeks' time period, for the total study duration of 12 weeks.
次要结局
- Eligibility rate(4 weeks)
- Self-referral rate(4 weeks)