A 3-arm Multi-Center Exploratory Trial of Universally Delivered Interventions for Prevention of Anxiety and Depression in Young People in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 564
- 试验地点
- 1
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
Mental health problems are amongst the major contributors to disease burden globally.
According to a recent study, 34% of young people worldwide (aged 10-19) suffer from depression and more than half of this population belongs to Southeast Asia such as Pakistan, India, and China.
Existing evidence shows that the access to mental health services in LMICs is limited and even fewer child psychiatric services are available.
One approach to overcome barriers such as limited availability of trained mental health professionals and risk of stigma may involve the use of simple, brief, scalable interventions based on basic psychological principles rather than treatment of psychopathology.
This study adapts and evaluates two brief interventions called behavioral activation single session intervention (BA-SSI) and 4-session Mindset intervention (MI) for teenage depression and anxiety in Pakistan, where access to mental health care is constrained by societal stigma and a shortage of clinicians.
详细描述
A 3-arm multi-center cluster exploratory Randomized Controlled Trial to determine the feasibility, acceptability and preliminary effectiveness of a universally delivered, culturally adapted, potentially low cost, 4-session Mindset intervention (MI) and behavioral activation single session intervention (BA-SSI) for school going young persons (YP) (12-15 years) in Pakistan.
Proposed study is designed using the updated Medical Research Council (MRC) Framework for the development and evaluation of complex interventions.
Three public schools will be recruited from each of 10 cities across Pakistan: Karachi, Hyderabad, Nawabshah, Thatta, Lahore, Gujrat, Rawalpindi, Multan, Quetta, and Peshawar.
All the participants, regardless of their treatment arm, will be assessed at baseline, 1 month post-baseline and at 3-month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Youth is between the age 12-15 years (inclusive) at the time of study enrollment.
- •Youth has one parent or legal guardian to give consent.
- •Youth speaks Urdu well enough to complete the paper based intervention.
排除标准
- •Intellectual disability, as this may undermine comprehension of intervention material.
- •Adolescent with history of hospitalization or those who received inpatient treatment for a mental health problem within the past two months as the intervention being tested and this study is not designed for adolescent with acute medical and/or psychiatric treatment needs (if identified with any acute medical and/or psychiatric problem, they would be referred to appropriate health services through parents).
- •Schools Inclusion Criteria
- •Schools in the study areas are eligible to participate if they meet all the following criteria:
- •the school authority agrees to participate;
- •the schools shall be non-specialist public schools;
- •school contains at least 80 students; Exclusion criteria
- •If the school meet the following exclusion criteria, they are ineligible to participate:
- •the school authority refuses to participate;
- •a specialist and/or independent or private school;
结局指标
主要结局
Feasibility of recruitment
时间窗: Total recruitment period is 3 months. Change in numbers will be recorded from first month of recruitment to 3rd month of recruitment
This will be monitored through a research trial log. This log will include information about number of schools approached, number of schools eligible to participate, number of schools consented to participate, number of YP approached, number of eligible YP and number of those who consented to participate
Feasibility of intervention
时间窗: Retention of participants in the Intervention at the completion of one month intervention period.
Session attendance for each participant in active study arms for each session will be recorded and maintained in participant intervention log.
Depression
时间窗: Change in scores from baseline to 3-month follow up.
The Patient Health Questionnaire -8 will be used to assess the symptoms of depression. PHQ-8 scores are highly correlated with PHQ-9 scores, and the same cutoffs can be used to assess depression severity
次要结局
- Beck's hopelessness Scale short version(Change in scores from baseline to 3-month follow up)
- EuroQol Quality of Life scale(Change in scores from baseline to 3-month follow up)
- The Revised Child Anxiety and Depression Scale(Change in scores from baseline to 3-month follow up)
- Growth Mindset scale(Change in scores from baseline to 3-month follow up)
- Program Feedback Scale(Total acceptability score at completion of one month intervention period.)