Early Adolescent Skills for Emotions (EASE) - A Skills Based Program to Address Psychosocial Distress Among Young Adolescents Studying in Public Schools of Pakistan. Pilot Cluster Randomized Controlled Trial (cRCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pediatric Symptoms Checklist (PSC)
研究概览
简要总结
Background: Emotional problems such as symptoms of depression, anxiety and psychosocial distress are the leading contributors to health burden among adolescents worldwide. There is an urgent need for evidence-based psychological interventions for young people, especially those living in adversity. WHO has developed Early Adolescent Skills for Emotions (EASE), a brief group psychological intervention delivered by non-specialist providers for young adolescents impaired by distress and exposed to adversity. We aim to evaluate the feasibility of delivering EASE for young adolescents living in public schools of rural Rawalpindi, Pakistan.
Objectives: To evaluate the feasibility of delivering Early Adolescent Skills for Emotions (EASE) program to young adolescents and their caregivers in Rawalpindi, Pakistan to inform the design, including sample size estimation, for a full-scale adequately powered definitive cluster randomised controlled trial.
Methods: A two arm, single blind, pilot cluster randomized controlled trial will be conducted with adolescents of both gender (aged 13-15 years) with high psychological distress, studying in grade 8 and 9th of middle and high public school in rural Rawalpindi.
Schools will be the units of randomization. 8 public schools, stratified by gender, will be randomized into EASE plus Treatment as Usual (TAU) (n=4) and TAU alone (n=6). 60 young adolescents at-risk of psychosocial distress as assessed by Self-Reported-Pediatric Symptom Checklist (PSC), cut-off ≥28 will be included in the study. No power calculations have been calculated for the present pilot trial; however, the sample will be adequate to inform the parameters of planned definitive cRCT. In the intervention arm, adolescents will receive 7-weekly group sessions and their caregivers will receive 3-weekly group sessions in public schools. Data on the number of outcomes will be collected at baseline, immediately and 3-months' post-intervention follow-up. The findings will inform the sample size required for a definitive trial. A detailed mixed-methods process evaluation will be conducted to identify areas of improvements prior to proceeding to a definitive cRCT.
Discussion: The results of pilot trial will be used to inform the design of definitive cluster randomized controlled trial in government led scaled-up implementation of healthy school initiative in Rawalpindi district of Pakistan.
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
Study investigators and outcome assessors will be blind to the allocations status of participants. To ensure blinding, participants will be instructed to not disclose their allocation during assessment.
Fidelity of masking will be ensured by having assessors guess the allocation status of participants at the end of assessments.
入排标准
- 年龄范围
- 13 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study participants will be 60 adolescents (aged 13-15), at-risk of psycho-social distress as assessed by self-reported Pediatric Symptoms Check list (score ≥ 28); studying in public schools of rural Rawalpindi, Pakistan and their primary caregivers. To estimate the magnitude of treatment effect and its variation for a sample size calculation in the definitive trial, a pilot study sample size of 24 - 50 has been recommended (Browne, 1995; Julious 2005). With a sample size of 60 (30 per arm), we aim to generate some reliable estimate of treatment effect as well as recruitment and attrition rates.
- •Adolescents in need of acute protection (at high risk of abuse or harm to self or others) and who require immediate or ongoing medical or psychiatric care reported by parents will be excluded from the study.
排除标准
- 未提供
结局指标
主要结局
Pediatric Symptoms Checklist (PSC)
时间窗: At 3-months' post-intervention.
Self-rated Pediatric Symptom Checklist (PSC) will be used to assess psychosocial distress of adolescents. Pediatric symptom checklist has 35 items and assesses psychosocial problems on 3 subscales; externalizing, internalizing and attention problems with cut-offs of 7, 5, 7 respectively. Items are rated on a three-point Likert scale (0= Never, 1= Sometimes, 2=Often). Total score is calculated by summing the responses of all items. Higher score indicates greater psychosocial distress. The recommended cutoff for identifying children and adolescents with psychosocial distress using Pediatric Symptom Checklist in a new setting is ≥ 28.
次要结局
- Somatic-symptom questionnaire(At baseline, immediate and 3-months' post-intervention.)
- Short Warwick Edinburgh Wellbeing Scale (SWEWS)(At baseline, immediate and 3-months' post-intervention.)
- Perceived Emotional/Personal Support Scale(At baseline, immediate and 3- months' post-intervention.)
- Patient Health Questionnaire (PHQ-9)- adapted for adolescents(At baseline, immediate and 3-months' post-intervention.)
- Pediatric Quality of Life (Peds-QL)-Family impact module(At baseline, immediate and 3-months' post-intervention.)
- Alabama parenting scale(At baseline, immediate and 3- months' post-intervention.)
- Social Problem-Solving Inventory - Revised Short Form(At baseline, immediate and 3-months' post-intervention.)
- Pediatric Quality of Life (PedsQL)(At baseline, immediate and 3-months' post-intervention.)
- Health Services Utilization:(At baseline and 3-months' post-intervention.)