Early Adolescent Skills for Emotions (EASE)-Pilot Cluster Randomized Controlled Trial (cRCT) in Public Schools of Rural Pakistan

Summary

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.

Conditions

• Psychological Distress
• Emotional Problem
• Anxiety
• Depression

Interventions

BEHAVIORAL

Early Adolescent Skills for Emotions (EASE) Program

EASE has been developed to manage and reduce symptoms of depression, anxiety and distress in adolescents. EASE is designed to be delivered by non-specialists in low resource settings such as a trained school-health counsellor. The intervention comprises of 7 young adolescent group sessions, each lasting 90 minutes and involves the empirically supported components of psycho education, problem solving, stress management (slow breathing), behavioural activation, and relapse prevention and 3 caregiver group sessions, each lasting 120 minutes and involve psycho education, active listening, quality time, praise, caregiver self-care and relapse prevention.

OTHER

Treatment As Usual (TAU)

Evidence based health practices are not available in schools to manage the mental health problems of children. No structured programs are being implemented in school settings for at-risk children. During the study, participants in TAU showing severe psychiatric symptoms that require immediate specialist treatment and follow-up, will be referred to the Institute of psychiatry (IoP)-the tertiary mental health care facility of the region.

Sponsors & Collaborators

• University of Liverpool

  collaborator OTHER

• Institute of Psychiatry, WHO Collaborating Center for Mental Health, Rawalpindi

  collaborator UNKNOWN

• Human Development Research Foundation, Pakistan

  lead OTHER

Principal Investigators

• Atif Rahman, PhD · University of Liverpool

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-07

Primary Completion

2020-06-30

Completion

2020-07-30

Countries

• Pakistan

Study Locations