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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-07

Study Completion Date

2020-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Psychological Distress Emotional Problem Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arm, single blind, pilot cluster randomized controlled trial (cRCT)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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Early Adolescent Skills for Emotions (EASE) Program

Early Adolescent Skills for Emotions (EASE) is a new, brief, targeted, group psychological intervention program (Dawson et al., 2019) based on cognitive behavioural therapy (CBT) techniques that are empirically supported and formally recommended by the WHO (WHO, 2016).

Group Type EXPERIMENTAL

Early Adolescent Skills for Emotions (EASE) Program

Intervention Type BEHAVIORAL

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.

Treatment as Usual (TAU)

Participants in control arm will be able to avail the routine services available in school settings.

Group Type PLACEBO_COMPARATOR

Treatment As Usual (TAU)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No