Early Adolescent Skills for Emotions (EASE)-Pilot Cluster Randomized Controlled Trial (cRCT) in Public Schools of Rural Pakistan
Condition: Psychological Distress; Emotional Problem; Anxiety; Depression
MeSH terms: Depression
Study type: Interventional

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.
    


Intervention name(s): Early Adolescent Skills for Emotions (EASE) Program; Treatment As Usual (TAU)
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arm, single blind, pilot cluster randomized controlled trial (cRCT)
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment