NCT04254393 2020.

Study name	Early Adolescent Skills for Emotions (EASE) ‐ pilot cluster randomized controlled trial (cRCT) in public schools of rural Pakistan
Methods	Cluster‐randomised controlled trial
Participants	Clusters are schools Inclusion criteria 1. Adolescents ages 13 to 15 2. Self‐reported Pediatric Symptoms Checklist score ≥ 28 Exclusion criteria 1. High risk of abuse or harm to self or others 2. Ongoing medical or psychiatric care
Interventions	Intervention Early Adolescent Skills for Emotion (EASE) Programme Group psychological intervention programme based on cognitive‐behavioural therapy techniques to manage symptoms of depression, anxiety, and distress in adolescents, to be delivered by non‐specialists in low resource settings. Includes 7 group adolescent sessions, each lasting 90 minutes, involving psychoeducation, problem‐solving, stress management, behavioural activation, and relapse prevention, and 3 caregiver group sessions, each lasting 120 minutes, involving psychoeducation, active listening, quality time, praise, caregiver self‐care, and relapse prevention Control Treatment as usual Participants access routine services available in school settings
Outcomes	Primary outcome measure   Pediatric Symptoms Checklist (PSC) [Time Frame: At 3 months post‐intervention] Secondary outcome measures 1. Somatic‐symptom questionnaire [Time Frame: At baseline, immediate and 3 months post‐intervention] 2. Social Problem‐Solving Inventory ‐ Revised Short Form [Time Frame: At baseline, immediate and 3 months post‐intervention] 3. Perceived Emotional/Personal Support Scale [Time Frame: At baseline, immediate and 3 months post‐intervention] 4. Patient Health Questionnaire (PHQ‐9) ‐ adapted for adolescents [Time Frame: At baseline, immediate and 3 months post‐intervention] 5. Pediatric Quality of Life (PedsQL) [Time Frame: At baseline, immediate and 3 months post‐intervention] 6. Pediatric Quality of Life (Peds‐QL)‐Family impact module [Time Frame: At baseline, immediate and 3 months post‐intervention] 7. Alabama Parenting Scale [Time Frame: At baseline, immediate and 3 months post‐intervention] 8. Health services utilisation [Time Frame: At baseline and 3 months post‐intervention] 9. Short Warwick Edinburgh Well‐being Scale (SWEWS) [Time Frame: At baseline, immediate and 3 months post‐intervention]
Starting date	7 February 2020
Contact information	Principal Investigator Atif Rahman, PhD University of Liverpool
Notes	Sponsored by Human Development Research Foundation, Pakistan