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

NCT04254393 | Completed

• 1 other identifier: EASE Pilot cRCT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pediatric Symptoms Checklist (PSC)

  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.

  At 3-months' post-intervention.

Secondary Outcomes (9)

• Somatic-symptom questionnaire

  At baseline, immediate and 3-months' post-intervention.

• Social Problem-Solving Inventory - Revised Short Form

  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 (PedsQL)

  At baseline, immediate and 3-months' post-intervention.

Study Arms (2)

Early Adolescent Skills for Emotions (EASE) Program

EXPERIMENTAL

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).

Behavioral: Early Adolescent Skills for Emotions (EASE) Program

Treatment as Usual (TAU)

PLACEBO COMPARATOR

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

Other: Treatment As Usual (TAU)

Interventions

Early Adolescent Skills for Emotions (EASE) Program 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.

Early Adolescent Skills for Emotions (EASE) Program

Treatment As Usual (TAU) 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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Human Development Research Foundation, Pakistan: lead
• University of Liverpool: collaborator
• Institute of Psychiatry, WHO Collaborating Center for Mental Health, Rawalpindi: collaborator

Study Sites (1)

Human Development Research Foundation

Islamabad, Pakistan

Location

Related Publications (6)

• Jellinek MS, Murphy JM, Burns BJ. Brief psychosocial screening in outpatient pediatric practice. J Pediatr. 1986 Aug;109(2):371-8. doi: 10.1016/s0022-3476(86)80408-5.

  PMID: 3734977 RESULT

• Dawson KS, Watts S, Carswell K, Shehadeh MH, Jordans MJD, Bryant RA, Miller KE, Malik A, Brown FL, Servili C, van Ommeren M. Improving access to evidence-based interventions for young adolescents: Early Adolescent Skills for Emotions (EASE). World Psychiatry. 2019 Feb;18(1):105-107. doi: 10.1002/wps.20594. No abstract available.

  PMID: 30600639 RESULT

• Richardson LP, McCauley E, Grossman DC, McCarty CA, Richards J, Russo JE, Rockhill C, Katon W. Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics. 2010 Dec;126(6):1117-23. doi: 10.1542/peds.2010-0852. Epub 2010 Nov 1.

  PMID: 21041282 RESULT

• Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

  PMID: 18042300 RESULT

• Thabane L, Hopewell S, Lancaster GA, Bond CM, Coleman CL, Campbell MJ, Eldridge SM. Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot Feasibility Stud. 2016 May 20;2:25. doi: 10.1186/s40814-016-0065-z. eCollection 2016.

  PMID: 27965844 RESULT

• Hamdani SU, Huma ZE, Tamizuddin-Nizami A, Baneen UU, Suleman N, Javed H, Malik A, Wang D, Mazhar S, Khan SA, Minhas FA, Rahman A. Feasibility and acceptability of a multicomponent, group psychological intervention for adolescents with psychosocial distress in public schools of Pakistan: a feasibility cluster randomized controlled trial (cRCT). Child Adolesc Psychiatry Ment Health. 2022 Jun 21;16(1):47. doi: 10.1186/s13034-022-00480-z.

  PMID: 35729589 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

methyl hydroxyethyl cellulose; Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Atif Rahman, PhD

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 1, 2020
• First Posted: February 5, 2020
• Study Start: February 7, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2020
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)