Early Adolescent Skills for Emotions Tanzania Pilot

NCT04082026 | Completed DMC

• 1 other identifier: CYPD 1.00.003
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot is to test the World Health Organization (WHO) Early Adolescent Skills for Emotions intervention, a new psychological intervention. The pilot in Tanzania adapted the manual for young adolescent Burundian refugees in Tanzania (ages 10 - 14) with prolonged disabling distress living in communities affected by adversity. We conducted a formative study to adapt the EASE material, followed by small feasibility RCT (M=72) along with a process evaluation.

Conditions

Mental Health Wellness 1

Outcome Measures

Primary Outcomes (1)

• African Youth Psychosocial Assessment

  Adolescent psychological distress was assessed using the total problem score from the African Youth Psychosocial Assessment (AYPA), which consists of 33 items capturing internalizing symptoms, externalizing symptoms, and somatic complaints with a 4-point response scale (range 0-99). The AYPA also includes a subscale capturing prosocial behaviors (8 items, range 0-24). While we relied on the adolescent-reported AYPA as our primary outcome, we also included a caregiver-reported version of the AYPA to allow for comparison.

  2 months

Secondary Outcomes (4)

• Short Warwick-Edinburgh Mental Wellbeing Scale

  2 months

• Child Post Traumatic Stress Disorder (PTSD) Symptom Scale

  2 months

• Child Trauma Questionnaire (CTQ)

  2 months

• Adolescent Exposure to Violence

  2 months

Study Arms (2)

Early Adolescent Skills for Emotions (EASE)

EXPERIMENTAL

EASE has four core features: Seven group sessions for young adolescents and three for their caregivers; Delivered by non-specialists; Trans-diagnostic: addressing depression, anxiety, distress, and other problems as defined by the young people themselves; and Designed for young people and their caregivers in low- and middle-income countries living in communities affected by adversity.

Behavioral: Early Adolescent Skills for Emotions EASE)

Enhanced Treatment As Usual (ETAU)

PLACEBO COMPARATOR

The Enhanced Treatment as Usual (ETAU) consisted of a single psychoeducation individual session, jointly for eligible adolescents and their caregivers, that included information on: (i) the results of the screening; (ii) self-care strategies; and, (iii) seeking services from local health or community services offering psychosocial / mental health care support.

Behavioral: Early Adolescent Skills for Emotions EASE)

Interventions

Early Adolescent Skills for Emotions EASE) BEHAVIORAL

EASE is conducted in 7 weekly group sessions with adolescents. EASE sessions help adolescents: * Identify their feelings and body reactions * Practice breathing exercises * Get active: Make a plan to positively change their actions * Manage their problems

Also known as: Enhanced Treatment as Usual (ETAU)

Early Adolescent Skills for Emotions (EASE); Enhanced Treatment As Usual (ETAU)

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• a score of eight or more points on the Child Psychosocial Distress Screener (CPDS)

You may not qualify if:

• High suicide risk
• Severe impairment
• Lack of parental consent

Sponsors & Collaborators

• International Rescue Committee: lead
• World Health Organization: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

International Rescue Committee

New York, New York, 10168, United States

Location

Study Design

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

Model Details: The research study compared the EASE treatment (7 weekly sessions for adolescents and 3 for their caregivers) against an Enhanced Treatment as Usual (ETAU) consisting of a single psychoeducation individual session, jointly for eligible adolescents and their caregivers. ETAU included information on: (i) the results of the screening; (ii) self-care strategies; and, (iii) seeking services from local health or community services offering psychosocial / mental health care support.

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 9, 2019
• Study Start: May 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2019
• Last Updated: September 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)