Skip to main content
OpenTrials
Completed

NCT Number: NCT04082026

Early Adolescent Skills for Emotions Tanzania Pilot

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Rescue Committee

New York, 10168, United States

About this study

WHO is developing a set of scalable brief psychological programs: a new generation of shorter, less expensive and trans-diagnostic programs that can be delivered by non-specialized providers (e.g. without formal education or experience in mental health), to reduce common mental health symptoms and improve psychosocial functioning. In this pilot in Tanzania, the IRC, JHU and WHO seek to assess EASE, a much needed, brief psychological intervention developed specifically for young adolescents and their caregivers, and applicable in different humanitarian contexts.

The IRC, JHU and WHO, in collaboration with UNHCR, Muhimbili University of Health and Allied Sciences in Tanzania, and Village Health Works , adapted and contextualized the EASE intervention for Burundian refugee young adolescents in Tanzania. The adaptation had three steps:

First, the IRC conducted a desk review focusing on the cultural context for mental health research among Burundian refugees, covering local concepts, beliefs and practices associated with psychosocial support.

Second, the IRC conducted a formative qualitative study, consisting of 88 semi-structured qualitative interviews (free listing (n=61) and key informant interviews (n=25)), including with Burundian adolescent boys and girls (See Tables 1 & 2 in Annex for breakdown of interview participants). This was followed by four focus group discussions (n=20) using cognitive interviewing techniques with adolescents and caregivers to seek feedback specifically on example intervention materials.

Third, the IRC and its partners used findings from the desk review and the qualitative study to inform an adaptation workshop in May 2018 held in Kibondo, Tanzania. For the adaptation workshop, the IRC convened the WHO, IRC mental health field staff, Village Health Works staff, and Dr Samuel Likindikoki from the Muhimbili University of Health and Allied Sciences. The adaptation workshop included a review of the data collected during the ethnographic study, as well as a mock run-through of the EASE materials, which allowed for an in-depth review of the intervention content.

The EASE pilot implementation and testing phase had eight main activities: 1) initial screening of adolescents for eligibility into the EASE program; 2) baseline data collection with the eligible participants and caregivers; 3) facilitator training; 4) development of a referral protocol to ensure adequate services for participants who experienced violence or were at high risk of suicide; 5) implementation of the EASE sessions; 6) implementation of the "Enhanced treatment as usual" sessions (our control condition, conducted at the same time as the EASE sessions); 7) endline data collection; and 8) process evaluation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Other names: Enhanced Treatment as Usual (ETAU)

Primary outcomes

  1. African Youth Psychosocial Assessment

    Time frame: 2 months

    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.

Secondary outcomes

  1. Short Warwick-Edinburgh Mental Wellbeing Scale

    Time frame: 2 months

    Adolescent mental well-being was assessed with the 14-item Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS; 5-point response scale, range 0-28) (Tennant et al., 2007).

  2. Child Post Traumatic Stress Disorder (PTSD) Symptom Scale

    Time frame: 2 months

    Adolescent PTSD symptoms were assessed with the Child PTSD Symptom Scale (CPSS) (Foa, Johnson, Feeny, & Treadwell, 2001). This 17-item measure uses a 4-point response scale to assess PTSD symptoms according to Diagnostic and Statistical Manual of Mental Disorders criteria (range 0-51).

  3. Child Trauma Questionnaire (CTQ)

    Time frame: 2 months

    Adolescent traumatic exposures were measured using a 15-item version of the Child Trauma Questionnaire (CTQ) that was adapted locally (5-point response scale, range 0-60) (Bernstein & Fink, 1998; Charak, de Jong, Berckmoes, Ndayisaba, & Reis, 2017).

  4. Adolescent Exposure to Violence

    Time frame: 2 months

    Adolescent exposure to violence was examined using a locally developed list of 33 dichotomous items (yes or no) that assessed lifetime experiences of violence perpetrated both by caregivers and non-caregivers (including emotional, physical, and sexual abuse). Follow-up questions to each item determined recency of violence (i.e., whether or not it had occurred within the past two months).

Sponsors and collaborators

Lead sponsor

International Rescue Committee

Other

Collaborators

  • Johns Hopkins University
  • World Health Organization

Registry information

Official study title

Towards an Evidence-based Scalable Psychological Intervention for Young Adolescents: Feasibility cRCT of Group Psychological Help for Young Burundian Refugee Adolescents in Tanzania.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2019
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.