Clinical trial NCT04082026: Early Adolescent Skills for Emotions Tanzania Pilot
Official title: Towards an Evidence-based Scalable Psychological Intervention for Young Adolescents: Feasibility cRCT of Group Psychological Help for Young Burundian Refugee Adolescents in Tanzania.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Lead sponsor: International Rescue Committee
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Johns Hopkins University
First posted: 2019-09-09
Enrollment: 72
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: African Youth Psychosocial Assessment
timeFrame: 2 months
Secondary outcomes:
measure: Short Warwick-Edinburgh Mental Wellbeing Scale
timeFrame: 2 months
measure: Child Post Traumatic Stress Disorder (PTSD) Symptom Scale
timeFrame: 2 months
measure: Child Trauma Questionnaire (CTQ)
timeFrame: 2 months
measure: Adolescent Exposure to Violence
timeFrame: 2 months
Other outcomes:
Locations:
city: New York
country: United States
facility: International Rescue Committee
state: New York
Study officials:
References: