- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04082026
Early Adolescent Skills for Emotions Tanzania Pilot
Towards an Evidence-based Scalable Psychological Intervention for Young Adolescents: Feasibility cRCT of Group Psychological Help for Young Burundian Refugee Adolescents in Tanzania.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10168
- International Rescue Committee
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early Adolescent Skills for Emotions (EASE)
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.
|
EASE is conducted in 7 weekly group sessions with adolescents. EASE sessions help adolescents:
Other Names:
|
Placebo Comparator: Enhanced Treatment As Usual (ETAU)
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.
|
EASE is conducted in 7 weekly group sessions with adolescents. EASE sessions help adolescents:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 months
|
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).
|
2 months
|
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).
|
2 months
|
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).
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CYPD 1.00.003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Health Wellness 1
-
Indiana UniversityCommunity Health Network; Boys & Girls Clubs of IndianapolisRecruitingMental Health Wellness 1 | Child Behavior | Adolescent Behavior | Mental Health Wellness 2United States
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Northern Arizona UniversityUniversity of Colorado, DenverNot yet recruitingMental Health Wellness 1
-
The New SchoolColumbia University; Universidad del Norte; HIASRecruitingMental Health Wellness 1Colombia
-
University of California, Los AngelesRecruiting
-
University of Wisconsin, MadisonCompletedMental Health Wellness 1United States
-
University of BathKing's College London; University of Pennsylvania; Newcastle University; University... and other collaboratorsCompletedMental Health Wellness 1United Kingdom
-
The University of Hong KongThe Boys' and Girls' Clubs Association of Hong KongCompleted
-
University of South WalesMIND CymruTerminated
-
NYU Silver School of Social WorkCompletedMental Health Wellness 1United States
Clinical Trials on Early Adolescent Skills for Emotions EASE)
-
Aga Khan UniversityShandong UniversityEnrolling by invitation
-
Human Development Research Foundation, PakistanUniversity of Liverpool; Institute of Psychiatry, WHO Collaborating Center...CompletedDepression | Anxiety | Psychological Distress | Emotional ProblemPakistan
-
Northwestern UniversityBraveNetCompletedMusculoskeletal Pain | Chronic PainUnited States
-
International Centre for Diarrhoeal Disease Research...Global Affairs CanadaRecruitingHealth Behavior | Gestational Weight Gain | Undernutrition | Diet, Food, and NutritionBangladesh
-
University Medical Centre LjubljanaUniversity of Ljubljana, Faculty of Medicine; National Institute of Chemistry... and other collaboratorsCompletedCTNNB1 Gene MutationSlovenia, Australia