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Early Adolescent Skills for Emotions Tanzania Pilot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082026
Recruitment Status : Completed
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborators:
World Health Organization
Johns Hopkins University
Information provided by (Responsible Party):
International Rescue Committee

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.

Condition or disease Intervention/treatment Phase
Mental Health Wellness 1 Behavioral: Early Adolescent Skills for Emotions EASE) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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.
Behavioral: Early Adolescent Skills for Emotions EASE)

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 Name: Enhanced Treatment as Usual (ETAU)

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.
Behavioral: Early Adolescent Skills for Emotions EASE)

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 Name: Enhanced Treatment as Usual (ETAU)




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082026


Locations
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United States, New York
International Rescue Committee
New York, New York, United States, 10168
Sponsors and Collaborators
International Rescue Committee
World Health Organization
Johns Hopkins University
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Responsible Party: International Rescue Committee
ClinicalTrials.gov Identifier: NCT04082026    
Other Study ID Numbers: CYPD 1.00.003
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No