Combining Mental Health and Parenting Interventions to Improve Child Wellbeing Among Refugee Families in Tanzania
WEMA
Combining Mental Health and Violence Prevention Interventions to Enhance Child Wellbeing Under Adversity - Study Protocol for a Three-arm, Cluster-randomized, Superiority Trial With Primary Caregivers in Nyarugusu Refugee Camp, Tanzania (WEMA Trial)
1 other identifier
interventional
1,296
1 country
2
Brief Summary
The goal of this clinical trial is to learn whether improving caregivers' mental health and parenting practices can enhance child wellbeing among Congolese refugee families living in the Nyarugusu Refugee Camp, Tanzania. The WEMA trial ("Wellbeing through combined Evidence-based tools for Mental health and Attuned parenting") is a three-arm, family-level cluster-randomized, controlled superiority trial involving 324 families (approximately 648 children aged 7-10 years and their two primary caregivers). Participants and intervention facilitators will know which program a family receives, but outcome assessors (enumerators) will not know group assignment. The main questions it aims to answer are:
- Does Self-Help Plus (SH+), a World Health Organization (WHO) group stress-management program, improve children's emotional and behavioral functioning at 12 months post-intervention, compared with usual care?
- Does adding Interaction Competencies with Children for Parents (ICC-P), a participatory parenting program, after SH+ further improve children's emotional and behavioral functioning at 12 months post-intervention, compared with SH+ alone? Researchers will compare (1) Usual Care, (2) SH+, and (3) SH+ followed by ICC-P to see whether SH+ improves outcomes versus usual care, and whether SH+ followed by ICC-P provides additional benefits beyond SH+ alone. Participants will:
- Be assigned by chance by family clusters to one of three groups: Usual Care, SH+, or SH+ followed by ICC-P.
- Receive either (a) information about available psychosocial and mental health services (Usual Care), (b) SH+ (five group sessions delivered by trained non-specialists), or (c) SH+ followed by ICC-P (a four-day participatory parenting training to strengthen positive parenting and reduce harsh discipline).
- Complete study assessments at baseline, 3 months, and 12 months post-intervention. The primary outcome is children's emotional and behavioral functioning, measured using the Pediatric Symptom Checklist-17 (PSC-17) at 12 months post-intervention. Secondary outcomes include children's wellbeing and quality of life, as well as caregivers' mental health, well-being, and parenting practices. Additional exploratory outcomes will also be assessed, including measures collected from caregivers and behavioral tasks with children. The trial is implemented by Uppsala University in collaboration with the Dar es Salaam University College of Education (DUCE) and partners, with funding from the Swedish Research Council (grant no. 2022-02476).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2026
CompletedFirst Posted
Study publicly available on registry
March 4, 2026
CompletedStudy Start
First participant enrolled
March 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
March 4, 2026
February 1, 2026
1.3 years
February 25, 2026
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Caregiver-reported child emotional and behavioral functioning (Pediatric Symptom Checklist-17, PSC-17)
Emotional and behavioral functioning of children aged 7-10 years will be assessed using the Pediatric Symptom Checklist-17 (PSC-17), a 17-item caregiver-report screening tool for psychosocial problems (total score range 0-34; higher scores indicate greater difficulties). Each child's PSC-17 will be completed independently by both primary caregivers. The primary outcome metric is the mean (average) of the two caregiver-reported PSC-17 total scores for each child at 12 months post-intervention. PSC-17 subscales (internalizing, externalizing, attention) will be examined in secondary/exploratory analyses.
Baseline, 3 months post-intervention, and 12 months post-intervention
Secondary Outcomes (12)
Self-reported child emotional and behavioral functioning (Youth-adapted Pediatric Symptom Checklist-17, Y-PSC-17)
Baseline and 12-months post-intervention
Child health-related quality of life (KINDL-R)
Baseline, 3 months post-intervention, and 12 months post-intervention
Psychological distress (Kessler Psychological Distress Scale, K6)
Baseline, 3 months post-intervention, and 12 months post-intervention
Depression (Patient Health Questionnaire-9, PHQ-9)
Baseline, 3 months post-intervention, and 12 months post-intervention
Anxiety (Generalized Anxiety Disorder 7-item scale, GAD-7)
Baseline, 3 months post-intervention, and 12 months post-intervention
- +7 more secondary outcomes
Other Outcomes (8)
Emotion recognition task (facial and vocal expressions)
Baseline and 12 months post-intervention
Executive functioning (Dimensional Change Card Sort, DCCS)
Baseline and 12 months post-intervention
Theory of mind (false-belief tasks)
Baseline and 12 months post-intervention
- +5 more other outcomes
Study Arms (3)
Self Help plus
EXPERIMENTALFamilies assigned to this arm receive the World Health Organization's Self-Help Plus (SH+), a brief, group-based stress-management program for caregivers. The two primary caregivers in each family participate. SH+ is delivered by trained non-specialist facilitators using a standardized, audio-guided format with an illustrated self-help manual and structured group discussion. The program consists of five sessions (about two hours each), with at least three days between sessions.
Self-Help Plus + Interaction Competencies with Children - for Parents (SH+ + ICC-P)
EXPERIMENTALFamilies assigned to this arm receive SH+ first, followed by Interaction Competencies with Children for Parents (ICC-P). The two primary caregivers in each family participate. SH+ is delivered as described above (five group sessions, approximately two hours each, spaced at least three days apart, delivered by trained non-specialists using standardized audio-guided materials and an illustrated manual). After SH+ is completed, caregivers receive ICC-P, a participatory parenting program designed to strengthen positive, responsive caregiving and reduce harsh or violent discipline. ICC-P is delivered as three consecutive full training days plus one refresher training day six weeks later, following a manualized group format.
Usual Care (Control)
NO INTERVENTIONParticipants in this arm receive Usual Care (UC). At baseline, caregivers are provided with a standardized information leaflet describing existing mental health and psychosocial support services available in the refugee camp, including organization names, contact information, and types of services offered. No structured intervention is delivered as part of this arm.
Interventions
The Self-Help Plus (SH+) intervention is a stress management program developed by the World Health Organization (WHO). It is based on Acceptance and Commitment Therapy and designed for use in resource-limited and humanitarian settings. SH+ is delivered in five group sessions led by trained non-specialist facilitators using pre-recorded audio, structured manuals, and illustrated participant guides in Kiswahili. The program teaches practical skills for coping with stress and managing difficult thoughts and emotions. Each session lasts approximately two hours and includes individual reflection and guided group discussion.
ICC-P is a four-day, group-based intervention designed to strengthen positive parenting and reduce harsh or violent discipline. It combines theoretical input with practical exercises, group discussions, and role-playing. A refresher session is held six weeks later to reinforce learning and promote sustainability. Both interventions are delivered by trained facilitators under supervision to ensure fidelity.
Eligibility Criteria
You may qualify if:
- Families residing in Nyarugusu Refugee Camp, Tanzania
- Congolese refugee origin (for cultural and linguistic homogeneity)
- Two primary caregivers (one male, one female) aged 18 years or older, caring for at least two children aged 7-10 years
- Ability to speak and understand Kiswahili
- Willingness to provide informed consent (and child assent)
- No plans to leave the camp within the next 12 months
You may not qualify if:
- Caregivers currently enrolled in other mental health or parenting programs
- Caregivers displaying imminent suicide risk, psychosis, or severe cognitive impairment that would impede participation
- Children with known developmental disabilities reported by caregivers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Bielefeld Universitycollaborator
- University of Konstanzcollaborator
- Dar es Salaam University College of Educationcollaborator
- University of North Carolina, Charlottecollaborator
Study Sites (2)
Dar es Salaam University College of Education
Dar es Salaam, Dar es Salaam Region, Tanzania
Dar es Salaam University College of Education
Dar es Salaam, Dar es Salaam Region, Tanzania
Related Publications (2)
Kabelege E, Kirika A, Nkuba M, Hermenau K, Schreiber A, Hoeffler A, Hecker T. Improving Parent-Child Interaction and Reducing Parental Violent Discipline - a Multi-Informant Multi-Method Pilot Feasibility Study of a School-Based Intervention. J Fam Violence. 2025;40:799-810. doi: 10.1007/s10896-023-00679-4.
BACKGROUNDTol WA, Leku MR, Lakin DP, Carswell K, Augustinavicius J, Adaku A, Au TM, Brown FL, Bryant RA, Garcia-Moreno C, Musci RJ, Ventevogel P, White RG, van Ommeren M. Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial. Lancet Glob Health. 2020 Feb;8(2):e254-e263. doi: 10.1016/S2214-109X(19)30504-2.
PMID: 31981556BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors (enumerators) and data analysts will be blinded to group allocation. Enumerators conducting baseline, 3- and 12-month follow-up assessments will not be informed of participants' intervention assignment. Participants and facilitators cannot be blinded due to the nature of the psychosocial interventions (Self-Help Plus and Interaction Competencies with Children for Parents). Data analysts will work with datasets coded using neutral group labels, and unblinding will occur only after completion of the primary analyses.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2026
First Posted
March 4, 2026
Study Start
March 15, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
March 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Due to the sensitive nature of the data and the vulnerability of the study population, including refugee parents and children, individual participant data (IPD) will not be shared. Data privacy concerns and ethical constraints related to participant protection in a humanitarian setting prevent open sharing of de-identified datasets.