Combining Mental Health and Parenting Interventions to Improve Child Wellbeing Among Refugee Families in Tanzania

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).

Conditions

• Mental Health
• Socio-emotional Well-being
• Functioning, Psychosocial
• Parenting Behavior

Interventions

BEHAVIORAL

Self Help Plus

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.

BEHAVIORAL

Interaction Competencies with Children - for Parents

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.

Sponsors & Collaborators

• Bielefeld University

  collaborator OTHER

• University of Konstanz

  collaborator OTHER

• Dar es Salaam University College of Education

  collaborator UNKNOWN

• University of North Carolina, Charlotte

  collaborator OTHER

• Uppsala University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-15

Primary Completion

2027-07-31

Completion

2027-07-31

Countries

• Tanzania

Study Locations