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

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)

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).

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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