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

Official title

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)

Overview

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).

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 tho
• 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.

Primary outcome measures

• Caregiver-reported child emotional and behavioral functioning (Pediatric Symptom Checklist-17, PSC-17) [Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention]

Secondary outcome measures (12)

• Self-reported child emotional and behavioral functioning (Youth-adapted Pediatric Symptom Checklist-17, Y-PSC-17) [Time frame: Baseline and 12-months post-intervention]
• Child health-related quality of life (KINDL-R) [Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention]
• Psychological distress (Kessler Psychological Distress Scale, K6) [Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention]
• Depression (Patient Health Questionnaire-9, PHQ-9) [Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention]
• Anxiety (Generalized Anxiety Disorder 7-item scale, GAD-7) [Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention]
• Post-traumatic stress symptoms (PTSD Checklist-Civilian Version, PCL-C) [Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention]
• Subjective wellbeing (WHO-5 Well-Being Index) [Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention]
• Functional impairment (WHO Disability Assessment Schedule 2.0, WHODAS-II) [Time frame: Baseline and 12 months post-intervention]
• Psychological flexibility (Acceptance and Action Questionnaire-II, AAQ-II) [Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention]
• Positive parenting (Alabama Parenting Questionnaire - Positive Parenting Subscale) [Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention]
• Child-reported maltreatment (Child-Reported CTSPC) [Time frame: Baseline and 12 months post-intervention]
• Child discipline/maltreatment (caregiver report): UNICEF MICS Child Discipline Module [Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Tanzania · 2 centers

• Dar es Salaam University College of Education — Dar es Salaam
• Dar es Salaam University College of Education — Dar es Salaam

Publications

• 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.
• Tol 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 31981556

Identifiers

NCT: NCT07447921 · 2022-02476

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗