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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7+
SponsorUppsala University

About this 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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Self Help Plus

    Behavioral

    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.

  • Interaction Competencies with Children - for Parents

    Behavioral

    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.

Treatment groups

1,296 Participants
are divided into 3 treatment groups
Group A: Self Help plusExperimental treatment 1 intervention
Group B: Self-Help Plus + Interaction Competencies with Children - for Parents (SH+ + ICC-P)Experimental treatment 2 interventions
Group C: Usual Care (Control)No intervention 0 interventions

Trial outcomes

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.

Time frame
Baseline, 3 months post-intervention, and 12 months post-intervention

Secondary outcomes

1

Self-reported child emotional and behavioral functioning (Youth-adapted Pediatric Symptom Checklist-17, Y-PSC-17)

Mental health problems in children will be assessed using a youth self-report version of the Pediatric Symptom Checklist-17 (PSC-17), adapted for child administration with newly developed pictorial response aids. The measure includes 17 items rated on a 3-point scale (Never, Sometimes, Often; scored 0-2) and summed to a total score (0-34), with higher scores indicating greater emotional/behavioral difficulties. Subscale scores for internalizing, externalizing, and attention problems will also be derived and examined separately.

Time frame
Baseline and 12-months post-intervention
2

Child health-related quality of life (KINDL-R)

Children's health-related quality of life will be assessed using the revised KINDL questionnaire (KINDL-R), which measures well-being across six domains: physical, emotional, self-esteem, family, friends, and school. Both the 24-item child self-report (Kid-KINDL-R) and parent proxy versions will be used. Items are rated on a 5-point Likert scale, with higher scores indicating better quality of life.

Time frame
Baseline, 3 months post-intervention, and 12 months post-intervention
3

Psychological distress (Kessler Psychological Distress Scale, K6)

General psychological distress among caregivers will be assessed using the 6-item Kessler Psychological Distress Scale (K6). Items capture symptoms of anxiety and depression experienced during the past month. Each item is scored from 0 ("none of the time") to 4 ("all of the time"), with higher scores reflecting greater distress.

Time frame
Baseline, 3 months post-intervention, and 12 months post-intervention
4

Depression (Patient Health Questionnaire-9, PHQ-9)

Caregiver depression symptoms will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Items assess frequency of depressive symptoms during the past two weeks on a 4-point scale (0-3), with higher scores indicating greater severity of depression.

Time frame
Baseline, 3 months post-intervention, and 12 months post-intervention

Other outcomes

1

Emotion recognition task (facial and vocal expressions)

Children's ability to identify and interpret emotions will be measured using an emotion recognition task consisting of approximately 50 short video clips depicting facial and vocal expressions across nine emotions. Participants indicate the emotion and rate confidence in their judgment. Accuracy scores will be calculated, with higher scores reflecting better emotion recognition ability.

Time frame
Baseline and 12 months post-intervention
2

Executive functioning (Dimensional Change Card Sort, DCCS)

Children's cognitive flexibility and inhibitory control will be assessed using the Dimensional Change Card Sort (DCCS) task. Participants sort cards according to changing rules (e.g., by color or shape), measuring their ability to shift attention between tasks. Higher accuracy and faster reaction times indicate better executive functioning.

Time frame
Baseline and 12 months post-intervention
3

Theory of mind (false-belief tasks)

Children's theory of mind will be assessed using two standard false-belief tasks (surprise content and surprise outcome). These tasks evaluate the ability to understand that others may hold beliefs different from one's own. The proportion of correct responses indicates higher levels of theory of mind development.

Time frame
Baseline and 12 months post-intervention
4

Social preferences (incentivized experimental games)

Social preferences will be measured through an incentivized experimental dictator game slightly adapted from Benenson et al. (2007). The children are instructed to first select six stickers from a larger set of ten and then make a one-shot allocation decision, choosing how many stickers to keep for themselves and how many to give to an anonymous child living in the same village. The allocation is made privately by placing tokens into separate opaque bags for "keep" and "give," while the enumerator turns away. Children may give zero, some, or all tokens. This task is designed to capture basic prosocial sharing behavior in a developmentally appropriate manner.

Time frame
Baseline and 12 months post-intervention

Sponsors and contacts

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Uppsala University

Lead sponsor

Bielefeld University

Collaborator

University of Konstanz

Collaborator

Dar es Salaam University College of Education

Collaborator

University of North Carolina, Charlotte

Collaborator

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