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)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Health; Functioning, Psychosocial; Parenting Behavior; Socio-emotional Well-being
• Intervention / Treatment: Behavioral: Self Help Plus; Behavioral: Interaction Competencies with Children - for Parents

• Study Type: Interventional
• Enrollment (Estimated): 1296
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Hall, PhD; Phone Number: +46709948737; Email: jonathan.hall@pcr.uu.se
• Study Contact Backup: Name: Sofia Nordenving; Phone Number: +46730555351; Email: sofia.nordenving@pcr.uu.se

Study Locations

• Tanzania
  • Dar es Salaam Region
    • Dar es Salaam, Dar es Salaam Region, Tanzania
      • Dar es Salaam University College of Education
      • Contact: Faustine Bwire Masath, PhD; Phone Number: +255 714 662 061; Email: faustine.masath@udsm.ac.tz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self Help plus; Families 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.	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.
Experimental: Self-Help Plus + Interaction Competencies with Children - for Parents (SH+ + ICC-P); Families 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.	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.
No Intervention: Usual Care (Control); Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 12-months post-intervention
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.	Baseline, 3 months post-intervention, and 12 months post-intervention
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.	Baseline, 3 months post-intervention, and 12 months post-intervention
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.	Baseline, 3 months post-intervention, and 12 months post-intervention
Anxiety (Generalized Anxiety Disorder 7-item scale, GAD-7)	Symptoms of generalized anxiety among caregivers will be assessed using the GAD-7. The 7 items rate frequency of core anxiety symptoms over the past two weeks on a scale from 0 ("not at all") to 3 ("nearly every day"). Higher scores indicate greater anxiety severity.	Baseline, 3 months post-intervention, and 12 months post-intervention
Post-traumatic stress symptoms (PTSD Checklist-Civilian Version, PCL-C)	Caregiver post-traumatic stress symptoms will be assessed with the 6-item PTSD Checklist-Civilian Version (PCL-C). Each symptom is rated on a 5-point scale from "not at all" to "extremely," with total scores ranging from 6 to 30. Higher scores indicate greater PTSD symptom severity.	Baseline, 3 months post-intervention, and 12 months post-intervention
Subjective wellbeing (WHO-5 Well-Being Index)	The WHO-5 Well-Being Index will assess caregivers' subjective wellbeing. It consists of five items rated from 0 ("at no time") to 5 ("all of the time") reflecting mood, vitality, and general interest. The total score (0-25) is multiplied by 4 to yield a final index ranging from 0 to 100, where higher scores indicate better wellbeing.	Baseline, 3 months post-intervention, and 12 months post-intervention
Functional impairment (WHO Disability Assessment Schedule 2.0, WHODAS-II)	Functional impairment among caregivers will be measured using the 15-item WHO Disability Assessment Schedule 2.0 (WHODAS-II). Items assess difficulties in understanding, mobility, self-care, interpersonal relationships, daily activities, and participation, scored from 0 ("none") to 4 ("extreme or cannot do"). Higher scores indicate greater functional impairment.	Baseline and 12 months post-intervention
Psychological flexibility (Acceptance and Action Questionnaire-II, AAQ-II)	Psychological flexibility will be measured using the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Items are rated on a 7-point Likert scale (1 = "never true," 7 = "always true"), and scores are reversed so that higher totals indicate greater psychological flexibility.	Baseline, 3 months post-intervention, and 12 months post-intervention
Positive parenting (Alabama Parenting Questionnaire - Positive Parenting Subscale)	Positive parenting practices will be measured using the 6-item Positive Parenting Subscale of the Alabama Parenting Questionnaire (APQ). Items assess the frequency of positive interactions between parents and children on a 5-point scale from "never" to "always," with higher scores indicating greater use of positive parenting behaviors.	Baseline, 3 months post-intervention, and 12 months post-intervention
Child-reported maltreatment (Child-Reported CTSPC)	Child-reported maltreatment will be assessed with a pictorial adaptation of the Parent-Child Conflict Tactics Scale (CTSPC). The instrument includes 22 items rated on a 7-point frequency scale for the past month; higher scores indicate more frequent maltreatment experiences.	Baseline and 12 months post-intervention
Child discipline/maltreatment (caregiver report): UNICEF MICS Child Discipline Module	Caregiver-reported child discipline will be assessed using the UNICEF Multiple Indicator Cluster Surveys (MICS) Child Discipline Module, which includes 11 yes/no items capturing both non-violent and violent discipline practices in the past month. Summary indices are derived from the item responses; higher values indicate more frequent use of harsh/violent discipline practices.	Baseline, 3 months post-intervention, and 12 months post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 12 months post-intervention
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.	Baseline and 12 months post-intervention
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.	Baseline and 12 months post-intervention
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.	Baseline and 12 months post-intervention
Sibling relationship quality	Quality of the relationship between the two participating siblings, assessed using an adapted 11-item version of the Dunn Sibling Relationship Questionnaire. The scale measures warmth, intimacy, conflict, and rivalry on a 5-point scale (1 = never to 5 = always). Each child reports on their relationship with the sibling who is also enrolled in the study. Higher scores on warmth and intimacy reflect more positive relationships, while higher conflict and rivalry indicate relational strain.	Baseline and 12 months post-intervention
Caregiver emotion recognition task (facial and vocal expressions)	Caregivers' 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.	Baseline and 12 months post-intervention
Intimate partner violence (DHS Domestic Violence Module)	Experiences of intimate partner violence among female caregivers will be assessed using the Domestic Violence Module from the Demographic and Health Surveys (DHS), adapted from the Conflict Tactics Scale. Items capture emotional, physical, and sexual violence and controlling behaviors. Higher frequency scores indicate greater exposure to violence.	Baseline and 12 months post-intervention
Alcohol use (Alcohol Use Disorders Identification Test, AUDIT)	Alcohol consumption among male caregivers will be measured using the 10-item Alcohol Use Disorders Identification Test (AUDIT) developed by the World Health Organization. Items assess alcohol consumption, dependence symptoms, and related problems on a 0-4 scale, yielding a total score between 0 and 40. Higher scores indicate hazardous or harmful drinking.	Baseline and 12 months post-intervention

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: University of Konstanz; Bielefeld University; Dar es Salaam University College of Education; University of North Carolina, Charlotte

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Tanzania; Mental health; Parenting; Refugees; Child development; Self-Help Plus; Interaction Competencies with Children - for Parents
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• Other Study ID Numbers: 2022-02476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No