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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,296
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.
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.
Dar es Salaam University College of Education
Dar es Salaam, Dar es Salaam Region, Tanzania
Dar es Salaam University College of Education
Dar es Salaam, Dar es Salaam Region, Tanzania
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
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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention
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