Functioning, Psychosocial, Mental Health, Parenting Behavior, Socio-emotional Well-being
Conditions
Keywords
Mental health, Child development, Parenting, Refugees, Self-Help Plus, Interaction Competencies with Children - for Parents, Tanzania
Brief summary
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
BEHAVIORALSelf 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.
BEHAVIORALInteraction 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.
Sponsors
Uppsala University
Bielefeld University
University of Konstanz
Dar es Salaam University College of Education
University of North Carolina, Charlotte
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors (enumerators) and data analysts will be blinded to group allocation. Enumerators conducting baseline, 3- and 12-month follow-up assessments will not be informed of participants' intervention assignment. Participants and facilitators cannot be blinded due to the nature of the psychosocial interventions (Self-Help Plus and Interaction Competencies with Children for Parents). Data analysts will work with datasets coded using neutral group labels, and unblinding will occur only after completion of the primary analyses.
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver-reported child emotional and behavioral functioning (Pediatric Symptom Checklist-17, PSC-17) | Baseline, 3 months post-intervention, and 12 months post-intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported child emotional and behavioral functioning (Youth-adapted Pediatric Symptom Checklist-17, Y-PSC-17) | Baseline and 12-months post-intervention | 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. |
| Child health-related quality of life (KINDL-R) | Baseline, 3 months post-intervention, and 12 months post-intervention | 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. |
| Psychological distress (Kessler Psychological Distress Scale, K6) | Baseline, 3 months post-intervention, and 12 months post-intervention | 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. |
| Depression (Patient Health Questionnaire-9, PHQ-9) | Baseline, 3 months post-intervention, and 12 months post-intervention | 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. |
| Anxiety (Generalized Anxiety Disorder 7-item scale, GAD-7) | Baseline, 3 months post-intervention, and 12 months post-intervention | 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. |
| Post-traumatic stress symptoms (PTSD Checklist-Civilian Version, PCL-C) | Baseline, 3 months post-intervention, and 12 months post-intervention | 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. |
| Subjective wellbeing (WHO-5 Well-Being Index) | Baseline, 3 months post-intervention, and 12 months post-intervention | 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. |
| Functional impairment (WHO Disability Assessment Schedule 2.0, WHODAS-II) | Baseline and 12 months post-intervention | 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. |
| Psychological flexibility (Acceptance and Action Questionnaire-II, AAQ-II) | Baseline, 3 months post-intervention, and 12 months post-intervention | 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. |
| Positive parenting (Alabama Parenting Questionnaire - Positive Parenting Subscale) | Baseline, 3 months post-intervention, and 12 months post-intervention | 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. |
| Child-reported maltreatment (Child-Reported CTSPC) | Baseline and 12 months post-intervention | 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. |
| Child discipline/maltreatment (caregiver report): UNICEF MICS Child Discipline Module | Baseline, 3 months post-intervention, and 12 months post-intervention | 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. |
Countries
Tanzania
Contacts
CONTACTJonathan Hall, PhD
CONTACTSofia Nordenving
Outcome results
None listed