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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,296
- 试验地点
- 1
- 主要终点
- Caregiver-reported child emotional and behavioral functioning (Pediatric Symptom Checklist-17, PSC-17)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Self Help Plus (Behavioral)
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.
干预措施: Self Help Plus (Behavioral)
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.
干预措施: Interaction Competencies with Children - for Parents (Behavioral)
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.
结局指标
主要结局
Caregiver-reported child emotional and behavioral functioning (Pediatric Symptom Checklist-17, PSC-17)
时间窗: 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.
次要结局
- Self-reported child emotional and behavioral functioning (Youth-adapted Pediatric Symptom Checklist-17, Y-PSC-17)(Baseline and 12-months post-intervention)
- Child health-related quality of life (KINDL-R)(Baseline, 3 months post-intervention, and 12 months post-intervention)
- Psychological distress (Kessler Psychological Distress Scale, K6)(Baseline, 3 months post-intervention, and 12 months post-intervention)
- Depression (Patient Health Questionnaire-9, PHQ-9)(Baseline, 3 months post-intervention, and 12 months post-intervention)
- Anxiety (Generalized Anxiety Disorder 7-item scale, GAD-7)(Baseline, 3 months post-intervention, and 12 months post-intervention)
- Post-traumatic stress symptoms (PTSD Checklist-Civilian Version, PCL-C)(Baseline, 3 months post-intervention, and 12 months post-intervention)
- Subjective wellbeing (WHO-5 Well-Being Index)(Baseline, 3 months post-intervention, and 12 months post-intervention)
- Functional impairment (WHO Disability Assessment Schedule 2.0, WHODAS-II)(Baseline and 12 months post-intervention)
- Psychological flexibility (Acceptance and Action Questionnaire-II, AAQ-II)(Baseline, 3 months post-intervention, and 12 months post-intervention)
- Positive parenting (Alabama Parenting Questionnaire - Positive Parenting Subscale)(Baseline, 3 months post-intervention, and 12 months post-intervention)
- Child-reported maltreatment (Child-Reported CTSPC)(Baseline and 12 months post-intervention)
- Child discipline/maltreatment (caregiver report): UNICEF MICS Child Discipline Module(Baseline, 3 months post-intervention, and 12 months post-intervention)