SMART Africa: Addressing African Youth Mental Health by Scaling Family and Community-Level EBPs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,117
- 试验地点
- 5
- 主要终点
- Child impairment
研究概览
简要总结
The objective of this research study is to examine the implementation of and outcomes associated with an evidence-based practice (EBP), specifically Multiple Family Group (MFG) targeting youth disruptive behavior challenges and success, through a scale up intervention study in Uganda, and two pilot studies that will be conducted in Kenya and Ghana.
详细描述
A longitudinal experimental mixed methods effectiveness-implementation hybrid research design will be employed. The study will be conducted across thirty primary schools representing both semi-urban and rural communities. We expect to involve 3,000 youth (in primary schools grades 2 through 7; 8 to 13 years) and their adult caregivers (3,000) in Uganda, 180 youth and their caregivers (180) in Ghana, and 180 youth and their caregivers (180) in Kenya.
Schools will be randomly assigned to 3 study conditions: 1) MFG-delivered by trained family peers; 2) MFG-delivered by community health workers (school health education program coordinators in Ghana); or, 3) Comparison: mental health and school support materials (e.g., books, uniforms). Data will be collected at baseline, 8 and 16 weeks, and 6 months follow-up (10 months from baseline).
More specifically the objectives of this study are:
Primary objectives
- To examine short- and long-term outcomes associated with the MFG. Hypothesis: Children in the treatment groups (MFG) will improve significantly more compared to those in the comparison (usual care) group.
- To examine how systematic variations in the delivery of an evidence-based MFG program impacts outcomes for children with behavioral difficulties and their caregivers in each country context.
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 (Participant)
入排标准
- 年龄范围
- 8 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for caregiver/child dyads:
- •Adult caregiver of a child in primary school, grades two through 7, ages 8 to 13 years
- •Adult caregiver willing to consent and available for research and intervention activities
- •Child between the ages 8 to 13 or in primary school (grades two through seven) who is screened for ODD or CD as measured by the Disruptive Behavior Disorder Rating Scale, Impairment Scale, and Iowa Conners Scale.
- •Child willing to assent.
- •Inclusion criteria for parent peers:
- •Caregivers of children who agree to be trained to provide support to families.
- •Inclusion criteria for community health workers
- •Lay paraprofessionals who work within primary care settings.
- •Inclusion criteria for school directors
- •Directors who oversee schools where the proposed intervention will have been tested.
排除标准
- •Exclusion criteria for caregiver/child dyads:
- •Lack of understanding of study and study procedures as determined by the research team
- •Child or caregiver refusal to participate
- •Exclusion criteria for parent peers:
- •Refusal to participate
- •Exclusion criteria for community health workers
- •Refusal to participate
- •Exclusion criteria for school directors
- •Refusal to participate
结局指标
主要结局
Child impairment
时间窗: baseline, 8 weeks, 16 weeks, 6 months
Change in disruptive behavior will be measured Impairment scale
Child disruptive behavior
时间窗: baseline, 8 weeks, 16 weeks, 6 months
Change in disruptive behavior will be measured by Iowa Connors
次要结局
- Sustainability(8 weeks, 16 weeks, 6 months)
- Child self-concept(baseline, 8 weeks, 16 weeks, 6 months)
- Implementation and Feasibility(8 weeks, 16 weeks, 6 months)
- Implementation process(8 weeks, 16 weeks, 6 months)
- Caregiver depression(baseline, 8 weeks, 16 weeks, 6 months)
- Child mental health(baseline, 8 weeks, 16 weeks, 6 months)
- Fidelity(end of session at week 1, week 2, week 3, week 4, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16)
- Caregiver stress(baseline, 8 weeks, 16 weeks, 6 months)
- Parenting(baseline, 8 weeks, 16 weeks, 6 months)
- Social support(baseline, 8 weeks, 16 weeks, 6 months)
- Caregiver mental health(baseline, 8 weeks, 16 weeks, 6 months)
- Child depression(baseline, 8 weeks, 16 weeks, 6 months)
- Family relations(baseline, 8 weeks, 16 weeks, 6 months)
研究者
Fred Ssewamala
Professor
Washington University School of Medicine