A Formative Study to Develop Culturally Valid Psychosocial Assessment Tools and Interventions to Promote Family Well-Being in Kenya - Part II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Harsh Parenting (Caregiver and Child Report)
研究概览
简要总结
The purpose of this study is to evaluate a family counseling intervention, entitled "Tuko Pamoja" (Translation "We are Together" in Kiswahili). The intervention, delivered by lay counselors and through existing community social structures, is expected to improve family functioning and individual mental health among members. The sample includes families with a child or adolescent (ages 8-17) experiencing problems in family functioning.
详细描述
The purpose of this study is to evaluate a family counseling intervention, entitled "Tuko Pamoja" (Translation "We are Together" in Kiswahili), using a pilot randomized control trial design.
The intervention, delivered by lay counselors and through existing community social structures, focuses on improving family relationships and mental health with content derived from evidence-based practices; these include family systems and solution-focused family therapies and cognitive behavioral strategies. It is components based, with modules delivered based on need. The content and structure has been adapted in both content and implementation model based on formative research in this context. Primary hypotheses include achieving improvements in outcomes related to:
- Family functioning, including elements such as communication, emotional closeness, structure and organization, and satisfaction for the overall family; this also includes indicators of functioning at dyadic levels (i.e., parent-child and couples functioning)
- Mental health of both children and caregivers.
The investigators also hypothesize feasibility and acceptability, including high fidelity and adequate clinical competency by the non-specialist counselors, based on a previous evaluation of the program.
The study will follow a randomized controlled design with a target sample size of 60 families, including up to 2 caregivers per family (who hold primary responsibility for the child whether biological or non-biological) and a target child identified either through caregiver-report of the child about whom they are most concerned or randomly, if there is no child with particular concerns. Families will be recruited in two rounds of 30 families due to logistical limitations of enrolling all 60 at the same time.
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
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Family with self-reported elevated distress (e.g., high levels of conflict) that also has a child/adolescent (ages 8-17) with caregiver-reported emotional or behavioral concerns
排除标准
- •Families without reported distress and/or without reported adolescent distress.
- •Families with children older than 17 or younger than 8 years of age.
- •Families in which primary caregivers or children are living too far outside of the community to participate in treatment.
结局指标
主要结局
Harsh Parenting (Caregiver and Child Report)
时间窗: Baseline, 1 month, and 3 month post-intervention
15 self-report items from the Parent Adolescent Relationship Questionnaire (PARQ) Hostility/Aggression Subscale. One composite score is calculated (range: 0 - 45); higher scores represent more harsh parenting characteristics.
Child Mental Health (Caregiver Report)
时间窗: Baseline, 1 month, and 3 month post-intervention
20 self-report items from the Child Behavior Checklist (CBCL) and 6 locally-developed items. One composite score is calculated (range: 20 - 60); higher scores represent worse child mental health.
Parent-Child Communication (Caregiver and Child Report)
时间窗: Baseline, 1 month, and 3 month post-intervention
20 self-report items from the Parent-Adolescent Communication Scale (PACS). Each include caregiver and child/adolescent report versions. Participants are asked to respond based on the past month. Children report on each caregiver separately. One composite score is calculated (range: 0 - 60); higher scores represent better parent-child communication.
Parent-Child Relationship Quality (Caregiver and Child Report)
时间窗: Baseline, 1 month, and 3 month post-intervention
20 self-report items from the Parent Adolescent Relationship Questionnaire (PARQ) Warmth Subscale. One composite score is calculated (range: 0 - 60); higher scores represent better parent-child relationship quality.
Couples Relationship Quality (Caregiver Report)
时间窗: Baseline, 1 month, and 3 month post-intervention
13 self-report items from the Dyadic Adjustment Scale (DAS) Cohesion and Satisfaction subscales and 9 locally-developed items. One composite score is calculated (range: 22 - 132); higher scores represent better couples relationship quality.
Caregiver Mental Health (Caregiver Report)
时间窗: Baseline, 1 month, and 3 month post-intervention
9 self-report items from the Patient Health Questionnaire (PHQ-9), 14 self-report items from the General Health Questionnaire (GHQ), and 6 locally-developed items. One composite score is calculated (range: 0 - 87); higher scores represent worse caregiver mental health.
Family Functioning (Caregiver and Child Report)
时间窗: Baseline, 1 month, and 3 month post-intervention
30 self-report items developed for the local context based on formative research (Family Togetherness Scale, FTS). Responses are endorsed on a 10-point scale and refer to the past month. One composite score is calculated (range: 0 - 30); higher scores represent more family distress.
Child Mental Health (Child Report)
时间窗: Baseline, 1 month, and 3 month post-intervention
19 self-report items from the Youth Self-Report (YSR) and 7 locally-developed items. One composite score is calculated (range: 0 - 52); higher scores represent worse child mental health.
次要结局
- Social Support (Caregiver Report)(Baseline, 1 month, and 3 month post-intervention)
- Physical Maltreatment (Caregiver and Child Report)(Baseline, 1 month, and 3 month post-intervention)
- Couples Violence (Caregiver Report)(Baseline, 1 month, and 3 month post-intervention)
- Child Hope (Child Report)(Baseline, 1 month, and 3 month post-intervention)
- Child Prosocial Behavior (Caregiver and Child Report)(Baseline, 1 month, and 3 month post-intervention)
- Caregiver Hope (Caregiver Report)(Baseline, 1 month, and 3 month post-intervention)
- Child Belongingness in Family (Child Report)(Baseline, 1 month, and 3 month post-intervention)
- Adult Well-being (Adult Report)(Baseline, 1 month, and 3 month post-intervention)
- Child Well-being (Child Report)(Baseline, 1 month, and 3 month post-intervention)
- Caregiver Coping (Caregiver Report)(Baseline, 1 month, and 3 month post-intervention)
研究者
Eve Puffer
Director, Duke Center for Global Mental Health; Associate Professor, Psychology and Neuroscience and Global Health
Duke University