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
- 20
- 试验地点
- 1
- 主要终点
- Family Functioning: Survey Measure (Change over time)
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 highly distressed families with a child or adolescent (ages 8-17) exhibiting emotional or behavioral concerns; as such, particular emphasis is placed on adolescent-focused outcomes, including mental health and well-being.
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 single case series 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 solution-focused family therapy 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, including positive well-being, with a particular emphasis on outcomes for children and adolescents.
The investigators also hypothesize feasibility and acceptability based on a previous evaluation of the program and are analyzing community-sourced practices used by lay counselors. Investigators hypothesize that they are integrating locally-grounded strategies that may influence the delivery or outcomes of the intervention.
The study will follow a single case series design with a sample size of 8 families, including up to 3 caregivers per family (who hold primary responsibility for the child whether biological or non-biological) and a target child identified through caregiver-report of the child about whom they are most concerned. This design will allow for tracking changes in outcome variables over time and for linking clinical changes to session content and delivery strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
Family Functioning: Survey Measure (Change over time)
时间窗: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
30 self-report items developed for the local context based on formative research. Responses are endorsed on a 10-point scale and refer to the past month. One composite score is calculated; higher scores reflect better family functioning. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments.
Couples Relationship (Change over time)
时间窗: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Locally-derived items and selected items adapted from standardized scales: Conflict Tactics Scale; Dyadic Adjustment Scale; additional locally-derived items. A total of 52 items are included, referring to both self and spouse behaviors. The majority of items are based on a frequency scale, referring to the past month; some items related to spousal maltreatment assess whether behaviors have ever occurred. As a primary outcome, responses across these items will be combined into one score. Follow-up analyses may be conducted using subsets of items to assess relationship quality and harsh treatment separately. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments.
Family Functioning: Direct Observation (Change over time)
时间窗: Baseline and 1 month post-intervention
A direct observational measure in which families complete standardized video-recorded activities. Behaviors are then coded on multiple domains, including ones related to positive/negative interactions, quality of communication, and problem-solving ability. Primary analyses will be conducted with higher scores indicating better functioning.
Parent-Child Relationship (Change over time)
时间窗: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Parent-Child Relationship: from standardized scales and locally developed items. Items selected and adapted from: (1) Parental Acceptance and Rejection Questionnaire, (2) Multiple Indicators Cluster Survey: Discipline Module, (3) Discipline Interview, (4) Parent-Adolescent Communication Scale. Each include caregiver and child/adolescent report versions. Caregiver report includes 66 items; Child report includes 60 items. Participants are asked to respond based on the past month. Children report on each caregiver separately. For primary analyses, one composite score will be calculated. For follow-up analyses, subsets of items may be analyzed, including those related specifically to harsh treatment/abuse. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments.
Child / Adolescent Mental Health (Change over time)
时间窗: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Items locally developed and adapted from standardized measures, including the Youth Self Report (YSR) and the Child Behavior Checklist (CBCL; for caregivers); locally-developed items assessed local terms reflecting symptoms, hope, prosocial behavior, risk behavior, and sense of belongingness. The majority of items reported on a 3-point scale (Not/Never True, Somewhat/Sometimes True, Very/Often True). Caregiver-report on child included 47 items; Child self-report included 56 items. A single composite score will be calculated, with potential follow-up analyses on subsets of items. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments.
Caregiver Mental Health (Change over time)
时间窗: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Locally-developed items and items adapted from subscales of standardized measures, including: Patient Health Questionnaire, General Health Questionnaire. Caregivers self-report on 29 total items. One composite score will be calculated, and potential follow-up analyses may examine subsets of items. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments.
Self-defined "Top Problem": Self (Change over time)
时间窗: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Each participant identifies the highest priority problem related to themself that they would like the intervention to help with. An item assesses how much the problem has bothered them in the past month. For repeated measures as part of the single case series design, these are also administered with participants reporting on the past 2-3 days.
Self-defined "Top Problem": Child (Change over time)
时间窗: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Each caregiver identifies the highest priority problem related to their child that they would like the intervention to help with. An item assesses how much the problem has bothered them in the past month. For repeated measures as part of the single case series design, these are also administered with participants reporting on the past 2-3 days.
Self-defined "Top Problem": Family (Change over time)
时间窗: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Each participant identifies the two highest priority problems related to their family that they would like the intervention to help with. Items assess how much each problem has bothered them in the past month. For repeated measures as part of the single case series design, these are also administered with participants reporting on the past 2-3 days.
次要结局
- Counselor Implementation Outcomes(Through study completion)
- Material Resources: Household Assets/Consumption (Change over time)(Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks)
- Alcohol Use: Adult (Change over time)(Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks)
- Extended family relationships (Change over time)(Baseline and 1 month post-intervention)
- Adolescent Risk Behavior (Change over time)(Baseline and 1 month post-intervention)
- Parent-Child Communication: Sex/HIV-Related (Change over time)(Baseline and 1 month post-intervention)
- Traumatic stress symptoms: Child/Adolescent (Change over time)(Baseline and 1 month post-intervention)