Clinical trial NCT06417918: An Evaluation of a Family Counseling Intervention ("Tuko Pamoja") in Kenya
Official title: A Formative Study to Develop Culturally Valid Psychosocial Assessment Tools and Interventions to Promote Family Well-Being in Kenya - Part II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Family Relations
Family Conflict
Child Mental Disorder
Adolescent - Emotional Problem
Adolescent Problem Behavior
Child Behavior
Child Abuse
Marital Conflict
Domestic Violence
Parent-Child Relations
Parenting
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Moi University
First posted: 2024-05-16
Enrollment: 240
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. 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)
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Family Functioning (Caregiver and Child Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Parent-Child Communication (Caregiver and Child Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Parent-Child Relationship Quality (Caregiver and Child Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Harsh Parenting (Caregiver and Child Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Couples Relationship Quality (Caregiver Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Child Mental Health (Caregiver Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Child Mental Health (Child Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Caregiver Mental Health (Caregiver Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
Secondary outcomes:
measure: Physical Maltreatment (Caregiver and Child Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Couples Violence (Caregiver Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Child Belongingness in Family (Child Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Child Hope (Child Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Child Prosocial Behavior (Caregiver and Child Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Caregiver Hope (Caregiver Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Social Support (Caregiver Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Child Well-being (Child Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Adult Well-being (Adult Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
measure: Caregiver Coping (Caregiver Report)
timeFrame: Baseline, 1 month, and 3 month post-intervention
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Moi University
Study officials:
References: