An Evaluation of a Family Counseling Intervention ("Tuko Pamoja") in Kenya (C0058 (4C))

A Formative Study to Develop Culturally Valid Psychosocial Assessment Tools and Interventions to Promote Family Well-Being in Kenya - Part II

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.

Study Overview

• Status: Completed
• Conditions: Child Abuse; Parent-Child Relations; Parenting; Child Behavior; Child Mental Disorder; Domestic Violence; Family Relations; Family Conflict; Mental Health Issue; Adolescent - Emotional Problem; Adolescent Problem Behavior; Marital Conflict
• Intervention / Treatment: Behavioral: Tuko Pamoja, "We are Together" in Kiswahili

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Eldoret, Kenya
    • Moi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Tuko Pamoja; The intervention, Tuko Pamoja, is in-home family counseling 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 including family systems and 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 based on formative research in this context. Tuko Pamoja is manualized and includes a tablet-based manual material and video content to support psychoeducation components and data collection.	Behavioral: Tuko Pamoja, "We are Together" in Kiswahili; Tuko Pamoja, "We are Together" in Kiswahili; This 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. Tuko Pamoja includes a smart phone component to support psychoeducation components and data collection. The content and structure has been adapted in both content and implementation model based on formative research in this context.
No Intervention: Control; Waitlist control (will receive the in-home counseling after the final data collection point)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family Functioning (Caregiver and Child Report)	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.	Baseline, 1 month, and 3 month post-intervention
Parent-Child Communication (Caregiver and Child Report)	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.	Baseline, 1 month, and 3 month post-intervention
Parent-Child Relationship Quality (Caregiver and Child Report)	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.	Baseline, 1 month, and 3 month post-intervention
Harsh Parenting (Caregiver and Child Report)	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.	Baseline, 1 month, and 3 month post-intervention
Couples Relationship Quality (Caregiver Report)	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.	Baseline, 1 month, and 3 month post-intervention
Child Mental Health (Caregiver Report)	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.	Baseline, 1 month, and 3 month post-intervention
Child Mental Health (Child Report)	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.	Baseline, 1 month, and 3 month post-intervention
Caregiver Mental Health (Caregiver Report)	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.	Baseline, 1 month, and 3 month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Maltreatment (Caregiver and Child Report)	2 items from the Multiple Indicator Cluster Survey (MICS) and 2 items from the Discipline Interview. One composite score is calculated (range: 0 - 12); higher scores represent more physical maltreatment.	Baseline, 1 month, and 3 month post-intervention
Couples Violence (Caregiver Report)	3 locally-developed items. One composite score is calculated (range: 0 - 12); higher scores represent more couples violence.	Baseline, 1 month, and 3 month post-intervention
Child Belongingness in Family (Child Report)	5 locally-developed items. One composite score is calculated (range: 0 - 10); higher scores represent more child belongingness in the family.	Baseline, 1 month, and 3 month post-intervention
Child Hope (Child Report)	6 self-report items from the Children's Hope Scale. One composite score is calculated (range: 6 - 36); higher scores represent higher hope levels.	Baseline, 1 month, and 3 month post-intervention
Child Prosocial Behavior (Caregiver and Child Report)	6 locally-developed items. One composite score is calculated (range: 0 - 12); higher scores represent more prosocial behaviors.	Baseline, 1 month, and 3 month post-intervention
Caregiver Hope (Caregiver Report)	12 self-report items from the Children's Hope Scale. One composite score is calculated (range: 6 - 48); higher scores represent higher hope levels.	Baseline, 1 month, and 3 month post-intervention
Social Support (Caregiver Report)	28 self-report items from the Inventory of Socially Supportive Behaviors (ISSB), 12 self-report items from the Multidimensional Scale of Perceived Social Support (MSPSS), and 7 locally-developed items. One composite score is calculated (range: 29 - 147); higher scores represent more social support.	Baseline, 1 month, and 3 month post-intervention
Child Well-being (Child Report)	7 self-report items from the Short Warwick Edinburgh Well-being Scale. One composite score is calculated (range: 7 - 35); higher scores represent better child well-being.	Baseline, 1 month, and 3 month post-intervention
Adult Well-being (Adult Report)	7 self-report items from the Short Warwick Edinburgh Well-being Scale. One composite score is calculated (range: 7 - 35); higher scores represent better adult well-being.	Baseline, 1 month, and 3 month post-intervention
Caregiver Coping (Caregiver Report)	28 self-report items from the Brief-COPE. One composite score is calculated (range: 28 - 112); higher scores represent better coping skills.	Baseline, 1 month, and 3 month post-intervention

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Moi University

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): June 25, 2023
• Study Completion (Actual): June 25, 2023

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: 2017-0210 (4C)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No