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

NCT06417918 | Completed

• 1 other identifier: 2017-0210 (4C)
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (10)

• 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 Belongingness in Family (Child 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

Study Arms (2)

Intervention: Tuko Pamoja

EXPERIMENTAL

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

Control

NO INTERVENTION

Waitlist control (will receive the in-home counseling after the final data collection point)

Interventions

Tuko Pamoja, "We are Together" in Kiswahili BEHAVIORAL

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.

Intervention: Tuko Pamoja

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Moi University: collaborator

Study Sites (1)

Moi University

Eldoret, Kenya

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders; Child Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Duke Center for Global Mental Health; Associate Professor, Psychology and Neuroscience and Global Health

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: January 9, 2023
• Primary Completion: June 25, 2023
• Study Completion: June 25, 2023
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)