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

Parenting Clinical Trial

— C0058 (4C)  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06417918
• Other study ID #: 2017-0210 (4C)
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: Eve S Puffer, PhD
• Phone: (919) 381-2494
• Email: eve.puffer[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent - Emotional Problem
• Adolescent Problem Behavior
• Child Abuse
• Child Behavior
• Child Mental Disorder
• Domestic Violence
• Family Conflict
• Family Relations
• Marital Conflict
• Mental Disorders
• Mental Health Issue
• Neurodevelopmental Disorders
• Parent-Child Relations
• Parenting
• Problem Behavior

Intervention

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.

Locations

Country	Name	City	State
Kenya	Moi University	Eldoret

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Moi University

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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