Clinical Trials Directory

Trials / Completed

CompletedNCT06417918

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
240 (actual)
Sponsor
Duke University · Academic / Other
Sex
All
Age
8 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTuko Pamoja, "We are Together" in KiswahiliTuko 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.

Timeline

Start date
2023-01-09
Primary completion
2023-06-25
Completion
2023-06-25
First posted
2024-05-16
Last updated
2025-03-07

Locations

1 site across 1 country: Kenya

Source: ClinicalTrials.gov record NCT06417918. Inclusion in this directory is not an endorsement.