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Completed

NCT Number: NCT06417918

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

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.

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Key information

Conditions

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

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moi University

Eldoret, Kenya

About this study

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:

  • 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)
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Family Functioning (Caregiver and Child Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    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.

  2. Parent-Child Communication (Caregiver and Child Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    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.

  3. Parent-Child Relationship Quality (Caregiver and Child Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    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.

  4. Harsh Parenting (Caregiver and Child Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    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.

  5. Couples Relationship Quality (Caregiver Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    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.

  6. Child Mental Health (Caregiver Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    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.

  7. Child Mental Health (Child Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    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.

  8. Caregiver Mental Health (Caregiver Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    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.

Secondary outcomes

  1. Physical Maltreatment (Caregiver and Child Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    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.

  2. Couples Violence (Caregiver Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    3 locally-developed items. One composite score is calculated (range: 0 - 12); higher scores represent more couples violence.

  3. Child Belongingness in Family (Child Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    5 locally-developed items. One composite score is calculated (range: 0 - 10); higher scores represent more child belongingness in the family.

  4. Child Hope (Child Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    6 self-report items from the Children's Hope Scale. One composite score is calculated (range: 6 - 36); higher scores represent higher hope levels.

  5. Child Prosocial Behavior (Caregiver and Child Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    6 locally-developed items. One composite score is calculated (range: 0 - 12); higher scores represent more prosocial behaviors.

  6. Caregiver Hope (Caregiver Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    12 self-report items from the Children's Hope Scale. One composite score is calculated (range: 6 - 48); higher scores represent higher hope levels.

  7. Social Support (Caregiver Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    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.

  8. Child Well-being (Child Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    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.

  9. Adult Well-being (Adult Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    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.

  10. Caregiver Coping (Caregiver Report)

    Time frame: Baseline, 1 month, and 3 month post-intervention

    28 self-report items from the Brief-COPE. One composite score is calculated (range: 28 - 112); higher scores represent better coping skills.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Moi University

Registry information

Official study title

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

Acronym: C0058 (4C)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 16, 2024
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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