An Evaluation of a Family Counseling Intervention ("Tuko Pamoja") in Kenya: a Single Case Series Design

NCT03360201 | Completed

• 1 other identifier: 2017-0210 (4A)
• Study Type: interventional
• Target: 20
• 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 highly distressed families with a child or adolescent (ages 8-17) exhibiting emotional or behavioral concerns; as such, particular emphasis is placed on adolescent-focused outcomes, including mental health and well-being.

Conditions

Mental Health; 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

Keywords

Africa; Kenya; Family relations; Child mental health; Adolescent mental health; Family therapy; Program evaluation; Family Conflict; Marital Conflict; Domestic Violence; Parenting; Parent-Child Relations; child abuse; low- and middle-income country

Outcome Measures

Primary Outcomes (9)

• Family Functioning: Survey Measure (Change over time)

  30 self-report items developed for the local context based on formative research. Responses are endorsed on a 10-point scale and refer to the past month. One composite score is calculated; higher scores reflect better family functioning. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments.

  Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks

• Family Functioning: Direct Observation (Change over time)

  A direct observational measure in which families complete standardized video-recorded activities. Behaviors are then coded on multiple domains, including ones related to positive/negative interactions, quality of communication, and problem-solving ability. Primary analyses will be conducted with higher scores indicating better functioning.

  Baseline and 1 month post-intervention

• Parent-Child Relationship (Change over time)

  Parent-Child Relationship: from standardized scales and locally developed items. Items selected and adapted from: (1) Parental Acceptance and Rejection Questionnaire, (2) Multiple Indicators Cluster Survey: Discipline Module, (3) Discipline Interview, (4) Parent-Adolescent Communication Scale. Each include caregiver and child/adolescent report versions. Caregiver report includes 66 items; Child report includes 60 items. Participants are asked to respond based on the past month. Children report on each caregiver separately. For primary analyses, one composite score will be calculated. For follow-up analyses, subsets of items may be analyzed, including those related specifically to harsh treatment/abuse. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments.

  Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks

• Couples Relationship (Change over time)

  Locally-derived items and selected items adapted from standardized scales: Conflict Tactics Scale; Dyadic Adjustment Scale; additional locally-derived items. A total of 52 items are included, referring to both self and spouse behaviors. The majority of items are based on a frequency scale, referring to the past month; some items related to spousal maltreatment assess whether behaviors have ever occurred. As a primary outcome, responses across these items will be combined into one score. Follow-up analyses may be conducted using subsets of items to assess relationship quality and harsh treatment separately. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments.

  Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks

• Child / Adolescent Mental Health (Change over time)

  Items locally developed and adapted from standardized measures, including the Youth Self Report (YSR) and the Child Behavior Checklist (CBCL; for caregivers); locally-developed items assessed local terms reflecting symptoms, hope, prosocial behavior, risk behavior, and sense of belongingness. The majority of items reported on a 3-point scale (Not/Never True, Somewhat/Sometimes True, Very/Often True). Caregiver-report on child included 47 items; Child self-report included 56 items. A single composite score will be calculated, with potential follow-up analyses on subsets of items. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments.

  Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks

• Caregiver Mental Health (Change over time)

  Locally-developed items and items adapted from subscales of standardized measures, including: Patient Health Questionnaire, General Health Questionnaire. Caregivers self-report on 29 total items. One composite score will be calculated, and potential follow-up analyses may examine subsets of items. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments.

  Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks

• Self-defined "Top Problem": Family (Change over time)

  Each participant identifies the two highest priority problems related to their family that they would like the intervention to help with. Items assess how much each problem has bothered them in the past month. For repeated measures as part of the single case series design, these are also administered with participants reporting on the past 2-3 days.

  Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks

• Self-defined "Top Problem": Self (Change over time)

  Each participant identifies the highest priority problem related to themself that they would like the intervention to help with. An item assesses how much the problem has bothered them in the past month. For repeated measures as part of the single case series design, these are also administered with participants reporting on the past 2-3 days.

  Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks

• Self-defined "Top Problem": Child (Change over time)

  Each caregiver identifies the highest priority problem related to their child that they would like the intervention to help with. An item assesses how much the problem has bothered them in the past month. For repeated measures as part of the single case series design, these are also administered with participants reporting on the past 2-3 days.

  Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks

Secondary Outcomes (7)

• Counselor Implementation Outcomes

  Through study completion

• Material Resources: Household Assets/Consumption (Change over time)

  Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks

• Alcohol Use: Adult (Change over time)

  Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks

• Adolescent Risk Behavior (Change over time)

  Baseline and 1 month post-intervention

• Traumatic stress symptoms: Child/Adolescent (Change over time)

  Baseline and 1 month post-intervention

Study Arms (1)

Intervention: Tuko Pamoja

EXPERIMENTAL

The intervention, Tuko Pamoja, is 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. The content and structure has been adapted in both content and implementation model based on formative research in this context. Tuko Pamoja includes a smart phone component to support psychoeducation components and data collection.

Behavioral: Tuko Pamoja, "We are Together" in Kiswahili

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, Uasin Gishu County, Kenya

Location

MeSH Terms

Conditions

Psychological Well-Being; Neurodevelopmental Disorders; Child Behavior

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Mental Disorders

Study Officials

• Eve S Puffer, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will follow a single case (N of 1) series design. Pre-post changes will be measured, and repeated measures will be administered before, during, and following the intervention to track change over time. The timing of entry into the study and the numbers of repeated measures data points are randomized across families. Data analysis will aim to (a) identify patterns of change over the course of the intervention and (b) relate change trajectories to theorized mechanisms of action.

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: December 4, 2017
• Study Start: July 10, 2017
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

KE (1)