Clinical trial NCT03360201: An Evaluation of a Family Counseling Intervention ("Tuko Pamoja") in Kenya: a Single Case Series Design
Official title: A Formative Study to Develop Culturally Valid Psychosocial Assessment Tools and Interventions to Promote Family Well-Being in Kenya - Part II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Moi University
First posted: 2017-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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 single case series 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 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. 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, including positive well-being, with a particular emphasis on outcomes for children and adolescents.

The investigators also hypothesize feasibility and acceptability based on a previous evaluation of the program and are analyzing community-sourced practices used by lay counselors. Investigators hypothesize that they are integrating locally-grounded strategies that may influence the delivery or outcomes of the intervention.

The study will follow a single case series design with a sample size of 8 families, including up to 3 caregivers per family (who hold primary responsibility for the child whether biological or non-biological) and a target child identified through caregiver-report of the child about whom they are most concerned. This design will allow for tracking changes in outcome variables over time and for linking clinical changes to session content and delivery strategies.

Eligibility criteria: 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.

Primary outcomes:
measure: Family Functioning: Survey Measure (Change over time)
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
measure: Family Functioning: Direct Observation (Change over time)
timeFrame: Baseline and 1 month post-intervention
measure: Parent-Child Relationship (Change over time)
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
measure: Couples Relationship (Change over time)
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
measure: Child / Adolescent Mental Health (Change over time)
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
measure: Caregiver Mental Health (Change over time)
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
measure: Self-defined "Top Problem": Family (Change over time)
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
measure: Self-defined "Top Problem": Self (Change over time)
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
measure: Self-defined "Top Problem": Child (Change over time)
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Secondary outcomes:
measure: Counselor Implementation Outcomes
timeFrame: Through study completion
measure: Material Resources: Household Assets/Consumption (Change over time)
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
measure: Alcohol Use: Adult (Change over time)
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
measure: Adolescent Risk Behavior (Change over time)
timeFrame: Baseline and 1 month post-intervention
measure: Traumatic stress symptoms: Child/Adolescent (Change over time)
timeFrame: Baseline and 1 month post-intervention
measure: Parent-Child Communication: Sex/HIV-Related (Change over time)
timeFrame: Baseline and 1 month post-intervention
measure: Extended family relationships (Change over time)
timeFrame: Baseline and 1 month post-intervention
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Moi University
state: Uasin Gishu County
Study officials:
affiliation: Duke University
name: Eve S Puffer, PhD
role: PRINCIPAL_INVESTIGATOR
References: