Clinical trial NCT06257927: Evaluating the Implementation of a Family Therapy Intervention ("Tuko Pamoja") Delivered Through Sexual and Reproductive Healthcare Settings
Official title: Evaluating the Implementation of a Family Therapy Intervention ("Tuko Pamoja") Delivered Through Sexual and Reproductive Healthcare Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Conflict
Family Dysfunctional
Adolescent Behavior
Child Behavior
Marital Conflict
Domestic Violence
Parent-Child Relations
Keywords: Kenya
Family Therapy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Center for Global Reproductive Health
First posted: 2024-02-14
Enrollment: 23
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: This study aims to contribute to the evidence base related to effective interventions for families in low-resource settings who are experiencing conflict and difficulties in relationships that affect child and caregiver well being alike. Results of this study will (a) inform whether a family therapy approach is feasible and promising in communities in and surrounding Kisumu, Kenya and (b) inform how family wellbeing and mental health can be integrated within the sexual reproductive health service points through culturally-valid ways in this context.

Main Objective: To pilot test the implementation of a family therapy intervention (Tuko Pamoja) in collaboration with two sexual and reproductive healthcare settings in Kisumu, Kenya. Specific Objective: To pilot test the Tuko Pamoja family therapy intervention to assess feasibility, acceptability, and preliminary effectiveness.


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
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
measure: Family Functioning: Direct Observation
timeFrame: Baseline and 1 month post-intervention
measure: Parent-Child Relationship
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
measure: Couples Relationship
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
measure: Child / Adolescent Mental Health
timeFrame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
measure: Caregiver Mental Health
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, approximately 6 months
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kisumu County Referral Hospital
city: Kisumu
country: Kenya
facility: Lumumba Sub-County Hospital
Study officials:
affiliation: Duke University
name: Eve S Puffer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Megan Huchko, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: