Evaluating the Implementation of a Family Therapy Intervention ("Tuko Pamoja") Delivered Through Sexual and Reproductive Healthcare Settings

Adolescent Behavior Clinical Trial

Official title:

Evaluating the Implementation of a Family Therapy Intervention ("Tuko Pamoja") Delivered Through Sexual and Reproductive Healthcare Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06257927
• Other study ID #: 2023-0183
• Status: Completed
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 31, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Child Behavior
• Domestic Violence
• Family Conflict
• Family Dysfunctional
• Marital Conflict
• Parent-Child Relations

Intervention

Behavioral:
• Tuko Pamoja
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.

Locations

Country	Name	City	State
Kenya	Kisumu County Referral Hospital	Kisumu
Kenya	Lumumba Sub-County Hospital	Kisumu

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Duke Center for Global Reproductive Health

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Family Functioning: Survey Measure	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
Primary	Family Functioning: Direct Observation	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
Primary	Parent-Child Relationship	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
Primary	Couples Relationship	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
Primary	Child / Adolescent Mental Health	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
Primary	Caregiver Mental Health	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
Secondary	Counselor Implementation Outcomes	This measure will assess feasibility, acceptability, and quality of delivery model.; Fidelity (Checklists, session transcript analysis) Lay counselor competency (session transcript ratings; Adapted ENACT), including counselor use of community practices (session transcript analysis); A composite score will be calculated, and follow-up analyses may examine subsets of items dividing fidelity and competency scores.	Through study completion, approximately 6 months