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

February 5, 2024 updated by: Duke University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya
        • Lumumba sub-County Hospital
      • Kisumu, Kenya
        • Kisumu County Referral Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Family Functioning: Survey Measure
Time Frame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
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
Time Frame: Baseline and 1 month post-intervention
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
Time Frame: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks

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

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

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

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Counselor Implementation Outcomes
Time Frame: Through study completion, approximately 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duke Center for Global Reproductive Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eve S Puffer, PhD, Duke University
  • Principal Investigator: Megan Huchko, MD, MPH, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-0183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parent-Child Relations

Clinical Trials on Tuko Pamoja

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings