## Protocol Section
### Identification Module
**NCT ID:** NCT06417918

**Acronym:** C0058 (4C)

**Brief Title:** An Evaluation of a Family Counseling Intervention ("Tuko Pamoja") in Kenya: a Pilot Randomized Controlled Trial

**Official Title:** A Formative Study to Develop Culturally Valid Psychosocial Assessment Tools and Interventions to Promote Family Well-Being in Kenya - Part II

#### Organization Study ID Info
**ID:** 2017-0210 (4C)
#### Organization
**Class:** OTHER
**Full Name:** Duke University
### Status Module
#### Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Moi University

#### Lead Sponsor

**Class:** OTHER

**Name:** Duke University

#### Responsible Party

**Investigator Affiliation:** Duke University

**Investigator Full Name:** Eve Puffer

**Investigator Title:** Director, Duke Center for Global Mental Health; Associate Professor, Psychology and Neuroscience and Global Health

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 randomized controlled trial with a sample size of 80 families, including up to 2 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.

### Conditions Module

**Conditions:**

- Mental Health Issue

- 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

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized Controlled Trial

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 240

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

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

**Label:** Intervention: Tuko Pamoja

**Type:** EXPERIMENTAL

#### Arm Group 2

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention: Tuko Pamoja

**Description:** 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.

**Name:** Tuko Pamoja, "We are Together" in Kiswahili

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 30 self-report items developed for the local context based on formative research (Family Togetherness Scale, FTS). 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.

**Measure:** Family Functioning (Change over time)

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

**Description:** 20 self-report items from the Parent-Adolescent Communication Scale (PACS). Each include caregiver and child/adolescent report versions. 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.

**Measure:** Parent-Child Communication (Change over time)

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

**Description:** 20 self-report items from the Parent Adolescent Relationship Questionnaire (PARQ) Warmth Subscale. 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.

**Measure:** Parent-Child Relationship Quality (Change over time)

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

**Description:** 15 self-report items from the Parent Adolescent Relationship Questionnaire (PARQ) Hostility/Aggression Subscale. 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.

**Measure:** Harsh Parenting (Change over time)

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

**Description:** 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. 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.

**Measure:** Couples Relationship Quality (Change over time)

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

**Description:** Items locally developed and adapted from standardized measures, including the Brief Problem Monitor (BPM) and 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). 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.

**Measure:** Child Mental Health (Change over time)

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

**Description:** 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.

**Measure:** Caregiver Mental Health (Change over time)

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

#### Secondary Outcomes

**Description:** Four items from the Multiple Indicator Cluster Survey (MICS). Participants reported frequency of (a) beating with an object and (b) spanking/slapping/hitting in the past 2 months using a 4-point scale from "never" (0) to "many times" (3)." 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.

**Measure:** Physical Maltreatment

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

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Minimum Age:** 8 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** eve.puffer@duke.edu

**Name:** Eve S Puffer, PhD

**Phone:** (919) 381-2494

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Eldoret

**Contacts:**

***Contact 1:***

- **Name:** Florence Jaguga, MBChB, MMed

- **Role:** CONTACT

**Country:** Kenya

**Facility:** Moi University

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4815

- Name: Mental Disorders

- Relevance: HIGH

- As Found: Mental Disorders

- ID: M85

- Name: Problem Behavior

- Relevance: HIGH

- As Found: Problem Behavior

- ID: M30644

- Name: Neurodevelopmental Disorders

- Relevance: HIGH

- As Found: Child Mental Disorder

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001523

- Term: Mental Disorders

- ID: D000066553

- Term: Problem Behavior

- ID: D000065886

- Term: Neurodevelopmental Disorders

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
