Mental HealthC0058 (4A)NCT03360201
An Evaluation of a Family Counseling Intervention ("Tuko Pamoja") in Kenya: a Single Case Series Design
A study testing Tuko Pamoja, "We are Together" in Kiswahili in people with Mental Health and Family Relations, run by Duke University at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Family Relations, Family Conflict
- What is being tested?
- Tuko Pamoja, "We are Together" in Kiswahili
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteKenya
- Study dates
- 10 Jul 2017to 15 Dec 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Formative Study to Develop Culturally Valid Psychosocial Assessment Tools and Interventions to Promote Family Well-Being in Kenya - Part II
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.
Read the 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:
- 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)
- 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.
- Conditions
- Mental Health, Family Relations, Family Conflict, Child Mental Disorder, Adolescent - Emotional Problem, Adolescent Problem Behavior
- Being tested
- Tuko Pamoja, "We are Together" in Kiswahili
- 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
- Medical subject headings
- Psychological Well-Being, Neurodevelopmental Disorders, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuko Pamoja, "We are Together" in KiswahiliBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Tuko Pamoja | Experimental | 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. Receives: Behavioral: Tuko Pamoja, "We are Together" in Kiswahili |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Functioning: Survey Measure (Change over time)
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.
Measured: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Family Functioning: Direct Observation (Change over time)
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.
Measured: Baseline and 1 month post-intervention
Parent-Child Relationship (Change over time)
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.
Measured: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Couples Relationship (Change over time)
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.
Measured: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Child / Adolescent Mental Health (Change over time)
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.
Measured: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Caregiver Mental Health (Change over time)
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.
Measured: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Self-defined "Top Problem": Family (Change over time)
Each participant identifies the two highest priority problems related to their family that they would like the intervention to help with. Items assess how much each problem has bothered them in the past month. For repeated measures as part of the single case series design, these are also administered with participants reporting on the past 2-3 days.
Measured: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Self-defined "Top Problem": Self (Change over time)
Each participant identifies the highest priority problem related to themself that they would like the intervention to help with. An item assesses how much the problem has bothered them in the past month. For repeated measures as part of the single case series design, these are also administered with participants reporting on the past 2-3 days.
Measured: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Self-defined "Top Problem": Child (Change over time)
Each caregiver identifies the highest priority problem related to their child that they would like the intervention to help with. An item assesses how much the problem has bothered them in the past month. For repeated measures as part of the single case series design, these are also administered with participants reporting on the past 2-3 days.
Measured: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Secondary outcomes (7)
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.
Measured: Through study completion
Material Resources: Household Assets/Consumption (Change over time)
This measure includes an inventory of locally-relevant household assets and a measure of consumption and spending. For repeated measures as part of the single case series design, these are also administered with participants reporting on the past 2-3 days.
Measured: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Alcohol Use: Adult (Change over time)
AUDIT (Alcohol Use Disorders Identification Test) and locally-derived items; single items related to associated risk behaviors, such as other substance use, also included. Caregivers self-report on 37 items and spouse-report on 32 items. The majority of items are reported on a frequency Likert scale. Higher scores indicate higher severity.
For repeated measures as part of the single case series design, these are also administered with participants reporting on the past 2-3 days.
Measured: Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks
Adolescent Risk Behavior (Change over time)
Sexually active (Yes/No); Sex past month; Condom use; Number partners; Locally-derived items on peer influence related to risky behaviors
One risk behavior composite will be calculated, and subsets or single items may be analyzed in follow-up analyses.
Measured: Baseline and 1 month post-intervention
Traumatic stress symptoms: Child/Adolescent (Change over time)
CRIES (Children's Revised Impact of Events Scale), self-reported experience of traumatic stress symptoms over the past week; 8 items (frequency scale). Higher scores indicate higher severity. (These items will be administered if a child endorses 1 or more experiences on the UCLA trauma exposure scale, self-reported experience of traumatic events; 16 items(yes/no)).
Measured: Baseline and 1 month post-intervention
Parent-Child Communication: Sex/HIV-Related (Change over time)
Survey items assessing frequency (6 items) and quality (6 items) of sex/HIV-related communication. Higher scores indicate better communication.
Measured: Baseline and 1 month post-intervention
Extended family relationships (Change over time)
Locally-derived items on quality of relationships with both maternal and paternal extended family members, including positive and negative interactions, as well as any financial or logistical support received. Items are rated on a scale of 1-10. Caregivers report on 10 items; Children report on 6 items. Higher scores indicate better relationships.
Measured: Baseline and 1 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start10 Jul 2017
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Moi University
- Responsible party
- Sponsor
- Investigators
- Eve S Puffer, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360201
- Sponsor's protocol ID
- 2017-0210 (4A)
- Acronym
- C0058 (4A)
- Status last verified
- Jun 2024
- First submitted
- 1 Nov 2017
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No