CompletedNot Applicable

An Evaluation of a Family Counseling Intervention ("Tuko Pamoja") in Kenya: a Single Case Series Design

Kenya20 participantsStarted 2017-07-10

Plain-language 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.

Who can participate

Age range

8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Family Functioning: Survey Measure (Change over time)

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

Family Functioning: Direct Observation (Change over time)

Timeframe: Baseline and 1 month post-intervention

Parent-Child Relationship (Change over time)

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

Couples Relationship (Change over time)

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

Child / Adolescent Mental Health (Change over time)

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

Caregiver Mental Health (Change over time)

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

Trial details

NCT IDNCT03360201

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-15

View on ClinicalTrials.gov More Mental Health trials

Plain-language summary

Who can participate

Age range

8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Family Functioning: Survey Measure (Change over time)

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

Family Functioning: Direct Observation (Change over time)

Timeframe: Baseline and 1 month post-intervention

Parent-Child Relationship (Change over time)

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

Couples Relationship (Change over time)

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

Child / Adolescent Mental Health (Change over time)

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

Caregiver Mental Health (Change over time)

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