Mental Health IssueC0058 (4C)NCT06417918
An Evaluation of a Family Counseling Intervention ("Tuko Pamoja") in Kenya
A study testing Tuko Pamoja, "We are Together" in Kiswahili in people with Mental Health Issue 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 Issue, Family Relations, Family Conflict
- What is being tested?
- Tuko Pamoja, "We are Together" in Kiswahili
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteKenya
- Study dates
- 9 Jan 2023to 25 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 families with a child or adolescent (ages 8-17) experiencing problems in family functioning.
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 pilot randomized control trial 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 family systems and solution-focused family therapies 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.
The investigators also hypothesize feasibility and acceptability, including high fidelity and adequate clinical competency by the non-specialist counselors, based on a previous evaluation of the program.
The study will follow a randomized controlled design with a target sample size of 60 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 either through caregiver-report of the child about whom they are most concerned or randomly, if there is no child with particular concerns. Families will be recruited in two rounds of 30 families due to logistical limitations of enrolling all 60 at the same time.
- Conditions
- Mental Health Issue, Family Relations, Family Conflict, Child Mental Disorder, Adolescent - Emotional Problem, Adolescent Problem Behavior
- Being tested
- Tuko Pamoja, "We are Together" in Kiswahili
- Medical subject headings
- 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 in-home family counseling 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 including family systems and 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 based on formative research in this context. Tuko Pamoja is manualized and includes a tablet-based manual material and video content to support psychoeducation components and data collection. Receives: Behavioral: Tuko Pamoja, "We are Together" in Kiswahili |
| Control | No intervention | Waitlist control (will receive the in-home counseling after the final data collection point) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Functioning (Caregiver and Child Report)
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 (range: 0 - 30); higher scores represent more family distress.
Measured: Baseline, 1 month, and 3 month post-intervention
Parent-Child Communication (Caregiver and Child Report)
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. One composite score is calculated (range: 0 - 60); higher scores represent better parent-child communication.
Measured: Baseline, 1 month, and 3 month post-intervention
Parent-Child Relationship Quality (Caregiver and Child Report)
20 self-report items from the Parent Adolescent Relationship Questionnaire (PARQ) Warmth Subscale. One composite score is calculated (range: 0 - 60); higher scores represent better parent-child relationship quality.
Measured: Baseline, 1 month, and 3 month post-intervention
Harsh Parenting (Caregiver and Child Report)
15 self-report items from the Parent Adolescent Relationship Questionnaire (PARQ) Hostility/Aggression Subscale. One composite score is calculated (range: 0 - 45); higher scores represent more harsh parenting characteristics.
Measured: Baseline, 1 month, and 3 month post-intervention
Couples Relationship Quality (Caregiver Report)
13 self-report items from the Dyadic Adjustment Scale (DAS) Cohesion and Satisfaction subscales and 9 locally-developed items. One composite score is calculated (range: 22 - 132); higher scores represent better couples relationship quality.
Measured: Baseline, 1 month, and 3 month post-intervention
Child Mental Health (Caregiver Report)
20 self-report items from the Child Behavior Checklist (CBCL) and 6 locally-developed items. One composite score is calculated (range: 20 - 60); higher scores represent worse child mental health.
Measured: Baseline, 1 month, and 3 month post-intervention
Child Mental Health (Child Report)
19 self-report items from the Youth Self-Report (YSR) and 7 locally-developed items. One composite score is calculated (range: 0 - 52); higher scores represent worse child mental health.
Measured: Baseline, 1 month, and 3 month post-intervention
Caregiver Mental Health (Caregiver Report)
9 self-report items from the Patient Health Questionnaire (PHQ-9), 14 self-report items from the General Health Questionnaire (GHQ), and 6 locally-developed items. One composite score is calculated (range: 0 - 87); higher scores represent worse caregiver mental health.
Measured: Baseline, 1 month, and 3 month post-intervention
Secondary outcomes (10)
Physical Maltreatment (Caregiver and Child Report)
2 items from the Multiple Indicator Cluster Survey (MICS) and 2 items from the Discipline Interview. One composite score is calculated (range: 0 - 12); higher scores represent more physical maltreatment.
Measured: Baseline, 1 month, and 3 month post-intervention
Couples Violence (Caregiver Report)
3 locally-developed items. One composite score is calculated (range: 0 - 12); higher scores represent more couples violence.
Measured: Baseline, 1 month, and 3 month post-intervention
Child Belongingness in Family (Child Report)
5 locally-developed items. One composite score is calculated (range: 0 - 10); higher scores represent more child belongingness in the family.
Measured: Baseline, 1 month, and 3 month post-intervention
Child Hope (Child Report)
6 self-report items from the Children's Hope Scale. One composite score is calculated (range: 6 - 36); higher scores represent higher hope levels.
Measured: Baseline, 1 month, and 3 month post-intervention
Child Prosocial Behavior (Caregiver and Child Report)
6 locally-developed items. One composite score is calculated (range: 0 - 12); higher scores represent more prosocial behaviors.
Measured: Baseline, 1 month, and 3 month post-intervention
Caregiver Hope (Caregiver Report)
12 self-report items from the Children's Hope Scale. One composite score is calculated (range: 6 - 48); higher scores represent higher hope levels.
Measured: Baseline, 1 month, and 3 month post-intervention
Social Support (Caregiver Report)
28 self-report items from the Inventory of Socially Supportive Behaviors (ISSB), 12 self-report items from the Multidimensional Scale of Perceived Social Support (MSPSS), and 7 locally-developed items. One composite score is calculated (range: 29 - 147); higher scores represent more social support.
Measured: Baseline, 1 month, and 3 month post-intervention
Child Well-being (Child Report)
7 self-report items from the Short Warwick Edinburgh Well-being Scale. One composite score is calculated (range: 7 - 35); higher scores represent better child well-being.
Measured: Baseline, 1 month, and 3 month post-intervention
Adult Well-being (Adult Report)
7 self-report items from the Short Warwick Edinburgh Well-being Scale. One composite score is calculated (range: 7 - 35); higher scores represent better adult well-being.
Measured: Baseline, 1 month, and 3 month post-intervention
Caregiver Coping (Caregiver Report)
28 self-report items from the Brief-COPE. One composite score is calculated (range: 28 - 112); higher scores represent better coping skills.
Measured: Baseline, 1 month, and 3 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 posted16 May 2024
- Study start9 Jan 2023
- Primary completion25 Jun 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Moi University
- Responsible party
- Principal investigator, Eve Puffer, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417918
- Sponsor's protocol ID
- 2017-0210 (4C)
- Acronym
- C0058 (4C)
- Status last verified
- Mar 2025
- First submitted
- 13 May 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Formative Study to Develop Culturally Valid Psychosocial Assessment Tools and Interventions to Promote Family Well-Being in Kenya - Part II
- ClinicalTrials.gov ID
- NCT06417918
- Acronym / sponsor ID
- C0058 (4C) / 2017-0210 (4C)
- Conditions
- Mental Health Issue, Family Relations, Family Conflict, Child Mental Disorder, Adolescent - Emotional Problem, Adolescent Problem Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Moi University
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 families with a child or adolescent (ages 8-17) experiencing problems in family functioning.
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 pilot randomized control trial 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 family systems and solution-focused family therapies 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.
The investigators also hypothesize feasibility and acceptability, including high fidelity and adequate clinical competency by the non-specialist counselors, based on a previous evaluation of the program.
The study will follow a randomized controlled design with a target sample size of 60 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 either through caregiver-report of the child about whom they are most concerned or randomly, if there is no child with particular concerns. Families will be recruited in two rounds of 30 families due to logistical limitations of enrolling all 60 at the same time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention: Tuko Pamoja | Experimental | Behavioral: Tuko Pamoja, "We are Together" in KiswahiliThe intervention, Tuko Pamoja, is in-home family counseling 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 including family systems and 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 based on formative research in this context. Tuko Pamoja is manualized and includes a tablet-based manual material and video content to support psychoeducation components and data collection. |
| Control | No intervention | –Waitlist control (will receive the in-home counseling after the final data collection point) |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuko Pamoja, "We are Together" in KiswahiliTuko 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. | Behavioural | Intervention: Tuko Pamoja |
Primary outcome
Family Functioning (Caregiver and Child Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
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 (range: 0 - 30); higher scores represent more family distress.
Parent-Child Communication (Caregiver and Child Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
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. One composite score is calculated (range: 0 - 60); higher scores represent better parent-child communication.
Parent-Child Relationship Quality (Caregiver and Child Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
20 self-report items from the Parent Adolescent Relationship Questionnaire (PARQ) Warmth Subscale. One composite score is calculated (range: 0 - 60); higher scores represent better parent-child relationship quality.
Harsh Parenting (Caregiver and Child Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
15 self-report items from the Parent Adolescent Relationship Questionnaire (PARQ) Hostility/Aggression Subscale. One composite score is calculated (range: 0 - 45); higher scores represent more harsh parenting characteristics.
Couples Relationship Quality (Caregiver Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
13 self-report items from the Dyadic Adjustment Scale (DAS) Cohesion and Satisfaction subscales and 9 locally-developed items. One composite score is calculated (range: 22 - 132); higher scores represent better couples relationship quality.
Child Mental Health (Caregiver Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
20 self-report items from the Child Behavior Checklist (CBCL) and 6 locally-developed items. One composite score is calculated (range: 20 - 60); higher scores represent worse child mental health.
Child Mental Health (Child Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
19 self-report items from the Youth Self-Report (YSR) and 7 locally-developed items. One composite score is calculated (range: 0 - 52); higher scores represent worse child mental health.
Caregiver Mental Health (Caregiver Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
9 self-report items from the Patient Health Questionnaire (PHQ-9), 14 self-report items from the General Health Questionnaire (GHQ), and 6 locally-developed items. One composite score is calculated (range: 0 - 87); higher scores represent worse caregiver mental health.
10 secondary outcomes
Physical Maltreatment (Caregiver and Child Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
Couples Violence (Caregiver Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
Child Belongingness in Family (Child Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
Child Hope (Child Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
Child Prosocial Behavior (Caregiver and Child Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
Caregiver Hope (Caregiver Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
Social Support (Caregiver Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
Child Well-being (Child Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
Adult Well-being (Adult Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
Caregiver Coping (Caregiver Report)
Time frame: Baseline, 1 month, and 3 month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuko Pamoja, "We are Together" in Kiswahili in people with Mental Health Issue and Family Relations, run by Duke University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Functioning (Caregiver and Child Report) (time frame: Baseline, 1 month, and 3 month post-intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.