Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-13
Brief Title:
An Evaluation of a Family Counseling Intervention Tuko Pamoja in Kenya
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Formative Study to Develop Culturally Valid Psychosocial Assessment Tools and Interventions to Promote Family Well-Being in Kenya - Part II
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
C0058 4C
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 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
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 ie parent-child and couples functioning
2 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
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
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 ie parent-child and couples functioning
2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None