Ignite Creation Date:
2024-07-17 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489314
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-25
Brief Title:
Mental Health Treatment to Improve Father Depression and Child Outcomes in Kenya
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
A Brief Task-shifted Treatment to Improve Father Depression and Child Outcomes in Kenya A Pilot Effectiveness-implementation Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The goal of this study is to evaluate the feasibility and acceptability of a peer-father counselor delivered psychosocial intervention for fathers at risk for depression and some alcohol use in Eldoret Kenya in a pilot randomized control trial RCT The study draws on existing partnerships with Moi Teaching and Referral Hospital MTRH and AMPATH a consortium of North American and Kenyan institution conducting research in Kenya It will also build on already completed preliminary work with AMPATHMTRH that showed proof-of-concept for Learn Engage Act Dedicate LEAD a 5-session task-shifted psychosocial intervention for fathers in Eldoret Kenya Proof-of-concept findings with nine fathers and families were promising with high participant satisfaction and improvements in father depression alcohol use parenting and child mental health This supported pursuit of a pilot RCT proposed here to explore preliminary effectiveness of LEAD and its implementation Specifically investigators aim to conduct a pilot RCT with fathers n102 randomized to either LEAD or a waitlist control group with treatment offered at the end of the waitlist period to explore change in fathers mental health MH explore drivers of change in father MH father parenting and child MH or non-response and explore the feasibility and acceptability of implementing a peer-father counselor delivered MH treatment for fathers Investigators will also refer all participants that screen positive for depression and alcohol use problems at recruitment the WL control and intervention group to services in the area using existing referral to care procedures
Detailed Description:
Investigators will conduct a pilot randomized control trial using an implementation-effectiveness Hybrid Type I design Fathers with depression n102 will be randomized to depression treatment LEAD or a wait list WL control at a rate of 21 LEAD will be offered to the WLC following treatment This is a pilot Aims focus on preliminary indicators of effectiveness and feasibility and acceptability implementation Data will inform a larger trial
The objective of this study is to conduct a pilot randomized control trial using an implementation-effectiveness Hybrid Type I design to explore improvements in father depression using a brief task-shifted intervention and explore implementation feasibility and acceptability Participants will be randomized to LEAD Learn Act Engage Dedicate a 5-session behavioral activation and motivational interviewing treatment or to a waitlist control group WL in Eldoret Kenya among men with depression symptoms WL participants will be offered treatment at their final assessment Fathers n102 will be randomized to treatment at a rate of 21 assessments will occur at baseline post treatment and 1 and 3 months post As part of Aim 1 investigators will explore changes between groups in father depression post-treatment as measured by the PHQ-9 as well as secondary outcomes of drinking parenting interparental problems and child mental health assessed among men a co-caregiver and one child with surveys Women n102 and children n102 will only report on themselves and family outcomes not father mental health The WL will receive all assessments at each timepoint and be monitored for safety rates of attrition will be tracked throughout as well as rates of those possibly pursuing care during the trial Next investigators will explore potential mechanisms of change on father depression and family and child outcomes using survey measures as well as qualitative data - both semi-structured interviews 1 month post with men and family participants n30 and transcript analysis n20 of men and families showing different patterns of response or non-response Lastly investigators will explore implementation feasibility and acceptability as measured by qualitative interviews assessing acceptability and barriersfacilitators to delivery including social determinant barriers such as economic hardship and brief surveys with providers 1-month after treatment as well as fidelity adherence to intervention steps coded from 20 of randomly selected session transcripts based on a previously developed and piloted adherence tool and participant retention and attendance
The objective of this study is to conduct a pilot randomized control trial using an implementation-effectiveness Hybrid Type I design to explore improvements in father depression using a brief task-shifted intervention and explore implementation feasibility and acceptability Participants will be randomized to LEAD Learn Act Engage Dedicate a 5-session behavioral activation and motivational interviewing treatment or to a waitlist control group WL in Eldoret Kenya among men with depression symptoms WL participants will be offered treatment at their final assessment Fathers n102 will be randomized to treatment at a rate of 21 assessments will occur at baseline post treatment and 1 and 3 months post As part of Aim 1 investigators will explore changes between groups in father depression post-treatment as measured by the PHQ-9 as well as secondary outcomes of drinking parenting interparental problems and child mental health assessed among men a co-caregiver and one child with surveys Women n102 and children n102 will only report on themselves and family outcomes not father mental health The WL will receive all assessments at each timepoint and be monitored for safety rates of attrition will be tracked throughout as well as rates of those possibly pursuing care during the trial Next investigators will explore potential mechanisms of change on father depression and family and child outcomes using survey measures as well as qualitative data - both semi-structured interviews 1 month post with men and family participants n30 and transcript analysis n20 of men and families showing different patterns of response or non-response Lastly investigators will explore implementation feasibility and acceptability as measured by qualitative interviews assessing acceptability and barriersfacilitators to delivery including social determinant barriers such as economic hardship and brief surveys with providers 1-month after treatment as well as fidelity adherence to intervention steps coded from 20 of randomly selected session transcripts based on a previously developed and piloted adherence tool and participant retention and attendance
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