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Mental Health Treatment to Improve Father Depression and Child Outcomes in Kenya

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date changed from estimate of Jul 1, 2026 to Jul 14, 2026
    • Eligibility criteria expanded, about 1 word
    v9
  2. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Primary completion date: Dec 1, 2026 to Jul 1, 2026
    • Secondary endpoints: 5 to 4
    v8
  3. Enrollment target: 332 to 116
    • Primary completion date: Jun 1, 2026 to Dec 1, 2026
    • Study completion date: Sep 6, 2027 to Dec 1, 2027
    v7
  4. Primary completion date: Dec 1, 2026 to Jun 1, 2026
    • Study completion date: Dec 1, 2027 to Sep 6, 2027
    v6
  5. Start date changed from estimate of May 1, 2025 to Apr 15, 2025v5
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  1. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date: Jun 1, 2025 to May 1, 2025
    • Site contact updated
    v4
  2. Start date: Dec 1, 2024 to Jun 1, 2025v3
  3. Lead sponsor: New York State Psychiatric Institute to Florida International Universityv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 AMPATH/MTRH 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 (n=102) 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.
Trial Details
NCT Number NCT06489314
Lead Sponsor Florida International University
Collaborators: Moi Teaching and Referral Hospital
Conditions
(from sponsor)		 Father-Child Relations, Depression, Alcohol Use, Unspecified
Related terms Alcohol Drinking, Depression
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov