Status:
ENROLLING_BY_INVITATION
Mental Health Treatment to Improve Father Depression and Child Outcomes in Kenya
Lead Sponsor:
Florida International University
Collaborating Sponsors:
Moi Teaching and Referral Hospital
Conditions:
Father-Child Relations
Depression
Eligibility:
MALE
18-65 years
Phase:
NA
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 Eldore...
Detailed Description
Investigators will conduct a pilot randomized control trial using an implementation-effectiveness Hybrid Type I design. Fathers with depression (n=102) will be randomized to depression treatment LEAD ...
Eligibility Criteria
Inclusion
- Male between the ages of 18-65;
- Live with and be responsible for at least one child between the ages of 8 and 17 years of age;
- Screen positive for depression symptoms, operationalized as a score above 5 on the patient health questionnaire (PHQ-9);
- Any reported alcohol use in the past 45 days measures with the AUDIT (score 1 or above);
- Child at risk of mental health issues as indicated by a score above 13 on the Strengths and Difficulties Questionnaire (SDQ) reported on by any caregiver;
- Willingness for co-caregiver and target child to participate in assessments (previously piloted strategy).
Exclusion
- Severe depression symptoms indicated a score above 19 on the PHQ-9;
- Severe risk/likely alcohol dependence that warrants medical management indicated as a score 20 or above on the alcohol use disorder identification test (AUDIT);
- Violent legal offenses (one question);
- Indicators of severe violence at home assessed with key items from the Conflict Tactics Scale (CTS), following previously used criteria. If any couple member answers yes (related to the father) to either of the following items: "punched or hit my partner with something that could hurt" and "kicked my partner," couples will be excluded. Couple members who answer yes to any of the following items: "I/he used a knife or gun on my partner/me," "I/he choked my partner/me," "I/he slammed my partner/me against a wall," "I/he beat up my partner/me," "I/he burned or scalded my partner/me on purpose," will be excluded.
- Inability to provide informed consent of complete procedures in Swahili or English;
- serious mental illness (current or history).
- Youth in age range not at risk for MH problems: No Score \<13 to 40 on the SDQ as reported by both caregivers
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06489314
Start Date
April 15 2025
End Date
December 1 2027
Last Update
December 11 2025
Active Locations (1)
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1
Moi Teaching and Referral Hospital
Eldoret, Kenya, 30100