New peer-led program aims to lift fathers out of depression in kenya
NCT ID NCT06489314
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 3 times
Summary
This study tests a short, 5-session counseling program called LEAD for fathers in Kenya who have depression and drink alcohol. About 102 fathers will be randomly assigned to the program or a waitlist. The goal is to see if the program improves fathers' mental health, parenting, and their children's well-being.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 116 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male between the ages of 18-65; 2. Live with and be responsible for at least one child between the ages of 8 and 17 years of age; 3. Screen positive for depression symptoms, operationalized as a score 5 or above on the patient health questionnaire (PHQ-9); 4. Any reported alcohol use in the past 45 days measures with the AUDIT (score 1 or above); 5. 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; 6. Willingness for co-caregiver and target child to participate in assessments (previously piloted strategy). Exclusion Criteria: 1. Severe depression symptoms indicated a score above 19 on the PHQ-9; 2. Severe risk/likely alcohol dependence that warrants medical management indicated as a score 20 or above on the alcohol use disorder identification test (AUDIT); 3. Violent legal offenses (one question); 4. 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. 5. Inability to provide informed consent of complete procedures in Swahili or English; 6. serious mental illness (current or history). 7. Youth in age range not at risk for MH problems: No Score \<13 to 40 on the SDQ as reported by both caregivers
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Moi Teaching and Referral Hospital
Eldoret, 30100, Kenya
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Other studies related to the condition(s) this trial covers.
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