Mental Health Treatment to Improve Father Depression and Child Outcomes in Kenya (NCT06489314) | Clinical Trial Compass
By InvitationNot Applicable
Mental Health Treatment to Improve Father Depression and Child Outcomes in Kenya
Kenya116 participantsStarted 2025-04-15
Plain-language 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 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.
Who can participate
Age range18 Years – 65 Years
SexMALE
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Inclusion criteria
✓. 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 criteria
✕. 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);
✕
What they're measuring
1
Depression Symptoms
Timeframe: Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
✕. 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