Mental Health Treatment to Improve Father Depression and Child Outcomes in Kenya
NCT Number: NCT06489314
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Father-Child Relations|Depression|Alcohol Use, Unspecified
Interventions: BEHAVIORAL: LEAD (Learn, Engage, Act, Dedicate)
Sponsor: New York State Psychiatric Institute
Collaborators: Moi Teaching and Referral Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 332
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2027-12-01
Locations: Moi Teaching and Referral Hospital, Eldoret, 30100, Kenya

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.

Primary Outcome Measures: Depression Symptoms, Patient Health Questionnaire (PHQ-9): a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression, previously validated and used in Kenya., Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
Secondary Outcome Measures: Type of Alcohol Use, AUDIT (Alcohol Use Disorders Identification Test): a simple and effective method of screening for unhealthy alcohol use, defined as risky or hazardous consumption or any alcohol use disorder. The AUDIT has been has been previously validated in Kenya., Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline|Gender Norms, Gender-Equitable Men (GEM) Scale: assesses men's beliefs about gender norms and gender roles. Higher scores correspond with more equitable gender views. This scale has been previously used in Kenya to measure inequitable attitudes, Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline|Disrupted Parenting, Alabama Parenting Questionnaire (APQ - Father Involvement Scale) (Adapted): The involvement subscale of the Alabama Parenting Questionnaire (APQ) assesses father level of participation in their child's life, such as father attendance at child activities or help with homework. Items have been adapted to enhance local acceptability, understandability, and completeness with minor adaptations and previously piloted in Eldoret, Kenya., Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline|Interparental Problems, Family Togetherness Scale (FTS): Interparental problems will be assessed with 25 items, such as "How often does your family have quarrels?" Items relate to issues of family structure, couple emotional climate, and couple communication. These items were locally developed (Puffer et al., 2018), and have been validated in the context. Scores are averaged by reporter (men reliability = 0.95; co-caregivers reliability = 0.96; Child reliability = 0.95), with higher scores indicating poorer family functioning in this study., Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline|Child Mental Health, Strengths and Difficulties Questionnaire (SDQ): The Strengths and Difficulties Questionnaire (SDQ) is a 25 item brief youth mental health screening questionnaire relevant to 3 to 17 year olds that has been validated for both caregiver and youth report. The measures assesses emotional symptoms (5 items); 2) conduct problems (5 items) ; 3) hyperactivity/inattention (5 items) ; 4) peer relationship problems (5 items); 5) prosocial behavior (5 items), as well as a total score (20 items. We will use the total item score. The SDQ has previously used in Kenya and Eldoret with good performance., Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
Other Outcome Measures: Treatment Engagement, engagement is defined as the percent of participant attendance these are sessions attended as scheduled or rescheduled. This will be tracked and logged by RA during treatment., through the treatment period, 2- 8 weeks after baseline|Activity Completion, RA's will code participants activity schedules that they complete as part of their treatment homework. Homework consists of scheduling activities that are pleasant, healthy or aligned with values. Schedules will be coded as the the percentage of positive activities they indicted that they would complete in the previous session as well as the frequency activities completed., through the treatment period, 2- 8 weeks after baseline|Positive Emotional Reinforcement, Positive emotion or positive reinforcement following activity completion will be assessed through the activities schedules completed as part of intervention homework. When reviewing homework in session, patient and counselor will discuss and write down the emotion felt after completing a scheduled activity. These schedules will coded by RA's following each treatment session for patient's report of what activities they completed and the emotion felt immediately after the completed activity. Emotions will be coded as 'positive' (e.g., proud, relief, mastery, pleasurable) or 'not positive' (e.g., boring, angry, frustrated) resulting in the percentage of positive emotion of completed activities., through the treatment period, 2- 8 weeks after baseline|Fidelity Checklist, All intervention sessions will be audiotaped; 20 percent of tapes will be transcribed, translated to English, and then reviewed by the PI and project coordinator. Fidelity ratings will be based on a previously piloted assessment of adherence and competency. A "fidelity score" will be calculated based on the proportion of key intervention components delivered as intended across sessions (Yes/No) as well as quality of delivery (1-4, 4 excellent)., through the treatment period, 2- 8 weeks after baseline|Retention, retention will be analyzed as the percentage of fathers: attending one session or more session, attending 75 percent of session or more, and those who dropped out of LEAD, through the treatment period, 2- 8 weeks after baseline|Participation, analyzed as the percentage of fathers who enroll in LEAD who are eligible and percent excluded due to ineligibility, through the treatment period, 2- 8 weeks after baseline|Feasibility of the Intervention and Implementation, 4-item feasibility of intervention measure. Scale 1-5 completely disagree to completely agree., 6-10 weeks after baseline|Acceptability (quantitative), 4-item acceptability of intervention measure. Scale 1-5 completely disagree to completely agree., 6-10 weeks after baseline|Appropriateness, 4-item measures assessing intervention appropriateness . Scale 1-5 completely disagree to completely agree., 6-10 weeks after baseline|General Counseling Competency, General clinical competency will be coded and rated using a previously adapted and piloted version of the ENhancing Assessment of Common Therapeutic factors (ENACT) rating scale using session recordings., through the treatment period, 2- 8 weeks after baseline