Moi Teaching and Referral Hospital
Eldoret, 30100, Kenya
NCT Number: NCT06489314
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
Male
Interventional
Not applicable
Eldoret, 30100, Kenya
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 or a wait list (WL) control at a rate of 2:1. LEAD will be offered to the WLC following treatment. This is a pilot. Aims focus on preliminary indicators of effectiveness and feasibility and acceptability (implementation). Data will inform a larger trial.
The objective of this study is to conduct a pilot randomized control trial using an implementation-effectiveness Hybrid Type I design to explore improvements in father depression using a brief, task-shifted intervention and explore implementation feasibility and acceptability. Participants will be randomized to LEAD (Learn, Act, Engage, Dedicate), a 5-session behavioral activation and motivational interviewing treatment, or to a waitlist control group (WL) in Eldoret, Kenya among men with depression symptoms (WL participants will be offered treatment at their final assessment). Fathers (n=102) will be randomized to treatment at a rate of 2:1; assessments will occur at baseline, post treatment, and 1 and 3 months post. As part of Aim 1, investigators will explore changes between groups in father depression post-treatment as measured by the PHQ-9, as well as secondary outcomes of drinking, parenting, interparental problems, and child mental health assessed among men, a co-caregiver, and one child with surveys (Women (n=102) and children (n=102) will only report on themselves and family outcomes not father mental health). The WL will receive all assessments at each timepoint and be monitored for safety; rates of attrition will be tracked throughout as well as rates of those possibly pursuing care during the trial. Next, investigators will explore potential mechanisms of change on father depression and family and child outcomes using survey measures as well as qualitative data - both semi-structured interviews 1 month post with men and family participants (n=30) and transcript analysis (n=20) of men and families showing different patterns of response or non-response. Lastly, investigators will explore implementation feasibility and acceptability as measured by qualitative interviews assessing acceptability and barriers/facilitators to delivery, including social determinant barriers such as economic hardship, and brief surveys with providers 1-month after treatment, as well as fidelity (adherence to intervention steps), coded from 20% of randomly selected session transcripts based on a previously developed and piloted adherence tool, and participant retention and attendance.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LEAD is a 5-session behavioral activation (BA) intervention delivered by peer-father counselors. LEAD also incorporates motivational interviewing (MI) and masculinity discussion strategies. This is a task-shifted intervention meaning mental health service tasks are delegated to non-specialist providers, in this case peer-fathers, as opposed to a specialized workforce (e.g., psychiatrists, psychologists).
Time frame: Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
Patient Health Questionnaire (PHQ-9): a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression, previously validated and used in Kenya.
Time frame: Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
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.
Time frame: Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
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.
Time frame: Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
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.
Time frame: Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
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.
Time frame: through the treatment period, 2- 8 weeks after baseline
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.
Time frame: through the treatment period, 2- 8 weeks after baseline
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).
Time frame: through the treatment period, 2- 8 weeks after baseline
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
Time frame: through the treatment period, 2- 8 weeks after baseline
analyzed as the percentage of fathers who enroll in LEAD who are eligible and percent excluded due to ineligibility
Time frame: 6-10 weeks after baseline
4-item feasibility of intervention measure. Scale 1-5 completely disagree to completely agree.
Time frame: 6-10 weeks after baseline
4-item acceptability of intervention measure. Scale 1-5 completely disagree to completely agree.
Time frame: through the treatment period, 2- 8 weeks after baseline
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.
Florida International University
Other
A Brief, Task-shifted Treatment to Improve Father Depression and Child Outcomes in Kenya: A Pilot Effectiveness-implementation Trial
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