Clinical trial NCT06489314: Mental Health Treatment to Improve Father Depression and Child Outcomes in Kenya
Official title: A Brief, Task-shifted Treatment to Improve Father Depression and Child Outcomes in Kenya: A Pilot Effectiveness-implementation Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Father-Child Relations
Depression
Alcohol Use, Unspecified
Keywords: Randomized Control Trial
Hybrid-Type 1 Trial
Depression
Alcohol Use
Peer Counseling
Task-Shifting
Fathers
Youth Mental Health
Kenya
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: Moi Teaching and Referral Hospital
First posted: 2024-07-05
Enrollment: 332
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid type-1 waitlist control pilot trial. Fathers at risk for depression will be randomized randomized 2:1 to the intervention or waitlist. All participants will receive referrals to treatment at usual at baseline. Waitlist participants will be offered the intervention at the completion of their assessments.
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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 above 5 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Type of Alcohol Use
timeFrame: Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
measure: Gender Norms
timeFrame: Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
measure: Disrupted Parenting
timeFrame: Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
measure: Interparental Problems
timeFrame: Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
measure: Child Mental Health
timeFrame: Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
Other outcomes:
measure: Treatment Engagement
timeFrame: through the treatment period, 2- 8 weeks after baseline
measure: Activity Completion
timeFrame: through the treatment period, 2- 8 weeks after baseline
measure: Positive Emotional Reinforcement
timeFrame: through the treatment period, 2- 8 weeks after baseline
measure: Fidelity Checklist
timeFrame: through the treatment period, 2- 8 weeks after baseline
measure: Retention
timeFrame: through the treatment period, 2- 8 weeks after baseline
measure: Participation
timeFrame: through the treatment period, 2- 8 weeks after baseline
measure: Feasibility of the Intervention and Implementation
timeFrame: 6-10 weeks after baseline
measure: Acceptability (quantitative)
timeFrame: 6-10 weeks after baseline
measure: Appropriateness
timeFrame: 6-10 weeks after baseline
measure: General Counseling Competency
timeFrame: through the treatment period, 2- 8 weeks after baseline
Locations:
city: Eldoret
country: Kenya
facility: Moi Teaching and Referral Hospital
Study officials:
affiliation: Florida International University
name: Ali Giusto, PhD
role: PRINCIPAL_INVESTIGATOR
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