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NCT Number: NCT06489314

Mental Health Treatment to Improve Father Depression and Child Outcomes in Kenya

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Moi Teaching and Referral Hospital

Eldoret, 30100, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 5 or above 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);
  • Violent legal offenses (one question);
  • 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

Treatment and study plan

LEAD (Learn, Engage, Act, Dedicate)

Behavioral

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).

Primary outcomes

  1. Depression Symptoms

    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.

Secondary outcomes

  1. Type of Alcohol Use

    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.

  2. Disrupted Parenting

    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.

  3. Interparental Problems

    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.

  4. Child Mental Health

    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.

Other outcomes

  1. Treatment Engagement

    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.

  2. Fidelity Checklist

    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).

  3. Retention

    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

  4. Participation

    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

  5. Feasibility of the Intervention and Implementation

    Time frame: 6-10 weeks after baseline

    4-item feasibility of intervention measure. Scale 1-5 completely disagree to completely agree.

  6. Acceptability (quantitative)

    Time frame: 6-10 weeks after baseline

    4-item acceptability of intervention measure. Scale 1-5 completely disagree to completely agree.

  7. General Counseling Competency

    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.

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • Moi Teaching and Referral Hospital

Registry information

Official study title

A Brief, Task-shifted Treatment to Improve Father Depression and Child Outcomes in Kenya: A Pilot Effectiveness-implementation Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 5, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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