Father-Child RelationsNCT06489314
Mental Health Treatment to Improve Father Depression and Child Outcomes in Kenya
A study testing LEAD (Learn, Engage, Act, Dedicate) in people with Father-Child Relations and Depression, run by Florida International University at 1 site in Kenya.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Father-Child Relations, Depression, Alcohol Use, Unspecified
- What is being tested?
- LEAD (Learn, Engage, Act, Dedicate)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteKenya
- Study dates
- 15 Apr 2025to 15 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 of 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Brief, Task-shifted Treatment to Improve Father Depression and Child Outcomes in Kenya: A Pilot Effectiveness-implementation Trial
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.
Read the 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.
- Conditions
- Father-Child Relations, Depression, Alcohol Use, Unspecified
- Being tested
- LEAD (Learn, Engage, Act, Dedicate)
- Keywords
- Randomized Control Trial, Hybrid-Type 1 Trial, Depression, Alcohol Use, Peer Counseling, Task-Shifting, Fathers, Youth Mental Health, Kenya
- Medical subject headings
- Depression, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEAD (Learn, Engage, Act, Dedicate)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| LEAD Intervention | Experimental | LEAD consists of behavioral activation (BA) and motivational interviewing (MI), as well as discussions of masculinity and a family focus throughout to target father's depression symptoms and common comorbidities, like drinking. LEAD is guided by a manual (in Swahili and English). It includes five, 60-90-minute weekly sessions. LEAD was adapted for context based on formative work. Each session begins with MH assessment and review of activity completion and ends with homework to monitor activities. LEAD uses MI strategies to engage men in the treatment and increase commitment to addressing problems. MI strategies are then integrated throughout. (Session 1-5) to enhance father motivation to complete activities as well as to build self-efficacy (e.g., when reviewing homework, peer-father counselors reflect successes). Receives: Behavioral: LEAD (Learn, Engage, Act, Dedicate) |
| Waitlist Control | No intervention | Those randomized to WL will complete assessments and be monitored at each timepoint; they will be offered LEAD following the last assessment. In a pilot, a control allows for a realistic examination of recruitment, randomization, implementation of LEAD, assessment procedures, and retention. If safety concerns arise, referrals and safety procedures will be implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start15 Apr 2025
- Primary completion15 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Father-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- Moi Teaching and Referral Hospital
- Responsible party
- Principal investigator, Ali Giusto, PhD, Florida International University
- Investigators
- Ali Giusto, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489314
- Sponsor's protocol ID
- 1K23MH128742-01A1
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will be dependent on what partners in Kenya prefer.
Publications
Monahan PO, Shacham E, Reece M, Kroenke K, Ong'or WO, Omollo O, Yebei VN, Ojwang C. Validity/reliability of PHQ-9 and PHQ-2 depression scales among adults living with HIV/AIDS in western Kenya. J Gen Intern Med. 2009 Feb;24(2):189-97. doi: 10.1007/s11606-008-0846-z. Epub 2008 Nov 20.
PubMed 19031037Puffer ES, Healy EF, Green EP, Giusto AM, Kaiser BN, Patel P, Ayuku D. Family Functioning and Mental Health Changes Following a Family Therapy Intervention in Kenya: a Pilot Trial. J Child Fam Stud. 2020 Dec;29(12):3493-3508. doi: 10.1007/s10826-020-01816-z. Epub 2020 Sep 24.
PubMed 33664559Puffer ES, Giusto A, Rieder AD, Friis-Healy E, Ayuku D, Green EP. Development of the Family Togetherness Scale: A Mixed-Methods Validation Study in Kenya. Front Psychol. 2021 Jun 8;12:662991. doi: 10.3389/fpsyg.2021.662991. eCollection 2021.
PubMed 34168594Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.
PubMed 11699809Vreeman RC, Scanlon ML, Marete I, Mwangi A, Inui TS, McAteer CI, Nyandiko WM. Characteristics of HIV-infected adolescents enrolled in a disclosure intervention trial in western Kenya. AIDS Care. 2015;27 Suppl 1(sup1):6-17. doi: 10.1080/09540121.2015.1026307.
PubMed 26616121Babor, T. F., Higgins-Biddle, J. C., Saunders, J. B. & Monteiro, M. G. Audit. The Alcohol Use Disorders Identification Test (AUDIT): guidelines for use in primary care (2001)
Pulerwitz, J. & Barker, G. Measuring Attitudes toward Gender Norms among Young Men in Brazil: Development and Psychometric Evaluation of the GEM Scale. Men and Masculinities 10, 322-338 (2007).
Essau, C. A., Sasagawa, S. & Frick, P. J. Psychometric properties of the Alabama parenting questionnaire. Journal of Child and Family Studies 15, 595-614 (2006).
Kohrt BA, Jordans MJ, Rai S, Shrestha P, Luitel NP, Ramaiya MK, Singla DR, Patel V. Therapist competence in global mental health: Development of the ENhancing Assessment of Common Therapeutic factors (ENACT) rating scale. Behav Res Ther. 2015 Jun;69:11-21. doi: 10.1016/j.brat.2015.03.009. Epub 2015 Mar 24.
PubMed 25847276Giusto A, Jaguga F, Aburi D, Korir M, Maina W, Rono W, Greenlee M. Protocol for a Hybrid-type 1 pilot study of a randomized control trial of a brief, peer-delivered treatment to improve father depression and child mental health in Kenya. PLoS One. 2025 Jun 26;20(6):e0325902. doi: 10.1371/journal.pone.0325902. eCollection 2025.
PubMed 40570024