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

NCT06489314 | Enrolling By Invitation DMC

• 1 other identifier: 1K23MH128742-01A1
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Type of Alcohol Use

  Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline

• Gender Norms

  Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline

• Disrupted Parenting

  Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline

• Interparental Problems

  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

  Baseline (Time point 1, in year 1); 6-10 weeks after baseline; 10-14 weeks after baseline; 19-23 weeks after baseline

Other Outcomes (10)

• Treatment Engagement

  through the treatment period, 2- 8 weeks after baseline

• Activity Completion

  through the treatment period, 2- 8 weeks after baseline

• Positive Emotional Reinforcement

  through the treatment period, 2- 8 weeks after baseline

Study Arms (2)

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).

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.

Interventions

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).

LEAD Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Fathers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 above 5 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida International University: lead
• Moi Teaching and Referral Hospital: collaborator

Study Sites (1)

Moi Teaching and Referral Hospital

Eldoret, 30100, Kenya

Location

Related Publications (10)

• 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.

  PMID: 19031037 BACKGROUND

• Puffer 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.

  PMID: 33664559 BACKGROUND

• Puffer 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.

  PMID: 34168594 BACKGROUND

• Goodman 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.

  PMID: 11699809 BACKGROUND

• Vreeman 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.

  PMID: 26616121 BACKGROUND

• Babor, 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)

  BACKGROUND

• 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).

  BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 25847276 BACKGROUND

• Giusto 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.

  PMID: 40570024 DERIVED

MeSH Terms

Conditions

Depression; Alcohol Drinking

Interventions

Lead; Educational Status; alpha 1-Antichymotrypsin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Drinking Behavior

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals; Socioeconomic Factors; Population Characteristics; Glycoproteins; Glycoconjugates; Carbohydrates; Serpins; Peptides; Amino Acids, Peptides, and Proteins; Acute-Phase Proteins; Blood Proteins; Proteins; Alpha-Globulins; Serum Globulins; Globulins

Study Officials

• Ali Giusto, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 5, 2024
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-04

Locations

KE (1)