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New peer-led program aims to lift fathers out of depression in kenya

NCT ID NCT06489314

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study tests a short, 5-session counseling program called LEAD for fathers in Kenya who have depression and drink alcohol. About 102 fathers will be randomly assigned to the program or a waitlist. The goal is to see if the program improves fathers' mental health, parenting, and their children's well-being.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 116 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 5 or above 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

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Conditions

The condition(s) this trial relates to.

Alcohol Drinking Depression depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Moi Teaching and Referral Hospital

    Eldoret, 30100, Kenya

More trials for these conditions

Other studies related to the condition(s) this trial covers.