NCT06100679

Brief Summary

The goal of this stepped-wedge cluster randomized control trial is to assess whether a Ugandan community-based intervention for young fathers (ages 18-25 years) of children ages 0-3 years impacts fathers' knowledge, attitudes, and behaviors surrounding positive parenting practices, father-child interaction, harsh physical punishment of children, and intimate partner violence.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,728

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Oct 2023Oct 2027

First Submitted

Initial submission to the registry

October 6, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

October 18, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

2.9 years

First QC Date

October 6, 2023

Last Update Submit

June 2, 2026

Conditions

Keywords

Violence PreventionEarly Childhood DevelopmentCouples CommunicationFather EngagementGender Norms

Outcome Measures

Primary Outcomes (5)

  • Reduced Intimate Partner Violence Perpetration (IPV-P)

    Proportion of young fathers and their wives reporting perpetrating physical, sexual, and/or emotional IPV in the past three months. Assessed via six measures: whether you shouted or yelled at your \[wife/husband\]; slapped your \[wife/husband\]; pushed or shoved your \[wife/husband\]; threw something at your \[wife/husband\] that could hurt \[her/him\]; physically forced your \[wife/husband\] to have sex with you when \[she/he\] did not want to; or insulted your \[wife/husband\]. Response options: never, once, a few times, many times, don't know/remember, refused.

    1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months

  • Reduced Intimate Partner Violence Victimization (IPV-V)

    Proportion of young fathers and their wives reporting being a victim of physical, sexual, and/or emotional IPV in the past three months. Six measures include: whether your spouse shouted or yelled at you; slapped you; pushed or shoved you; threw something at you that could hurt you; physically forced you to have sex with you when you did not want to; or insulted you. Response options: never, once, a few times, many times, don't know/remember, refused.

    1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months

  • Reduced Unmet Need for Family Planning

    Proportion of men and women with unmet need for healthy timing and spacing of children. Assessed via those who are fecund and sexually active but are not using any method of contraception, and report not wanting any more children or wanting to delay the next child for 2 or more years.

    1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months

  • Early Child Development (ECD) - CREDI

    Scores on the short-form version of the Caregiver Reported Early Development Instruments (CREDI).

    1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months

  • Father engagement in child immunization

    Proportion of fathers reporting that they took their child(ren) for rounds of immunization(s).

    1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months

Secondary Outcomes (8)

  • Fathers' knowledge of positive parenting and discipline skills

    1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months

  • Fathers' attitudes towards positive parenting and discipline

    1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months

  • Father engagement at home

    1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months

  • Couple communication and conflict resolution

    1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months

  • Fathers' positive parenting and discipline behaviors

    1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months

  • +3 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Standard of care. Participants will have access to existing health centers and early childhood development centers.

Intervention

EXPERIMENTAL

Participants will engage in the Responsible, Engaged and Loving (REAL) Fathers Intervention-an evidence-based community mentoring education program for young fathers and their spouses. Over 7 months, fathers receive monthly home visits from a community-identified male mentor. Mentors share information and skills-building tools on conflict resolution, non-violent discipline, family planning, and couple communication. At the end of each month, pairs or trios of mentors hold group reflection sessions with all mentored fathers. In months 5 and 6 of the intervention, spouses join the home visits and group sessions. Community-level intervention components include: 1) monthly educational poster campaigns that showcase nonviolent discipline and conflict resolution strategies; 2) community-hosted celebrations at the end of the intervention to acknowledge the accomplishments of the young fathers.

Behavioral: Responsible Engaged and Loving (REAL) Fathers Initiative

Interventions

REAL Fathers is a multilevel norms-shifting intervention among: young fathers (ages 16-25 whose oldest child is under the age of 3); couple dyads (fathers and wives); mentoring dyads and groups; and communities. Respected men in the community are identified by participating young fathers, their partners and community members to become mentors. Mentors participate in a training and mentor young fathers through home and group sessions on conflict resolution, non-violent discipline, family planning, and couple communication. Mentoring is supplemented with a monthly poster campaign designed to reinforce messages from the home and group mentoring sessions and a community celebration. REAL Fathers aims to build positive partnerships and parenting practices among young fathers to: 1) reduce incidence of intimate partner violence; 2) reduce harsh physical punishment of children; 3) improve early childhood development; 4) decrease unmet need for family planning.

Also known as: REAL Fathers
Intervention

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Living in one of the six selected regions and districts across each region
  • Being male aged between aged 16-25 years
  • Being biological father to a child(ren) who is younger than 3 years old
  • Living in union and in the same household with the mother or guardian of the child(ren)
  • Living in union and in the same household as the young father

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

All Nations

Lira, Dokolo, Uganda

Location

Forum for African Women Educationalists (FAWE) - Uganda Chapter

Mbarara, Isingiro, Uganda

Location

Somero Uganda

Kampala, Kayunga, Bugiri, Luweero, Uganda

Location

Bantwana Initiatives Uganda

Kampala, Masindi, Kiryandongo and Katakwi, Uganda

Location

Related Publications (1)

  • Barker KM, Wandiembe S, Wandega A, Jeong J, Ojamuge D, Lundgren R, Yiga D, Nabembezi D. Testing the effectiveness of the Responsible, Engaged, and Loving Fathers (REAL Fathers) intervention for improving early childhood development and reducing family violence in Uganda: Study protocol for a cluster-randomized controlled trial. Trials. 2025 Sep 29;26(1):372. doi: 10.1186/s13063-025-09061-9.

MeSH Terms

Conditions

CoitusContraception BehaviorCommunicationNegotiating

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorReproductive Behavior

Study Officials

  • Kathryn M Barker, PhD, MPH

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Trained enumerators will be blinded to the treatment conditions from the beginning of the study (i.e., at baseline data collection) and before entering clusters (i.e., villages/communities) at mid-term and endline.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Stepped-wedge cluster randomized controlled trial-sequential transition of clusters from control to intervention conditions in randomized order, until all clusters are exposed.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Division of Infectious Diseases and Global Public Health

Study Record Dates

First Submitted

October 6, 2023

First Posted

October 25, 2023

Study Start

October 18, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

June 3, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Due to the highly sensitive nature of the resulting data on violence against children and women, these data will be available only through request to the study PI, who will vet requests to be certain that appropriate IRB approvals and data safety guidelines are in place.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Baseline data will become available Summer 2024; Endline data will become available Summer 2026.
Access Criteria
Appropriate IRB approvals and data safety guidelines.

Locations