MedDataX Logo

Responsible Engaged and Loving (REAL) Fathers Intervention Evaluation

NCT ID: NCT06100679

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4728 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-18

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. BACKGROUND. The prevalence of violence against women and children in Uganda takes a substantial toll on the overall health and welfare of families. Globally three in four children aged 2 to 4 years are exposed to harsh physical punishment. Child maltreatment not only inflicts immediate harm but also has long-lasting consequences on a child's physical and mental health, educational attainment, and overall development. One in four children under the age of five live with a mother who is a victim of intimate partner violence. Based on data from recent population surveys, 60% of Ugandan women reported having experienced intimate partner violence (IPV) at some point, while 45% reported experiencing IPV within the past year. These statistics underscore the urgent need for effective measures to address and mitigate the impact of such violence on the well-being of individuals and families in Uganda.
2. INTERVENTION. The Responsible, Engaged and Loving (REAL) Fathers Initiative is an evidence-based father-centered mentoring program designed to address social and gender norms that promote use of violence in child discipline and with intimate partners through promotion of positive parenting and partnership skills building. The REAL Fathers Initiative uses a 7-month mentoring program and a community poster campaign to model alternative strategies for nonviolent discipline and conflict resolution to improve fathers' parenting and communication skills and confidence in adapting nonviolent strategies. The project works with young fathers (ages 18-25) who have toddler-aged children (0-3 years) who are learning new roles as parents and husbands. This stage in a man's life is an ideal time to promote nonviolence in parenting and partner relationships as there is still ambiguity in the normative expectations about these roles and behaviors.
3. STUDY DESCRIPTION. This study will examine the impacts of a multilevel community-based intervention for young fathers and their families in Uganda on positive parenting, childhood development, and violence reduction. We will use a stepped-wedge cluster-randomized controlled trial design within 72 sub-counties randomly sampled from 24 districts in six regions of Uganda. Sub-counties are randomly allocated to treatment or control conditions at three successive time points from November 2023 to December 2025. Study participants are couple dyads (young fathers and their wives) ages 16-25 years with children ≤3 years (n=3,744 dyads). Quantitative longitudinal data will be collected via trained enumerators in six local languages on KoboCollect software. Intervention effects on primary and secondary outcomes will be assessed using difference-in-differences statistical approaches in mixed-effects models that account for the clustered stepped-wedge design.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Violence, Gender-Based Violence, Domestic Violence, Sexual Violence, Physical Contraception Behavior Child Development Child Abuse Communication, Partner Conflict Resolution Parent-Child Relations

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Violence Prevention Early Childhood Development Couples Communication Father Engagement Gender Norms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stepped-wedge cluster randomized controlled trial-sequential transition of clusters from control to intervention conditions in randomized order, until all clusters are exposed.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type EXPERIMENTAL

Responsible Engaged and Loving (REAL) Fathers Initiative

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Responsible Engaged and Loving (REAL) Fathers Initiative

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

REAL Fathers

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Impact and Innovations Development Centre (IIDC), Uganda

UNKNOWN

Sponsor Role collaborator

NaNa Development Consultants Ltd, Uganda

UNKNOWN

Sponsor Role collaborator

LEGO Foundation

UNKNOWN

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kathryn Barker

Assistant Professor, Division of Infectious Diseases and Global Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kathryn M Barker, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

All Nations

Lira, Dokolo, Uganda

Site Status RECRUITING

Forum for African Women Educationalists (FAWE) - Uganda Chapter

Mbarara, Isingiro, Uganda

Site Status RECRUITING

Somero Uganda

Kampala, Kayunga, Bugiri, Luweero, Uganda

Site Status RECRUITING

Bantwana Initiatives Uganda

Kampala, Masindi, Kiryandongo and Katakwi, Uganda

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Uganda

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kathryn M Barker, PhD, MPH

Role: CONTACT

Phone: 919-360-3951

Email: [email protected]

Dennis Nabembezi, MPH

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rita Edwe

Role: primary

Sheilla Amulen

Role: primary

Stephen Ediru

Role: primary

Christine Kiiza

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 41024259 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

808321

Identifier Type: -

Identifier Source: org_study_id