Clinical trial NCT06100679: Responsible Engaged and Loving (REAL) Fathers Intervention Evaluation
Official title: Responsible Engaged and Loving (REAL) Fathers: Study Protocol for a Cluster-randomized Controlled Trial of Mentored Parenting Sessions for Young Fathers to Promote Child Development and Reduce Violence in Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Violence, Gender-Based
Violence, Domestic
Violence, Sexual
Violence, Physical
Contraception Behavior
Child Development
Child Abuse
Communication, Partner
Conflict Resolution
Parent-Child Relations
Keywords: Violence Prevention
Early Childhood Development
Couples Communication
Father Engagement
Gender Norms
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Impact and Innovations Development Centre (IIDC), Uganda
name: NaNa Development Consultants Ltd, Uganda
name: LEGO Foundation
First posted: 2023-10-25
Enrollment: 4728
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge cluster randomized controlled trial-sequential transition of clusters from control to intervention conditions in randomized order, until all clusters are exposed.
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria for Young Fathers:

* 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)

Inclusion Criteria for Spouses:

* Living in union and in the same household as the young father

Primary outcomes:
measure: Reduced Intimate Partner Violence Perpetration (IPV-P)
timeFrame: 1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months
measure: Reduced Intimate Partner Violence Victimization (IPV-V)
timeFrame: 1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months
measure: Reduced Unmet Need for Family Planning
timeFrame: 1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months
measure: Early Child Development (ECD) - CREDI
timeFrame: 1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months
measure: Father engagement in child immunization
timeFrame: 1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months
Secondary outcomes:
measure: Fathers' knowledge of positive parenting and discipline skills
timeFrame: 1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months
measure: Fathers' attitudes towards positive parenting and discipline
timeFrame: 1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months
measure: Father engagement at home
timeFrame: 1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months
measure: Couple communication and conflict resolution
timeFrame: 1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months
measure: Fathers' positive parenting and discipline behaviors
timeFrame: 1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months
measure: Reduced harsh violent discipline of children
timeFrame: 1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months
measure: Supportive environments for father engagement and positive parenting
timeFrame: 1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months
measure: Knowledge of where to access family planning method(s)
timeFrame: 1) Baseline to Wave 2 (Endline) = 8 months; and 2) Baseline to Wave 3 (Follow-Up) = 16 months
Other outcomes:
Locations:
city: Lira
country: Uganda
facility: All Nations
state: Dokolo
city: Mbarara
country: Uganda
facility: Forum for African Women Educationalists (FAWE) - Uganda Chapter
state: Isingiro
city: Kampala
country: Uganda
facility: Somero Uganda
state: Kayunga, Bugiri, Luweero
city: Kampala
country: Uganda
facility: Bantwana Initiatives Uganda
state: Masindi, Kiryandongo And Katakwi
Study officials:
affiliation: University of California, San Diego
name: Kathryn M Barker, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: