Child Development Clinical Trial
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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06315036 -
Effects of Developmental Gymnastics on Preschoolers' Motor Skills
|
N/A | |
Active, not recruiting |
NCT05143294 -
Conectar Jugando: Board Games in Elementary Classrooms (6-12 Years Old) to Improve Executive Functions
|
N/A | |
Completed |
NCT05267730 -
Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions
|
N/A | |
Completed |
NCT03680157 -
Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
|
||
Completed |
NCT00362076 -
The Role of Motion in Infants' Ability to Categorize
|
N/A | |
Recruiting |
NCT05525962 -
Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
|
||
Completed |
NCT03232606 -
Physical Activity of Asthmatic Children
|
||
Completed |
NCT05955755 -
The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle on the Level of Pain and Fear
|
N/A | |
Recruiting |
NCT04443855 -
WASH Benefits Child Development Follow up
|
N/A | |
Not yet recruiting |
NCT06335524 -
Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants
|
N/A | |
Not yet recruiting |
NCT05783141 -
Prebiotic Effects in Healthy Toddlers
|
N/A | |
Completed |
NCT02800616 -
The Healthy Elementary School of the Future
|
N/A | |
Completed |
NCT02451059 -
Reducing Socioeconomic Disparities in Health at Pediatric Visits
|
N/A | |
Completed |
NCT02539251 -
Arabic Ages and Stages Questionnaire-III
|
||
Completed |
NCT02242539 -
Tools to Improve Parental Recognition of Developmental Deficits in Children
|
N/A | |
Completed |
NCT03010306 -
CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru
|
N/A | |
Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
Completed |
NCT00989859 -
Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants
|
||
Recruiting |
NCT00980733 -
Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits
|
Phase 3 | |
Terminated |
NCT04347707 -
Building Regulation in Dual Generations
|
N/A |