Clinical trial NCT06111651: Family-Based Prevention With Black and Latinx Children
Official title: Family-Based Prevention to Promote the Social-Emotional Functioning and Healthy Lifestyle Behaviors of Black & Latinx Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Behavior
Health Behavior
Keywords: parent training
randomized controlled trial
pilot study
child development
implementation trial
prevention
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2023-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this project is to test whether providing parenting support, with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors, improves the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children.

Detailed description: This pilot project is novel in that it (a) interweaves positive parenting practices, ethnic-racial socialization, and healthy lifestyle behaviors into a prevention program for Black and Latinx families, and (b) targets preschool-aged children using a brief, universal prevention approach, which increases potential for dissemination and scalability. The guiding hypothesis is that incorporating these components into a parenting intervention will lead to improvements in children's health as compared to a control condition. A type 1 hybrid effectiveness-implementation design is used to simultaneously test intervention effectiveness while also gathering information on intervention delivery to inform future implementation trials. The specific aims are to: (a) test the preliminary effects of a preventive intervention on the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children, (b) identify the preliminary effects of the intervention on parenting outcomes, and (c) examine potential barriers and facilitators to intervention delivery.

Eligibility criteria: Inclusion Criteria:

Eligible children will:

* be between the ages of 3-6 years
* identify as Black/African American or Latinx/Hispanic
* have a parent or caregiver willing to participate in the intervention that: (a) lives in the same household as the child ≥50% of the time, (b) has primary responsibility for the child, and (c) speaks English or Spanish.

Exclusion Criteria:

Consistent with typical methods associated with a universal prevention approach, there are minimal exclusion criteria. Children will be excluded who:

* have a cognitive/psychological condition that limits the child's ability to communicate
* have a physical health condition that limits the child's ability to be physically active

Primary outcomes:
measure: child social-emotional functioning
timeFrame: pre (weeks 0-2) and post intervention (weeks 6-8)
measure: child physical activity
timeFrame: pre (weeks 0-2) and post intervention (weeks 6-8)
measure: child sleep
timeFrame: pre (weeks 0-2) and post intervention (weeks 6-8)
Secondary outcomes:
measure: parenting practices
timeFrame: pre (weeks 0-2) and post intervention (weeks 6-8)
measure: ethnic-racial socialization practices
timeFrame: pre (weeks 0-2) and post intervention (weeks 6-8)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References: