Resilience Through Interventions for Successful Early Outcomes

Part of paid clinical trials in Chapel Hill, South Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06669624
Status
Recruiting
Apply to this trial

Conditions

  • Caregiver Child Relationship
  • Child Behavior Problem
  • Mental Health
  • Parenting Intervention
  • Stress

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Attachment and Biobehavioral Catch-up (ABC) — BEHAVIORAL
    10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.
  • Waitlist with 4-month delay, then ABC — OTHER
    A 4-month waitlist period, after which they will also receive the home-based ABC program (same as Intervention group).

Study Details

Purpose: The purpose of this research is to determine the effects of Attachment and Biobehavioral Catch-up (ABC), an evidence-based parenting program, on stress biomarkers in children. Participants: The study will involve approximately 150 caregiver-child dyads, with children aged between 24 and 42 months. Participants will include primary caregivers fluent in English or Spanish, along with their children who have experienced social risk factors for adversity. Procedures (Methods): Participants will be randomly assigned to either receive the ABC parenting program (10 sessions) immediately or be placed on a wait-list, receiving the program after about 4 months. The study procedures include caregivers completing online surveys, engaging in play-based observational tasks with their children, and collecting non-invasive biological samples (saliva, cheek swab, hair) from the children and saliva samples from the caregivers at 2-3 time-points.

Key Dates

Start date
Nov 12, 2024
Status verified
Jan 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: ABC Program - no wait
    Participants immediately receive the home-based ABC, which targets parenting sensitivity and nurturance.
  • Other: Waitlist-Control (ABC after delay)
    Participants will be placed on a four-month waitlist and then receive ABC in the same manner as the Experimental Group

Primary Outcome Measure

Child inflammation [ Time Frame: Pre-intervention baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillSouth Carolina27599
Natalie O'Brien
[email protected]
919-966-0421

Find similar trials in Chapel Hill, SC

By research site
University of North Carolina at Chapel Hill· Chapel Hill, SC

Related Studies