Clinical Trials Directory

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RecruitingNCT06669624

Resilience Through Interventions for Successful Early Outcomes

Leveraging Scientific Advances to Strengthen the Implementation, Evaluation, and Impacts of Intervention Programs for Children Experiencing Early Life Adversity

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
University of North Carolina, Chapel Hill · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

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

Timeline

Start date
2024-11-12
Primary completion
2027-08-01
Completion
2027-08-01
First posted
2024-11-01
Last updated
2026-02-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06669624. Inclusion in this directory is not an endorsement.