Trials / Recruiting
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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Attachment and Biobehavioral Catch-up (ABC) | 10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior. |
| OTHER | Waitlist with 4-month delay, then ABC | A 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.