NCT06669624 Resilience Through Interventions for Successful Early Outcomes
| NCT ID | NCT06669624 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Parenting Intervention |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-11-12 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-11-12 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Parent/Caregiver Inclusion Criteria : * Aged 18 or older * Speaks English or Spanish * Is the parent or legal guardian with legal custody of a child aged between 24 months and 42 months * Is a primary caregiver/parent * Has a home-like environment in which to participate in the intervention Child Inclusion Criteria: * Aged between 24 months and 42 months at enrollment * Lives with the parent/caregiver at least 50% of the time * Has experienced social risk factors, including low income, community or family violence, previous trauma/adversity exposure, prolonged separation from caregiver, significant difficulties in relationship with caregiver Child Exclusion Criteria * Has a diagnosed genetic or congenital disorders, including but not limited to Down syndrome, cerebral palsy, seizure disorders, endocrine disorders (or is using steroid medications, including human growth hormone), or was born with birth defects
Contact & Investigator
Danielle Roubinov, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06669624 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parenting Intervention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06669624 currently recruiting?
Yes, NCT06669624 is actively recruiting participants. Contact the research team at roubinov@email.unc.edu for enrollment information.
Where is the NCT06669624 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06669624 clinical trial?
NCT06669624 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Danielle Roubinov, PhD at University of North Carolina, Chapel Hill. The trial plans to enroll 150 participants.