RecruitingNot Applicable

Resilience Through Interventions for Successful Early Outcomes

United States150 participantsStarted 2024-11-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Child inflammation

Timeframe: Pre-intervention baseline

Child inflammation

Timeframe: 13-20 weeks after baseline

Child epigenetic age acceleration

Timeframe: Pre-intervention baseline

Child epigenetic age acceleration

Timeframe: 13-20 weeks after baseline

Child telomere length

Timeframe: Pre-intervention baseline

Child telomere length

Timeframe: 13-20 weeks after baseline

Child hair cortisol

Timeframe: Pre-intervention baseline

Child hair cortisol

Timeframe: 13-20 weeks after baseline

Trial details

NCT IDNCT06669624

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Danielle Rouvinov, PhD

919-843-5898 roubinov@email.unc.edu

View on ClinicalTrials.gov More Parenting Intervention trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Child inflammation

Timeframe: Pre-intervention baseline

Child inflammation

Timeframe: 13-20 weeks after baseline

Child epigenetic age acceleration

Timeframe: Pre-intervention baseline

Child epigenetic age acceleration

Timeframe: 13-20 weeks after baseline

Child telomere length

Timeframe: Pre-intervention baseline

Child telomere length

Timeframe: 13-20 weeks after baseline

Child hair cortisol

Timeframe: Pre-intervention baseline

Child hair cortisol

Timeframe: 13-20 weeks after baseline