Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06669624

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

Led by University of North Carolina, Chapel Hill ยท Updated on 2026-02-02

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

U

University of California, San Francisco

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of the Attachment and Biobehavioral Catch-up (ABC) parenting program on stress-related biological markers in young children. The study involves about 150 caregiver-child pairs, focusing on children aged 24 to 42 months who have faced social challenges such as low income, violence, trauma, or caregiver separation. The aim is to understand how this evidence-based parenting program may influence child stress and wellbeing. Participants will be randomly assigned to two groups: one will receive the 10-session home-based ABC program immediately, which focuses on improving parental sensitivity and nurturing behaviors. The other group will be placed on a waitlist for about four months before receiving the same ABC program. The intervention is delivered in the home environment to support positive caregiver-child interactions. During the study, caregivers will complete online surveys and engage in play-based observation tasks with their children. Non-invasive biological samples like saliva, cheek swabs, and hair will be collected from children, and saliva samples from caregivers, at two to three different times. Researchers will measure various outcomes including child inflammation, stress hormones, epigenetic age, telomere length, hair cortisol, parenting behaviors, child wellbeing, executive functioning, mental health, and caregiver anxiety and depression. The study is designed to monitor changes from before the intervention to 13-20 weeks after baseline.

CONDITIONS

Brief Title

Resilience Through Interventions for Successful Early Outcomes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Caregiver aged 18 or older
  • Speaks English or Spanish
  • Is the parent or legal guardian with legal custody of a child aged between 24 and 42 months
  • Is a primary caregiver or parent
  • Has a home-like environment to participate in the intervention
  • Child aged between 24 and 42 months at enrollment
  • Child lives with the parent/caregiver at least 50% of the time
  • Child has experienced social risk factors such as low income, community or family violence, prior trauma or adversity, caregiver separation, or relationship difficulties
Not Eligible

You will not qualify if you...

  • Child has diagnosed genetic or congenital disorders, including Down syndrome, cerebral palsy, seizure disorders, endocrine disorders, or birth defects
  • Child uses steroid medications including human growth hormone

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Outpatient Treatment

Duration - 10 sessions over approximately 4 months

Participants receive the Attachment and Biobehavioral Catch-up (ABC) home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior. Participants in the waitlist group begin this intervention after a 4-month delay.

Approximately 10 home visits

Follow-up

Duration - Approximately 13 to 20 weeks after baseline

Participants are assessed for child wellbeing, parenting, child stress hormones, and caregiver mental health outcomes following the intervention period.

1 to 2 visits

Trial Site Locations

Total: 1 location

1

University of North Carolina at Chapel Hill

Chapel Hill, South Carolina, United States, 27599

Actively Recruiting

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Research Team

D

Danielle Rouvinov, PhD

N

Nicole Bush, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Do dyadic interventions impact biomarkers of child health? A state-of-the-science narrative review.

Alexandra D W Sullivan, Danielle Roubinov, Amanda N Noroรฑa-Zhou...

https://pubmed.ncbi.nlm.nih.gov/38295654

Linking specific biological signatures to different childhood adversities: findings from the HERO project.

Euclides Josรฉ de Mendonรงa Filho, Irina Pokhvisneva, Christina Maria Maalouf...

https://pubmed.ncbi.nlm.nih.gov/36650307