Recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06669624

Conditions

Parenting Intervention

Stress

Caregiver Child Relationship

Child Behavior Problem

Mental Health

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Attachment and Biobehavioral Catch-up (ABC)

Waitlist with 4-month delay, then ABC

Study Details

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.

Conditions

Parenting Intervention

Stress

Caregiver Child Relationship

Child Behavior Problem

Mental Health

Study ID

NCT06669624

Start date

Nov 12, 2024

Status verified date

Jan, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: ABC Program - no wait

Participants immediately receive the home-based ABC, which targets parenting sensitivity and nurturance.

other: Waitlist-Control (ABC after delay)

Participants will be placed on a four-month waitlist and then receive ABC in the same manner as the Experimental Group

Interventions

Attachment and Biobehavioral Catch-up (ABC)

10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.

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).

Primary outcome measure

  • Child inflammation [ Time Frame: Pre-intervention baseline ]
  • Child inflammation [ Time Frame: 13-20 weeks after baseline ]
  • Child epigenetic age acceleration [ Time Frame: Pre-intervention baseline ]
  • Child epigenetic age acceleration [ Time Frame: 13-20 weeks after baseline ]
  • Child telomere length [ Time Frame: Pre-intervention baseline ]
  • Child telomere length [ Time Frame: 13-20 weeks after baseline ]
  • Child hair cortisol [ Time Frame: Pre-intervention baseline ]
  • Child hair cortisol [ Time Frame: 13-20 weeks after baseline ]
  • Child stress hormones [ Time Frame: Pre-intervention baseline ]
  • Child stress hormones [ Time Frame: 13-20 weeks after baseline ]
  • Parenting [ Time Frame: Pre-intervention baseline ]
  • Parenting [ Time Frame: 13-20 weeks after baseline ]
  • Child wellbeing [ Time Frame: Pre-intervention baseline ]
  • Child wellbeing [ Time Frame: 13-20 weeks after baseline ]
  • Child executive functioning [ Time Frame: Pre-intervention baseline ]
  • Child executive functioning [ Time Frame: 13-20 weeks after baseline ]
  • Child mental health [ Time Frame: Pre-intervention baseline ]
  • Child mental health [ Time Frame: 13-20 weeks after baseline ]
  • Caregiver anxiety [ Time Frame: Pre-intervention baseline ]
  • Caregiver anxiety [ Time Frame: 13-20 weeks after baseline ]
  • Caregiver depression [ Time Frame: Pre-intervention baseline ]
  • Caregiver depression [ Time Frame: 13-20 weeks after baseline ]

Central Contacts and Locations

Central contacts

Danielle Rouvinov, PhD

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

Nicole Bush, PhD

415-476-7655Nicole.Bush@ucsf.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, South Carolina, United States, 27599

Contacts

Natalie O'Brien

919-966-0421natalie_obrien@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

  • Attachment and Biobehavioral CatchUp
  • Parenting Intervention
  • RISE study
  • Child behavior
  • Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-02-02.