Resilience Through Interventions for Successful Early Outcomes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Attachment and Biobehavioral Catch-up (ABC)

    Behavioral

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

  • Waitlist with 4-month delay, then ABC

    Other intervention

    A 4-month waitlist period, after which they will also receive the home-based ABC program (same as Intervention group).

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: ABC Program - no waitExperimental treatment 1 intervention
Group B: Waitlist-Control (ABC after delay)Other 2 interventions

Trial outcomes

Primary outcomes

1

Child inflammation

Pediatric saliva samples will be assayed for cytokine concentrations.

Time frame
Pre-intervention baseline
2

Child inflammation

Pediatric saliva samples will be assayed for cytokine concentrations.

Time frame
13-20 weeks after baseline
3

Child epigenetic age acceleration

Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age

Time frame
Pre-intervention baseline
4

Child epigenetic age acceleration

Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age

Time frame
13-20 weeks after baseline

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

University of North Carolina at Chapel HillRecruiting27599, Chapel Hill, South CarolinaUnited StatesUnited States

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

University of California, San Francisco

Collaborator

The Duke Endowment

Collaborator