RECRUITING

Resilience Through Interventions for Successful Early Outcomes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06669624

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged between 24 months and 42 months at enrollment
  2. * Lives with the parent/caregiver at least 50% of the time
  3. * 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
  4. * 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
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Danielle Rouvinov, PhD
CONTACT
919-843-5898
roubinov@email.unc.edu
Nicole Bush, PhD
CONTACT
415-476-7655
Nicole.Bush@ucsf.edu

Principal Investigator

Danielle Roubinov, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill
Chapel Hill, South Carolina, 27599
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Danielle Roubinov, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11
Study Completion Date2027-08

Study Record Updates

Study Start Date2024-11
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Parenting Intervention
  • Stress
  • Caregiver Child Relationship
  • Child Behavior Problem
  • Mental Health