RECRUITING

Building Resilient Families

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

Prior research suggests that it is possible to improve health outcomes in children with ACEs through multi-component interventions. The challenge for most communities is that health and education systems are fragmented and fail to accommodate families based upon different levels of need. This study utilizes cross-sectoral partnerships to mobilize three vectors (pediatricians, community health workers and parenting educators) to optimize the delivery of vital information and resources to a diverse population of families with ACEs. All vectors are trained in an evidence-informed curriculum to strengthen families and build youth resilience. The study design is a randomized controlled trial of 340 families of children between the ages of 3 to 11 who are generally healthy and have recently seen a pediatrician for a well-child visit. To evaluate the efficacy of this intervention, pediatric patients are invited to participate in repeat evaluations within 2 weeks, 3 months, 6 months, and 12 months after their well-child visit. The study will evaluate the following: 1) the association between Child-ACE scores and biomarkers of toxic stress at baseline in children age 3-11 years old; 2) whether the intervention reduces toxic stress and child health and psychosocial problems at follow-up for children with ACEs compared to usual well-child care for children with ACEs; and 3) the impact of mediating and moderating variables. These results will demonstrate that for families with ACEs the intervention will decrease toxic stress associated with ACEs, improve health outcomes, and reduce health disparities.

Official Title

A Multi-Component Intervention to Strengthen Families With Adverse Childhood Experiences (ACEs)

Quick Facts

Study Start:2022-05-24
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05388864

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:3 Years to 11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Ages 3-11
  2. * Seen for a well-child visit at a participating pediatric clinic
  1. * \< 3 years or \>11 years of age
  2. * Significant congenital medical problems
  3. * Previous participation in parenting program (last 12 months)
  4. * Sibling enrollment in current study

Contacts and Locations

Study Contact

Ariane Marie-Mitchell, MD, PhD, MPH
CONTACT
909-651-5672
amariemitchell@llu.edu

Principal Investigator

Ariane Marie-Mitchell, MD, PhD, MPH
PRINCIPAL_INVESTIGATOR
Loma Linda University

Study Locations (Sites)

Loma Linda University
Loma Linda, California, 92354
United States

Collaborators and Investigators

Sponsor: Loma Linda University

  • Ariane Marie-Mitchell, MD, PhD, MPH, PRINCIPAL_INVESTIGATOR, Loma Linda University

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 Date2022-05-24
Study Completion Date2027-05

Study Record Updates

Study Start Date2022-05-24
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • adverse childhood experiences
  • pediatrics
  • prevention
  • preventive health services
  • quality improvement
  • childhood abuse and neglect

Additional Relevant MeSH Terms

  • Adverse Childhood Experiences