RECRUITING

Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program

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

Primary Objective: Conduct a rigorous evaluation of a prevention-based intervention designed to mitigate the harms of adverse childhood experiences (ACEs) exposure and prevent future ACEs, substance use, and overdose within 36 communities experiencing a disproportionate burden of substance use and ACEs. The study has three aims: (1) use a cluster randomized controlled trial to test effectiveness of the Strengthening Families Program (SFP) + Family Advocate (FA) intervention on substance use, overdose, and ACEs in 18 communities compared with SFP-only in 18 communities; (2) conduct a robust process evaluation informed by the Consolidated Framework for Implementation Research (CFIR) to explore implementation barriers and facilitators; and (3) conduct a cost evaluation to accurately estimate the costs required to implement SFP and SFP+FA and assess the cost-effectiveness of SFP+FA relative to SFP alone. Findings will provide a roadmap about the best ways to help disproportionately affected communities prevent substance use, overdose, and ACEs.

Official Title

Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program: A Hybrid Type 1 Effectiveness-Implementation Trial

Quick Facts

Study Start:2023-11-29
Study Completion:2027-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06236100

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:7 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Either reside in, or attend SFP meetings, within one of the 36 New Jersey communities with disproportionate levels of ACEs and substance use disorder (SUD) issues that are assigned to either the treatment or control conditions via the study's cluster randomized controlled trial design
  2. * Meet family eligibility requirements:
  3. * One or more adult caregivers
  4. * One or more adolescents, ages 7 to 17
  5. * Caregiver provision of signed and dated informed consent form
  6. * For children, informed assent and parental permission via the informed consent to participate in the study
  7. * Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
  8. * Willingness to adhere to the regimens of the SFP and FA interventions
  9. * Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access)
  1. * Caregiver has previously completed SFP with one or more children, ages 7 to 17
  2. * Intellectual disabilities (i.e., cognitive impairments that would prohibit the completion of the SFP curriculum or data collection instruments)
  3. * Language difficulties (caregivers and children must read and understand spoken English)

Contacts and Locations

Study Contact

Andrea L. Zapcic, BA
CONTACT
908-433-2064
Andrea@njpn.org
Brittany Simon, MA
CONTACT
201-218-5551
Brittany.Simon@rwjbh.org

Principal Investigator

Phillip W. Graham, DrPH
PRINCIPAL_INVESTIGATOR
RTI International
Dallas J Elgin, PhD
PRINCIPAL_INVESTIGATOR
RTI International

Study Locations (Sites)

New Jersey Prevention Network
Tinton Falls, New Jersey, 07724
United States

Collaborators and Investigators

Sponsor: RTI International

  • Phillip W. Graham, DrPH, PRINCIPAL_INVESTIGATOR, RTI International
  • Dallas J Elgin, PhD, PRINCIPAL_INVESTIGATOR, RTI International

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 Date2023-11-29
Study Completion Date2027-09-29

Study Record Updates

Study Start Date2023-11-29
Study Completion Date2027-09-29

Terms related to this study

Keywords Provided by Researchers

  • Adverse Childhood Experiences
  • Strengthening Families Program
  • Family Advocate
  • Community-level interventions
  • Hybrid Type 1 Design
  • Mixed-Method Evaluation
  • Effectiveness Trial
  • Cluster Randomized Controlled Trial
  • Process Evaluation
  • Cost Evaluation

Additional Relevant MeSH Terms

  • Substance-Related Disorders
  • Adverse Childhood Experiences