RECRUITING

Improving the Part C Early Intervention Service Delivery System for Children with ASD

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

Despite strong consensus that early, specialized intervention for children with autism spectrum disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to increase timely and equitable access to ASD-specialized early intervention during the critical first three years of life by capitalizing on the existing infrastructure of the Part C Early Intervention (EI) system, which is publicly funded and available in all states in the United States. This project will train EI providers to use an evidence-based, parent-mediated intervention that can improve child and family outcomes as well as mitigate the long-term substantial economic costs associated with ASD.

Official Title

Improving the Part C Early Intervention Service Delivery System for Children with ASD: a Randomized Clinical Trial

Quick Facts

Study Start:2021-09-27
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05114538

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:16 Months to 33 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Child has a diagnosis of ASD or displays early social communication challenges
  2. * Child receives ≥ 1 weekly session with the participating provider (not co-treated with another provider)
  3. * Caregiver is present during EI sessions
  4. * Caregiver is the biological parent or custodial guardian
  5. * Caregiver is at least 18 years of age
  6. * Caregiver speaks either English or Spanish
  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

Carol A Schubert, MPH
CONTACT
206-543-2823
schubca@uw.edu
Wendy K Stone, PhD
CONTACT
206-685-2821
stonew@uw.edu

Principal Investigator

Wendy L Stone, PhD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

Rush University Medical Center
Chicago, Illinois, 60612
United States
University of Massachusetts Boston
Boston, Massachusetts, 02125
United States
Michigan State University
East Lansing, Michigan, 48824
United States
Carol A Schubert
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Wendy L Stone, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

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 Date2021-09-27
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2021-09-27
Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder