RECRUITING

A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students

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

The goal of this clinical trial is to compare two school based interventions to manage anxiety in autistic students. The main question\[s\] it aims to answer are: 1) Compare the effectiveness of Facing Your Fears-School Based Program (FYF-SB) with Zones of Regulation (ZOR) on anxiety reduction and emotion regulation; and 2) examine the feasibility and satisfaction of FYF-SB and ZOR, according to students, caregivers and school providers. Autistic students with anxiety between 8-14 years will be randomized to either FYF-SB and ZOR. They will participate in one of the programs for 12 weeks and pre, post and follow-up measures will occur.

Official Title

A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students

Quick Facts

Study Start:2023-08-25
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05863520

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 to 15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * known medical diagnosis of ASD OR educational identification of ASD OR suspected ASD
  2. * clinical anxiety according to either student, parent or teacher report
  3. * clinically significant impairment (T-score above 70) in reciprocal social behavior according to the Social Responsiveness Scale - Second Edition (SRS-2).
  4. * known intellectual disability
  5. * significant behavior or psychiatric challenge that prevents them from participation in small group activities
  6. * lack of parent or caregiver permission for participation
  7. * degreed professionals in one of the following: education (special or general education), school psychology, counseling, social work, speech/language pathology, occupational or physical therapy OR paraprofessional who assist ISPs
  8. * working with autistic students with anxiety
  9. * be able to complete study requirements including attending the training workshops, delivering at least 80% of the program they were randomized to, and participating in 80% of bi-monthly consultation sessions with the research team.
  10. * if they are unable to participate in the trainings, deliver the program they are assigned to, or participate in any of the consultation visits
  11. * if they do not work with students with autism and anxiety
  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

Judy Reaven, Ph.D.
CONTACT
303-724-7646
judy.reaven@cuanschutz.edu
Katherine Pickard, Ph.D.
CONTACT
303-724-7646
Katherine.e.pickard@emory.edu

Principal Investigator

Judy Reaven, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Colorado - Anschutz Medical Campus

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Judy Reaven, Ph.D., PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus

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 Date2023-08-25
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-08-25
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • intervention
  • schools
  • cognitive behavior therapy
  • group

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Anxiety Disorders
  • Emotion Regulation