Clinical trial for Autism Spectrum Disorder
Official title A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students
ClinicalTrials.gov ID: NCT05863520
What this study is testing
- What it's testing
- The study will see which program, Facing Your Fears‑School Based or Zones of Regulation, better reduces anxiety and improves emotion control, and will check how easy and satisfying each program is for students, caregivers, and teachers.
- Who it's for
- Autistic students aged 8 to 14 who have anxiety.
- What's involved
- Participants will be randomly assigned to one of the two programs and will attend the program for 12 weeks. Assessments will be done before the program, after it ends, and at a follow‑up time.
- Time commitment
- The study lasts 12 weeks of program participation, plus visits for pre‑study, post‑study, and follow‑up assessments.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 15. Healthy volunteers may be eligible.
You may be able to join if
- known medical diagnosis of ASD OR educational identification of ASD OR suspected ASD
- clinical anxiety according to either student, parent or teacher report
- clinically significant impairment (T-score above 70) in reciprocal social behavior according to the Social Responsiveness Scale - Second Edition...
You likely can't join if
- for students
- known intellectual disability
- significant behavior or psychiatric challenge that prevents them from participation in small group activities
- lack of parent or caregiver permission for participation Inclusion Criteria for Caregivers of students 8-14 \- legal guardian of a student who meets...
- degreed professionals in one of the following: education (special or general education), school psychology, counseling, social work, speech/language...
- working with autistic students with anxiety
See the full eligibility criteria
- known medical diagnosis of ASD OR educational identification of ASD OR suspected ASD
- clinical anxiety according to either student, parent or teacher report
- clinically significant impairment (T-score above 70) in reciprocal social behavior according to the Social Responsiveness Scale - Second Edition (SRS-2).
- for students
- known intellectual disability
- significant behavior or psychiatric challenge that prevents them from participation in small group activities
- lack of parent or caregiver permission for participation Inclusion Criteria for Caregivers of students 8-14 \- legal guardian of a student who meets inclusion criteria defined above Inclusion criteria for...
- 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...
- working with autistic students with anxiety
- be able to complete study requirements including attending the training workshops, delivering at least 80% of the program they were assigned by chance to, and participating in 80% of bi-monthly consultation sessions...
- if they are unable to participate in the trainings, deliver the program they are assigned to, or participate in any of the consultation visits
- if they do not work with students with autism and anxiety
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 15 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.