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Behavioral Intervention

School-Based Interventions for Anxiety in Autism

N/A

Recruiting

Led By Judy Reaven, Ph.D.

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

known medical diagnosis of ASD OR educational identification of ASD OR suspected ASD

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 4 weeks post-intervention

Awards & highlights

Study Summary

This trial will compare two school-based interventions for reducing anxiety in autistic students aged 8-14. It will measure effectiveness, feasibility, and satisfaction of both programs.

Who is the study for?

This trial is for autistic students aged 8-14 who experience anxiety and have a medical or educational diagnosis of ASD, or suspected ASD. They must also show significant social challenges as measured by the SRS-2. It's not suitable for those outside this age range or without these specific needs.Check my eligibility

What is being tested?

The study compares two programs: Facing Your Fears-School Based (FYF-SB) and Zones of Regulation (ZOR), to see which is better at reducing anxiety and helping with emotion regulation in autistic students. Participants will be randomly assigned to one program for 12 weeks, with evaluations before, after, and following the intervention.See study design

What are the potential side effects?

Since both FYF-SB and ZOR are behavioral interventions rather than medications, they may not have typical 'side effects'. However, participants might experience increased anxiety or resistance during initial stages of the programs as they adjust to new strategies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed or suspected to have autism spectrum disorder (ASD).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 4 weeks post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 4 weeks post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 4 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in anxiety on the clinician-administered Pediatric Anxiety Rating Scale - Autism Spectrum Disorder (PARS-ASD)

Change from Baseline in child reported anxiety on the Screening for Childhood Anxiety and Related Emotional Disorders (SCARED)

Change from Baseline in parent reported anxiety on the Screening for Childhood Anxiety and Related Emotional Disorders (SCARED)

Secondary outcome measures

Change from Baseline in child reported emotion regulation and reactivity on the Emotion Dysregulation Inventory (EDI)

Change from Baseline in child reported prosocial behavior and psychopathology on the Strengths and Difficulties Questionnaire (SDQ).

Change from Baseline in child reported social competence and emotion regulation on the Emotion Regulation Index for Children and Adolescents (ERICA)

+5 more

Other outcome measures

Acceptability - Children

Acceptability - parents

Semi-structured exit interviews - ISPs

+3 more

Trial Design

2Treatment groups

Active Control

Group I: Zones of RegulationActive Control1 Intervention

Zones of Regulation (ZOR) focuses on four different emotional states called "zones." Each zone is represented by different colors that represent different levels of emotions or arousal. ZOR includes psychoeducation about emotions and emotional states (e.g., reading facial expressions, identifying triggers for emotion dysregulations, using emotion regulation tools) and problem-solving strategies. In ZOR, students are also taught emotion regulation strategies (e.g., "calming", "cognitive" and "sensory" strategies) to stay in a specific zone and/or to move from one zone to another.

Group II: Facing Your Fears - School BasedActive Control1 Intervention

Facing Your Fears-School Based (FYF-SB) is a 12 week school based group program comprised of psychoeducation (somatic management, development of positive self-statements and strategies for managing emotions), and graded exposure (facing fears a little at a time).

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Emory UniversityOTHER

1,640 Previous Clinical Trials

2,560,457 Total Patients Enrolled

23 Trials studying Autism Spectrum Disorder

21,387 Patients Enrolled for Autism Spectrum Disorder

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,326 Total Patients Enrolled

12 Trials studying Autism Spectrum Disorder

1,636 Patients Enrolled for Autism Spectrum Disorder

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,997,258 Total Patients Enrolled

5 Trials studying Autism Spectrum Disorder

3,051 Patients Enrolled for Autism Spectrum Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can adults of 20 years and above participate in this research?

"The target demographic for this study are children aged between 7 and 15."

Answered by AI

Who is eligible to take part in the experiment?

"Those with autism spectrum disorder, between the ages of 7 and 15, are encouraged to apply for this clinical trial. Up to 200 applicants will be selected for participation."

Answered by AI

Are subjects currently being accepted for this investigation?

"Clinicaltrials.gov states that this clinical study is actively seeking participants; it was initially listed on August 25th 2023 and last updated November 28th of the same year."

Answered by AI

How many individuals are allowed to take part in this research endeavor?

"Indeed, the clinicaltrials.gov website shows that this research trial is currently searching for participants to enroll in their study. The initial posting was on August 25th 2023 and it was most recently updated on November 28th of that same year. 200 patients are sought after from 1 specific medical centre."

Answered by AI

What desired outcome is this trial attempting to achieve?

"The primary assessment of this intervention's efficacy is a Change from Baseline in child-reported anxiety on the Screening for Childhood Anxiety and Related Emotional Disorders (SCARED) scale. Secondary outcomes include Change from Baseline scores on the Emotion Dysregulation Inventory (EDI) and School Anxiety Scale - Teacher Report (SAS-TR), which are 5 point Likert scales that measure emotion regulation, reactivity, and anxiety respectively. These assessments will take place at baseline; 4 weeks after completion of treatment; and 6 months post-intervention."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05863520.

All > Anxiety Disorder