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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

Acceptability - Children

Acceptability - parents

Semi-structured exit interviews - ISPs

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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