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

NCT05863520 | Recruiting DMC

• 1 other identifier: 23-0521
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Anxiety Disorders; Emotion Regulation

Keywords

intervention; schools; cognitive behavior therapy; group

Outcome Measures

Primary Outcomes (3)

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

  The PARS-ASD is a clinician administered semi-structured interview to assess anxiety symptoms and severity. The PARS-ASD will be administered by an independent evaluator (IE) masked to condition. It includes: a Symptom Checklist and five Severity Items. The Symptom Checklist covers social anxiety, separation anxiety, generalized anxiety, panic, specific phobia, and other anxiety symptoms. The severity of symptoms is examined by assessing the frequency and pervasiveness of anxiety, as well as the extent to which the child avoids anxiety provoking situations (e.g., behavioral manifestations of anxiety).

  Baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention

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

  The SCARED is a 41-item inventory of statements that assesses five types of anxiety experienced by children and adolescents, to be completed separately by caregivers and students. A total score, as well as cutoffs for specific domains of anxiety (e.g., social, generalized) are obtained. A total score of 25 or higher is clinically significant. Scores range from 0-82 and higher scores indicate a worse outcome.

  baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention

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

  The SCARED is a 41-item inventory of statements that assesses five types of anxiety experienced by children and adolescents, to be completed separately by caregivers and students. A total score, as well as cutoffs for specific domains of anxiety (e.g., social, generalized) are obtained. A total score of 25 or higher is clinically significant. Scores range from 0-82 and higher scores indicate a worse outcome.

  baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention

Secondary Outcomes (8)

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

  baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention

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

  baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention

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

  baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention

• Change from Baseline in teacher reported anxiety on The School Anxiety Scale - Teacher Report (SAS-TR)

  baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention

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

  baseline, within 4 weeks post-intervention and 6 months after completion of the intervention

Other Outcomes (6)

• Treatment Fidelity

  From the beginning of the intervention through the end of intervention, up to a period of 20 weeks, the fidelity measure will be completed weekly by the independent research team

• Acceptability - Children

  within 4 weeks post-intervention

• Acceptability - parents

  within 4 weeks post-intervention

Study Arms (2)

Facing Your Fears - School Based

ACTIVE COMPARATOR

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).

Behavioral: Facing Your Fears - School Based

Zones of Regulation

ACTIVE COMPARATOR

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.

Behavioral: Zones of Regulation

Interventions

Zones of Regulation BEHAVIORAL

ZOR is rooted in CBT principles and uses a metacognitive framework to increase awareness of feelings and to build regulation, prosocial skills, and overall wellness.

Zones of Regulation

Facing Your Fears - School Based BEHAVIORAL

FYF-SB is a CBT program for managing anxiety in autistic youth.

Facing Your Fears - School Based

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify 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 (SRS-2).

You may not qualify if:

• 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
• 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
• 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 randomized to, and participating in 80% of bi-monthly consultation sessions with the research team.
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of North Carolina, Chapel Hill: collaborator
• Emory University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (1)

• Pickard K, Maddox B, Boles R, Reaven J. A cluster randomized controlled trial comparing the effectiveness of two school-based interventions for autistic youth with anxiety. BMC Psychiatry. 2024 Jan 2;24(1):6. doi: 10.1186/s12888-023-05441-0.

  PMID: 38166851 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Judy Reaven, Ph.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators will be masked to condition and collect post- intervention data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Up to 100 schools will be randomized to either Zones of Regulation or Facing Your Fears - School Based. Autistic students with anxiety within each school will be assigned to one of the programs.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: May 18, 2023
• Study Start: August 25, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)