Facing Your Fears in Schools: Implementing a CBT Program for Students With ASD or Other Special Learning Needs

NCT03685474 | Completed

• 1 other identifier: 18-0114
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of the project is to develop a feasible, effective and sustainable school-based program to manage anxiety in elementary and middle school students with Autism Spectrum Disorder (ASD) and other special learning needs. There are two phases to this Department of Health and Human Services/Health Resources and Services Administration-funded research. In the first phase, there will be engagement of community partners in the process of developing the adapted intervention for implementation in schools. The first phase is ongoing until approximately fall of 2018. This project is the second phase of this program of research and is focused on piloting and implementing the school-based intervention within 3 local school districts in a systematic and sustainable way - through a "train-the-trainer" model. Primary aims are:

1. 1.to prepare cross-disciplinary teams of School - Based Trainers to conduct three pilot student groups of Facing Your Fears - School Based (FYF-SB) within their own district, with the goal of later training others in their districts to deliver FYF-SB.
2. 2.at the start of the following academic year (2019-2020), within each of the three participating districts, 10 schools will be randomized to one of two conditions for the fall semester: a) FYF-SB or b) Usual Care; and assess implementation and treatment outcomes.

Conditions

Autism Spectrum Disorder

Keywords

Special Learning Needs; Minority Groups

Outcome Measures

Primary Outcomes (6)

• Reduction in symptoms of anxiety of the participant as measured by scores from the teacher - completed questionnaire, The School Anxiety Scale (SAS).

  The School Anxiety Scale (Lyneham et al. 2008) is a 16 item teacher-reported measure of anxiety designed to assess the behavior of children at school from 5 to 12 years of age. Items are answered on a four-point scale. This measure provides a total score for anxiety, with scores ranging from 0 - 48. Two subscales are also calculated, reflecting social anxiety and generalized anxiety. This measure will be completed by teachers before and after study treatment.

  13 weeks

• Reduction in symptoms of anxiety of participants as measured by scores from the parent-completed questionnaire, Parent-Rated Anxiety Scale for ASD (PRAS-ASD).

  The Parent - Rated Anxiety Scale for ASD (Scahill et al.) is a 25 item, parent report measure created to assess anxiety in youth with ASD. This measure has good test - retest reliability of 0.88 and 0.86, and strong convergent validity with other anxiety measures (0.83). This measure will be completed by parents before and after study treatment.

  13 weeks

• Reduction in symptoms of anxiety of participant as measured by scores from parent -, and self - completed questionnaire, Screening for Childhood Anxiety and Related Emotional Disorders (SCARED).

  Screening for Childhood Anxiety and Related Emotional Disorders (Birmaher et al, 1999) if a 40 - item inventory of statements that assess five types of anxiety experienced by children and adolescents, to be completed separately by parents and students. A total score, as well as cutoffs for specific domains on anxiety (e.g., social, generalized) are obtained. A total score of 25 or higher is considered to be clinically significant. Youth who obtain a score above the clinical cutoff for the total score or for 1 or more domains are eligible. This measure will be completed by parents and students before and after study treatment.

  13 weeks

• Reduction in symptoms of anxiety of participants as measured by scores from parent - completed questionnaire, The Social Responsiveness Scale, Second Edition (SRS-2).

  The Social Responsiveness Scale (Constantino \& Gruber, 2012) is a parent - reported 65 - item questionnaire that uses a 4 - point Likert scale to assess behaviors associated with ASD. It included five subscales: awareness, cognition, communication, motivation, and autistic mannerisms. Higher scores suggest greater impairment. The SRS is commonly used in autism research, has good reliability, and is valid across cultures (Bolte et al., 2008). This measure will be completed by parents before and after study treatment.

  13 weeks

• Reduction in symptoms of anxiety of participants as measured by scores from parent -, and teacher - completed questionnaire, Emotion Regulation Checklist (ERC).

  The Emotion Regulation Checklist (Shields \& Cicchetti, 1997) is a 24 - item parent/teacher report measure that provides information regarding a child's typical responses to emotionally intense experiences. The instrument has good reliability and validity across adult informants and provides indices regarding the child's ability to modulate and express affect in a manner that is context - appropriate. The ERC has been shown to be sensitive to change in effectiveness studies of CBT protocols with anxious youth (Suveg, Kendall, Comer, \& Robin, 2006). This measure will be completed by teachers and parents before and after study treatment.

  13 weeks

• Classroom attendance

  Teachers will track participants' daily attendance, including late arrivals and amount of time spent outside of classroom. Progression will be tracked for any trends before, during, and after study participation.

  13 weeks

Secondary Outcomes (8)

• Protocol adherence as measured by fidelity checklist.

  13 weeks

• Emotion Dysregulation Inventory Scores: Dysphoria

  Baseline, 13 Weeks

• Emotion Dysregulation Inventory Scores: Reactivity

  Baseline, 13 Weeks

• Teacher Concern Inventory: Time Management Subscale

  Baseline, 13 Weeks

• Teacher Concern Inventory: Work Stressors

  Baseline, 13 Weeks

Other Outcomes (2)

• Exploratory measure to assess plans for long-term maintenance of the program.

  13 weeks

• Exploratory measure to assess individual schools' organizational and training climates through the Organizational Readiness for Change (ORC) measure.

  13 weeks

Study Arms (2)

Facing Your Fears-School Based (FYF-SB)

EXPERIMENTAL

This group will receive the Facing Your Fears - School Based intervention during the fall semester

Behavioral: Facing Your Fears - School Based

Usual Care (UC)

ACTIVE COMPARATOR

This group will receive usual care of anxiety treatment during the fall semester, but will be in the FYF-SB arm the following spring semester.

Behavioral: Usual Care

Interventions

Facing Your Fears - School Based BEHAVIORAL

Participants receiving FYF-SB will receive cognitive-behavioral treatment (CBT), which is an evidence-based practice (EBP) for treating anxiety in typical youth, within their school setting.

Also known as: Cognitive Behavioral Treatment

Facing Your Fears-School Based (FYF-SB)

Usual Care BEHAVIORAL

Participants receiving usual care will experience no different therapies, strategies, or recommendations other than what would typically be administered within the school setting in the absence of the proposed study.

Usual Care (UC)

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Estimated Verbal intelligence quotient (IQ) of 80 or above as determined by the Weschler Abbreviated Scales of Intelligence (WASI), or an equivalent measure administered within the past three years; or presents with achievement scores in school records that suggest average-low average-borderline intellectual functioning
• Clinically significant anxiety symptoms as defined by significant elevations on either the SCARED, or PRAS-ASD, according to either student, parent, or teacher report
• Currently staffed into special education with an individualized education plan (IEP) or 504 with one of the following eligibility categories: autism, other health impairment, emotional disturbance, specific learning disabilities, multiple disabilities or other speech/language impairment; OR currently identified as at risk and in need of Response to Intervention (RTI) consultation and not yet found to be eligible for special education services OR currently in the process of completing the educational eligibility evaluation
• Significant deficits in reciprocal social behavior as defined by a Total T Score on the Social Responsive Scale Version 2 (SRS-2) of 60 or above
• Lives with parent/guardian who can provide consent for participation.

You may not qualify if:

• (1) Presentation of psychosis, severe aggressive behavior, or other severe clinical symptoms that require more intensive treatment such as day treatment or hospitalization

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Health Resources and Services Administration (HRSA): collaborator

Study Sites (1)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Reaven J, Cosgrove KT, Losh A, Nickles S, Kerns CM, Pickard K, Blakeley-Smith A, Hayutin L, Meyer AT, Middleton C, Reyes NM, Boles RE. Facing your fears in schools: using the ADIS/ASA to characterize anxiety and intervention outcomes in students with autism or suspected autism. Front Psychiatry. 2025 Jul 23;16:1569435. doi: 10.3389/fpsyt.2025.1569435. eCollection 2025.

  PMID: 40778329 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Judy Reaven

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In the present study, we will use the measure entitled Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM; Glasgow, 2013) as a framework for planning and implementing FYF-SB in the school environment. The translation of research from controlled research settings to natural environments is often an exceptionally slow process, perhaps because of the emphasis on efficacy. A pragmatic framework such as RE-AIM can hasten the portability of evidenced based intervention to "real-world" practice by focusing on stakeholder feedback and environmental context, in conjunction with intervention development and content. We plan to conduct a randomized controlled trial of the FYF-SB intervention across 30 schools within 3 districts. The intervention conditions occur for 1 semester within an academic year. Data will be collected in a pre-post design (before and after the condition of either Facing Your Fears - School Based or Usual Care).

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 26, 2018
• Study Start: August 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)