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Facing Your Fears in Schools: Implementing a CBT Program for Students With ASD or Other Special Learning Needs (FYF-SB)

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ClinicalTrials.gov Identifier: NCT03685474
Recruitment Status : Enrolling by invitation
First Posted : September 26, 2018
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
University of Colorado, Denver

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. 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. 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Facing Your Fears - School Based Behavioral: Usual Care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 618 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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).

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Facing Your Fears in Schools: Implementing a CBT Program for Students With ASD or Other Special Learning Needs
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Facing Your Fears-School Based (FYF-SB)
This group will receive the Facing Your Fears - School Based intervention during the fall semester
Behavioral: Facing Your Fears - School Based
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.
Other Name: Cognitive Behavioral Treatment

Active Comparator: Usual Care (UC)
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
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.




Primary Outcome Measures :
  1. Reduction in symptoms of anxiety of the participant as measured by scores from the teacher - completed questionnaire, The School Anxiety Scale (SAS). [ Time Frame: 13 weeks ]

    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.


  2. Reduction in symptoms of anxiety of participants as measured by scores from the parent-completed questionnaire, Parent-Rated Anxiety Scale for ASD (PRAS-ASD). [ Time Frame: 13 weeks ]

    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.


  3. 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). [ Time Frame: 13 weeks ]

    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.


  4. Reduction in symptoms of anxiety of participants as measured by scores from parent - completed questionnaire, The Social Responsiveness Scale, Second Edition (SRS-2). [ Time Frame: 13 weeks ]

    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.


  5. Reduction in symptoms of anxiety of participants as measured by scores from parent -, and teacher - completed questionnaire, Emotion Regulation Checklist (ERC). [ Time Frame: 13 weeks ]

    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.


  6. Classroom attendance [ Time Frame: 13 weeks ]
    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.


Secondary Outcome Measures :
  1. Protocol adherence as measured by fidelity checklist. [ Time Frame: 13 weeks ]
    The Treatment fidelity/acceptability checklist will be used to assess facilitators' adherence to protocol. The measure is a checklist that assesses the presence / absence of core treatment components on a session - by - session basis, while simultaneously assessing usefulness and acceptability. Because school providers, students, and parents will complete this measure, we will be able to cross - check adherence and utility of core activities.


Other Outcome Measures:
  1. Exploratory measure to assess plans for long-term maintenance of the program. [ Time Frame: 13 weeks ]
    The Evidence - Based Practice Attitude Scale (EBPAS; Aarons et al., 2004) is a 15 - item scale measured on a five point scale that assesses general attitude towards the adoption of EBP. There are four subscales that measure appeal, requirements, openness, and divergence. Subscale and total scores can be calculated. The EBPAS has demonstrated strong internal consistency. This measure will be used in order to plan for long-term maintenance and sustainability of the program.

  2. Exploratory measure to assess individual schools' organizational and training climates through the Organizational Readiness for Change (ORC) measure. [ Time Frame: 13 weeks ]
    The ORC (Lehman, et al. 2002) is a 129 item scale that measures organizational characteristics on a five point Likert scale, across five domains: motivation, resources, staff attributes, organizational climate, and training climate. This measure will be used to assess the potential for program sustainability within each participating school.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Clinically significant anxiety symptoms as defined by significant elevations on either the SCARED, or PRAS-ASD, according to either student, parent, or teacher report
  3. 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
  4. 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
  5. Lives with parent/guardian who can provide consent for participation.

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685474


Locations
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United States, Colorado
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Health Resources and Services Administration (HRSA)
Investigators
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Principal Investigator: Judy Reaven University of Colorado School of Medicine

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03685474     History of Changes
Other Study ID Numbers: 18-0114
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Special Learning Needs
Minority Groups

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders