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
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:
- 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.
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||618 participants|
|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)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Colorado|
|University of Colorado School of Medicine|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Judy Reaven||University of Colorado School of Medicine|