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Facing Your Fears: Adolescents With ASD and Intellectual Disability (FYF:ASD/ID)

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ClinicalTrials.gov Identifier: NCT05131425
Recruitment Status : Recruiting
First Posted : November 23, 2021
Last Update Posted : December 13, 2021
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

Adolescents with ASD and intellectual disability (ID) are a complex and underserved population. Approximately 50% of individuals with ASD/ID experience significant anxiety. Yet, there are very limited mental health care interventions available for this population. Addressing anxiety and building coping skills is particularly important during adolescence as coping skills can support a successful transition to adulthood and family functioning during a difficult developmental period.

The current investigators adapted a cognitive behavioral treatment (CBT) manualized intervention, Facing Your Fears, for adolescents with ASD/ID (FYF:ASD/ID) and completed a pilot study with 23 teens. Preliminary results indicated significant improvements in anxiety and mood symptoms. The proposed study seeks to test whether FYF:ASD/ID is more effective in reducing anxiety than treatment-as-usual (TAU). The investigators propose a Randomized Control Trial (RCT) with 36 adolescents with ASD/ID (12-18 years) randomized to FYF: ASD/ID and 36 adolescents randomized to TAU for 14 weeks. The 36 teens randomized to TAU will then cross-over and complete FYF:ASD/ID. Evaluations will take place at Baseline, Post-Intervention, and 6-month follow-up. Teens in the TAU will have two baseline assessments prior to crossing over to FYF:ASD/ID; both groups will complete a 6-month follow-up assessment after finishing FYF:ASD/ID.

There are three aims for this project: (1) examine the efficacy of FYF: ASD/ID relative to TAU in improving anxiety as measured by parent report and determine if any gains noted in the FYF:ASD/ID are maintained at 6-month follow-up; (2) examine secondary outcomes of anxiety such as how emotion regulation and problem behavior are affected by participation in FYF:ASD/ID; and (3) examine whether adolescents' independent use of CBT skills (as assessed by goal attainment ratings of prompting level required to use strategies) to manage anxiety are increased following participation in FYF:ASD/ID.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Intellectual Disability Anxiety Behavioral: Facing Your Fears: ASD/ID Other: Treatment as Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The main objective of the current proposal is to conduct an RCT (i.e., treatment group and treatment-as-usual (TAU) control group) to examine the impact of a cognitive behavioral treatment for anxiety in an adolescent sample of Autistic youth with intellectual disability. This clinical trial incorporates random assignment, a control group, and a treatment group. All participants in the TAU control group can crossover and complete the intervention.
Masking: Single (Outcomes Assessor)
Masking Description: A blinded clinical evaluator will assess outcome
Primary Purpose: Treatment
Official Title: Group Cognitive Behavioral Treatment for Anxiety in Adolescents With ASD and Intellectual Disability: A Randomized Controlled Trial
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024


Arm Intervention/treatment
Experimental: Cognitive Behavioral Intervention
The experimental condition is a CBT intervention which focuses on developing 1) emotion regulation skills, 2) somatic management skills individually tailored for sensory and regulatory needs; 3) cognitive strategies such as individualized helpful thoughts and mantras (I can do it); and 4) graded exposure (e.g., facing fears).
Behavioral: Facing Your Fears: ASD/ID
This cognitive behavioral therapy, entitled Facing Your Fears for Adolescents with Autism and Intellectual Disability, is focused on somatic management, helpful cognitive mantras, emotion regulation, and graduated exposure adapted for the cognitive and linguistic needs of an Intellectual Disability population.
Other Name: Cognitive behavioral therapy

Treatment as Usual
The TAU condition will serve as the control condition and participants' medication use and outside therapies will be tracked monthly. Following completion of the 16-week wait period, the TAU group will be invited to enroll in FYF:ASD/ID.
Other: Treatment as Usual
The treatment as usual condition is being used in this study as a control condition. The investigators will track what medication and intervention services families are currently receiving.




Primary Outcome Measures :
  1. Change in number of anxiety diagnoses as measured by the Anxiety Disorders Interview Schedule: Autism Addendum (ADIS:ASA) [ Time Frame: Baseline (i.e., within 6 weeks' start of the treatment or TAU condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition) ]
    The ADIS:ASA is a semi-structured clinical interview completed with a parent that assesses anxiety diagnoses in children and adolescents with ASD. This measure provides a total number of anxiety diagnoses for a child. The interview will be administered and anxiety diagnoses recorded at the following time points: Baseline (i.e., within 6 weeks' start of the treatment or TA condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition). Change in the total number of anxiety diagnoses that a child meets diagnostic criteria for on the ADIS:ASA will be calculated across the aforementioned time points.

  2. Change in the Clinical Global Improvement-Severity score as derived by the Anxiety Disorders Interview Schedule: Autism Addendum (ADIS:ASA) [ Time Frame: Baseline (i.e., within 6 weeks' start of the treatment or TAU condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition) ]
    Clinical Global Improvement-severity (CGI-S) scores are derived from the ADIS:ASA. The CGI-S is a summary rating (i.e., likert scale of 1 to 7 with 7 indicating very severe) indicating the extent to which the teen's anxiety symptoms assessed via the ADIS:ASA impact daily functioning. To calculate change in anxiety severity, the CGI-S ratings are calculated at baseline (i.e., 6 weeks prior to the start of the 14-week TAU condition of intervention condition), post-treatment (i.e., within 6 weeks of the end of the completion of the 14-week TAU condition and intervention group conditions) and at follow-up (i.e., 6 months following the completion of the 14-week TAU intervention group). Change in CGI-S ratings across these time points are calculated.


Secondary Outcome Measures :
  1. Change in the Reactivity subscale as assessed by the Emotion Dysregulation Inventory (EDI) [ Time Frame: Baseline (i.e., within 6 weeks' start of the treatment or TAU condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition) ]
    The EDI is a parent report measure of emotion dysregulation in youth with ASD. Items are rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very severe). The Reactivity sub-scale contains 7-items. Possible scores on the Reactivity sub-scale could range from 7 to 35, with higher scores indicating a worse outcome. To calculate change in Reactivity the total score on the sub-scale is calculated at baseline (i.e., 6 weeks prior to the start of the 14-week TAU condition of intervention condition), post-treatment (i.e., within 6 weeks of the end of the completion of the 14-week TAU condition and intervention group conditions) and at follow-up (i.e., 6 months following the completion of the 14-week TAU intervention group).

  2. Change in the Dysphoria subscale as assessed by the Emotion Dysregulation Inventory (EDI) [ Time Frame: Baseline (i.e., within 6 weeks' start of the treatment or TAU condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition) ]
    The EDI is a parent report measure of emotion dysregulation in youth with ASD. Items are rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very severe). The Dysphoria subscale contains 6-items. Possible scores on the Reactivity subscale could range from 6 to 30, with higher scores indicating a worse outcome. To assess change in Dysphoria, the total score on the Dysphoria subscale is calculated at baseline (i.e., 6 weeks prior to the start of the 14-week TAU condition of intervention condition), post-treatment (i.e., within 6 weeks of the end of the completion of the 14-week TAU condition and intervention group conditions) and at follow-up (i.e., 6 months following the completion of the 14-week TAU intervention group). Change is assessed across these time points.

  3. Change in problem behavior as assessed by the The Aberrant Behavior Checklist-Community (ABC-C) [ Time Frame: Baseline (i.e., within 6 weeks' start of the treatment or TAU condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition) ]
    The ABC-C is a 58-item parent report questionnaire that evaluates the presence and severity of problem behavior across five sub-scales: Irritability, Lethargy/Social Withdrawal, Stereotypic Behavior, Hyperactivity/Noncompliance sub-scales, and Inappropriate Speech. Each item is rated on a scale of 0-3 with 0 being "not at all a problem" and 3 being "the problem is severe in degree." Total problem behavior raw scores across the five sub-scales range from 0-174.To assess change in problem behavior, the total raw score is calculated at baseline (i.e., 6 weeks prior to the start of the 14-week TAU condition of intervention condition), post-treatment (i.e., within 6 weeks of the end of the completion of the 14-week TAU condition and intervention group conditions) and at follow-up (i.e., 6 months following the completion of the 14-week TAU intervention group). Change is assessed across these time points.


Other Outcome Measures:
  1. Exploratory Aim: Exploratory analyses will be conducted to evaluate the effect of treatment participation on teens' independent use of somatic management, emotion regulation, and cognitive strategies using goal attainment scaling (e.g., GAS) [ Time Frame: Baseline (i.e., within 6 weeks' start of the treatment or TAU condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition) ]
    Teens use of somatic management, emotion regulation and cognitive strategies is assessed by a clinician via the CBT goal attainment scale interview. Scores from 0-4 are established for each participant based on outlined criteria for strategy use (0 indicates extremely limit skills and high dependence on others to use skills, 4 indicates independent use of skills, low dependence on others to use skills). Ratings are calculated at baseline (i.e., 6 weeks prior to the start of the 14-week TAU condition of intervention condition), post-treatment (i.e., within 6 weeks of the end of the completion of the 14-week TAU condition and intervention group conditions) and at follow-up (i.e., 6 months following the completion of the 14-week TAU intervention group). Change is assessed across these time points. Within-subject changes from baseline to post-treatment and follow-up on GAS will be evaluated using mixed model analyses.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chronological age between 12-18 years
  • A confirmed diagnosis of ASD, as based on a score above ASD cutoff on the Autism Diagnostic Observation Schedule-Second Edition and DSM-5 clinical evaluation
  • Cognitive and adaptive behavior abilities in the ID range as determined by a Brief IQ standard score between 40 - 70 on the Stanford Binet-Fifth Edition (SB-5) and a Total Adaptive Composite below 70 on the Adaptive Behavior Assessment System, 3rd Edition (ABAS-3)
  • Clinically significant symptoms of anxiety, defined by clinically significant anxiety elevations on the ADAMS and meeting diagnostic criteria for at least one anxiety diagnosis on the Anxiety Disorders Interview Schedule: Autism Addendum (ADIS:ASA)

Exclusion Criteria:

  • A primary mental health diagnosis of a non-anxiety psychiatric condition such as a thought disorder, as determined following administration of the ADIS:ASA, thus suggesting that a different treatment approach is merited
  • A raw score above 18 on the Irritability sub-scale of the Aberrant Behavior Checklist-Community (ABC-C), indicating problem behavior is 1.5-2 SD above the mean for youth with ID within this age range, thus suggesting a group treatment may not be appropriate
  • Inability of families to attend at least 11 of 14 sessions

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): NCT05131425


Contacts
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Contact: Audrey B Blakeley-Smith, Ph.D. 303-724-7630 audrey.blakeleysmith@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Grants and Contracts, Psychiatry Research Innovations       chelsea.hansen@cuanschutz.edu   
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Chelsea Hansen, MFA    303-724-4940    chelsea.hansen@cuanschutz.edu   
Principal Investigator: Audrey Blakeley-Smith, PhD         
Sub-Investigator: Judy Reaven, PhD         
Sponsors and Collaborators
University of Colorado, Denver
United States Department of Defense
Investigators
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Principal Investigator: Audrey D Blakeley-Smith, Ph.d. University of Colorado, Denver
Publications:
Reaven J, Blakeley-Smith A, Nichols S, & Hepburn, S. (2011). Facing Your Fears: Group Therapy for Managing Anxiety in Children with High-Functioning Autism Spectrum Disorders. Baltimore, MD: Paul Brookes Publishing
Hurlbutt K, Chalmers L. Employment and Adults With Asperger Syndrome. Focus on Autism and Other Developmental Disabilities. 2004;19(4):215-222. doi:10.1177/10883576040190040301

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT05131425    
Other Study ID Numbers: 20-3142
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: December 13, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
autism spectrum disorder
intellectual disability
cognitive behavioral therapy
anxiety
Additional relevant MeSH terms:
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Intellectual Disability
Anxiety Disorders
Autism Spectrum Disorder
Mental Disorders
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases