Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism
1 other identifier
interventional
31
1 country
1
Brief Summary
Due to the considerable prevalence of anxiety in youth with autism spectrum disorders, this study seeks to establish the efficacy of a modified cognitive behavioral therapy protocol in 50 adolescents versus other available treatment options.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 22, 2012
CompletedFirst Posted
Study publicly available on registry
March 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
April 17, 2015
CompletedApril 17, 2015
April 1, 2015
3.8 years
March 22, 2012
April 1, 2015
April 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pediatric Anxiety Rating Scale
Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity.
After an average of 16 weeks (Post-treatment)
Secondary Outcomes (2)
Anxiety Disorders Interview Schedule Clinical Severity Rating
After an average of 16 weeks (Post-treatment)
Clinical Global Impression - Severity Scale
After an average of 16 weeks (Post-treatment)
Study Arms (2)
Cognitive Behavioral Therapy Condition
EXPERIMENTALThis arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases
Treatment as Usual
ACTIVE COMPARATORThis arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Interventions
This condition involves 16 weekly CBT sessions.
This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.
Eligibility Criteria
You may qualify if:
- Outpatient children with an autism spectrum disorder (see #2 below) between the ages 11-16 years.
- Meets criteria for a diagnosis of autism, Asperger syndrome (AS), or PDD-NOS using scores from the Autism Diagnostic Interview-Revised and the Childhood Autism Rating Scale.
- Meets DSM-IV criteria for a diagnosis of one of the following anxiety disorders: separation anxiety disorder (SAD), generalized anxiety disorder (GAD), social phobia, or obsessive compulsive disorder (OCD) as determined by the ADIS-IV-C/P (with CSR 4) and all available information.
- Minimum score of 13 on the PARS Severity Scale; this score indicates clinically significant anxiety symptom severity (RUPP, 2002) and has been used in recent major clinical trials (e.g., Walkup et al., 2008).
- Child has a Full Scale and Verbal Comprehension IQ \> 80 as assessed on a commonly used IQ test.
- Subjects with co-morbid depression, ADHD, tic disorder or disruptive behavior disorders will be acceptable as long as the anxiety disorder is primary (i.e., most impairing/distressing).
You may not qualify if:
- Receiving concurrent psychotherapy, social skills training, or behavioral interventions (e.g., applied behavior analysis). Families will have the option of discontinuing such services to enroll in the study.
- New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritionals or therapeutic diets within 6 weeks of study enrollment.
- Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications that might have behavioral effects must be stable for 6 weeks prior to the study baseline assessment. Any medications that the adolescent is on must remain stable during treatment. If a potential participant is taking psychotropic medication at the time of the phone evaluation or the first in-person study assessment and wishes to discontinue this medication to enter the study, the patient will be asked to discuss this option with their prescribing physician to determine whether medication discontinuation would be safe and in the adolescent's best interest. In addition, we will obtain the patient's written consent to contact their treating clinician to determine the appropriateness of study participation. We will not influence the decision patients make with their prescribing physician. All pharmacotherapy recommendations will be made in consultation with Dr. Murphy.
- (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.
- Lifetime DSM-IV bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.
- Unwillingness of parents to make the commitment to accompany their child for multiple study visits.
- Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rothman Center for Neuropsychiatry
St. Petersburg, Florida, 33701, United States
Related Publications (2)
Elliott SJ, Marshall D, Morley K, Uphoff E, Kumar M, Meader N. Behavioural and cognitive behavioural therapy for obsessive compulsive disorder (OCD) in individuals with autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2021 Sep 3;9(9):CD013173. doi: 10.1002/14651858.CD013173.pub2.
PMID: 34693989DERIVEDStorch EA, Lewin AB, Collier AB, Arnold E, De Nadai AS, Dane BF, Nadeau JM, Mutch PJ, Murphy TK. A randomized controlled trial of cognitive-behavioral therapy versus treatment as usual for adolescents with autism spectrum disorders and comorbid anxiety. Depress Anxiety. 2015 Mar;32(3):174-81. doi: 10.1002/da.22332. Epub 2014 Nov 25.
PMID: 25424398DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eric Storch, Ph.D.
- Organization
- University of South Florida
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2012
First Posted
March 26, 2012
Study Start
June 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
April 17, 2015
Results First Posted
April 17, 2015
Record last verified: 2015-04