Cognitive Behavioral Therapy (CBT) for Anxiety Disorders in Autism: Adapting Treatment for Adolescents
CBT for Anxiety Disorders in Autism: Adapting Treatment for Adolescents
1 other identifier
interventional
33
1 country
2
Brief Summary
Comorbid anxiety disorders affect as many as 80% of youth with autism spectrum disorders, causing substantial distress and impairment over and above the autism spectrum diagnosis alone. Cognitive behavioral therapy (CBT) is the gold standard treatment among typically developing youth with an anxiety disorder and when adapted, shows promise in children with ASD and comorbid anxiety. However, there is currently no psychotherapy protocol tailored to meet the unique needs of young adolescents with Autism spectrum disorders (ASD) and comorbid anxiety. Given this, the present study seeks to develop and test a new CBT therapy in adolescents with autism and comorbid anxiety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2009
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 5, 2010
CompletedFirst Posted
Study publicly available on registry
August 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
July 1, 2014
CompletedJuly 1, 2014
June 1, 2014
4.4 years
August 5, 2010
April 25, 2014
June 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pediatric Anxiety Rating Scale.
The Pediatric Anxiety Rating Scale is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The scale includes 5 items which are summed to form a total score, which represents anxiety severity. The scale score ranges from 0 to 25 with higher scores indicating more severe anxiety symptoms.
Post-treatment, which is an average of 16 weeks after Baseline
Secondary Outcomes (1)
Anxiety Disorders Interview Schedule: Child and Parent Versions
Post-treatment, which was an average of 16 weeks after Baseline
Study Arms (2)
Cognitive-Behavioral Therapy
EXPERIMENTALThe form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.
Wait-list
PLACEBO COMPARATORA wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.
Interventions
The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.
A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.
Eligibility Criteria
You may qualify if:
- Outpatient adolescents with ASD (see below) between the ages 11-14 years.
- Meets criteria for a diagnosis of autism, Asperger syndrome (AS), or Pervasive Developmental Disorder Not Otherwise Specified .
- Meets 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).
- Child has a Full Scale and Verbal Comprehension IQ≥85.
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.
- Has started an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment.
- Has changed established psychotropic medications (e.g., antidepressants, anxioloytics) within 8 weeks before study enrollment (6 weeks for antipsychotic).
- Is currently suicidal or has been actively suicidal in the last 6 months.
- Has been diagnosed with bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.
- 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 (2)
Univeristy of California at Los Angeles
Los Angeles, California, United States
University of South Florida
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: 34693989DERIVEDWood JJ, Ehrenreich-May J, Alessandri M, Fujii C, Renno P, Laugeson E, Piacentini JC, De Nadai AS, Arnold E, Lewin AB, Murphy TK, Storch EA. Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial. Behav Ther. 2015 Jan;46(1):7-19. doi: 10.1016/j.beth.2014.01.002. Epub 2014 Jan 22.
PMID: 25526831DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Modest sample size Lack of objective measures of anxiety that go beyond diagnostic interview or checklist measures
Results Point of Contact
- Title
- Dr. Eric Storch
- Organization
- University of South Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Storch, PhD
University of South Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 5, 2010
First Posted
August 9, 2010
Study Start
November 1, 2009
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
July 1, 2014
Results First Posted
July 1, 2014
Record last verified: 2014-06