Cognitive Behavioral Therapy (CBT) for Anxiety Disorders in Autism: Adapting Treatment for Adolescents

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
University of Miami
Information provided by (Responsible Party):
Eric Storch, University of South Florida
ClinicalTrials.gov Identifier:
NCT01177969
First received: August 5, 2010
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Anxiety Disorders in Youth With Autism, Asperger's Syndrome, and Pervasive Developmental Disorder Not Otherwise Specified
Behavioral: Cognitive-Behavioral Therapy
Behavioral: Wait-list
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CBT for Anxiety Disorders in Autism: Adapting Treatment for Adolescents

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Pediatric Anxiety Rating Scale. [ Time Frame: Post-treatment, which is an average of 16 weeks after Baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Anxiety Disorders Interview Schedule: Child and Parent Versions [ Time Frame: Post-treatment, which was an average of 16 weeks after Baseline ] [ Designated as safety issue: No ]
    The Anxiety Disorders Interview Schedule: Child and Parent Versions are clinician-rated scales assessing anxiety symptoms and the associated severity and impairment in children over the past month. The clinician interviewer interviews the child and parent separately about the nature and severity of the child's anxiety. If a child meets criteria for an anxiety disorder, a single item is rated by the interviewer, which represents anxiety severity. The scale score for this single item ranges from 0 to 8 with higher scores indicating more severe anxiety symptoms.


Enrollment: 33
Study Start Date: November 2009
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-Behavioral Therapy
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.
Behavioral: Cognitive-Behavioral Therapy
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.
Other Names:
  • CBT
  • Exposure therapy
Placebo Comparator: Wait-list
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'.
Behavioral: Wait-list
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'.
Other Name: Placebo

Detailed Description:

Autism spectrum disorders (ASD) affect approximately 1 out of 150 children and adolescents in the United States, making them one of the most common neurobiological conditions. Comorbid anxiety disorders affect as many as 80% of youth with ASD, causing substantial distress and impairment over and above that caused by an ASD diagnosis alone. While cognitive-behavioral therapy (CBT) has been established as the gold standard treatment for anxiety disorders among typically developing youth, a protocol does not exist for early adolescents with ASD and comorbid anxiety disorders. Accordingly, we are proposing to develop a CBT protocol for anxiety and comorbid ASD in early adolescence.

Initial protocol development efforts will focus on adapting relevant treatment elements from an effective CBT program for younger children with ASD and comorbid anxiety to the characteristics and clinical needs of early adolescents. Thereafter, protocol and measure development will be refined during Phases I and II of this study through our experiences treating a total of 20 young adolescents (ages 11-14 years - 10 will be treated at USF; 10 at University of California, Los Angeles (UCLA)) with ASD and comorbid anxiety disorder(s). The CBT protocol will then be examined in a trial comparing CBT to a waitlist condition (N = 32 total; 16 at each study site).

The two recruitment sites for this study are the University of California, Los Angeles and the University of South Florida. The University of Miami will assist with quality assurance checks. Considering the rising number of youth diagnosed with ASD, and the lack of tested treatment options for those young adolescents with comorbid anxiety, our proposed work toward an efficacious CBT protocol will provide a timely contribution to public health efforts.

  Eligibility

Ages Eligible for Study:   11 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177969

Locations
United States, California
Univeristy of California at Los Angeles
Los Angeles, California, United States
United States, Florida
University of South Florida
St. Petersburg, Florida, United States, 33701
Sponsors and Collaborators
University of South Florida
University of California, Los Angeles
University of Miami
Investigators
Principal Investigator: Eric Storch, PhD University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: Eric Storch, Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT01177969     History of Changes
Other Study ID Numbers: 1R34HD065274-01, 1R34HD065274-01
Study First Received: August 5, 2010
Results First Received: April 25, 2014
Last Updated: June 27, 2014
Health Authority: National Institute of Child Health and Human Development: USA

Keywords provided by University of South Florida:
Autism
Anxiety
Asperger's Syndrome
Cognitive-behavioral therapy
Treatment
Obsessive-compulsive disorder
Fears

Additional relevant MeSH terms:
Anxiety Disorders
Autistic Disorder
Developmental Disabilities
Asperger Syndrome
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on September 11, 2014