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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of California, Los Angeles
University of Miami
Information provided by:
University of South Florida
ClinicalTrials.gov Identifier:
NCT01177969
First received: August 5, 2010
Last updated: April 8, 2013
Last verified: April 2013

August 5, 2010
April 8, 2013
November 2009
December 2013   (final data collection date for primary outcome measure)
Pediatric Anxiety Rating Scale. The Pediatric Anxiety Rating Scale (RUPP, 2002) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. [ Time Frame: Baseline, an average of 16 weeks after Baseline (post-treament), and 1-month after the post-treatment assessment (follow-up) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01177969 on ClinicalTrials.gov Archive Site
Anxiety Disorders Interview Schedule: Child and Parent Versions [ Time Frame: Baseline, an average of 16 weeks after Baseline (post-treament), and 1-month after the post-treatment assessment (follow-up) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cognitive Behavioral Therapy (CBT) for Anxiety Disorders in Autism: Adapting Treatment for Adolescents
CBT for Anxiety Disorders in Autism: Adapting Treatment for Adolescents

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Anxiety Disorders in Youth With Autism, Asperger's Syndrome, and Pervasive Developmental Disorder Not Otherwise Specified
  • 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
  • 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
  • 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.
    Intervention: Behavioral: Cognitive-Behavioral 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'.
    Intervention: Behavioral: Wait-list
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
52
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
11 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01177969
1R34HD065274-01, 1R34HD065274-01
Yes
Eric Storch, Ph.D., University of South Florida
University of South Florida
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of California, Los Angeles
  • University of Miami
Principal Investigator: Eric Storch, PhD University of South Florida
University of South Florida
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP