search
Back to results

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

Primary Purpose

Anxiety Disorders in Youth With Autism, Asperger's Syndrome, and Pervasive Developmental Disorder Not Otherwise Specified

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy
Wait-list
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders in Youth With Autism, Asperger's Syndrome, and Pervasive Developmental Disorder Not Otherwise Specified focused on measuring Autism, Anxiety, Asperger's Syndrome, Cognitive-behavioral therapy, Treatment, Obsessive-compulsive disorder, Fears

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Univeristy of California at Los Angeles
  • University of South Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cognitive-Behavioral Therapy

Wait-list

Arm Description

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'.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Anxiety Disorders Interview Schedule: Child and Parent Versions
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.

Full Information

First Posted
August 5, 2010
Last Updated
June 27, 2014
Sponsor
University of South Florida
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, Los Angeles, University of Miami
search

1. Study Identification

Unique Protocol Identification Number
NCT01177969
Brief Title
Cognitive Behavioral Therapy (CBT) for Anxiety Disorders in Autism: Adapting Treatment for Adolescents
Official Title
CBT for Anxiety Disorders in Autism: Adapting Treatment for Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, Los Angeles, University of Miami

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders in Youth With Autism, Asperger's Syndrome, and Pervasive Developmental Disorder Not Otherwise Specified
Keywords
Autism, Anxiety, Asperger's Syndrome, Cognitive-behavioral therapy, Treatment, Obsessive-compulsive disorder, Fears

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Behavioral Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy
Other Intervention Name(s)
CBT, Exposure therapy
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Wait-list
Other Intervention Name(s)
Placebo
Intervention Description
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'.
Primary Outcome Measure Information:
Title
Pediatric Anxiety Rating Scale.
Description
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.
Time Frame
Post-treatment, which is an average of 16 weeks after Baseline
Secondary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule: Child and Parent Versions
Description
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.
Time Frame
Post-treatment, which was an average of 16 weeks after Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Storch, PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of California at Los Angeles
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of South Florida
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34693989
Citation
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.
Results Reference
derived
PubMed Identifier
25526831
Citation
Wood 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.
Results Reference
derived
Links:
URL
http://hscweb3.hsc.usf.edu/health/now/?p=8518
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs