Trial record 1 of 1 for:    •Cognitive Behavioral Therapy (CBT) for Anxiety Disorders in Autism: Adapting Treatment for Adolescents
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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
Results First Received: April 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anxiety Disorders in Youth With Autism, Asperger's Syndrome, and Pervasive Developmental Disorder Not Otherwise Specified
Interventions: Behavioral: Cognitive-Behavioral Therapy
Behavioral: Wait-list

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.

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'.

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'.


Participant Flow:   Overall Study
    Cognitive-Behavioral Therapy     Wait-list  
STARTED     19     14  
COMPLETED     16     11  
NOT COMPLETED     3     3  
Protocol Violation                 2                 1  
Withdrawal by Subject                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

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'.

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'.

Total Total of all reporting groups

Baseline Measures
    Cognitive-Behavioral Therapy     Wait-list     Total  
Number of Participants  
[units: participants]
  19     14     33  
Age  
[units: years]
Mean ± Standard Deviation
  12.4  ± 1.3     12.2  ± .98     12.3  ± 1.14  
Gender  
[units: participants]
     
Female     6     4     10  
Male     13     10     23  
Region of Enrollment  
[units: participants]
     
United States     19     14     33  



  Outcome Measures
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1.  Primary:   Pediatric Anxiety Rating Scale.   [ Time Frame: Post-treatment, which is an average of 16 weeks after Baseline ]

2.  Secondary:   Anxiety Disorders Interview Schedule: Child and Parent Versions   [ Time Frame: Post-treatment, which was an average of 16 weeks after Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Modest sample size Lack of objective measures of anxiety that go beyond diagnostic interview or checklist measures


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Eric Storch
Organization: University of South Florida
phone: 727-767-8230
e-mail: estorch@health.usf.edu


No publications provided


Responsible Party: Eric Storch, 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