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Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563003
First Posted: March 26, 2012
Last Update Posted: April 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of South Florida
Results First Submitted: April 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Autism
Asperger's Syndrome
Pervasive Developmental Disorder Not Otherwise Specified
Generalized Anxiety Disorder
Social Phobia
Separation Anxiety Disorder
Obsessive-compulsive Disorder
Interventions: Other: Cognitive Behavioral Therapy
Other: Treatment as usual

  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
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Reporting Groups
  Description
Cognitive Behavioral Therapy Condition

This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases

Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions.

Treatment as Usual

This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.

Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.


Participant Flow:   Overall Study
    Cognitive Behavioral Therapy Condition   Treatment as Usual
STARTED   16   15 
COMPLETED   16   15 
NOT COMPLETED   0   0 



  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 Condition

This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases

Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions.

Treatment as Usual

This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.

Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.

Total Total of all reporting groups

Baseline Measures
   Cognitive Behavioral Therapy Condition   Treatment as Usual   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   15   31 
Age 
[Units: Participants]
     
<=18 years   16   15   31 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.75  (1.24)   12.73  (1.49)   12.74  (1.34) 
Gender 
[Units: Participants]
     
Female   4   2   6 
Male   12   13   25 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   12   14   26 
Pacific Islander   1   0   1 
Hispanic   3   1   4 
Region of Enrollment 
[Units: Participants]
     
United States   16   15   31 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pediatric Anxiety Rating Scale   [ Time Frame: After an average of 16 weeks (Post-treatment) ]

2.  Secondary:   Anxiety Disorders Interview Schedule Clinical Severity Rating   [ Time Frame: After an average of 16 weeks (Post-treatment) ]

3.  Secondary:   Clinical Global Impression - Severity Scale   [ Time Frame: After an average of 16 weeks (Post-treatment) ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01563003     History of Changes
Other Study ID Numbers: AASD-2012
First Submitted: March 22, 2012
First Posted: March 26, 2012
Results First Submitted: April 1, 2015
Results First Posted: April 17, 2015
Last Update Posted: April 17, 2015