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

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ClinicalTrials.gov Identifier: NCT01177969
Recruitment Status : Completed
First Posted : August 9, 2010
Results First Posted : July 1, 2014
Last Update Posted : July 1, 2014
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Los Angeles
University of Miami
Information provided by (Responsible Party):
Eric Storch, University of South Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (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
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive-Behavioral Therapy Wait-list
Hide Arm/Group 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.

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.

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'.

Period Title: Overall Study
Started 19 14
Completed 16 11
Not Completed 3 3
Reason Not Completed
Protocol Violation             2             1
Withdrawal by Subject             1             2
Arm/Group Title Cognitive-Behavioral Therapy Wait-list Total
Hide Arm/Group 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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 19 14 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 14 participants 33 participants
12.4  (1.3) 12.2  (.98) 12.3  (1.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 14 participants 33 participants
Female
6
  31.6%
4
  28.6%
10
  30.3%
Male
13
  68.4%
10
  71.4%
23
  69.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 14 participants 33 participants
19 14 33
1.Primary Outcome
Title Pediatric Anxiety Rating Scale.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive-Behavioral Therapy Wait-list
Hide Arm/Group 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.

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.

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'.

Overall Number of Participants Analyzed 19 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.62  (3.26) 14.04  (2.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive-Behavioral Therapy, Wait-list
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .04
Comments This analysis applies to the post-treatment assessment (16 weeks after baseline)
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Anxiety Disorders Interview Schedule: Child and Parent Versions
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive-Behavioral Therapy Wait-list
Hide Arm/Group 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.

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.

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'.

Overall Number of Participants Analyzed 19 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.28  (2.1) 4.04  (1.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive-Behavioral Therapy, Wait-list
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .25
Comments This analysis applies to the post-treatment assessment (16 weeks after baseline)
Method ANCOVA
Comments [Not Specified]
Time Frame 16 weeks
Adverse Event Reporting Description Queries by study staff at study visits.
 
Arm/Group Title Cognitive-Behavioral Therapy Wait-list
Hide Arm/Group 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.

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.

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'.

All-Cause Mortality
Cognitive-Behavioral Therapy Wait-list
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive-Behavioral Therapy Wait-list
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cognitive-Behavioral Therapy Wait-list
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/14 (0.00%) 
Modest sample size Lack of objective measures of anxiety that go beyond diagnostic interview or checklist measures
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
Responsible Party: Eric Storch, University of South Florida
ClinicalTrials.gov Identifier: NCT01177969     History of Changes
Other Study ID Numbers: 1R34HD065274-01 ( U.S. NIH Grant/Contract )
1R34HD065274-01 ( U.S. NIH Grant/Contract )
First Submitted: August 5, 2010
First Posted: August 9, 2010
Results First Submitted: April 25, 2014
Results First Posted: July 1, 2014
Last Update Posted: July 1, 2014