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Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism

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ClinicalTrials.gov Identifier: NCT01563003
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : April 17, 2015
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
University of South Florida

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
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive Behavioral Therapy Condition Treatment as Usual
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 16 15
Completed 16 15
Not Completed 0 0
Arm/Group Title Cognitive Behavioral Therapy Condition Treatment as Usual Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 16 15 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
<=18 years
16
 100.0%
15
 100.0%
31
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 31 participants
12.75  (1.24) 12.73  (1.49) 12.74  (1.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Female
4
  25.0%
2
  13.3%
6
  19.4%
Male
12
  75.0%
13
  86.7%
25
  80.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Caucasian 12 14 26
Pacific Islander 1 0 1
Hispanic 3 1 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 15 participants 31 participants
16 15 31
1.Primary Outcome
Title Pediatric Anxiety Rating Scale
Hide Description Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity.
Time Frame After an average of 16 weeks (Post-treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioral Therapy Condition Treatment as Usual
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 16 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.94  (3.91) 13.93  (3.56)
2.Secondary Outcome
Title Anxiety Disorders Interview Schedule Clinical Severity Rating
Hide Description Scale range - 0 (minimum) to 8 (maximum). Higher scores represent worse anxiety symptom severity.
Time Frame After an average of 16 weeks (Post-treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioral Therapy Condition Treatment as Usual
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 16 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.69  (1.35) 5.33  (.9)
3.Secondary Outcome
Title Clinical Global Impression - Severity Scale
Hide Description Scale range - 0 (minimum) to 6 (maximum). Higher scores represent worse anxiety symptom severity.
Time Frame After an average of 16 weeks (Post-treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioral Therapy Condition Treatment as Usual
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 16 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.88  (.72) 3.67  (.82)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Behavioral Therapy Condition Treatment as Usual
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Cognitive Behavioral Therapy Condition Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Behavioral Therapy Condition Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/15 (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 Condition Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/15 (0.00%) 
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
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