Trial Outcomes & Findings for Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism (NCT NCT01563003)
NCT ID: NCT01563003
Last Updated: 2015-04-17
Results Overview
Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
After an average of 16 weeks (Post-treatment)
Results posted on
2015-04-17
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy Condition
n=16 Participants
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
n=15 Participants
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
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12.75 years
STANDARD_DEVIATION 1.24 • n=5 Participants
|
12.73 years
STANDARD_DEVIATION 1.49 • n=7 Participants
|
12.74 years
STANDARD_DEVIATION 1.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After an average of 16 weeks (Post-treatment)Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity.
Outcome measures
| Measure |
Cognitive Behavioral Therapy Condition
n=16 Participants
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
n=15 Participants
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.
|
|---|---|---|
|
Pediatric Anxiety Rating Scale
|
10.94 units on a scale
Standard Deviation 3.91
|
13.93 units on a scale
Standard Deviation 3.56
|
SECONDARY outcome
Timeframe: After an average of 16 weeks (Post-treatment)Scale range - 0 (minimum) to 8 (maximum). Higher scores represent worse anxiety symptom severity.
Outcome measures
| Measure |
Cognitive Behavioral Therapy Condition
n=16 Participants
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
n=15 Participants
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.
|
|---|---|---|
|
Anxiety Disorders Interview Schedule Clinical Severity Rating
|
3.69 units on a scale
Standard Deviation 1.35
|
5.33 units on a scale
Standard Deviation .9
|
SECONDARY outcome
Timeframe: After an average of 16 weeks (Post-treatment)Scale range - 0 (minimum) to 6 (maximum). Higher scores represent worse anxiety symptom severity.
Outcome measures
| Measure |
Cognitive Behavioral Therapy Condition
n=16 Participants
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
n=15 Participants
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.
|
|---|---|---|
|
Clinical Global Impression - Severity Scale
|
2.88 units on a scale
Standard Deviation .72
|
3.67 units on a scale
Standard Deviation .82
|
Adverse Events
Cognitive Behavioral Therapy Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place