Trial Outcomes & Findings for Cognitive Behavioral Therapy (CBT) for Anxiety Disorders in Autism: Adapting Treatment for Adolescents (NCT NCT01177969)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Post-treatment, which is an average of 16 weeks after Baseline

Results posted on

2014-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	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'.
Overall Study STARTED	19	14
Overall Study COMPLETED	16	11
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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'.
Overall Study Protocol Violation	2	1
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive-Behavioral Therapy n=19 Participants 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 n=14 Participants 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 n=33 Participants Total of all reporting groups
Age, Continuous	12.4 years STANDARD_DEVIATION 1.3 • n=5 Participants	12.2 years STANDARD_DEVIATION .98 • n=7 Participants	12.3 years STANDARD_DEVIATION 1.14 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	14 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Post-treatment, which is an average of 16 weeks after Baseline

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.

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Therapy n=19 Participants 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 n=14 Participants 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'.
Pediatric Anxiety Rating Scale.	11.62 units on a scale Standard Deviation 3.26	14.04 units on a scale Standard Deviation 2.64

SECONDARY outcome

Timeframe: Post-treatment, which was an average of 16 weeks after Baseline

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.

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Therapy n=19 Participants 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 n=14 Participants 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'.
Anxiety Disorders Interview Schedule: Child and Parent Versions	3.28 units on a scale Standard Deviation 2.1	4.04 units on a scale Standard Deviation 1.88

Adverse Events

Cognitive-Behavioral Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait-list

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

Dr. Eric Storch

University of South Florida

Phone: 727-767-8230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place