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Due to the considerable prevalence of anxiety in youth with autism spectrum disorders, this study seeks to establish the efficacy of a modified cognitive behavioral therapy protocol in 50 adolescents versus other available treatment options.
This study will further examine a treatment plan for adolescents with autism spectrum disorderS (ASD) and anxiety. Many children who have an autism spectrum disorder experience substantial anxiety that can cause impairment above that of an ASD alone. Few studies have examined effective treatment options for anxiety in this population. In typically developing youth, Cognitive Behavioral Therapy (CBT) is considered the gold standard for treating anxiety. But, in order to address the unique needs of children with ASD, this study utilizes a modified CBT treatment plan which includes social skills and parent training. In our past studies, this cognitive-behavioral treatment plan has been effective in kids with ASD and anxiety compared to kids who did not receive any treatment.The current study compares this modified treatment plan to other treatment options in the community. The experimental component of this study is being assigned to 1 of 2 groups. The first group will receive CBT immediately for a period of 16 weeks. The second group will have to wait 16 weeks before receiving CBT. During this time period, children may receive any other services in the community. Overall, all adolescents receive the same type of therapy; it's matter of whether he/she receives it immediately or after a wait period. Sixteen weekly sessions comprise CBT. All therapy and assessments associated with this study will be free of charge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy Condition | Experimental | 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 |
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| Treatment as Usual | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Other | This condition involves 16 weekly CBT sessions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Anxiety Rating Scale | Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity. | After an average of 16 weeks (Post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Disorders Interview Schedule Clinical Severity Rating | Scale range - 0 (minimum) to 8 (maximum). Higher scores represent worse anxiety symptom severity. | After an average of 16 weeks (Post-treatment) |
| Clinical Global Impression - Severity Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Center for Neuropsychiatry | St. Petersburg | Florida | 33701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34693989 | Derived | Elliott SJ, Marshall D, Morley K, Uphoff E, Kumar M, Meader N. Behavioural and cognitive behavioural therapy for obsessive compulsive disorder (OCD) in individuals with autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2021 Sep 3;9(9):CD013173. doi: 10.1002/14651858.CD013173.pub2. | |
| 25424398 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Treatment as usual | Other | 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. |
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Scale range - 0 (minimum) to 6 (maximum). Higher scores represent worse anxiety symptom severity. |
| After an average of 16 weeks (Post-treatment) |
| Storch EA, Lewin AB, Collier AB, Arnold E, De Nadai AS, Dane BF, Nadeau JM, Mutch PJ, Murphy TK. A randomized controlled trial of cognitive-behavioral therapy versus treatment as usual for adolescents with autism spectrum disorders and comorbid anxiety. Depress Anxiety. 2015 Mar;32(3):174-81. doi: 10.1002/da.22332. Epub 2014 Nov 25. |
| FG001 | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pediatric Anxiety Rating Scale | Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity. | Posted | Mean | Standard Deviation | units on a scale | After an average of 16 weeks (Post-treatment) |
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| Secondary | Anxiety Disorders Interview Schedule Clinical Severity Rating | Scale range - 0 (minimum) to 8 (maximum). Higher scores represent worse anxiety symptom severity. | Posted | Mean | Standard Deviation | units on a scale | After an average of 16 weeks (Post-treatment) |
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| Secondary | Clinical Global Impression - Severity Scale | Scale range - 0 (minimum) to 6 (maximum). Higher scores represent worse anxiety symptom severity. | Posted | Mean | Standard Deviation | units on a scale | After an average of 16 weeks (Post-treatment) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 16 | 0 | 16 | ||
| EG001 | 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. | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Storch, Ph.D. | University of South Florida | 727-767-8230 | estorch@health.usf.edu |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D020817 | Asperger Syndrome |
| D000098647 | Generalized Anxiety Disorder |
| D000072861 | Phobia, Social |
| D001010 | Anxiety, Separation |
| D009771 | Obsessive-Compulsive Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| >=65 years |
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| Male |
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| Pacific Islander |
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| Hispanic |
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