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Autism spectrum disorders affect as many as 1 out of 88 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Accordingly, we are proposing a randomized controlled trial to examine the effectiveness of a form of cognitive-behavioral therapy relative to treatment as usual (TAU) in 50 youth ages 6-12 with autism spectrum disorders and comorbid anxiety.
Autism spectrum disorders affect as many as 1 out of 88 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Many children with anxiety disorders, especially those on the autism spectrum, do not receive evidence based treatment, which has fueled the development and evaluation of cognitive-behavioral therapy (CBT). Accordingly, we are proposing a randomized controlled trial to examine the efficacy of exposure based CBT that heavily incorporates parents (EF-CBT) relative to a TAU condition (TAU) in 50 youth ages 6-12 years with ASD and comorbid anxiety disorder(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy Condition | Experimental | This arm is the experimental condition; it consists of 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers. |
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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 12 weekly CBT sessions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Anxiety Rating Scale | This scale measures the severity of anxiety symptoms in children. The total scale range is 0-30 where 0 is the minimum and 30 the maximum. Higher scores correspond to more severe anxiety symptom severity. The total scale was used which corresponds to summing the 6 severity items. The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual). | After an average of 12 weeks (post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression - Severity Scale | This scale measures the severity of anxiety symptoms in children. The total scale range is 0-6 where 0 is the minimum and 6 the maximum. Higher scores correspond to more severe anxiety symptom severity. The scale consists of only 1 item that a clinician rates based on their judgement of anxiety severity. The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual). |
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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 |
Only 32 subjects were enrolled in this study (versus the N=40) indicated in the Protocol attached.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Therapy Condition | This arm is the experimental condition; it consists of 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers. Cognitive Behavioral Therapy: This condition involves 12 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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| After an average of 12 weeks (Post-treatment) |
| 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 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers. Cognitive Behavioral Therapy: This condition involves 12 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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| 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 | This scale measures the severity of anxiety symptoms in children. The total scale range is 0-30 where 0 is the minimum and 30 the maximum. Higher scores correspond to more severe anxiety symptom severity. The total scale was used which corresponds to summing the 6 severity items. The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual). | Posted | Mean | Standard Deviation | units on a scale | After an average of 12 weeks (post-treatment) |
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| Secondary | Clinical Global Impression - Severity Scale | This scale measures the severity of anxiety symptoms in children. The total scale range is 0-6 where 0 is the minimum and 6 the maximum. Higher scores correspond to more severe anxiety symptom severity. The scale consists of only 1 item that a clinician rates based on their judgement of anxiety severity. The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual). | Posted | Mean | Standard Deviation | units on a scale | After an average of 12 weeks (Post-treatment) |
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3 months
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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 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers. Cognitive Behavioral Therapy: This condition involves 12 weekly CBT sessions. | 0 | 14 | 0 | 14 | 0 | 14 |
| 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 | 18 | 0 | 18 | 0 | 18 |
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Small sample size. Short follow-up period. Many youth receiving usual care did not seek active treatment.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Storch | Baylor College of Medicine | 727-767-8230 | eric.storch@bcm.edu |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D020817 | Asperger Syndrome |
| D000098647 | Generalized Anxiety Disorder |
| D000072861 | Phobia, Social |
| D001010 | Anxiety, Separation |
| D009771 | Obsessive-Compulsive Disorder |
| C562465 | Phobia, Specific |
| 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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