A Phase 1/2 interventional study of Cognitive-Behavioral Therapy and Wait-list in Anxiety Disorders in Youth With Autism, Asperger's Syndrome, and Pervasive Developmental Disorder Not Otherwise Specified, sponsored by University of South Florida. Completed at 2 sites in United States. Open to participants aged 11 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-01.
Sponsored by University of South Florida · Phase 1/2, Interventional, and Treatment
Comorbid anxiety disorders affect as many as 80% of youth with autism spectrum disorders, causing substantial distress and impairment over and above the autism spectrum diagnosis alone. Cognitive behavioral therapy (CBT) is the gold standard treatment among typically developing youth with an anxiety disorder and when adapted, shows promise in children with ASD and comorbid anxiety. However, there is currently no psychotherapy protocol tailored to meet the unique needs of young adolescents with Autism spectrum disorders (ASD) and comorbid anxiety. Given this, the present study seeks to develop and test a new CBT therapy in adolescents with autism and comorbid anxiety.
Autism spectrum disorders (ASD) affect approximately 1 out of 150 children and adolescents in the United States, making them one of the most common neurobiological conditions. Comorbid anxiety disorders affect as many as 80% of youth with ASD, causing substantial distress and impairment over and above that caused by an ASD diagnosis alone. While cognitive-behavioral therapy (CBT) has been established as the gold standard treatment for anxiety disorders among typically developing youth, a protocol does not exist for early adolescents with ASD and comorbid anxiety disorders. Accordingly, we are proposing to develop a CBT protocol for anxiety and comorbid ASD in early adolescence.
Initial protocol development efforts will focus on adapting relevant treatment elements from an effective CBT program for younger children with ASD and comorbid anxiety to the characteristics and clinical needs of early adolescents. Thereafter, protocol and measure development will be refined during Phases I and II of this study through our experiences treating a total of 20 young adolescents (ages 11-14 years - 10 will be treated at USF; 10 at University of California, Los Angeles (UCLA)) with ASD and comorbid anxiety disorder(s). The CBT protocol will then be examined in a trial comparing CBT to a waitlist condition (N = 32 total; 16 at each study site).
The two recruitment sites for this study are the University of California, Los Angeles and the University of South Florida. The University of Miami will assist with quality assurance checks. Considering the rising number of youth diagnosed with ASD, and the lack of tested treatment options for those young adolescents with comorbid anxiety, our proposed work toward an efficacious CBT protocol will provide a timely contribution to public health efforts.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 33 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Cognitive-Behavioral Therapy
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'.
Behavioral: Wait-list
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.
Also known as: CBT, Exposure therapy
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'.
Also known as: Placebo
Pediatric Anxiety Rating Scale.
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.
Time frame: Post-treatment, which is an average of 16 weeks after Baseline
Anxiety Disorders Interview Schedule: Child and Parent Versions
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.
Time frame: Post-treatment, which was an average of 16 weeks after Baseline
| Milestone | Cognitive-Behavioral Therapy | Wait-list |
|---|---|---|
| Started | 19 | 14 |
| Completed | 16 | 11 |
| Not completed | 3 | 3 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 |
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.
| units on a scale | Cognitive-Behavioral Therapy | Wait-list |
|---|---|---|
| Pediatric Anxiety Rating Scale. | 11.62 ± 3.26 | 14.04 ± 2.64 |
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.
| units on a scale | Cognitive-Behavioral Therapy | Wait-list |
|---|---|---|
| Anxiety Disorders Interview Schedule: Child and Parent Versions | 3.28 ± 2.1 | 4.04 ± 1.88 |
Collected over 16 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive-Behavioral Therapy | — | 0/19 (0%) | 0/19 (0%) |
| Wait-list | — | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Cognitive-Behavioral Therapy | Wait-list | Total |
|---|---|---|---|
| Mean | 12.4 ± 1.3 | 12.2 ± .98 | 12.3 ± 1.14 |
| Sex: Female, Male(Participants) | Cognitive-Behavioral Therapy | Wait-list | Total |
|---|---|---|---|
| Female | 6 | 4 | 10 |
| Male | 13 | 10 | 23 |
| Region of Enrollment(participants) | Cognitive-Behavioral Therapy | Wait-list | Total |
|---|---|---|---|
| United States | 19 | 14 | 33 |
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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University of South Florida