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| Name | Class |
|---|---|
| Johns Hopkins All Children's Hospital | OTHER |
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Autism spectrum disorders (ASD) affect approximately 1.1% of late adolescents and young adults, making it one of the most common neurodevelopmental disorders. Comorbid anxiety disorders affect many higher-functioning adolescents and young adults with ASD, causing substantial distress and impairment over and above that caused by an ASD diagnosis alone. While cognitive-behavioral therapy (CBT) is a first-line treatment for anxiety disorders among typically developing late adolescents, and work by the investigative team supports its utility in children with ASD and comorbid anxiety, very few evidence-based treatment approaches exist for late adolescents with ASD and comorbid anxiety. Accordingly, the investigators are proposing to develop a CBT protocol for clinical anxiety that is personalized to the unique clinical characteristics of late adolescents (ages 16-21 years) with ASD namely, the Treatment of Anxiety in Late Adolescents with Autism (TALAA).
Autism spectrum disorders (ASD) affect approximately 1.1% of late adolescents and young adults, making it one of the most common neurodevelopmental disorders. Comorbid anxiety disorders affect many higher-functioning adolescents and young adults with ASD, causing substantial distress and impairment over and above that caused by an ASD diagnosis alone. While cognitive-behavioral therapy (CBT) is a first-line treatment for anxiety disorders among typically developing late adolescents, and work by the investigative team supports its utility in children with ASD and comorbid anxiety, very few evidence-based treatment approaches exist for late adolescents with ASD and comorbid anxiety. Accordingly, the investigators are proposing to develop a CBT protocol for clinical anxiety that is personalized to the unique clinical characteristics of late adolescents (ages 16-21 years) with ASD namely, the Treatment of Anxiety in Late Adolescents with Autism (TALAA). Initial TALAA development efforts will focus on adapting relevant treatment elements from an efficacious CBT program for early adolescents with ASD and comorbid anxiety to the characteristics and clinical needs of the age group. Developmentally appropriate, novel treatment components will be added, including those focusing on fostering successful transitions to adulthood (e.g., work readiness). In response to the NIH Roadmap Initiative, attention will be paid to protocol adaptability with varying clinical presentations. Measures of treatment integrity and competence will be developed. Thereafter, protocol and measure development will be refined through our experiences treating 8 young adults (ages 16-21 years) with ASD and comorbid anxiety disorder(s) as well as through clinician, patient, and expert feedback. The feasibility of implementing TALAA will then be examined in the context of a pilot study incorporating all the features of the planned future efficacy trial comparing TALAA to treatment as usual, but with a limited sample size (N=44).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-Behavior Therapy | Experimental | This consists of 16 weekly sessions up to 90 minutes each that helps the participant learn to cope with anxiety by facing fears, thinking more logically, and calming oneself. |
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| Treatment as Usual | Placebo Comparator | Participants randomized to this condition will wait for a period of 16 weeks before receiving treatment in the context of the study. During this time, youth may receive psychotherapy and/or initiate or change current psychiatric medication (if applicable). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavior Therapy | Behavioral | This therapy has been designed for adolescents with high functioning ASD and involves 16 weekly session where the participant learns coping skills related to addressing anxiety (e.g., exposure therapy, cognitive therapy, social skills training). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in anxiety severity on the Hamilton Anxiety Scale after 16 weeks of treatment. | This measure is administered by a clinician and assesses anxiety with scores between 0-30. Higher ratings correspond to more severe anxiety symptoms. | After 16 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in anxiety severity on the Clinical Global Impressions Scale after 16 weeks of treatment. | This measure is completed by the clinician and assesses the severity of anxiety on a 7 point scale (0-6; higher scores correspond to worse anxiety). | After 16 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam B Lewin, Ph.D. | Contact | 7277678230 | alewin@health.usf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adam Lewin, Ph.D. | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Center for Neuropsychiatry, University of South Florida | Recruiting | 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. |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental 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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| Treatment as Usual | Other | Those who choose to participate will be enrolled in the 16 week study. They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 16). Those in this group will not receive the Cognitive-Behavior Therapy, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist. |
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