Treatment of Anxiety in Late Adolescents With Autism (TALAA)
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|ClinicalTrials.gov Identifier: NCT02977962|
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : March 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Cognitive-Behavior Therapy Other: Treatment as Usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treatment of Anxiety in Late Adolescents With Autism|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||August 2021|
Experimental: Cognitive-Behavior Therapy
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.
Behavioral: Cognitive-Behavior Therapy
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).
Other Name: CBT
Placebo Comparator: Treatment as Usual
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).
Other: Treatment as Usual
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.
- Change from Baseline in anxiety severity on the Hamilton Anxiety Scale after 16 weeks of treatment. [ Time Frame: 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.
- Change from Baseline in anxiety severity on the Clinical Global Impressions Scale after 16 weeks of treatment. [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977962
|Contact: Adam B Lewin, Ph.D.||firstname.lastname@example.org|
|United States, Florida|
|Rothman Center for Neuropsychiatry, University of South Florida||Recruiting|
|Saint Petersburg, Florida, United States, 33701|
|Contact: Adam B Lewin, Ph.D. 727-767-8230 email@example.com|
|Contact: Jane Mutch, Ph.D. 727-767-8230 firstname.lastname@example.org|
|Sub-Investigator: Jane Mutch, Ph.D.|
|Principal Investigator: Adam B Lewin, Ph.D.|
|Sub-Investigator: Tanya K Murphy, MD|
|Principal Investigator:||Adam Lewin, Ph.D.||University of South Florida|