Psychotherapy for Anxiety in Children With Autism Spectrum Disorder (TAASD)
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|ClinicalTrials.gov Identifier: NCT02028247|
Recruitment Status : Active, not recruiting
First Posted : January 7, 2014
Last Update Posted : December 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders Autism Asperger's Syndrome Pervasive Developmental Disability - Not Otherwise Specified Obsessive-compulsive Disorder Social Phobia Generalized Anxiety Disorder Specific Phobia Separation Anxiety Disorder||Behavioral: Personalized Cognitive-behavioral therapy Behavioral: Standard Practice Cognitive-behavioral therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||2/3 Treatment of Anxiety in Autism Spectrum Disorder|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: Personalized Cognitive-behavioral therapy
Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.
Behavioral: Personalized Cognitive-behavioral therapy
Other Name: Behavioral Interventions for Anxiety in Children with Autism
Active Comparator: Standard Practice Cognitive-behavioral therapy
Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.
Behavioral: Standard Practice Cognitive-behavioral therapy
Other Name: Coping Cat
No Intervention: Waitlist condition
Participants randomized to the Waitlist condition will be asked to refrain from seeking out psychotherapy for anxiety as well as making psychiatric medication changes (if applicable) for a 16-week period.
- Change from Baseline in anxiety severity on the Pediatric Anxiety Rating Scale after 16 weeks of treatment. [ Time Frame: After 16 weeks of treatment ]This measure is administered by a clinician and assesses anxiety symptom severity on a scale from 0-25 with higher scores corresponding to worse anxiety.
- 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 (1-7; higher scores correspond to worse anxiety).
- Change from Baseline in anxiety severity on the Child and Adolescent Symptom Inventory after 16 weeks of treatment. [ Time Frame: After 16 weeks of treatment ]This questionnaire is completed by parents and will be used to assess anxiety with higher scores representing worse anxiety.
- Change from Baseline in anxiety related impairment as measured by the Childhood Anxiety Impact Scale after 16 weeks of treatment. [ Time Frame: After 16 weeks of treatment ]The Childhood Anxiety Impact Scale is a questionnaire completed by parents about the impact of the child's anxiety on functioning in certain situations. Higher scores correspond to more associated impact.
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): NCT02028247
|United States, Florida|
|Rothman Center for Neuropsychiatry, University of South Florida|
|Saint Petersburg, Florida, United States, 33701|
|Principal Investigator:||Eric A Storch, Ph.D.||University of South Florida|
|Principal Investigator:||Jeff Wood, Ph.D.||University of California, Los Angeles|
|Principal Investigator:||Philip C Kendall, Ph.D.||Temple University|