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Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01919970
First Posted: August 9, 2013
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of South Florida
  Purpose
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.

Condition Intervention
Autism Asperger's Syndrome Pervasive Developmental Disorder Not Otherwise Specified Generalized Anxiety Disorder Social Phobia Separation Anxiety Disorder Obsessive-compulsive Disorder Specific Phobia Other: Cognitive Behavioral Therapy Other: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Pediatric Anxiety Rating Scale [ Time Frame: After an average of 12 weeks (post-treatment) ]

Secondary Outcome Measures:
  • Clinical Global Impression - Severity Scale [ Time Frame: After an average of 12 weeks (Post-treatment) ]

Estimated Enrollment: 50
Study Start Date: August 2013
Study Completion Date: August 2017
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Cognitive Behavioral Therapy
This condition involves 12 weekly CBT sessions.
Active Comparator: 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.
Other: 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.

Detailed Description:
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Outpatient children with an autism spectrum disorder between the ages 6-12 years.
  • Meets criteria for a diagnosis of one of the following anxiety disorders: generalized anxiety disorder, separation anxiety disorder, social phobia, specific phobia, panic disorder or obsessive-compulsive disorder.
  • Minimum score of 12 on the Pediatric Anxiety Rating Scale - Severity Scale.
  • Child has a Full Scale and Verbal Comprehension IQ > 80.

Exclusion Criteria:

  • Current clinically significant suicidality or engagement in suicidal behaviors within the last 6 months.
  • Presence of any clinical features requiring a higher level of care (inpatient or partial hospital treatment).
  • Any lifetime diagnosis (meeting DSM-IV criteria) of bipolar disorder, schizophrenia or schizoaffective disorder; or Substance abuse in the past 6 months.
  • Initiation of an antidepressant medication within 10 weeks before study enrollment or an antipsychotic medication 6 weeks before study enrollment or the child has changed the dose of an established medication within 6 weeks before study enrollment (4 weeks for antipsychotic) or during psychotherapy (unless the dose is lowered because of side effects). If the child is on a medication, she or he can remain on it at its current dose. While in their treatment arm, children randomized to the EF-CBT condition will not be able to continue or initiate psychosocial interventions targeting anxiety(psychotherapy, certain types of social skills training, applied behavior analysis targeting anxiety). Those in the TAU arm will be able to seek out psychiatric/psychological services at their discretion.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01919970


Locations
United States, Florida
Rothman Center for Neuropsychiatry
Saint Petersburg, Florida, United States, 33701
Sponsors and Collaborators
University of South Florida
  More Information

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01919970     History of Changes
Other Study ID Numbers: ASD-FET 2013
First Submitted: August 6, 2013
First Posted: August 9, 2013
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by University of South Florida:
Autism
Asperger's Syndrome
Pervasive Developmental Disorder Not Otherwise Specified
Treatment
Cognitive-behavioral therapy
Anxiety
Children
Therapy
Generalized Anxiety Disorder
Social Phobia
Separation Anxiety Disorder
Obsessive-compulsive Disorder
Specific Phobia

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Phobic Disorders
Phobia, Social
Developmental Disabilities
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Autistic Disorder
Asperger Syndrome
Anxiety, Separation
Pathologic Processes
Mental Disorders
Personality Disorders
Neurodevelopmental Disorders