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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of South Florida
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01919970
First received: August 6, 2013
Last updated: July 28, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression - Severity Scale [ Time Frame: After an average of 12 weeks (Post-treatment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (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

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919970

Contacts
Contact: Eric Storch, Ph.D. 727 767 8230 estorch@health.usf.edu
Contact: Amanda Collier, B.A. 727 767 7376 acollie2@health.usf.edu

Locations
United States, Florida
Rothman Center for Neuropsychiatry Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Eric Storch, Ph.D.    727-767-8230    estorch@health.usf.edu   
Contact: Amanda Collier, B.A.    727 767 7376    acollie2@health.usf.edu   
Sub-Investigator: Adam Lewin, Ph.D.         
Sub-Investigator: Tanya Murphy, M.D.         
Sponsors and Collaborators
University of South Florida
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01919970     History of Changes
Other Study ID Numbers: ASD-FET 2013
Study First Received: August 6, 2013
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Anxiety Disorders
Anxiety, Separation
Asperger Syndrome
Child Development Disorders, Pervasive
Compulsive Personality Disorder
Developmental Disabilities
Disease
Mental Disorders
Obsessive-Compulsive Disorder
Phobic Disorders
Syndrome
Mental Disorders Diagnosed in Childhood
Pathologic Processes
Personality Disorders

ClinicalTrials.gov processed this record on October 23, 2014