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

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ClinicalTrials.gov Identifier: NCT01919970
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
University of South Florida

August 6, 2013
August 9, 2013
October 26, 2017
August 2013
August 2016   (Final data collection date for primary outcome measure)
Pediatric Anxiety Rating Scale [ Time Frame: After an average of 12 weeks (post-treatment) ]
Same as current
Complete list of historical versions of study NCT01919970 on ClinicalTrials.gov Archive Site
Clinical Global Impression - Severity Scale [ Time Frame: After an average of 12 weeks (Post-treatment) ]
Same as current
Not Provided
Not Provided
 
Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety
Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety
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.
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).
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • 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
    This condition involves 12 weekly CBT sessions.
  • 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.
  • 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.
    Intervention: Other: Cognitive Behavioral Therapy
  • 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.
    Intervention: Other: Treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
August 2017
August 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Years to 12 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01919970
ASD-FET 2013
No
Not Provided
Not Provided
University of South Florida
University of South Florida
Not Provided
Not Provided
University of South Florida
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP