Overview

This trial is active, not recruiting.

Conditions autism, asperger's syndrome, pervasive developmental disorder not otherwise specified, generalized anxiety disorder, social phobia, separation anxiety disorder, obsessive-compulsive disorder, specific phobia
Treatments cognitive behavioral therapy, treatment as usual
Sponsor University of South Florida
Start date August 2013
End date August 2016
Trial size 50 participants
Trial identifier NCT01919970, ASD-FET 2013

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
cognitive behavioral therapy
This condition involves 12 weekly CBT sessions.
(Active Comparator)
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.
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.

Primary Outcomes

Measure
Pediatric Anxiety Rating Scale
time frame: After an average of 12 weeks (post-treatment)

Secondary Outcomes

Measure
Clinical Global Impression - Severity Scale
time frame: After an average of 12 weeks (Post-treatment)

Eligibility Criteria

Male or female participants from 6 years up to 12 years old.

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.

Additional Information

Official title Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of South Florida.