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

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University of South Florida

Status

Completed

Conditions

Obsessive-compulsive Disorder
Asperger's Syndrome
Social Phobia
Pervasive Developmental Disorder Not Otherwise Specified
Specific Phobia
Generalized Anxiety Disorder
Separation Anxiety Disorder
Autism

Treatments

Other: Treatment as usual
Other: Cognitive Behavioral Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01919970
ASD-FET 2013

Details and patient eligibility

About

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.

Full 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).

Enrollment

32 patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

32 participants in 2 patient groups

Cognitive Behavioral Therapy Condition
Experimental group
Description:
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.
Treatment:
Other: Cognitive Behavioral Therapy
Treatment as Usual
Active Comparator group
Description:
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:
Other: Treatment as usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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