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

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919970
• Other study ID #: ASD-FET 2013
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: August 2017

Study information

• Verified date: March 2019
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Asperger Syndrome
• Asperger's Syndrome
• Autism
• Autism Spectrum Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities
• Disease
• Generalized Anxiety Disorder
• Obsessive-compulsive Disorder
• Pervasive Developmental Disorder Not Otherwise Specified
• Phobia, Social
• Phobic Disorders
• Separation Anxiety Disorder
• Social Phobia
• Specific Phobia

Intervention

Other:
• Cognitive Behavioral Therapy
This condition involves 12 weekly CBT sessions.
• 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.

Locations

Country	Name	City	State
United States	Rothman Center for Neuropsychiatry	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Anxiety Rating Scale	This scale measures the severity of anxiety symptoms in children. The total scale range is 0-30 where 0 is the minimum and 30 the maximum. Higher scores correspond to more severe anxiety symptom severity. The total scale was used which corresponds to summing the 6 severity items.; The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual).	After an average of 12 weeks (post-treatment)
Secondary	Clinical Global Impression - Severity Scale	This scale measures the severity of anxiety symptoms in children. The total scale range is 0-6 where 0 is the minimum and 6 the maximum. Higher scores correspond to more severe anxiety symptom severity. The scale consists of only 1 item that a clinician rates based on their judgement of anxiety severity.; The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual).	After an average of 12 weeks (Post-treatment)