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

NCT01919970 | Completed Results

• 1 other identifier: ASD-FET 2013
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Autism; Asperger's Syndrome; Pervasive Developmental Disorder Not Otherwise Specified; Treatment; Cognitive-behavioral therapy; Anxiety; Children; Therapy; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder; Obsessive-compulsive Disorder; Specific Phobia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Global Impression - Severity Scale

  After an average of 12 weeks (Post-treatment)

Study Arms (2)

Cognitive Behavioral Therapy Condition

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.

Other: Cognitive Behavioral Therapy

Treatment as Usual

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.

Other: Treatment as usual

Interventions

Cognitive Behavioral Therapy OTHER

This condition involves 12 weekly CBT sessions.

Cognitive Behavioral Therapy Condition

Treatment as usual OTHER

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.

Treatment as Usual

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Rothman Center for Neuropsychiatry

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Asperger Syndrome; Generalized Anxiety Disorder; Phobia, Social; Anxiety, Separation; Obsessive-Compulsive Disorder; Phobia, Specific; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Small sample size. Short follow-up period. Many youth receiving usual care did not seek active treatment.

Results Point of Contact

• Title: Dr. Eric Storch
• Organization: Baylor College of Medicine

eric.storch@bcm.edu

727-767-8230

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 9, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-03

Locations

US (1)