Clinical trial NCT02028247: Psychotherapy for Anxiety in Children With Autism Spectrum Disorder
Official title: 2/3 Treatment of Anxiety in Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Autism
Asperger's Syndrome
Pervasive Developmental Disability - Not Otherwise Specified
Obsessive-compulsive Disorder
Social Phobia
Generalized Anxiety Disorder
Specific Phobia
Separation Anxiety Disorder
Keywords: Autism spectrum disorders
Autism
Asperger's syndrome
Pervasive developmental disability - not otherwise specified
obsessive-compulsive disorder
Social phobia
Generalized anxiety disorder
Specific phobia
Separation anxiety disorder
Counseling
Cognitive-behavioral therapy
Psychotherapy
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Temple University
name: University of California, Los Angeles
First posted: 2014-01-07
Enrollment: 214
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD), contributing to substantial distress and impairment. The goal of this study is to examine the effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for addressing anxiety in youth with ASD.

Detailed description: Autism spectrum disorders (ASD) are common neurodevelopmental syndromes affecting 1% of U.S. children. Comorbid anxiety disorders affect 40 to 50% of children with ASD, causing substantial distress and impairment over and above that caused by ASD alone. Although standard practice cognitive-behavioral therapy (CBT) has been established as an efficacious and safe treatment for anxiety disorders among typically developing youth, its utility in comorbid cases with ASD remains unknown. To date, no studies have experimentally compared standard practice CBT to a cognitive-behavioral intervention that has been personalized for children with a comorbid presentation of anxiety and ASD. Accordingly, we are proposing a randomized controlled trial to be conducted at three treatment sites to evaluate the efficacy of personalized CBT for anxiety in ASD (Behavioral Intervention for Anxiety in Children with Autism: BIACA) relative to standard practice CBT for anxiety (Coping Cat program). Furthermore, this study will employ a waitlist control group to assess the efficacy of each CBT arm relative to the absence of treatment (i.e., a Waitlist control arm). The proposed research will: (1) examine the efficacy of BIACA relative to Coping Cat, which represents standard practice treatment, and the efficacy of both these treatments relative to a waitlist control group, (2) evaluate the maintenance of treatment gains, (3) examine the impact of personalized intervention on functional outcomes. A total of 201youth across 3 study locations (ages 8-13 years) with ASD and co-occurring anxiety will be randomly assigned to one of the three conditions. The three recruitment sites for this study are University of California, Los Angeles, the University of South Florida (USF), and Temple University. Considering the rising number of children diagnosed with ASD together with the frequency and severity of comorbid anxiety, the proposed work is tailored to the unique needs of youth with ASD and will provide a timely contribution to public health efforts.

Eligibility criteria: Inclusion Criteria:

* Outpatient boys and girls with ASD between the ages 7-13 years at consent/assent.
* The child meets criteria for ASD.
* The child meets criteria for clinically significant anxiety symptoms.
* The child has a Full Scale and Verbal Comprehension Intelligence Quotient \>70 as assessed on the Wechsler Intelligence Scale for Children-IV or another acceptable Intelligence Quotient test.

Exclusion Criteria:

* Receiving concurrent therapy targeting anxiety, social skills training with homework, or behavioral interventions (e.g., applied behavior analysis). This excludes academic tutoring, occupational therapy, speech therapy, school counseling that is no more than 60 minutes per week in duration, school aides, and social skills training groups that do not include homework and are no more than 60 minutes/week in duration.
* (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.
* Child has been nonresponsive to an adequate trial of CBT for anxiety within the previous 2 years.
* Lifetime bipolar disorder, schizophrenia or schizoaffective disorder.
* Initiation of an antidepressant medication within 12 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 8 weeks before study enrollment (4 weeks for antipsychotic) or during psychotherapy (unless the dose is lowered because of side effects).

Primary outcomes:
measure: Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment.
timeFrame: Baseline and After 16 Weeks of Treatment
Secondary outcomes:
measure: Percentage of Participants With Positive Treatment Response as Assessed by the Clinical Global Impressions-Improvement Scale
timeFrame: After 16 weeks of treatment
measure: Change From Baseline in Anxiety/Depression Severity on the Child Behavior Checklist After 16 Weeks of Treatment.
timeFrame: Baseline and After 16 weeks of treatment
measure: Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment.
timeFrame: Baseline and After 16 weeks of treatment
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Rothman Center for Neuropsychiatry, University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Eric A Storch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Jeff Wood, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Philip C Kendall, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Storch EA, Wood JJ, Guzick AG, Small BJ, Kerns CM, Ordaz DL, Schneider SC, Kendall PC. Moderators of Response to Personalized and Standard Care Cognitive-Behavioral Therapy for Youth with Autism Spectrum Disorder and Comorbid Anxiety. J Autism Dev Disord. 2022 Feb;52(2):950-958. doi: 10.1007/s10803-021-05000-0. Epub 2021 Apr 7.
citation: Wood JJ, Kendall PC, Wood KS, Kerns CM, Seltzer M, Small BJ, Lewin AB, Storch EA. Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):474-483. doi: 10.1001/jamapsychiatry.2019.4160.