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Psychotherapy for Anxiety in Children With Autism Spectrum Disorder (TAASD)

Primary Purpose

Autism Spectrum Disorders, Autism, Asperger's Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Cognitive-behavioral therapy
Standard Practice Cognitive-behavioral therapy
Treatment as Usual
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring 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

Eligibility Criteria

7 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Rothman Center for Neuropsychiatry, University of South Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Personalized Cognitive-behavioral therapy

Standard Practice Cognitive-behavioral therapy

Treatment as Usual

Arm Description

Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.

Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.

Participants randomized to the TAU condition 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) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in 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.

Outcomes

Primary Outcome Measures

Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment.
This measure is administered by a clinician and assesses anxiety symptom severity on a scale from 0-25 with higher scores corresponding to worse anxiety.

Secondary Outcome Measures

Percentage of Participants With Positive Treatment Response as Assessed by the Clinical Global Impressions-Improvement Scale
The Clinical Global Impressions-Improvement scale (CGI-I) was completed by a clinician after 16 weeks of treatment. The CGI-I assesses the severity of anxiety on a 7 point scale, ranging from 1 (very much improved) to 7 (very much worse). A rating of 1 or 2 on the CGI-I designated a positive treatment response.
Change From Baseline in Anxiety/Depression Severity on the Child Behavior Checklist After 16 Weeks of Treatment.
The Child Behavior Checklist (CBCL) is completed by parents and the anxiety/depression subscale of the CBCL was used to assess anxiety/depression symptomatology. The CBCL anxiety/depression subscale is rated on a 3-point scale, ranging from 0 (Not true) to 2 (Very True), with higher scores indicating more symptoms.
Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment.
The Childhood Anxiety Impact Scale (CAIS) is a questionnaire completed by parents about the impact of the child's anxiety on functioning in three situational categories (i.e., school, social, and family functioning). The CAIS is rated on a 4-point scale, ranging from 0 (not at all) to 3 (very much). The CAIS items are summed and sorted into 3 subscales, corresponding to each situational category: school, social, and family. For all 3 subscales, higher scores correspond to more associated impact in that area.

Full Information

First Posted
January 2, 2014
Last Updated
November 10, 2021
Sponsor
University of South Florida
Collaborators
Temple University, University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02028247
Brief Title
Psychotherapy for Anxiety in Children With Autism Spectrum Disorder
Acronym
TAASD
Official Title
2/3 Treatment of Anxiety in Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida
Collaborators
Temple University, University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized Cognitive-behavioral therapy
Arm Type
Experimental
Arm Description
Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.
Arm Title
Standard Practice Cognitive-behavioral therapy
Arm Type
Active Comparator
Arm Description
Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.
Arm Title
Treatment as Usual
Arm Type
Other
Arm Description
Participants randomized to the TAU condition 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) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in 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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Cognitive-behavioral therapy
Other Intervention Name(s)
Behavioral Interventions for Anxiety in Children with Autism
Intervention Type
Behavioral
Intervention Name(s)
Standard Practice Cognitive-behavioral therapy
Other Intervention Name(s)
Coping Cat
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Primary Outcome Measure Information:
Title
Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment.
Description
This measure is administered by a clinician and assesses anxiety symptom severity on a scale from 0-25 with higher scores corresponding to worse anxiety.
Time Frame
Baseline and After 16 Weeks of Treatment
Secondary Outcome Measure Information:
Title
Percentage of Participants With Positive Treatment Response as Assessed by the Clinical Global Impressions-Improvement Scale
Description
The Clinical Global Impressions-Improvement scale (CGI-I) was completed by a clinician after 16 weeks of treatment. The CGI-I assesses the severity of anxiety on a 7 point scale, ranging from 1 (very much improved) to 7 (very much worse). A rating of 1 or 2 on the CGI-I designated a positive treatment response.
Time Frame
After 16 weeks of treatment
Title
Change From Baseline in Anxiety/Depression Severity on the Child Behavior Checklist After 16 Weeks of Treatment.
Description
The Child Behavior Checklist (CBCL) is completed by parents and the anxiety/depression subscale of the CBCL was used to assess anxiety/depression symptomatology. The CBCL anxiety/depression subscale is rated on a 3-point scale, ranging from 0 (Not true) to 2 (Very True), with higher scores indicating more symptoms.
Time Frame
Baseline and After 16 weeks of treatment
Title
Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment.
Description
The Childhood Anxiety Impact Scale (CAIS) is a questionnaire completed by parents about the impact of the child's anxiety on functioning in three situational categories (i.e., school, social, and family functioning). The CAIS is rated on a 4-point scale, ranging from 0 (not at all) to 3 (very much). The CAIS items are summed and sorted into 3 subscales, corresponding to each situational category: school, social, and family. For all 3 subscales, higher scores correspond to more associated impact in that area.
Time Frame
Baseline and After 16 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric A Storch, Ph.D.
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeff Wood, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philip C Kendall, Ph.D.
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rothman Center for Neuropsychiatry, University of South Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33826038
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.
Results Reference
derived
PubMed Identifier
31755906
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.
Results Reference
derived

Learn more about this trial

Psychotherapy for Anxiety in Children With Autism Spectrum Disorder

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