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Computer- Assisted Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders (CCAL)

Primary Purpose

Autism, Asperger's Syndrome, Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer assisted cognitive behavioral therapy.
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, Asperger's Syndrome, Treatment, Cognitive-behavioral therapy, Anxiety, Children, Therapy

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Outpatient children with an autism spectrum disorder (see #2 below) between the ages 7-12 years.
  2. Meets criteria for a diagnosis of an autism spectrum disorder using scores from the Autism Diagnostic Observation Schedule and Childhood Autism Rating Scale-II High Functioning Version.
  3. Meets DSM-IV criteria for a diagnosis of one of the following anxiety disorders: separation anxiety disorder (SAD), generalized anxiety disorder (GAD), social phobia, panic disorder or specific phobia as determined by the ADIS-IV-C/P (with CSR 4) and all available information.
  4. Minimum score of 12 on the PARS Severity Scale
  5. Child has a Full Scale and Verbal Comprehension IQ > 85 as assessed on the KBIT-2.
  6. Subjects with co-morbid depression, ADHD, tic disorder or disruptive behavior disorders will be acceptable as long as the anxiety disorder is primary (i.e., most impairing/distressing).

Exclusion Criteria:

  1. Receiving concurrent psychotherapy, social skills training, or behavioral interventions (e.g., applied behavior analysis). Families will have the option of discontinuing such services to enroll in the study.
  2. New Treatments: Initiation of an antidepressant within 10 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritionals or therapeutic diets within 8 weeks of study enrollment.
  3. Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 6 weeks before study enrollment, or any change in alternative medications that might have behavioral effects within 4 weeks prior to the study baseline assessment.
  4. (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.
  5. Lifetime DSM-IV bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.
  6. Unwillingness of parents to make the commitment to accompany their child for multiple study visits.
  7. Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study or if the computer-assisted CBT is not a good avenue of treatment for the child.

Sites / Locations

  • University of South Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waitlist Condition

Computer Assisted CBT

Arm Description

Children in this condition will withhold from any type of intervention for a period of 12 weeks.

Those who choose to participate will be required to attend 4 assessments - pre-treatment (week 0), mid-treatment (week 8), post-treatment, and a 4th assessment for a 3 month Follow-up. All children regardless of condition will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.

Outcomes

Primary Outcome Measures

Pediatric Anxiety Rating Scale

Secondary Outcome Measures

Anxiety Disorders Interview Schedule: Parent and Child Versions
Clinical Global Impression - Severity Scale

Full Information

First Posted
March 26, 2012
Last Updated
October 25, 2017
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01565629
Brief Title
Computer- Assisted Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders
Acronym
CCAL
Official Title
Computer- Assisted Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT) program for children with anxiety and autism spectrum disorders.
Detailed Description
Many children who have an autism spectrum disorder (ASD) experience substantial anxiety that can cause impairment above that of an ASD alone. Few studies have examined effective treatment options for anxiety in this population.Preliminary studies have established the efficacy of computer-assisted cognitive behavioral therapy in otherwise typically developing youth with anxiety. Accordingly, this study seeks to examine the efficacy of computer assisted CBT in children with autism and ASD. A randomized-control trial will examine the ability of computer-assisted CBT to treat anxiety in comparison to a waitlist condition. This study will recruit approximately 40 youth ages 7-12 years. Significant reductions in anxiety severity and overall improvement of functioning will establish this treatment's ability to treat anxiety. This study aims to evaluate the acute efficacy of CCBT relative to WAITLIST in children with ASD and comorbid anxiety disorders;examine the short-term durability of treatment gains for youth receiving CCBT; examine whether, relative to WAITLIST, CCBT results in improved social; adaptive; and global functioning, as well as reduced child- and parent-rated anxiety symptoms; and examine whether, relative to WAITLIST, CCBT is associated with greater satisfaction and consumer acceptability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Asperger's Syndrome, Generalized Anxiety Disorder, Social Phobia, Separation Anxiety Disorder, Obsessive-compulsive Disorder
Keywords
Autism, Asperger's Syndrome, Treatment, Cognitive-behavioral therapy, Anxiety, Children, Therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Waitlist Condition
Arm Type
No Intervention
Arm Description
Children in this condition will withhold from any type of intervention for a period of 12 weeks.
Arm Title
Computer Assisted CBT
Arm Type
Experimental
Arm Description
Those who choose to participate will be required to attend 4 assessments - pre-treatment (week 0), mid-treatment (week 8), post-treatment, and a 4th assessment for a 3 month Follow-up. All children regardless of condition will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
Intervention Type
Behavioral
Intervention Name(s)
Computer assisted cognitive behavioral therapy.
Other Intervention Name(s)
CCAL, CCBT, Camp Cope-A-Lot
Intervention Description
Those who choose to participate will be required to attend 4 assessments - pre-treatment (week 0), mid-treatment (week 8), post-treatment, and a 4th assessment for a 3 month Follow-up. All children regardless of condition will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
Primary Outcome Measure Information:
Title
Pediatric Anxiety Rating Scale
Time Frame
After an average of 12 weeks (Post-treatment)
Secondary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule: Parent and Child Versions
Time Frame
After an average of 12 weeks (Post-treatment)
Title
Clinical Global Impression - Severity Scale
Time Frame
After an average of 12 weeks (Post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Outpatient children with an autism spectrum disorder (see #2 below) between the ages 7-12 years. Meets criteria for a diagnosis of an autism spectrum disorder using scores from the Autism Diagnostic Observation Schedule and Childhood Autism Rating Scale-II High Functioning Version. Meets DSM-IV criteria for a diagnosis of one of the following anxiety disorders: separation anxiety disorder (SAD), generalized anxiety disorder (GAD), social phobia, panic disorder or specific phobia as determined by the ADIS-IV-C/P (with CSR 4) and all available information. Minimum score of 12 on the PARS Severity Scale Child has a Full Scale and Verbal Comprehension IQ > 85 as assessed on the KBIT-2. Subjects with co-morbid depression, ADHD, tic disorder or disruptive behavior disorders will be acceptable as long as the anxiety disorder is primary (i.e., most impairing/distressing). Exclusion Criteria: Receiving concurrent psychotherapy, social skills training, or behavioral interventions (e.g., applied behavior analysis). Families will have the option of discontinuing such services to enroll in the study. New Treatments: Initiation of an antidepressant within 10 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritionals or therapeutic diets within 8 weeks of study enrollment. Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 6 weeks before study enrollment, or any change in alternative medications that might have behavioral effects within 4 weeks prior to the study baseline assessment. (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. Lifetime DSM-IV bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months. Unwillingness of parents to make the commitment to accompany their child for multiple study visits. Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study or if the computer-assisted CBT is not a good avenue of treatment for the child.
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
Facility Information:
Facility Name
University of South Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States

12. IPD Sharing Statement

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Computer- Assisted Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders

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