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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01565629
First received: March 26, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT) program for children with anxiety and autism spectrum disorders.


Condition Intervention
Autism
Asperger's Syndrome
Generalized Anxiety Disorder
Social Phobia
Separation Anxiety Disorder
Obsessive-compulsive Disorder
Behavioral: Computer assisted cognitive behavioral therapy.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Computer- Assisted Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Pediatric Anxiety Rating Scale [ Time Frame: After an average of 12 weeks (Post-treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety Disorders Interview Schedule: Parent and Child Versions [ Time Frame: After an average of 12 weeks (Post-treatment) ] [ Designated as safety issue: No ]
  • Clinical Global Impression - Severity Scale [ Time Frame: After an average of 12 weeks (Post-treatment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Waitlist Condition
Children in this condition will withhold from any type of intervention for a period of 12 weeks.
Experimental: Computer Assisted CBT
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.
Behavioral: Computer assisted cognitive behavioral therapy.
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.
Other Names:
  • CCAL
  • CCBT
  • Camp Cope-A-Lot

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.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565629

Locations
United States, Florida
University of South Florida
St.Petersburg, Florida, United States, 33701
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Eric A Storch, Ph.D. University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01565629     History of Changes
Other Study ID Numbers: CCAL-2012
Study First Received: March 26, 2012
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Autism
Asperger's Syndrome
Treatment
Cognitive-behavioral therapy
Anxiety
Children
Therapy

Additional relevant MeSH terms:
Anxiety Disorders
Anxiety, Separation
Mental Disorders
Autistic Disorder
Obsessive-Compulsive Disorder
Phobic Disorders
Asperger Syndrome
Child Development Disorders, Pervasive
Compulsive Personality Disorder
Mental Disorders Diagnosed in Childhood
Personality Disorders

ClinicalTrials.gov processed this record on July 24, 2014