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CompletedNCT01565629CCALUpdated Oct 26, 2017

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

An interventional study of Computer assisted cognitive behavioral therapy. in Autism, Asperger's Syndrome and Generalized Anxiety Disorder, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by University of South Florida · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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.

Interventions

  • BehavioralComputer 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.

    Also known as: CCAL, CCBT, Camp Cope-A-Lot

05

What researchers measure

Primary outcomes

  1. Pediatric Anxiety Rating Scale

    Time frame: After an average of 12 weeks (Post-treatment)

Secondary outcomes

  1. Anxiety Disorders Interview Schedule: Parent and Child Versions

    Time frame: After an average of 12 weeks (Post-treatment)

  2. Clinical Global Impression - Severity Scale

    Time frame: After an average of 12 weeks (Post-treatment)

06

Study locations

1 site
  • University of South Florida
    Saint Petersburg, Florida 33701, United States
07

Registry details

Key details

Study ID
NCT01565629
Lead sponsor
University of South Florida
Responsible party
Sponsor
First posted
Mar 28, 2012
Start date
Feb 2012
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Oct 26, 2017

Study contacts

Eric A Storch, Ph.D.
principal investigator · University of South Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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