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



Status:Completed
Conditions:Anxiety, Healthy Studies, Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology, Other
Healthy:No
Age Range:7 - 12
Updated:10/28/2017
Start Date:February 2012
End Date:October 2016

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

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.

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.
We found this trial at
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Saint Petersburg, Florida 33701
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Saint Petersburg, FL
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