Trial record 19 of 2262 for:    ANXIETY

Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01563003
First received: March 22, 2012
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

Due to the considerable prevalence of anxiety in youth with autism spectrum disorders, this study seeks to establish the efficacy of a modified cognitive behavioral therapy protocol in 50 adolescents versus other available treatment options.


Condition Intervention
Autism
Asperger's Syndrome
Pervasive Developmental Disorder Not Otherwise Specified
Generalized Anxiety Disorder
Social Phobia
Separation Anxiety Disorder
Obsessive-compulsive Disorder
Other: Cognitive Behavioral Therapy
Other: Treatment as usual

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: Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism

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 16 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 16 weeks (Post-treatment) ] [ Designated as safety issue: No ]
  • Clinical Global Impression - Severity Scale [ Time Frame: After an average of 16 weeks (Post-treatment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Therapy Condition
This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases
Other: Cognitive Behavioral Therapy
This condition involves 16 weekly CBT sessions.
Active Comparator: Treatment as Usual
This arm acts as the comparison condition. Participants randomized to this arm 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). Treatment changes (e.g., medication increase, starting psychotherapy in the 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.
Other: Treatment as usual
This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.

Detailed Description:

This study will further examine a treatment plan for adolescents with autism spectrum disorderS (ASD) and anxiety. Many children who have an autism spectrum disorder 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. In typically developing youth, Cognitive Behavioral Therapy (CBT) is considered the gold standard for treating anxiety. But, in order to address the unique needs of children with ASD, this study utilizes a modified CBT treatment plan which includes social skills and parent training. In our past studies, this cognitive-behavioral treatment plan has been effective in kids with ASD and anxiety compared to kids who did not receive any treatment.The current study compares this modified treatment plan to other treatment options in the community. The experimental component of this study is being assigned to 1 of 2 groups. The first group will receive CBT immediately for a period of 16 weeks. The second group will have to wait 16 weeks before receiving CBT. During this time period, children may receive any other services in the community. Overall, all adolescents receive the same type of therapy; it's matter of whether he/she receives it immediately or after a wait period. Sixteen weekly sessions comprise CBT. All therapy and assessments associated with this study will be free of charge.

  Eligibility

Ages Eligible for Study:   11 Years to 16 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 11-16 years.
  2. Meets criteria for a diagnosis of autism, Asperger syndrome (AS), or PDD-NOS using scores from the Autism Diagnostic Interview-Revised and the Childhood Autism Rating Scale.
  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, or obsessive compulsive disorder (OCD) as determined by the ADIS-IV-C/P (with CSR 4) and all available information.
  4. Minimum score of 13 on the PARS Severity Scale; this score indicates clinically significant anxiety symptom severity (RUPP, 2002) and has been used in recent major clinical trials (e.g., Walkup et al., 2008).
  5. Child has a Full Scale and Verbal Comprehension IQ > 80 as assessed on a commonly used IQ test.
  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 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritionals or therapeutic diets within 6 weeks of study enrollment.
  3. Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications that might have behavioral effects must be stable for 6 weeks prior to the study baseline assessment. Any medications that the adolescent is on must remain stable during treatment. If a potential participant is taking psychotropic medication at the time of the phone evaluation or the first in-person study assessment and wishes to discontinue this medication to enter the study, the patient will be asked to discuss this option with their prescribing physician to determine whether medication discontinuation would be safe and in the adolescent's best interest. In addition, we will obtain the patient's written consent to contact their treating clinician to determine the appropriateness of study participation. We will not influence the decision patients make with their prescribing physician. All pharmacotherapy recommendations will be made in consultation with Dr. Murphy.
  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.
  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: NCT01563003

Locations
United States, Florida
Rothman Center for Neuropsychiatry
St. Petersburg, Florida, United States, 33701
Sponsors and Collaborators
University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01563003     History of Changes
Other Study ID Numbers: AASD-2012
Study First Received: March 22, 2012
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Autism
Asperger's Syndrome
Pervasive Developmental Disorder Not Otherwise Specified
Treatment
Cognitive-behavioral therapy
Anxiety
Children
Therapy

Additional relevant MeSH terms:
Anxiety Disorders
Anxiety, Separation
Mental Disorders
Autistic Disorder
Developmental Disabilities
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 August 28, 2014