Clinical trial NCT01177969: Cognitive Behavioral Therapy (CBT) for Anxiety Disorders in Autism: Adapting Treatment for Adolescents
Official title: CBT for Anxiety Disorders in Autism: Adapting Treatment for Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anxiety Disorders in Youth With Autism, Asperger's Syndrome, and Pervasive Developmental Disorder Not Otherwise Specified
Keywords: Autism
Anxiety
Asperger's Syndrome
Cognitive-behavioral therapy
Treatment
Obsessive-compulsive disorder
Fears
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of California, Los Angeles
name: University of Miami
First posted: 2010-08-09
Enrollment: 33
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comorbid anxiety disorders affect as many as 80% of youth with autism spectrum disorders, causing substantial distress and impairment over and above the autism spectrum diagnosis alone. Cognitive behavioral therapy (CBT) is the gold standard treatment among typically developing youth with an anxiety disorder and when adapted, shows promise in children with ASD and comorbid anxiety. However, there is currently no psychotherapy protocol tailored to meet the unique needs of young adolescents with Autism spectrum disorders (ASD) and comorbid anxiety. Given this, the present study seeks to develop and test a new CBT therapy in adolescents with autism and comorbid anxiety.

Detailed description: Autism spectrum disorders (ASD) affect approximately 1 out of 150 children and adolescents in the United States, making them one of the most common neurobiological conditions. Comorbid anxiety disorders affect as many as 80% of youth with ASD, causing substantial distress and impairment over and above that caused by an ASD diagnosis alone. While cognitive-behavioral therapy (CBT) has been established as the gold standard treatment for anxiety disorders among typically developing youth, a protocol does not exist for early adolescents with ASD and comorbid anxiety disorders. Accordingly, we are proposing to develop a CBT protocol for anxiety and comorbid ASD in early adolescence.

Initial protocol development efforts will focus on adapting relevant treatment elements from an effective CBT program for younger children with ASD and comorbid anxiety to the characteristics and clinical needs of early adolescents. Thereafter, protocol and measure development will be refined during Phases I and II of this study through our experiences treating a total of 20 young adolescents (ages 11-14 years - 10 will be treated at USF; 10 at University of California, Los Angeles (UCLA)) with ASD and comorbid anxiety disorder(s). The CBT protocol will then be examined in a trial comparing CBT to a waitlist condition (N = 32 total; 16 at each study site).

The two recruitment sites for this study are the University of California, Los Angeles and the University of South Florida. The University of Miami will assist with quality assurance checks. Considering the rising number of youth diagnosed with ASD, and the lack of tested treatment options for those young adolescents with comorbid anxiety, our proposed work toward an efficacious CBT protocol will provide a timely contribution to public health efforts.

Eligibility criteria: Inclusion Criteria:

* Outpatient adolescents with ASD (see below) between the ages 11-14 years.
* Meets criteria for a diagnosis of autism, Asperger syndrome (AS), or Pervasive Developmental Disorder Not Otherwise Specified .
* Meets 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).
* Child has a Full Scale and Verbal Comprehension IQ≥85.

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.
* Has started an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment.
* Has changed established psychotropic medications (e.g., antidepressants, anxioloytics) within 8 weeks before study enrollment (6 weeks for antipsychotic).
* Is currently suicidal or has been actively suicidal in the last 6 months.
* Has been diagnosed with bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.
* Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.

Primary outcomes:
measure: Pediatric Anxiety Rating Scale.
timeFrame: Post-treatment, which is an average of 16 weeks after Baseline
Secondary outcomes:
measure: Anxiety Disorders Interview Schedule: Child and Parent Versions
timeFrame: Post-treatment, which was an average of 16 weeks after Baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Univeristy of California at Los Angeles
state: California
city: St. Petersburg
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Eric Storch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elliott SJ, Marshall D, Morley K, Uphoff E, Kumar M, Meader N. Behavioural and cognitive behavioural therapy for obsessive compulsive disorder (OCD) in individuals with autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2021 Sep 3;9(9):CD013173. doi: 10.1002/14651858.CD013173.pub2.
citation: Wood JJ, Ehrenreich-May J, Alessandri M, Fujii C, Renno P, Laugeson E, Piacentini JC, De Nadai AS, Arnold E, Lewin AB, Murphy TK, Storch EA. Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial. Behav Ther. 2015 Jan;46(1):7-19. doi: 10.1016/j.beth.2014.01.002. Epub 2014 Jan 22.