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

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178385
• Other study ID #: ACH-2010
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 5, 2010
• Last updated: February 25, 2013
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Autism spectrum disorders affect as many as 1 out of 150 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Although effective interventions have been developed for typically developing youth with anxiety disorders, this approach needs to be adapted for children with autism. Accordingly, we are proposing a randomized controlled trial to examine the effectiveness of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with autism spectrum disorders and comorbid anxiety disorder(s).

Description:

Autism spectrum disorders affect as many as 1 out of 150 children (Centers for Disease Control, 2007), with many higher-functioning children not being diagnosed until elementary school or later (Fombonne, 2003). Significant impairment in social, adaptive, and school functioning is prevalent and longstanding (Howlin et al., 2004). In addition, comorbid psychological disorders are common in the ASD population (Simonoff et al., 2008), and may cause substantial distress and impairment beyond that caused by the ASD diagnosis. Comorbid anxiety disorders, in particular, affect as many as 80% of children and adolescents with ASD (Bellini, 2004; de Bruin et al., 2007; Klin et al., 2005; Muris et al., 1998). Although efficacious interventions have been developed for otherwise typically developing youth with anxiety disorders, the linguistic; cognitive; and social characteristics of ASD may render standard treatment approaches less effective for children with ASD (Volkmar & Klin, 2000). Thus, there is a clinical need for the modification of existing treatment modalities for this unique group. To date, few studies have experimentally tested the efficacy of CBT for youth with a comorbid presentation of anxiety and ASD. This gap in the literature is of particular concern given the prevalence of comorbid anxiety among children, consequences of untreated anxiety, unknown efficacy of antidepressant medication for anxiety in ASD, and potential safety and tolerability issues related to medication use. Accordingly, we are proposing a randomized controlled trial to examine the efficacy of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with ASD and comorbid anxiety disorder(s). In the proposed grant, we will: (1) examine the acute efficacy of CBT relative to TAU, and (2) evaluate the short-term maintenance of treatment gains. Forty-six children (ages 7-11 years) with ASD and comorbid anxiety disorder(s) will be randomly assigned to one of the two treatment conditions. Primary outcomes will be assessed by an independent evaluator, and will include change in anxiety symptom severity; response rates; and remission rates. Considering the rising number of children diagnosed with ASD, our proposed work toward the advent of an efficacious CBT protocol will provide a timely contribution to public health efforts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

1. Outpatient children with an autism spectrum disorder (see #2 below) between the ages 7-11years.

2. Meets criteria for a diagnosis of autism, Asperger syndrome (AS), or PDD-NOS using scores from the Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule.

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 14 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 > 70 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. Those randomized to TAU will be able to continue or initiate psychosocial interventions (psychotherapy, social skills training, applied behavior analysis, or family therapy) whereas those randomized to CBT will not receive these interventions concurrent with CBT.

2. New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment or an antipsychotic 8 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, anxioloytics) within 8 weeks before study enrollment, or any change in alternative medications that might have behavioral effects within 6 weeks prior to the study baseline assessment. Those randomized to TAU may make medication changes following randomization, including starting a medication; those randomized to CBT will remain stable on medications during the study.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Asperger Syndrome
• Asperger's Syndrome
• Autism
• Autistic Disorder
• Child Development Disorders, Pervasive
• Compulsive Behavior
• Disease
• Generalized Anxiety Disorder
• Mental Disorders
• Obsessive-Compulsive Disorder
• Separation Anxiety Disorder
• Social Phobia

Intervention

Behavioral:
• Cognitive-behavioral therapy
Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA 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 exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
• Treatment as Usual
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.

Locations

Country	Name	City	State
United States	Rothman Center for Neuropsychiatry, University of South Florida	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Anxiety Rating Scale (Measures the Severity of Anxiety Symptoms)	This scale assesses the severity of anxiety symptoms. The scale ranges from 0 (minimum score) to 25 (maximum score). Higher scores reflect more severe anxiety symptoms; lower scores reflect lower anxiety severity. There are no subscales to this measure.	After an average of 16 weeks (Post-treatment)	No
Secondary	Anxiety Disorders Interview Schedule Highest Anxiety Clincian Severity Rating (Measures the Severity of the Child's Anxiety Symptoms)	This is a measure of severity of the child's primary anxiety disorder. The maximum rating is 8, the minimum rating is 0. Higher scores correspond to more severe anxiety.	After an average of 16 weeks (Post-treatment)	No
Secondary	Clinical Global Impression - Severity Scale (This Scale Measures the Severity of the Child's Anxiety Symptoms).	This scale measures severity of the child's overall anxiety presentation. The minimum rating is 0, the maximum is 6. Higher scores correspond to greater anxiety; lower scores correspond to less severe anxiety. There are no subscales for this measure.	After an average of 16 weeks (Post-treatment)	No

External Links

•   Weblink for study site