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

NCT01178385 | Completed Phase 2 Results

• 1 other identifier: ACH-2010
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Anxiety Disorders Interview Schedule Highest Anxiety Clincian Severity Rating (Measures the Severity of the Child's Anxiety Symptoms)

  After an average of 16 weeks (Post-treatment)

• Clinical Global Impression - Severity Scale (This Scale Measures the Severity of the Child's Anxiety Symptoms).

  After an average of 16 weeks (Post-treatment)

Study Arms (2)

Cognitive-behavioral therapy

EXPERIMENTAL

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.

Behavioral: Cognitive-behavioral therapy

Treatment as Usual

ACTIVE COMPARATOR

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.

Behavioral: Treatment as Usual

Interventions

Cognitive-behavioral therapy BEHAVIORAL

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.

Also known as: psychotherapy, counseling, therapy

Cognitive-behavioral therapy

Treatment as Usual BEHAVIORAL

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.

Treatment as Usual

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Outpatient children with an autism spectrum disorder (see #2 below) between the ages 7-11years.
• 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.
• 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.
• 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).
• Child has a Full Scale and Verbal Comprehension IQ \> 70 as assessed on a commonly used IQ test.
• 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).

You may not qualify if:

• 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.
• 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.
• 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.
• (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.
• Lifetime DSM-IV bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.
• Unwillingness of parents to make the commitment to accompany their child for multiple study visits.
• Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Rothman Center for Neuropsychiatry, University of South Florida

St. Petersburg, Florida, 33701, United States

Location

Related Publications (1)

• Storch EA, Arnold EB, Lewin AB, Nadeau JM, Jones AM, De Nadai AS, Jane Mutch P, Selles RR, Ung D, Murphy TK. The effect of cognitive-behavioral therapy versus treatment as usual for anxiety in children with autism spectrum disorders: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 2013 Feb;52(2):132-142.e2. doi: 10.1016/j.jaac.2012.11.007. Epub 2013 Jan 2.

  PMID: 23357440 DERIVED

MeSH Terms

Conditions

Autistic Disorder; Asperger Syndrome; Generalized Anxiety Disorder; Phobia, Social; Anxiety, Separation; Obsessive-Compulsive Disorder; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy; Psychotherapy; Counseling; Therapeutics

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Behavioral Disciplines and Activities; Mental Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

1. Modest sample size was modest. 2. Only \~75% of families in the treatment as usual arm had some form of active intervention. 3. Short follow-up interval that only included treatment responders in the CBT arm.

Results Point of Contact

• Title: Dr. Eric Storch
• Organization: University of South Florida

estorch@health.usf.edu

727-767-8230

Study Officials

• Eric A Storch, Ph.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 10, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 2, 2013
• Results First Posted: April 2, 2013

Record last verified: 2012-12

Locations

US (1)