Autistic DisorderPhase 2BIACANCT00280670
CBT for Comorbid Anxiety Disorders in Children With Autism, Asperger Syndrome, or PDD-NOS
A Phase 2 study testing Cognitive-behavioral therapy in people with Autistic Disorder and Asperger Syndrome, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT) program for treating anxiety symptoms, social problems, and adaptive behavior deficits in children with autism spectrum disorders. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Autistic Disorder, Asperger Syndrome, Anxiety Disorders
- What is being tested?
- Cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Aug 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 7 - 11 years of age
- Meet research criteria for a diagnosis of Asperger Syndrome or PDD-NOS
- Meet DSM-IV criteria for one of the following anxiety disorders: Separation Anxiety Disorder, Social Phobia, Obsessive-Compulsive Disorder
- If taking medication, have maintained a stable dose for 1 month prior to baseline assessment
Who cannot join
- Child has an IQ of less than 70
- Begin taking new medication(s) or current medication dose changes either (1) less than 1 month prior to baseline assessment, or (2) during the study period
- For any reason the child or parents appear unable to participate in the treatment program
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT) program for treating anxiety symptoms, social problems, and adaptive behavior deficits in children with autism spectrum disorders.
Read the detailed description
Anxiety disorders are commonly diagnosed in children with autism, Asperger syndrome (AS), and pervasive developmental disorder not otherwise specified (PDD-NOS). Anxiety disorders contribute to children's functional impairment over and above the functional deficits attributable to autism, AS, and PDD-NOS. Thus, investigators have called for the development of anxiety treatments for this population (Attwood, 2003). Cognitive behavioral therapy (CBT) has been found to be efficacious for anxiety disorders in typically developing children. This pilot study will advance the field by providing an estimate of the treatment effects of CBT for anxiety disorders among children with autism, AS, or PDD-NOS. The sample will include 20 children aged 7-11 years with autism, AS, or PDD-NOS and a comorbid anxiety disorder. Children will be randomly assigned to immediate treatment or a 3-month waitlist. The manualized CBT program includes traditional anxiety treatment components including coping skills training (e.g., cognitive restructuring), in vivo exposure, operant procedures, and parent training. Additional treatment components have been added to enhance intervention response in children with AS or PDD-NOS, including emotion education, social skills/friendship skills training, and peer tutoring/mentoring modules. Trained graduate students with expertise in CBT and developmental disabilities will serve as therapists. Treatment fidelity will be checked using a session-by-session adherence checklist. Treatment acceptability and consumer satisfaction will be assessed at posttreatment, providing guidance on the extent to which the manual will need to be revised. Multiple measures of children's anxiety, including a structured diagnostic interview administered by an independent evaluator, will comprise the primary outcomes. Children's social functioning, adaptive behavior, and service use will also be assessed to determine if CBT can affect relevant distal outcomes. By comparing outcomes for children in the immediate treatment group versus those in the waitlist group, we will estimate effect sizes of CBT for this population. Subsequently, power analyses will be conducted in planning for a larger clinical trial. This study could contribute to public health efforts to address the mental health needs of the rising number of children diagnosed with autism-spectrum disorders. If CBT is found to be efficacious, it will be the first evidence-based psychological treatment to be successfully adapted for children with autism, AS, and PDD-NOS.
- Conditions
- Autistic Disorder, Asperger Syndrome, Anxiety Disorders
- Being tested
- Cognitive-behavioral therapy
- Medical subject headings
- Autistic Disorder, Asperger Syndrome, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapyBehavioural
Cognitive behavioral therapy for children with autism and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Not described Receives: Behavioral: Cognitive-behavioral therapy |
| Waitlist | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on anxiety diagnostic interview after treatment or waitlist
Measured: post-treatment
Score on anxiety rating scale after treatment or waitlist
Measured: post-treatment
Secondary outcomes (2)
Score on daily living skills rating scale after treatment or waitlist
Measured: post-treatment
Score on children's social functioning and service use after treatment or waitlist
Measured: post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study startJan 2005
- Primary completionAug 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey J. Wood, University of California, Los Angeles
- Investigators
- Jeffrey J Wood, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280670
- Sponsor's protocol ID
- R03MH075806-01
- Acronym
- BIACA
- Status last verified
- Mar 2012
- First submitted
- 20 Jan 2006
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wood JJ, Drahota A, Sze K, Har K, Chiu A, Langer DA. Cognitive behavioral therapy for anxiety in children with autism spectrum disorders: a randomized, controlled trial. J Child Psychol Psychiatry. 2009 Mar;50(3):224-34. doi: 10.1111/j.1469-7610.2008.01948.x.
PubMed 19309326
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT for Comorbid Anxiety Disorders in Children With Autism, Asperger Syndrome, or PDD-NOS
- ClinicalTrials.gov ID
- NCT00280670
- Acronym / sponsor ID
- BIACA / R03MH075806-01
- Conditions
- Autistic Disorder, Asperger Syndrome, Anxiety Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT) program for treating anxiety symptoms, social problems, and adaptive behavior deficits in children with autism spectrum disorders.
Detailed description
Anxiety disorders are commonly diagnosed in children with autism, Asperger syndrome (AS), and pervasive developmental disorder not otherwise specified (PDD-NOS). Anxiety disorders contribute to children's functional impairment over and above the functional deficits attributable to autism, AS, and PDD-NOS. Thus, investigators have called for the development of anxiety treatments for this population (Attwood, 2003). Cognitive behavioral therapy (CBT) has been found to be efficacious for anxiety disorders in typically developing children. This pilot study will advance the field by providing an estimate of the treatment effects of CBT for anxiety disorders among children with autism, AS, or PDD-NOS. The sample will include 20 children aged 7-11 years with autism, AS, or PDD-NOS and a comorbid anxiety disorder. Children will be randomly assigned to immediate treatment or a 3-month waitlist. The manualized CBT program includes traditional anxiety treatment components including coping skills training (e.g., cognitive restructuring), in vivo exposure, operant procedures, and parent training. Additional treatment components have been added to enhance intervention response in children with AS or PDD-NOS, including emotion education, social skills/friendship skills training, and peer tutoring/mentoring modules. Trained graduate students with expertise in CBT and developmental disabilities will serve as therapists. Treatment fidelity will be checked using a session-by-session adherence checklist. Treatment acceptability and consumer satisfaction will be assessed at posttreatment, providing guidance on the extent to which the manual will need to be revised. Multiple measures of children's anxiety, including a structured diagnostic interview administered by an independent evaluator, will comprise the primary outcomes. Children's social functioning, adaptive behavior, and service use will also be assessed to determine if CBT can affect relevant distal outcomes. By comparing outcomes for children in the immediate treatment group versus those in the waitlist group, we will estimate effect sizes of CBT for this population. Subsequently, power analyses will be conducted in planning for a larger clinical trial. This study could contribute to public health efforts to address the mental health needs of the rising number of children diagnosed with autism-spectrum disorders. If CBT is found to be efficacious, it will be the first evidence-based psychological treatment to be successfully adapted for children with autism, AS, and PDD-NOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive-behavioral therapy |
| Waitlist | No intervention | – |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 7 - 11 years of age
- Meet research criteria for a diagnosis of Asperger Syndrome or PDD-NOS
- Meet DSM-IV criteria for one of the following anxiety disorders: Separation Anxiety Disorder, Social Phobia, Obsessive-Compulsive Disorder
- If taking medication, have maintained a stable dose for 1 month prior to baseline assessment
Key exclusion criteria (3 listed)
- Child has an IQ of less than 70
- Begin taking new medication(s) or current medication dose changes either (1) less than 1 month prior to baseline assessment, or (2) during the study period
- For any reason the child or parents appear unable to participate in the treatment program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapyCognitive behavioral therapy for children with autism and anxiety. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Score on anxiety diagnostic interview after treatment or waitlist
Time frame: post-treatment
Score on anxiety rating scale after treatment or waitlist
Time frame: post-treatment
2 secondary outcomes
Score on daily living skills rating scale after treatment or waitlist
Time frame: post-treatment
Score on children's social functioning and service use after treatment or waitlist
Time frame: post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
- Derived from this study: PubMed 19309326Wood JJ, Drahota A, Sze K, Har K, Chiu A, Langer DA. Cognitive behavioral therapy for anxiety in children with autism spectrum disorders: a randomized, controlled trial. J Child Psychol Psychiatry. 2009 Mar;50(3):224-34. doi: 10.1111/j.1469-7610.2008.01948.x.
- UCLA Center for Autism Research and TreatmentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J Wood, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive-behavioral therapy in people with Autistic Disorder and Asperger Syndrome, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on anxiety diagnostic interview after treatment or waitlist (time frame: post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00280670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012; AzTrials last refreshed its copy on 8 Nov 2026.