Autism Spectrum DisorderPhase 1/2BIACA-2NCT00789932
Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial
A Phase 1/2 study testing cognitive behavioral therapy and Usual community care in people with Autism Spectrum Disorder, 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 core autism symptoms, social and emotional 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
- Autism Spectrum Disorder
- What is being tested?
- cognitive behavioral therapy and Usual community care
- 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
- Sep 2008to Dec 2011
- Phase
- Phase 1/2
- 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 autism, 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 80
- 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.
About this study
This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT) program for treating core autism symptoms, social and emotional problems, and adaptive behavior deficits in children with autism spectrum disorders.
- Conditions
- Autism Spectrum Disorder
- Being tested
- cognitive behavioral therapy, Usual community care
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
32 weeks of CBT, 1.5 hours weekly.
Usual community careBehavioural
16 weeks of community care, 16 weeks of CBT, 1.5 hours/week.
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Not described Receives: Behavioral: cognitive behavioral therapy |
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual community care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADIS-C/P (Anxiety Disorder Interview Schedule for Children and Parents)
Measured: 8 months (post-treatment)
Secondary outcomes (1)
Behavioral observations of social responsiveness
Measured: 8 months (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Organization for Autism Research
- Responsible party
- Principal investigator, Jeffrey J. Wood, University of California, Los Angeles
- Investigators
- Jeffrey Wood, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789932
- Sponsor's protocol ID
- OAR-UCLA-2009
- Acronym
- BIACA-2
- Status last verified
- Feb 2013
- First submitted
- 12 Nov 2008
- Last updated
- 5 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00789932
- Acronym / sponsor ID
- BIACA-2 / OAR-UCLA-2009
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Organization for Autism Research
- Study start
- Sep 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Nov 2008 (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 core autism symptoms, social and emotional problems, and adaptive behavior deficits in children with autism spectrum disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: cognitive behavioral therapy |
| Usual Care | Active comparator | Behavioral: Usual community care |
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 autism, 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 80
- 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 therapy32 weeks of CBT, 1.5 hours weekly. | Behavioural | CBT |
| Usual community care16 weeks of community care, 16 weeks of CBT, 1.5 hours/week. | Behavioural | Usual Care |
Primary outcome
ADIS-C/P (Anxiety Disorder Interview Schedule for Children and Parents)
Time frame: 8 months (post-treatment)
1 secondary outcome
Behavioral observations of social responsiveness
Time frame: 8 months (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 5 Feb 2013.
Related trials for Autism Spectrum Disorder
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Autism Spectrum Disorder, Autism
RecruitingPhase 2
A Study of Esomeprazole in Children With Autism
Autism, Autism Spectrum Disorder
Recruiting
A Center Based Early Intervention Program For Preschoolers With Developmental Disorders
Development Disorder, Child, Developmental Disability
Recruiting
Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
Autism Spectrum Disorder, Autism
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 Wood, PhD 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 1/2 study testing cognitive behavioral therapy and Usual community care in people with Autism Spectrum Disorder, 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 5 Feb 2013. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
ADIS-C/P (Anxiety Disorder Interview Schedule for Children and Parents) (time frame: 8 months (post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2013; AzTrials last refreshed its copy on 6 Nov 2026.