Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT00789932
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2008-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-01', 'studyFirstSubmitDate': '2008-11-12', 'studyFirstSubmitQcDate': '2008-11-12', 'lastUpdatePostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADIS-C/P (Anxiety Disorder Interview Schedule for Children and Parents)', 'timeFrame': '8 months (post-treatment)'}], 'secondaryOutcomes': [{'measure': 'Behavioral observations of social responsiveness', 'timeFrame': '8 months (post-treatment)'}]}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 7 - 11 years of age\n* meet research criteria for a diagnosis of autism, Asperger Syndrome, or PDD-NOS\n* meet DSM-IV criteria for one of the following anxiety disorders: Separation Anxiety Disorder, Social Phobia, Obsessive-Compulsive Disorder\n* If taking medication, have maintained a stable dose for 1 month prior to baseline assessment\n\nExclusion Criteria:\n\n* child has an IQ of less than 80\n* 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\n* for any reason the child or parents appear unable to participate in the treatment program'}, 'identificationModule': {'nctId': 'NCT00789932', 'acronym': 'BIACA-2', 'briefTitle': 'Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'OAR-UCLA-2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT', 'interventionNames': ['Behavioral: cognitive behavioral therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'interventionNames': ['Behavioral: Usual community care']}], 'interventions': [{'name': 'cognitive behavioral therapy', 'type': 'BEHAVIORAL', 'description': '32 weeks of CBT, 1.5 hours weekly.', 'armGroupLabels': ['CBT']}, {'name': 'Usual community care', 'type': 'BEHAVIORAL', 'description': '16 weeks of community care, 16 weeks of CBT, 1.5 hours/week.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Jeffrey Wood, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Organization for Autism Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeffrey J. Wood', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}