Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT00095420
Status:
COMPLETED
Last Update Posted:
2025-10-30
First Post:
2004-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship Training for Children With Autism and Their Peers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2004-11-04', 'studyFirstSubmitQcDate': '2004-11-04', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social network involvement of autistic children', 'timeFrame': 'Measured before and after treatment and at 3-month follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Interpersonal Relationships', 'Child'], 'conditions': ['Autism', 'Autistic Disorder']}, 'referencesModule': {'availIpds': [{'url': 'http://pubmed.ncbi.nlm.nih.gov/22118062/', 'type': 'Clinical Study Report'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/20673234/', 'type': 'Clinical Study Report'}, {'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3076578/', 'type': 'Clinical Study Report'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/27620949/', 'type': 'Clinical Study Report'}], 'references': [{'pmid': '26567264', 'type': 'DERIVED', 'citation': 'Anderson A, Locke J, Kretzmann M, Kasari C; AIR-B Network. Social network analysis of children with autism spectrum disorder: Predictors of fragmentation and connectivity in elementary school classrooms. Autism. 2016 Aug;20(6):700-9. doi: 10.1177/1362361315603568. Epub 2015 Nov 13.'}, {'pmid': '26341991', 'type': 'DERIVED', 'citation': 'Locke J, Shih W, Kretzmann M, Kasari C. Examining playground engagement between elementary school children with and without autism spectrum disorder. Autism. 2016 Aug;20(6):653-62. doi: 10.1177/1362361315599468. Epub 2015 Sep 4.'}, {'pmid': '25039696', 'type': 'DERIVED', 'citation': 'Dean M, Kasari C, Shih W, Frankel F, Whitney R, Landa R, Lord C, Orlich F, King B, Harwood R. The peer relationships of girls with ASD at school: comparison to boys and girls with and without ASD. J Child Psychol Psychiatry. 2014 Nov;55(11):1218-25. doi: 10.1111/jcpp.12242. Epub 2014 Jul 16.'}, {'pmid': '22215436', 'type': 'DERIVED', 'citation': 'Locke J, Rotheram-Fuller E, Kasari C. Exploring the social impact of being a typical peer model for included children with autism spectrum disorder. J Autism Dev Disord. 2012 Sep;42(9):1895-905. doi: 10.1007/s10803-011-1437-0.'}, {'pmid': '22118062', 'type': 'DERIVED', 'citation': 'Kasari C, Rotheram-Fuller E, Locke J, Gulsrud A. Making the connection: randomized controlled trial of social skills at school for children with autism spectrum disorders. J Child Psychol Psychiatry. 2012 Apr;53(4):431-9. doi: 10.1111/j.1469-7610.2011.02493.x. Epub 2011 Nov 26.'}], 'seeAlsoLinks': [{'url': 'http://www.semel.ucla.edu/autism', 'label': 'Click here for more information about this study and others at the University of California, Los Angeles Center for Autism Research and Treatment Web site.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine whether peer interaction training interventions are effective in enhancing the social relationships of children with autism.', 'detailedDescription': 'Children with autism often have poor relationships with other children during their childhood and through their adult lives. A number of peer-related intervention models have been developed, but these models have not been thoroughly reviewed or implemented within the school setting. This study will examine the social inclusion of children with autism, following different peer-related interventions training children with autism and their peers.\n\nChildren will be randomly assigned to one of four interventions that comprise all autistic children, all nonautistic children, or a mixed group of both. The first intervention focuses on improving the social skills of autistic children. The second intervention involves educating the peers of autistic children to increase their acceptance of their autistic peers. The third intervention is a combination of the first two interventions. Children assigned to the fourth intervention will receive the usual training offered in their local school districts. Training for each group will be conducted twice a week for 6 weeks.\n\nCharacteristics of the autistic child will be assessed through an interview that evaluates intelligence quotient (IQ), language skills, and social interaction. Teachers will be asked to complete a questionnaire describing the autistic child and his or her interaction with peers. The autistic children will complete a friendship survey, clinical global impressions scales, and a battery of neuropsychiatric tests. All assessments will be conducted at study start and again at study completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Autistic and Nonautistic Participants:\n\n* Autistic OR nonautistic peer of autistic child\n* Full inclusion in a classroom with nonautistic children\n* Currently in kindergarten or grades 1 through 5\n* Intelligence quotient higher than 70\n* Expectation to stay in the same school and classroom for the duration of the study\n* Able to provide parent consent and child assent\n\nExclusion Criteria:\n\n* Mental age-equivalent less than 4 years\n* Conditions other than autism, or sensory or motor impairments'}, 'identificationModule': {'nctId': 'NCT00095420', 'briefTitle': 'Relationship Training for Children With Autism and Their Peers', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Peer Related School Interventions in Autism', 'orgStudyIdInfo': {'id': 'U54MH068172', 'link': 'https://reporter.nih.gov/quickSearch/U54MH068172', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U54MH068172', 'link': 'https://reporter.nih.gov/quickSearch/U54MH068172', 'type': 'NIH'}, {'id': 'DDTR BD-DD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants with autism will receive social skills training targeting children with autism', 'interventionNames': ['Behavioral: Social skills training targeting children with autism']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Participants without autism will receive social skills training to increase acceptance of peers with autism', 'interventionNames': ['Behavioral: Social skills training of peers without autism']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Participants with and without autism will receive a combination treatment of social skills/education about autism', 'interventionNames': ['Behavioral: Combination treatment of social skills/education about autism']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Participants with and without autism will receive usual training provided by their school district', 'interventionNames': ['Behavioral: Usual training']}], 'interventions': [{'name': 'Social skills training targeting children with autism', 'type': 'BEHAVIORAL', 'description': 'Sessions will focus on improving the social skills of autistic children. Thirty-minute sessions will be held twice a week for 6 weeks.', 'armGroupLabels': ['1']}, {'name': 'Social skills training of peers without autism', 'type': 'BEHAVIORAL', 'description': 'Sessions will involve educating the peers of autistic children to increase their acceptance of their autistic peers. Thirty-minute sessions will be held twice a week for 6 weeks.', 'armGroupLabels': ['2']}, {'name': 'Combination treatment of social skills/education about autism', 'type': 'BEHAVIORAL', 'description': 'The combination treatment includes children with and without autism. Sessions will involve social skills training and education about autism to increase acceptance of autistic peers. Training will be conducted twice a week for 6 weeks', 'armGroupLabels': ['3']}, {'name': 'Usual training', 'type': 'BEHAVIORAL', 'description': 'Participants will receive the usual training offered in their local school districts.', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Marian Sigman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}