Social and Communication Outcomes for Young Children With Autism
| Tracking Information | |||||
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| First Received Date ICMJE | August 4, 2009 | ||||
| Last Updated Date | June 12, 2012 | ||||
| Start Date ICMJE | April 2009 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Early Social Communication Scale [ Time Frame: Before treatment, after treatment and 3 months after treatment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
joint attention [ Time Frame: 3 months and 6 months after treatment has started ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00953095 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Mullen Scales of Early Learning [ Time Frame: Before treatment, after treatment, and 3 months after treatment ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
language abilities [ Time Frame: 3 months and 6 months after treatment has started ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Social and Communication Outcomes for Young Children With Autism | ||||
| Official Title ICMJE | Optimizing Social and Communication Outcomes for Young Children With Autism | ||||
| Brief Summary | The goal of this project is to test an intervention program for caregivers and their young children with autism that is focused on improving social communication. This study specifically targets underserved populations, specifically children from low SES and racial/ethnic minority families. Participants will include 40 children (aged 24 months to 60 months) and their caregivers who will be randomized (as if by flipping a coin) to one of the two treatments: Parent education sessions for two hours a week for 12 weeks or parent-child intervention sessions with the child for one hour, twice a week for 12 weeks. Young children with autism have difficulty with engaging in joint attention with others (e.g. pointing, showing. Joint attention skills are important to later development of language. Therefore, targeting this problem in young children may result in better language outcomes for these children. In order to examine the effects of the interventions, all participants will be complete cognitive, language, communication and play-based assessments prior to treatment, at the end of the first 12 weeks of the intervention, and post-treatment immediately following the intervention (approximately 2.5 to 3 hours each). |
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| Detailed Description | Child/parent dyads will be randomized to one of two intervention conditions: (1) Parent-child model, also known as the Caregiver Education Model (CMM):focuses on joint attention/engagement intervention using an established evidence based treatment (Kasari et al., 2006). It involves individual interventionist meetings with the parents and their children in their homes for one hour, twice a week for 12 weeks. In this intervention, the parent-child pair meet with the interventionist (as opposed to the group training in the CEM condition). Parents will be specifically taught techniques for altering the home environment and ways to enhance children's language, social, and play development. Parents will given guided practice (input and coaching from the interventionist) as they implement these techniques with their child. (2)Parent-education intervention, also known as the Caregiver Education Model (CEM): focuses on teaching parents information about autism, behavior modification, and community services using a manualized approach (Brereton & Tonge, 2005). Parents will receive information on child development each week, and will be able to ask questions and discuss the information vis-à-vis their own child. This intervention is manualized (Brereton & Tonge 2005). In the CEM condition, parents meet in a group, without their children, in a community-based setting to receive the intervention. Intervention in both conditions occurs for 2 hours for 12 weeks. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment |
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| Condition ICMJE | Autism Spectrum Disorder | ||||
| Intervention ICMJE | Behavioral: Joint Attention Intervention
Intervention in both conditions occurs once a week for 2 hours. Participants will be randomized to 1 of 2 interventions : (1) Caregiver Mediated Model (CMM):focuses on joint attention/engagement and involves individual meetings with the parents and children at their homes. Parents will be specifically taught techniques for altering the home environment and ways to enhance children's language, social, and play development. Parents will given guided practice (input/ coaching from the interventionist) as they implement these techniques with their child. (2) Caregiver Education Model (CEM): focuses on teaching parents information about autism, behavior modification, and community services. Parents will receive information on child development each week, and will be able to ask questions and discuss the information. Parents meet in a group (without their children) in a community-based setting to receive the intervention. |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 24 Months to 60 Months | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00953095 | ||||
| Other Study ID Numbers ICMJE | G09-02-016-01, UA3MC11055 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Connie Kasari, Ph.D., Health Resources and Services Administration (HRSA) | ||||
| Study Sponsor ICMJE | Health Resources and Services Administration (HRSA) | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Health Resources and Services Administration (HRSA) | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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