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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 1, 2003 | ||||
| Last Updated Date | June 28, 2007 | ||||
| Start Date ICMJE | September 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00065910 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improving Attention Skills of Children With Autism | ||||
| Official Title ICMJE | A Joint Attention Intervention With Caregivers and Their Children With Autism | ||||
| Brief Summary | Toddlers with autism have poor joint attention skills. Joint attention skills include pointing to objects, following another person’s gaze, and responding to invitations to join in a social interaction. Improved joint attention skills may lead to better verbal ability as the child ages. This study teaches caregivers how to help their toddlers with autism develop joint attention skills. |
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| Detailed Description | Young children with autism show impairment in joint attention. The impairment affects their ability to sustain a shared interest in social interaction and to use specific joint attention skills, such as pointing and showing. The importance of joint attention is underscored by data suggesting these skills are important to later language skills. Targeting joint attention deficits in developmentally young children using familiar caregivers may result in better child language outcomes. This study will teach caregivers how to initiate and maintain episodes of joint engagement with their children. Participants will be randomized to either the intervention group or to a wait list control group. Each caregiver and child in the intervention group will participate in 24 1-hour sessions, 3 times a week for 8 weeks. In these sessions, caregivers will be taught 10 different modules for teaching joint attention skills to their children. Outcome measures will include language and joint attention skills in the child and caregiver adherence to the intervention protocols. Children and caregivers will be assessed at baseline, during the course of the 8-week intervention, and 10 weeks after the end of the intervention. Participants assigned to the wait list group will begin the intervention at Week 12. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study | ||||
| Condition ICMJE | Autism | ||||
| Intervention ICMJE | Behavioral: Caregiver joint attention intervention | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | January 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Gender | Both | ||||
| Ages | 12 Months to 36 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 ID ICMJE | NCT00065910 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R21MH64927 | ||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
| Investigators ICMJE |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Verification Date | June 2003 | ||||
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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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