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Does Block Play Improve Language Acquisition: A Randomized Trial
This study has been completed.
Sponsor:
University of Washington
Collaborator:
Megablocks
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00428376
First received: January 26, 2007
Last updated: September 25, 2008
Last verified: September 2008
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | January 26, 2007 | |||
| Last Updated Date | September 25, 2008 | |||
| Start Date ICMJE | September 2005 | |||
| Primary Completion Date | September 2006 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Macarthur Bates Language Inventory | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT00428376 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Does Block Play Improve Language Acquisition: A Randomized Trial | |||
| Official Title ICMJE | Clinical Trial of Building Block Distribution in Children | |||
| Brief Summary | This is a randomized controlled trial of distributing blocks to children ages 1.5 -2.5 years of age to see if language acquisition improves. | |||
| Detailed Description | Children in age group are randomized to get two sets of blocks or not. Outcomes include language development assessed using the Macarthur Bates CDI 6 months after enrollment. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Not Provided | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind |
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| Condition ICMJE | Healthy | |||
| Intervention ICMJE | Device: Building Blocks | |||
| Study Arms | Not Provided | |||
| Publications * | Not Provided | |||
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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 | |||
| Enrollment ICMJE | 200 | |||
| Completion Date | September 2006 | |||
| Primary Completion Date | September 2006 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Months to 30 Months (Child) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00428376 | |||
| Other Study ID Numbers ICMJE | 05-0636-01 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Dmitri Christakis, MD, MPH, University of Washington | |||
| Study Sponsor ICMJE | University of Washington | |||
| Collaborators ICMJE | Megablocks | |||
| Investigators ICMJE |
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| PRS Account | University of Washington | |||
| Verification Date | September 2008 | |||
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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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