Does Block Play Improve Language Acquisition: A Randomized Trial

Tracking Information
First Submitted Date ICMJE	January 26, 2007
First Posted Date ICMJE	January 30, 2007
Last Update Posted Date	September 29, 2008
Study Start Date ICMJE	September 2005
Actual Primary Completion Date	September 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 29, 2007)	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; (submitted: January 29, 2007)	TV viewing; Block play
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 Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single
Condition ICMJE	Healthy
Intervention ICMJE	Device: Building Blocks
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: January 29, 2007)	200
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	September 2006
Actual Primary Completion Date	September 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: healthy children Exclusion Criteria: developmental delay, non-English
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Dimitri Christakis, MD MPH University of Washington
PRS Account	University of Washington
Verification Date	September 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP