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The Use of a Language Toolkit for Toddlers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00926510
First Posted: June 23, 2009
Last Update Posted: October 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Steiner, MD, University of North Carolina, Chapel Hill
June 22, 2009
June 23, 2009
October 12, 2011
August 2009
June 2010   (Final data collection date for primary outcome measure)
Language/Words acquisition [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00926510 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The Use of a Language Toolkit for Toddlers
Two to Talk: The Use of a Language Toolkit for Toddlers

To investigate whether young children with isolated expressive language delay benefit from early intervention with a simple language toolkit and brief instructions provided to their caregivers.

We hypothesize that children whose families are provided the language toolkit will develop more words over the subsequent 3 months.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Language Acquisition
  • Behavioral: Language toolkit
    Simple toolkit of interactive things to stimulate language.
  • Behavioral: Safety counseling
    Smoke detector and general safety counseling
  • Experimental: Language Toolkit
    Language toolkit composed of simple tools that parents can use to interact with child and help language acquisition.
    Intervention: Behavioral: Language toolkit
  • Placebo Comparator: 2
    Safety counseling and smoke detector
    Intervention: Behavioral: Safety counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2011
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 14.5 to 18.5 months
  • Below average expressive language
  • Otherwise normal development

Exclusion Criteria:

  • Other developmental delay
  • Non-English primary language
Sexes Eligible for Study: All
14 Months to 19 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00926510
09-0549
No
Not Provided
Not Provided
Michael Steiner, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Study Director: Michael J Steiner, MD UNC Hospitals
Principal Investigator: Jennifer Hartz, MD UNC Hospitals
Principal Investigator: Mary Ann Cross, MD UNC Hospitals
Study Director: Karen L Wysocki, MS, M Ed UNC Hospitals
University of North Carolina, Chapel Hill
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP