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The Use of a Language Toolkit for Toddlers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Steiner, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00926510
First received: June 22, 2009
Last updated: October 10, 2011
Last verified: October 2011

June 22, 2009
October 10, 2011
August 2009
June 2010   (final data collection date for primary outcome measure)
Language/Words acquisition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Both
14 Months to 19 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00926510
09-0549
No
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