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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
  Purpose

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.


Condition Intervention
Language Acquisition Behavioral: Language toolkit Behavioral: Safety counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Two to Talk: The Use of a Language Toolkit for Toddlers

Further study details as provided by Michael Steiner, MD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Language/Words acquisition [ Time Frame: 3 months ]

Estimated Enrollment: 40
Study Start Date: August 2009
Study Completion Date: September 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Language Toolkit
Language toolkit composed of simple tools that parents can use to interact with child and help language acquisition.
Behavioral: Language toolkit
Simple toolkit of interactive things to stimulate language.
Placebo Comparator: 2
Safety counseling and smoke detector
Behavioral: Safety counseling
Smoke detector and general safety counseling

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Months to 19 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926510


Locations
United States, North Carolina
North Carolina Children's Hospital
Chapel Hill, North Carolina, United States, 27516
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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
  More Information

Responsible Party: Michael Steiner, MD, Asst. Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00926510     History of Changes
Other Study ID Numbers: 09-0549
First Submitted: June 22, 2009
First Posted: June 23, 2009
Last Update Posted: October 12, 2011
Last Verified: October 2011