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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
History of Changes
  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 Blind (Investigator)
Primary Purpose: Treatment
Official Title: Two to Talk: The Use of a Language Toolkit for Toddlers

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Language/Words acquisition [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   14 Months to 19 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 22, 2009
Last Updated: October 10, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013