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

Tracking Information

First Received Date ^ICMJE

June 22, 2009

Last Updated Date

October 10, 2011

Start Date ^ICMJE

August 2009

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00926510 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Use of a Language Toolkit for Toddlers

Official Title ^ICMJE

Two to Talk: The Use of a Language Toolkit for Toddlers

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Language Acquisition

Intervention ^ICMJE

Behavioral: Language toolkit
Simple toolkit of interactive things to stimulate language.
Behavioral: Safety counseling
Smoke detector and general safety counseling

Study Arm (s)

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

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

Estimated Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

14 Months to 19 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00926510

Other Study ID Numbers ^ICMJE

09-0549

Has Data Monitoring Committee

Responsible Party

Michael Steiner, MD, University of North Carolina, Chapel Hill

Study Sponsor ^ICMJE

University of North Carolina, Chapel Hill

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University of North Carolina, Chapel Hill

Verification Date

October 2011

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

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