The Use of a Language Toolkit for Toddlers

October 10, 2011 updated by: Michael Steiner, MD, University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • North Carolina Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Language/Words acquisition
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 22, 2009

First Submitted That Met QC Criteria

June 22, 2009

First Posted (Estimate)

June 23, 2009

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 10, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 09-0549

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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