The Use of a Language Toolkit for Toddlers

Language Acquisition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926510
• Other study ID #: 09-0549
• Status: Completed
• Phase: N/A
• First received: June 22, 2009
• Last updated: October 10, 2011
• Start date: August 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Months to 19 Months

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Language Acquisition

Intervention

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

Locations

Country	Name	City	State
United States	North Carolina Children's Hospital	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Language/Words acquisition		3 months	No