CClinicalTrials.gg
CompletedNCT00926510Updated Oct 12, 2011

The Use of a Language Toolkit for Toddlers

An interventional study of Language toolkit and Safety counseling in Language Acquisition, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 14 Months to 19 Months. Per ClinicalTrials.gov, last updated 2011-10-12.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
14 Months to 19 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Language Acquisition
03

In context

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Months to 19 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 14.5 to 18.5 months
  • Below average expressive language
  • Otherwise normal development

Exclusion criteria

Exclusion Criteria:

  • Other developmental delay
  • Non-English primary language
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Language Toolkit

    Language toolkit composed of simple tools that parents can use to interact with child and help language acquisition.

    Behavioral: Language toolkit

  • Placebo comparator
    2

    Safety counseling and smoke detector

    Behavioral: Safety counseling

Interventions

  • BehavioralLanguage toolkit

    Simple toolkit of interactive things to stimulate language.

  • BehavioralSafety counseling

    Smoke detector and general safety counseling

06

What researchers measure

Primary outcomes

  1. Language/Words acquisition

    Time frame: 3 months

07

Study locations

1 site
  • North Carolina Children's Hospital
    Chapel Hill, North Carolina 27516, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00926510
Lead sponsor
University of North Carolina, Chapel Hill
Responsible party
Michael Steiner, MD (Asst. Professor, University of North Carolina, Chapel Hill) — Principal investigator
First posted
Jun 23, 2009
Start date
Aug 2009
Primary completion
Jun 2010
Completion
Sep 2011
Last update
Oct 12, 2011

Study contacts

Michael J Steiner, MD
study director · UNC Hospitals
Jennifer Hartz, MD
principal investigator · UNC Hospitals
Mary Ann Cross, MD
principal investigator · UNC Hospitals
Karen L Wysocki, MS, M Ed
study director · UNC Hospitals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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