NCT00926510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

10 months

First QC Date

June 22, 2009

Last Update Submit

October 10, 2011

Conditions

Language Acquisition

Outcome Measures

Primary Outcomes (1)

  • Language/Words acquisition

    3 months

Study Arms (2)

Language Toolkit

EXPERIMENTAL

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

Behavioral: Language toolkit

2

PLACEBO COMPARATOR

Safety counseling and smoke detector

Behavioral: Safety counseling

Interventions

Language toolkitBEHAVIORAL

Simple toolkit of interactive things to stimulate language.

Language Toolkit
Safety counselingBEHAVIORAL

Smoke detector and general safety counseling

2

Eligibility Criteria

Age14 Months - 19 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Other developmental delay
  • Non-English primary language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carolina Children's Hospital

Chapel Hill, North Carolina, 27516, United States

Location

Study Officials

  • Michael J Steiner, MD

    UNC Hospitals

    STUDY DIRECTOR

  • Jennifer Hartz, MD

    UNC Hospitals

    PRINCIPAL INVESTIGATOR

  • Mary Ann Cross, MD

    UNC Hospitals

    PRINCIPAL INVESTIGATOR

  • Karen L Wysocki, MS, M Ed

    UNC Hospitals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Professor

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 23, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2010

Study Completion

September 1, 2011

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

US(1)