NCT01975922

Brief Summary

The goal of the study is to examine the effects of teaching parents to use language support strategies on language skills in toddlers with language delays. We hypothesize that children whose parents who learn to use language support strategies at home will have greater language skills than those children whose parents do not learn the strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 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

Study Start

First participant enrolled

September 1, 2009

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

January 26, 2018

Completed
Last Updated

January 26, 2018

Status Verified

June 1, 2017

Enrollment Period

6.3 years

First QC Date

October 23, 2013

Results QC Date

May 5, 2016

Last Update Submit

June 27, 2017

Conditions

Language Developmental Disorders

Keywords

language impairmentlanguage disorderlanguage delaylate talkerslate talking

Outcome Measures

Primary Outcomes (1)

  • Language Skills at 4 Months After Baseline as Measured by the Pre-school Language Scale - 4th Edition

    Pre-school Language Scale - 4th Edition (a norm-referenced measure of receptive and expressive language) This scale measures the child's expressive and receptive language by going through a standard protocol of items, beginning based on the child's age, requiring a Basal of 3 consecutive correct responses and a Ceiling of 6 consecutive incorrect responses. A higher score is considered better. A standard score of 100 is considered average for the child's age with scores ranging from 50-150.

    4 months

Secondary Outcomes (1)

  • Expressive Vocabulary at 4 Months After Baseline

    4 months

Study Arms (2)

Enhanced Milieu Teaching

EXPERIMENTAL

Parents receive 28 intervention sessions in which they learn to use language support strategies with their children. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.

Behavioral: Enhanced Milieu Teaching

Community Services

NO INTERVENTION

Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.

Interventions

Enhanced Milieu TeachingBEHAVIORAL

Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts.

Enhanced Milieu Teaching

Eligibility Criteria

Age24 Months - 42 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Language delay

You may not qualify if:

  • Hearing loss
  • Language other than English as the home language
  • Additional disabilities (e.g., autism, Down syndrome)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Roberts MY, Kaiser AP. Early intervention for toddlers with language delays: a randomized controlled trial. Pediatrics. 2015 Apr;135(4):686-93. doi: 10.1542/peds.2014-2134. Epub 2015 Mar 2.

    PMID: 25733749DERIVED

MeSH Terms

Conditions

Language Development DisordersLanguage Disorders

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Ann Kaiser
Organization
Vanderbilt University
ann.kaiser@vanderbilt.edu
615-322-8163

Study Officials

  • Ann P Kaiser, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 5, 2013

Study Start

September 1, 2009

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 26, 2018

Results First Posted

January 26, 2018

Record last verified: 2017-06

Locations

US(1)