Working on Rapid Language Development in Toddlers

NCT ID: NCT01975922

Last Updated: 2018-01-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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The goal of the proposed project is to conduct an efficacy trial to determine whether Enhanced Milieu Teaching (EMT) significantly improves language deficits in young children at high risk for persistent language delays. The target population is children ages 24 -36 months who exhibit significant co-occurring delays in productive and receptive language skills, who have cognitive skills within the range of normal development, and who do not have other identified disabilities. An empirically based and manualized language intervention, Enhanced Milieu Teaching (EMT), implemented by therapists and parents will be compared to community based "business as usual" services in a randomized experiment enrolling 120 children and their parents. Children assigned to the EMT group will receive 24, 1-hour sessions of direct intervention at home that will include teaching their parents to implement EMT procedures across activities. Children will be assessed at 4 time points (before and after intervention, at 6 months and 12 months post-intervention) allowing the description and comparison of individual language growth trajectories over a period of 18 months. In addition, we will examine the relation between language growth and emergent problems in behavior and social skill development to determine whether early language intervention can prevent these difficulties frequently associated with early language delays. Results from this study will determine the efficacy of parent-plus-therapist implemented EMT with a new population of children, provide evidence about the potential for preventing persistent language delays and secondary social effects of early language delays, and expand developmental theory linking persistent language delays to specific risk factors and behavioral outcomes. The results of this study will have specific policy implications related to early identification and the inclusion of young children with language delays as a target population for early intervention.

Conditions

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Language Developmental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enhanced Milieu Teaching

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.

Group Type EXPERIMENTAL

Enhanced Milieu Teaching

Intervention Type BEHAVIORAL

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.

Community Services

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced Milieu Teaching

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Language delay

Exclusion Criteria

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

24 Months

Maximum Eligible Age

42 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Ann Kaiser

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann P Kaiser, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25733749 (View on PubMed)

Other Identifiers

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R324A090181

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

090904

Identifier Type: -

Identifier Source: org_study_id

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