NCT00723151

Brief Summary

The purpose of the study is to determine if a more intensive application of communication intervention, i.e. 5 hours per week, will result in more frequent intentional communication acts, greater lexical density, and a better verbal comprehension level than children who receive the same communication intervention only one time per week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 1, 2010

Status Verified

October 1, 2010

Enrollment Period

5.2 years

First QC Date

July 24, 2008

Last Update Submit

October 29, 2010

Conditions

Communication DisordersDevelopmental Disabilities

Outcome Measures

Primary Outcomes (1)

  • Rate of intentional communication, lexical density (observational), and vocabulary (parent report)

    Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment

Secondary Outcomes (2)

  • Parental stress level

    Pre-treatment and post-treatment

  • Parental responsivity

    Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment

Study Arms (2)

Low Intensity

EXPERIMENTAL

One hour of intervention per week

Behavioral: Milieu Communication Teaching

High Intensity

EXPERIMENTAL

Five hours of intervention per week, one hour per day for five days per week

Behavioral: Milieu Communication Teaching

Interventions

Milieu Communication TeachingBEHAVIORAL

Communication intervention targeting intentional communication and language skills provided either one hour per week or one hour per day, five days per week

Also known as: Parent Responsivity Education-Milieu Communication Teaching
High IntensityLow Intensity

Eligibility Criteria

Age18 Months - 27 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • must produce at least one intentional communication act during administration of the Communication and Symbolic Behavior Scale
  • a minimum raw score of 34 or a composite score not greater than 75 on the cognitive subtest of the Bayley Scales of Infant Development

You may not qualify if:

  • spontaneous production of more than 20 words
  • failure of a screening test for Autism
  • English is not the primary language spoken in the home
  • corrected hearing or corrected vision is not within normal limits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

Related Publications (5)

  • Yoder PJ, Warren SF. Maternal responsivity predicts the prelinguistic communication intervention that facilitates generalized intentional communication. J Speech Lang Hear Res. 1998 Oct;41(5):1207-19. doi: 10.1044/jslhr.4105.1207.

    PMID: 9771641BACKGROUND

  • Yoder PJ, Warren SF. Relative treatment effects of two prelinguistic communication interventions on language development in toddlers with developmental delays vary by maternal characteristics. J Speech Lang Hear Res. 2001 Feb;44(1):224-37. doi: 10.1044/1092-4388(2001/019).

    PMID: 11218105BACKGROUND

  • Yoder PJ, Warren SF. Effects of prelinguistic milieu teaching and parent responsivity education on dyads involving children with intellectual disabilities. J Speech Lang Hear Res. 2002 Dec;45(6):1158-74. doi: 10.1044/1092-4388(2002/094).

    PMID: 12546485BACKGROUND

  • Fey ME, Warren SF, Brady N, Finestack LH, Bredin-Oja SL, Fairchild M, Sokol S, Yoder PJ. Early effects of responsivity education/prelinguistic milieu teaching for children with developmental delays and their parents. J Speech Lang Hear Res. 2006 Jun;49(3):526-47. doi: 10.1044/1092-4388(2006/039).

    PMID: 16787894BACKGROUND

  • Warren SF, Fey ME, Finestack LH, Brady NC, Bredin-Oja SL, Fleming KK. A randomized trial of longitudinal effects of low-intensity responsivity education/prelinguistic milieu teaching. J Speech Lang Hear Res. 2008 Apr;51(2):451-70. doi: 10.1044/1092-4388(2008/033).

    PMID: 18367689BACKGROUND

MeSH Terms

Conditions

Communication DisordersDevelopmental Disabilities

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Steven F. Warren, Ph.D.

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 28, 2008

Study Start

July 1, 2005

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

November 1, 2010

Record last verified: 2010-10

Locations

US(2)