Communication DisordersPhase 2NCT00723151
Effects of Intensity of Early Communication Intervention
A Phase 2 study testing Milieu Communication Teaching in people with Communication Disorders and Developmental Disabilities, run by University of Kansas at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 27 monthsHealthy volunteers can take part
- Conditions the study is for
- Communication Disorders, Developmental Disabilities
- What is being tested?
- Milieu Communication Teaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2005to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 27 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
Vanderbilt University
Nashville, Tennessee, 37203
About this study
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.
Read the detailed description
Our research team has pioneered the development of a prelinguistic communication intervention referred to as Parent Responsivity Education-Milieu Communication Teaching (PRE-MCT). This intervention is designed to establish and enhance the development of intentional communication prior to the onset of spoken language in children with language delays and disorders. In the early stages of intervention, clinicians target children's use of gestures, vocalizations, and eye contact to produce more frequent and more complex nonverbal communication acts. As the children develop, goals shift to the direct teaching of words and sentence structures.
Our preliminary research using randomized experimental designs has tested the effects of the intervention when delivered in a very small 'dose', averaging just over one hour per week for six months. This standard dose has led to significant but modest effects in the children's use of intentional communication and early language, such that it could be adopted by speech-language pathologists as part of standard care. Unfortunately, the early benefits have not always been maintained 6 and 12 months after the therapy phase ends and have not always benefitted all children.
This research is a test of the hypothesis that a more intensive application of the intervention will have dramatically more positive outcomes than the standard dosage.
- Being tested
- Milieu Communication Teaching
- Medical subject headings
- Communication Disorders, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milieu Communication TeachingBehavioural
Also called Parent Responsivity Education-Milieu Communication Teaching
Communication intervention targeting intentional communication and language skills provided either one hour per week or one hour per day, five days per week
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity | Experimental | One hour of intervention per week Receives: Behavioral: Milieu Communication Teaching |
| High Intensity | Experimental | Five hours of intervention per week, one hour per day for five days per week Receives: Behavioral: Milieu Communication Teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of intentional communication, lexical density (observational), and vocabulary (parent report)
Measured: Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment
Secondary outcomes (2)
Parental stress level
Measured: Pre-treatment and post-treatment
Parental responsivity
Measured: Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startJul 2005
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Communication DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Investigators
- Steven F. Warren, Ph.D., Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723151
- Sponsor's protocol ID
- DC007660
- Other IDs
- R01DC007660
- Status last verified
- Oct 2010
- First submitted
- 24 Jul 2008
- Last updated
- 1 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9771641Yoder 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).
PubMed 11218105Yoder 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).
PubMed 12546485Fey 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).
PubMed 16787894Warren 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).
PubMed 18367689
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensity of Early Communication Intervention
- ClinicalTrials.gov ID
- NCT00723151
- Acronym / sponsor ID
- DC007660
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Jul 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 28 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our research team has pioneered the development of a prelinguistic communication intervention referred to as Parent Responsivity Education-Milieu Communication Teaching (PRE-MCT). This intervention is designed to establish and enhance the development of intentional communication prior to the onset of spoken language in children with language delays and disorders. In the early stages of intervention, clinicians target children's use of gestures, vocalizations, and eye contact to produce more frequent and more complex nonverbal communication acts. As the children develop, goals shift to the direct teaching of words and sentence structures.
Our preliminary research using randomized experimental designs has tested the effects of the intervention when delivered in a very small 'dose', averaging just over one hour per week for six months. This standard dose has led to significant but modest effects in the children's use of intentional communication and early language, such that it could be adopted by speech-language pathologists as part of standard care. Unfortunately, the early benefits have not always been maintained 6 and 12 months after the therapy phase ends and have not always benefitted all children.
This research is a test of the hypothesis that a more intensive application of the intervention will have dramatically more positive outcomes than the standard dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Intensity | Experimental | Behavioral: Milieu Communication TeachingOne hour of intervention per week |
| High Intensity | Experimental | Behavioral: Milieu Communication TeachingFive hours of intervention per week, one hour per day for five days per week |
Who may qualify
- Ages
- 18 to 27 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milieu Communication TeachingAlso: Parent Responsivity Education-Milieu Communication TeachingCommunication intervention targeting intentional communication and language skills provided either one hour per week or one hour per day, five days per week | Behavioural | High Intensity, Low Intensity |
Primary outcome
Rate of intentional communication, lexical density (observational), and vocabulary (parent report)
Time frame: Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment
2 secondary outcomes
Parental stress level
Time frame: Pre-treatment and post-treatment
Parental responsivity
Time frame: Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2010.
- Background: PubMed 9771641Yoder 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.
- Background: PubMed 11218105Yoder 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).
- Background: PubMed 12546485Yoder 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).
- Background: PubMed 16787894Fey 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).
- Background: PubMed 18367689Warren 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven F. Warren, Ph.D. principal investigator
University of Kansas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Milieu Communication Teaching in people with Communication Disorders and Developmental Disabilities, run by University of Kansas at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of intentional communication, lexical density (observational), and vocabulary (parent report) (time frame: Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00723151, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2010.