Delivering Early Intervention to Children With Down Syndrome

February 27, 2022 updated by: Emily Quinn, Oregon Health and Science University

Delivering Early Intervention to Children With Down Syndrome Through Telemedicine

Children with Down syndrome (DS) are at risk for significant language and communication impairments. Enhancing the service delivery of early intervention for children with DS is a key research and policy issue given the prevalence and detrimental effects of persistent language impairments. Using a telemedicine approach allows clinicians to provide evidence-based treatment to families from a wide geographic area in Oregon who may not otherwise have access to a language intervention specialized for children with DS. Our innovative project involves the creation of a new treatment optimized for children with DS, as it will be the first study that translates an existing evidence-based language intervention-Enhanced Milieu Teaching (EMT) into a telemedicine model. The goal of this study is to examine whether a telemedicine approach is effective for training parents to implement EMT language support strategies and whether changes in parent behavior are associated with child communication and language growth. The investigators will pilot the telemedicine initiative to provide early intervention services to ten children with DS (aged 18- 48 months) and their families who live in rural and /or under-served areas of Oregon. The investigators will use single-case research design methodology to pilot this intervention research. The investigators will use secure video-teleconferencing technology to provide EMT. Clinicians will provide EMT to parents through interactive coaching, teaching them how to foster their children's social communication and language skills. Outcomes will focus on parents' use of language support strategies and children's social communication and language skills. Delivering early intervention to children with DS and providing parent-training at a distance using a telemedicine approach has the potential to transform the delivery of early language interventions for children with DS. Results of this study will directly inform the development and refinement of language interventions for young children with DS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Aim 1: To examine the effect of using a telemedicine service delivery model to teach parents of children with DS to use EMT language support strategies. The investigators hypothesize that parents will learn to use EMT language support strategies from the personalized instruction provided during 36 intervention sessions.
  2. Aim 2: To examine the effect of delivering EMT using a telemedicine service delivery model to improve the spoken language and social communication skills of children with DS. The investigators hypothesize that improvements in child communication and language skills will result from increasing parents' use of EMT language support strategies during everyday parent-child interactions such as play with toys, singing songs, book reading, and mealtimes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97236
        • Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • child age between 18 and 36 months
  • developmental age of 9 months as measured on the Visual Reception Scale of the Mullen Scales of Early Learning (MSEL; Mullen, 1995)
  • primary diagnosis of Down syndrome as indicated in medical history,
  • secondary diagnosis of language delay as measured by a score of at least 1.33 SD below the mean on the Preschool Language Scales -5th Edition (PLS-5; Zimmerman, Steiner, & Evatt-Pond, 2011),
  • hearing (with or without amplification) reported at 25dB HL or better confirmed by audiological testing, or medical record.

Exclusion Criteria:

  • concomitant sensory impairments (e.g., hearing impairment, blindness), and
  • symptoms of autism spectrum disorder as measured by a result indicating "high risk" for autism (e.g., scores of 8 or higher) on the Modified Checklist for Autism In Toddlers-Revised with Follow-up (MCHAT-R/F Robins, Fein & Barton, 2009).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EMT
After a period of stable baseline performance (3 to 5 sessions) for parents and children the interventionists will apply the EMT Language Intervention.
Behavioral: Enhanced Milieu teaching
Enhanced Milieu Teaching (EMT) an evidence-based, naturalistic language intervention that has been optimized to address the specific language and communication deficits associated with DS. EMT is a parent-implemented intervention that involves home-visits during which clinicians teach parents to support their child learning language during typical parent-child interactions at home (play with toys, music, book reading, and snack time). Clinicians follow an evidence-based instructional framework called "Teach-Model-Coach-Review" to teach parents language support strategies.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Between Session Change:Number of EMT Strategies Used by Parents During Parent-Child Interaction
Time Frame: Assessed 1-2 times per week for 3- 4 months.
Observational measure coded from video-recordings of a 15 minute caregiver-child interaction. 10 minutes of play and toys and 5 minutes of a home routine. Changes in the number of different EMT strategies used by parents will be quantified.
Assessed 1-2 times per week for 3- 4 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Between Session Change: Rate of Symbolic Communication During Parent-Child Interaction
Time Frame: Assessed 1-2 times per week for 3-4 months.
Observational measure coded from video-recordings of a 15 minute caregiver-child interaction. 10 minutes of play and toys and 5 minutes of a home routine.
Assessed 1-2 times per week for 3-4 months.
Communication Matrix Scores
Time Frame: Assessed at T00 (Study Entry) and T01 (3- 4 months post intervention).
Total score on an assessment of early expressive communication skills.
Assessed at T00 (Study Entry) and T01 (3- 4 months post intervention).
Between Session Change: Number of Different Words Expressed During Parent-Child Interaction
Time Frame: Assessed 1-2 times per week for 3-4 months.
Observational measure coded from video-recordings of a 15 minute caregiver-child interaction. 10 minutes of play and toys and 5 minutes of a home routine.
Assessed 1-2 times per week for 3-4 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00018508

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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