Delivering Early Intervention to Children With Down Syndrome
Primary Purpose
Down Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Milieu teaching
Sponsored by
About this trial
This is an interventional treatment trial for Down Syndrome
Eligibility Criteria
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).
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EMT
Arm Description
After a period of stable baseline performance (3 to 5 sessions) for parents and children the interventionists will apply the EMT Language Intervention.
Outcomes
Primary Outcome Measures
Between Session Change:Number of EMT Strategies Used by Parents During Parent-Child Interaction
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.
Secondary Outcome Measures
Between Session Change: Rate of Symbolic Communication During Parent-Child Interaction
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.
Communication Matrix Scores
Total score on an assessment of early expressive communication skills.
Between Session Change: Number of Different Words Expressed During Parent-Child Interaction
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.
Full Information
NCT ID
NCT03935620
First Posted
April 29, 2019
Last Updated
February 27, 2022
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT03935620
Brief Title
Delivering Early Intervention to Children With Down Syndrome
Official Title
Delivering Early Intervention to Children With Down Syndrome Through Telemedicine
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single case multiple-baseline across behaviors (i.e., EMT strategies) design-replicated across ten caregiver-child dyads will be used to evaluate the effect of implementing EMT via telepractice on parent's EMT strategy usage and concomitant increases in child communication. Within each design there will be three potential demonstrations of effect and three potential replications across participants
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMT
Arm Type
Experimental
Arm Description
After a period of stable baseline performance (3 to 5 sessions) for parents and children the interventionists will apply the EMT Language Intervention.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Milieu teaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Between Session Change:Number of EMT Strategies Used by Parents During Parent-Child Interaction
Description
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.
Time Frame
Assessed 1-2 times per week for 3- 4 months.
Secondary Outcome Measure Information:
Title
Between Session Change: Rate of Symbolic Communication During Parent-Child Interaction
Description
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.
Time Frame
Assessed 1-2 times per week for 3-4 months.
Title
Communication Matrix Scores
Description
Total score on an assessment of early expressive communication skills.
Time Frame
Assessed at T00 (Study Entry) and T01 (3- 4 months post intervention).
Title
Between Session Change: Number of Different Words Expressed During Parent-Child Interaction
Description
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.
Time Frame
Assessed 1-2 times per week for 3-4 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily D Quinn, Ph.D
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97236
Country
United States
12. IPD Sharing Statement
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Delivering Early Intervention to Children With Down Syndrome
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