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出境医 / 临床实验 / Delivering Early Intervention to Children With Down Syndrome

Delivering Early Intervention to Children With Down Syndrome

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.

Condition or disease Intervention/treatment Phase
Down Syndrome Behavioral: Enhanced Milieu teaching Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Delivering Early Intervention to Children With Down Syndrome Through Telemedicine
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2021
Arms and Interventions
Arm Intervention/treatment
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.
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

Locations
Layout table for location information
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97236
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Layout table for investigator information
Principal Investigator: Emily D Quinn, Ph.D Oregon Health and Science University
Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE June 1, 2019
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • 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.
  • 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.
  • Between Session Change: Number of Different Words Expressed During Parent-Child Interaction [ Time Frame: Assessed 1-2 times per week for 3-4 months. ]
    bservational 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Delivering Early Intervention to Children With Down Syndrome
Official Title  ICMJE Delivering Early Intervention to Children With Down Syndrome Through Telemedicine
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
  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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Down Syndrome
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Enhanced Milieu teaching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months to 36 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03935620
Other Study ID Numbers  ICMJE STUDY00018508
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emily Quinn, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emily D Quinn, Ph.D Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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