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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Delivering Early Intervention to Children With Down Syndrome

Clinicaltrials.gov identifier NCT03935620

Recruitment Status Active, not recruiting

First Posted May 2, 2019

Last update posted September 25, 2020

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:Down Syndrome
  • Intervention/Treatment: Behavioral: Enhanced Milieu teaching
  • Phase: N/A
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
  • Study Type: Interventional
  • Estimated Enrollment: 10 participants
  • 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 2019
  • Estimated Primary Completion Date: July 2020
  • Actual Study Completion Date: December 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. 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.
  • 2. 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.
  • 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
  • Ages Eligible for Study: 18 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
Contacts
Locations

United States, Oregon
Oregon Health and Science University
Portland

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator: Emily D Quinn, Ph.D Oregon Health and Science University

More Information
  • Responsible Party: Oregon Health and Science University
  • ClinicalTrials.gov Identifier: NCT03935620 History of Changes
  • Other Study ID Numbers: STUDY00018508
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: September 25, 2020
  • Last Verified: September 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Down Syndrome Syndrome