Delivering Early Intervention to Children With Down Syndrome

NCT03935620 | Completed

• 1 other identifier: STUDY00018508
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed 1-2 times per week for 3- 4 months.

Secondary Outcomes (3)

• Between Session Change: Rate of Symbolic Communication During Parent-Child Interaction

  Assessed 1-2 times per week for 3-4 months.

• Communication Matrix Scores

  Assessed at T00 (Study Entry) and T01 (3- 4 months post intervention).

• Between Session Change: Number of Different Words Expressed During Parent-Child Interaction

  Assessed 1-2 times per week for 3-4 months.

Study Arms (1)

EMT

EXPERIMENTAL

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

Interventions

Enhanced Milieu teaching BEHAVIORAL

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.

EMT

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97236, United States

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Emily D Quinn, Ph.D

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 2, 2019
• Study Start: June 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

US (1)