Delivering EMT Via Telehealth to Children and Families

NCT04604821 | Withdrawn

• 1 other identifier: STUDY00019997
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In the U.S., approximately 12% of children under 36 months have language impairments, yet less than 2% receive early language intervention. Early language intervention is underutilized nationally, with pronounced service gaps in rural communities. This gap is a significant issue because children with language impairments are at increased risk for learning and reading disabilities that can persist into adulthood. Telehealth has the potential to mitigate service gaps by improving access to treatments, increasing the availability of clinicians with expertise in language intervention, and reducing healthcare costs. Telehealth can alleviate logistic and geographic barriers to treatment facing children with disabilities and their families in rural communities. However, there is insufficient evidence on the effects of telehealth interventions for children with language impairments under 36 months. Consequently, there is an urgent need to explore innovative telehealth interventions with potential to improve the quality and efficiency of language treatments. The investigators will conduct a feasibility trial (small randomized control trial) to evaluate a telehealth intervention for children with language impairments and their caregivers.

Conditions

Language Impairment

Keywords

Language Impairment; Telehealth; Rural; Enhanced Milieu Teaching

Outcome Measures

Primary Outcomes (1)

• Change in Parent use of EMT Strategies during a parent child interaction.

  A parent-child interaction is a brief, repeatable, play-based, observational measure of a child's communicative performance during a 10-minute play period with the parent who agreed to participate in as a research volunteer in the study. It measures the number and percentage of correct of matched turns, expansions, time delays, and milieu teaching episodes during this play period. An increase in the Parent use of EMT strategies is a positive outcome. Metric/ Measurement Unit: Number and percentage of turns parents used EMT Strategies (e.g. matched turns, expansions, time delays, and milieu teaching episodes) during a 10 minute play interaction.

  1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).

Secondary Outcomes (4)

• Change in Productive Vocabulary on the Mac-Arthur Bates Communication Development Inventory (MCDI) score after 3-4 months of intervention

  1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).

• Change in Individual Growth and Development Indicators for Infants and Toddlers- Early Communication Indicator (IGDI-ECI) score through 3-4 months of intervention

  Once per month of intervention through study completion (3-4 months of intervention)

• Change in Preschool-Language Scales - 5th edition (PLS-5)

  1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).

• Change in number of Different Words on Structured Language Sample

  1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).

Study Arms (2)

Enhanced Milieu Teaching

EXPERIMENTAL

Child-caregiver dyads receive up to 24 speech-language therapy sessions (50minutes, 2x per week for 3 months) where parents are taught by the interventionist to use Enhanced Milieu Teaching Strategies. Children and their families may continue to participate community-based educational programs.

Behavioral: Enhanced Milieu Teaching

Community Treatment as Usual

OTHER

Child-caregiver dyads may continue to participate in community-based educational programs. Researchers provide up to 4 educational sessions to caregivers (50 minutes, every 3 weeks). During educational sessions parents are taught developmental milestones from the CDC Learn the Signs Act Early Public Health Campaign.

Behavioral: Parent Education

Interventions

Enhanced Milieu Teaching BEHAVIORAL

A behavioral language intervention that uses naturally occurring interactions to facilitate young children's language skills.

Enhanced Milieu Teaching

Parent Education BEHAVIORAL

Parents receive information on child developmental milestones.

Community Treatment as Usual

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• (a) primary diagnosis of any specific disability other than a language impairment including severe motor impairment
• (b) concomitant sensory impairments (e.g., hearing impairment, blindness), and
• (c) 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
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Language Disorders

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily D Quinn, Ph.D

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor of the primary outcome will be blind to treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Feasibility Study (Small Randomized Control Trial)

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 27, 2020
• Study Start: January 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 31, 2021
• Last Updated: March 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)