Delivering EMT Via Telehealth to Children and Families

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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ENROLLING_BY_INVITATION PHASE2

Detailed Description

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Aim 1: Explore stakeholders' preferences, experiences, and information needs regarding the delivery of language interventions via telehealth. Ethnographic interviews will be conducted with 16 stakeholders (n= 8 caregivers, 8 clinicians) to explore their preferences, experiences, and needs.

Aim 2: Determine the effect of telehealth Enhanced Milieu Teaching on caregiver language strategy use. Caregiver language strategy use will be compared between the intervention and control groups (n = 28 families, 14 intervention,14 control) during semi-structured caregiver-child interactions.

Conditions

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Language Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Feasibility Study (Small Randomized Control Trial)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The assessor of the primary outcome will be blind to treatment condition.

Study Groups

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Enhanced Milieu Teaching

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.

Group Type EXPERIMENTAL

Enhanced Milieu Teaching

Intervention Type BEHAVIORAL

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

Community Treatment as Usual

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.

Group Type OTHER

Parent Education

Intervention Type BEHAVIORAL

Parents receive information on child developmental milestones.

Interventions

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Enhanced Milieu Teaching

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

Intervention Type BEHAVIORAL

Parent Education

Parents receive information on child developmental milestones.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* (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.

Exclusion Criteria

* (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).

Minimum Eligible Age

18 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes