Clinical trial NCT04604821: Delivering EMT Via Telehealth to Children and Families
Official title: Delivering Enhanced Milieu Teaching (EM-Teach) Via Telehealth to Children and Families in Rural Communities
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Language Impairment
Keywords: Language Impairment
Telehealth
Rural
Enhanced Milieu Teaching
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility Study (Small Randomized Control Trial)
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Parent use of EMT Strategies during a parent child interaction.
timeFrame: 1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).
Secondary outcomes:
measure: Change in Productive Vocabulary on the Mac-Arthur Bates Communication Development Inventory (MCDI) score after 3-4 months of intervention
timeFrame: 1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).
measure: Change in Individual Growth and Development Indicators for Infants and Toddlers- Early Communication Indicator (IGDI-ECI) score through 3-4 months of intervention
timeFrame: Once per month of intervention through study completion (3-4 months of intervention)
measure: Change in Preschool-Language Scales - 5th edition (PLS-5)
timeFrame: 1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).
measure: Change in number of Different Words on Structured Language Sample
timeFrame: 1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Emily D Quinn, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: