Delivering EMT Via Telehealth to Children and Families

Language Impairment Clinical Trial

Official title:

Delivering Enhanced Milieu Teaching (EM-Teach) Via Telehealth to Children and Families in Rural Communities

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04604821
• Other study ID #: STUDY00019997
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 36 Months

Eligibility

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).

Related Conditions & MeSH terms

• Language Disorders
• Language Impairment

Intervention

Behavioral:
• Enhanced Milieu Teaching
A behavioral language intervention that uses naturally occurring interactions to facilitate young children's language skills.
• Parent Education
Parents receive information on child developmental milestones.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Productive Vocabulary on the Mac-Arthur Bates Communication Development Inventory (MCDI) score after 3-4 months of intervention	The MacArthur-Bates Communicative Development Inventory (MCDI) is a parent report instrument which captures important information about children's developing abilities in early language, including vocabulary comprehension, production, gestures, and grammar.; An increase in the productive vocabulary represents a positive outcome.; Metric/ Measurement Unit: Number of words expressed on the MCDI. The range of this instrument is 0 - 396.	1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).
Secondary	Change in Individual Growth and Development Indicators for Infants and Toddlers- Early Communication Indicator (IGDI-ECI) score through 3-4 months of intervention	The ECI is a brief, repeatable, play-based, observational measure of a child's communicative performance during a 6-minute play period with a familiar adult. It measures the number of gestures, vocalizations, single words, and multiple word combinations during this play period.; An increase in the ECI presents a positive outcome.; Metric/ Measurement Unit: Frequency count of communication utterances expressed during the 6 minute play interaction. ECI scores are weighted such that each single-word utterance is given a weight of two (each tally is multiplied by two), and each multiple word utterance is given a weight of three (each tally is multiplied by three)	Once per month of intervention through study completion (3-4 months of intervention)
Secondary	Change in Preschool-Language Scales - 5th edition (PLS-5)	PLS™-5 Preschool Language Scales Fifth Edition offers a comprehensive developmental language assessment with items that range from pre-verbal, interaction-based skills to emerging language to early literacy.; Increases on the PLS-5 represent a positive outcome.; Metric/ Measurement Unit: Total Standard Score Range = 50 - 150 (Mean = 100, SD = 15).; If we are unable to administer assessments to all participants in person due to public health impacts of COVID-19, we will report the raw scores because the PLS-5 is not standardized for telepractice administration. Raw scores range 0 - 132.	1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).
Secondary	Change in number of Different Words on Structured Language Sample	A language sample is a naturalistic adult-child interaction with a specific set of toys to evaluate a child's spontaneous expressive language ability.; Metric/ Measurement Unit: Change in frequency count of the number of different words spoken during a 20 minute language sample.	1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).