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Delivering EMT Via Telehealth to Children and Families

Primary Purpose

Language Impairment

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Milieu Teaching
Parent Education
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Language Impairment focused on measuring Language Impairment, Telehealth, Rural, Enhanced Milieu Teaching

Eligibility Criteria

18 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Oregon Health and Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Enhanced Milieu Teaching

Community Treatment as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)
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.
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.

Full Information

First Posted
October 20, 2020
Last Updated
February 27, 2022
Sponsor
Oregon Health and Science University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT04604821
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
PI decided to pursue the same aims using a different methodology, specifically a single-case experimental design, also called N-of-1 Trial to answer research questions after consultation with research mentors and consultants.
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Impairment
Keywords
Language Impairment, Telehealth, Rural, Enhanced Milieu Teaching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Feasibility Study (Small Randomized Control Trial)
Masking
Outcomes Assessor
Masking Description
The assessor of the primary outcome will be blind to treatment condition.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Milieu Teaching
Arm Type
Experimental
Arm Description
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.
Arm Title
Community Treatment as Usual
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Milieu Teaching
Intervention Description
A behavioral language intervention that uses naturally occurring interactions to facilitate young children's language skills.
Intervention Type
Behavioral
Intervention Name(s)
Parent Education
Intervention Description
Parents receive information on child developmental milestones.
Primary Outcome Measure Information:
Title
Change in Parent use of EMT Strategies during a parent child interaction.
Description
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.
Time Frame
1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).
Secondary Outcome Measure Information:
Title
Change in Productive Vocabulary on the Mac-Arthur Bates Communication Development Inventory (MCDI) score after 3-4 months of intervention
Description
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.
Time Frame
1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).
Title
Change in Individual Growth and Development Indicators for Infants and Toddlers- Early Communication Indicator (IGDI-ECI) score through 3-4 months of intervention
Description
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)
Time Frame
Once per month of intervention through study completion (3-4 months of intervention)
Title
Change in Preschool-Language Scales - 5th edition (PLS-5)
Description
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.
Time Frame
1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).
Title
Change in number of Different Words on Structured Language Sample
Description
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.
Time Frame
1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily D Quinn, Ph.D
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Delivering EMT Via Telehealth to Children and Families

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