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Language ImpairmentNCT04604821

Delivering EMT Via Telehealth to Children and Families

A study testing Enhanced Milieu Teaching and Parent Education in people with Language Impairment, run by Oregon Health and Science University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 36 monthsHealthy volunteers can take part
Conditions the study is for
Language Impairment
What is being tested?
Enhanced Milieu Teaching and Parent Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jan 2021to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • (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.

Who cannot join

  • (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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health and Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Enhanced Milieu Teaching, Parent Education
Keywords
Language Impairment, Telehealth, Rural, Enhanced Milieu Teaching
Medical subject headings
Language Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced Milieu TeachingBehavioural

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

  • Parent EducationBehavioural

    Parents receive information on child developmental milestones.

Study groups in NCT04604821
Study groupRoleWhat they receive
Enhanced Milieu TeachingExperimentalChild-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.
Receives: Behavioral: Enhanced Milieu Teaching
Community Treatment as UsualOtherChild-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.
Receives: Behavioral: Parent Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. 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.

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

  2. 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)

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

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2020
  2. Study start1 Jan 2021
  3. Primary completion1 Oct 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Feasibility Study (Small Randomized Control Trial)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04604821
Sponsor's protocol ID
STUDY00019997
Status last verified
Feb 2022
First submitted
20 Oct 2020
Last updated
14 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Milieu Teaching and Parent Education in people with Language Impairment, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Parent use of EMT Strategies during a parent child interaction. (time frame: 1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04604821.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.

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