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Language Development DisordersNCT03525951

Parent-Level Predictors of Early Language Interaction Quality and Intervention Outcomes

A study testing Enhanced Milieu Teaching in people with Language Development Disorders and Autism Spectrum Disorder, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Children with poor early language skills are at risk for academic, social, vocational, and health difficulties across the lifespan. Parent training-as part of early language intervention-is a cost-effective option to address this public health issue, but these interventions demonstrate large individual differences in… Read more about this study

Who is it for?
Ages 30 months and olderHealthy volunteers can take part
What is being tested?
Enhanced Milieu Teaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteUnited States
Study dates
22 Mar 2021to 18 Sep 2025
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 30 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Live in a Pennsylvania or New Jersey zip code that is within a 30-mile radius of Weiss Hall at Temple University (STUDY 1) or live in Wisconsin (STUDY 2).
  • Have access to the internet and willingness to videoconference (STUDY 1 AND 2)
  • If a family does not have an adequate digital device (e.g., smartphone only) to videoconference and complete testing, we might lend them a device.
  • 18 or older (STUDY 1 AND 2)
  • Be an adult parent able to consent for the child to participate in the study (parents in this study can include any caregiver who meets these criteria) (STUDY 1 AND 2)
  • English dominant (at least 80%) (STUDY 1 AND 2)
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  • Have no self-reported diagnosed hearing loss (or no concerns if they have not been tested) (STUDY 1 AND 2).
  • Have no reported disabling developmental or acquired disorders or impairments that might significantly affect their performance beyond autism spectrum disorder (ASD) or speech-language disorders (e.g., legal blindness, Down Syndrome, traumatic head injury, stroke) (STUDY 1 AND 2).
  • Inclusion - Children, Typically Developing Group (TD) (Study 1 and 2)
  • age 1 year 4 months - 1 year 8 months 30 days at the start of testing
  • English dominant (at least 80%)
  • No parent-reported diagnosed hearing loss (or no concerns if the child has not been tested).
  • Have typical language abilities as evidenced by meeting two criteria:
  • Score above the 10th percentile on the Mac Arthur Communicative Development Inventories-Words and Sentences (CDI-WS; long form) Complexity section using sex-specific norms.
  • Score above the 10th percentile on the CDI-WS (long form) Words Produced using sex-specific norms
  • Meet cognitive inclusion criteria: Score greater than or equal to 81.25 standard score (-1.25 SD) on the Cognition subtest of the DAYC-2
  • Have no parent reported disabling developmental or acquired disorders/impairments that might significantly affect their performance including speech- language disorders (e.g., ASD, DLD, cancer, stroke, legal blindness, intellectual disability, Down Syndrome, traumatic head injury, cerebral palsy, seizures, or a genetic condition associated with neurodevelopmental disability).
  • Pass the Modified Checklist for Autism in Toddlers-Revised with Follow-Up screener
  • age 2 years 6 months - 4 years 0 months 0 days at the start of testing
  • English dominant (at least 80%)
  • No parent-reported diagnosed hearing loss (or no concerns if the child has not been tested).
  • Qualify as at risk for persistent language disorder by meeting two criteria:
  • Score at or below the 10th percentile on the Mac Arthur-Bates Communicative Development Inventory-III (CDI-III) Sentences section using sex-specific norms. For children over 37 mos., score must be less than or equal to the 10th percentile equivalent for 37 mos.
  • Score at or below the 10th percentile on the CDI-III Vocabulary section using sex-specific norms. For children over 37 mos., score must be less than or equal to the 10th percentile equivalent for 37 mos. The child must also produce at least 10 different words on either the CDI-III or CDI-Words and Sentences (CDI-WS long form).
  • Meet cognitive inclusion criteria: Score greater than or equal to 70 standard score (-2 SD) on the Cognition subtest of the DAYC-2 (Voress et al., 2012).
  • Have no parent reported disabling developmental or acquired disorders/impairments that might significantly affect their performance beyond speech- language disorders (e.g., ASD, cancer, stroke, legal blindness, intellectual disability, Down Syndrome, traumatic head injury, cerebral palsy, seizures, or a genetic condition associated with neurodevelopmental disability other than DLD).
  • Pass the Modified Checklist for Autism in Toddlers-Revised with Follow-Up screener
  • 2 years 6 months - 4 years 0 months 0 days at the start of testing
  • English dominant (at least 80%)
  • No parent-reported diagnosed hearing loss (or no concerns if the child has not been tested).
  • Have received ASD diagnosis from a healthcare professional prior to beginning the study.
  • Qualify as at risk for persistent language disorder by meeting two criteria:
  • Score at or below the 10th percentile on the Mac Arthur-Bates Communicative Development Inventory-III (CDI-III) Sentences section using sex-specific norms.
  • For children over 37 mos., score must be less than or equal to the 10th percentile equivalent for 37 mos.
  • Score at or below the 10th percentile on the CDI-III Vocabulary section using sex-specific norms. For children over 37 mos., score must be less than or equal to the 10th percentile equivalent for 37 mos. The child must also produce at least 10 different words on either the CDI-III or CDI-Words and Sentences (CDI-WS long form).
  • Meet cognitive inclusion criteria: Score greater than or equal to 70 standard score (-2 SD) on the Cognition subtest of the DAYC-2 (Voress et al., 2012).
  • Have no parent reported disabling developmental or acquired disorders/impairments that might significantly affect their performance beyond speech-language disorders or ASD (e.g., cancer, stroke, legal blindness, intellectual disability, Down Syndrome, traumatic head injury, cerebral palsy, seizures, or a genetic condition associated with neurodevelopmental disability other than ASD/DLD).

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin

    Madison, Wisconsin, 53705

Other trials in United States

About this study

Children with poor early language skills are at risk for academic, social, vocational, and health difficulties across the lifespan. Parent training-as part of early language intervention-is a cost-effective option to address this public health issue, but these interventions demonstrate large individual differences in outcomes and barriers to scalability. The purpose of this research is to examine parent-level predictors of early language interaction quality and modifiability during training, which will help increase intervention effectiveness.

Read the detailed description

This is a minimal-risk, behavioral clinical trial for adult parents and their children (2;6-4;0). The purpose of this study is to determine if and how parent language skills and behavioral awareness influence early language interactions and parent training. Participants will include parent-child dyads in three groups: 1) children who are typically developing (TD; Study 1 and 2), 2) children at risk for persistent developmental language disorder (DLD; Study 1 and 2), and 3) children with autism spectrum disorder and at risk for persistent DLD (ASD+DLD; Study 2). The investigators will examine whether parental language skills predict early language interaction quality (Aim 1; Study 1), whether parental behavioral awareness predicts modifiability during training (Aim 2; Study 2), and whether these predictors vary across children-specifically TD children, children with DLD, or with ASD+DLD (Aim 3; Study 2). The primary outcome measure will be parents' use of language stimulation strategies. The secondary outcome measure will be the number of adult-child conversational turns. The investigators hypothesize that parent language skills (Study 1) and behavioral awareness (Study 2) will be positively associated with the outcomes. However, the strength of the association may vary across the groups. The Study 1 protocol will involve a screening session and observational data collection sessions (TD and DLD groups). Study 1 will be a fully remote model of data collection. The Study 2 protocol will involve five sessions-baseline data collection (all groups), three parent training sessions (DLD and ASD+DLD), and follow-up data collection (all groups) across approximately five weeks. Study 2 will be fully remote. The investigators will collect data from demographic questionnaires, language and learning assessments, measures of parental behavioral awareness, and measures of parent-child language interaction quality (Study 1 and 2). These measures will be administered before and after three parent training sessions (Study 2). These sessions will follow the Teach-Model-Coach-Review framework (TMCR; 1) to train the Enhanced Milieu Teaching (EMT) strategies of responsive interaction, matched turns, language modeling, and expansions. After the training, parent-child dyads will complete the structured interaction and behavioral awareness tasks again (Study 2). The investigators will conduct inter- and intra-group analyses to explore the relationships between the independent (i.e., parent language abilities and behavioral awareness) and dependent (i.e., parent-child language interaction quality and parent modifiability during training) variables.

Being tested
Enhanced Milieu Teaching, no intervention comparison group
Medical subject headings
Language Development Disorders, Autism Spectrum Disorder

What participants receive

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

  • Enhanced Milieu TeachingBehavioural

    The parent training will incorporate the EMT strategies of responsive interaction, matched turns, language modeling, and expansions. There will be three, hour-long parent training sessions following the teach-model-coach-review format (TMCR). The TMCR framework teaching component will involve 10 minutes of verbal and visual instruction on the language stimulation target of interest. The teaching component will be followed by 15 minutes of clinician modeling of the target strategies with the child while the parent watches. The parent will then have the opportunity to practice using the strategy during naturalistic interaction with their child. The clinician will provide individualized coaching on the use of the target strategy during this 20-minute, parent-child interaction. Finally, the clinician will review the target strategies and set goals.

  • no intervention comparison groupOther

    No intervention for observational (Study 1 and 2) and training (Study 2) data comparison.

Study groups in NCT03525951
Study groupRoleWhat they receive
Typically Developing Children Study 2 (TD2)OtherNo-intervention comparison group measured over time.
Receives: Other: no intervention comparison group
Children with Dev Language Disorder Study 2 (DLD2)ExperimentalEnhanced Milieu Teaching
Receives: Behavioral: Enhanced Milieu Teaching
Children with Autism Spectrum Disorders Study 2 (ASD+DLD 2)ExperimentalEnhanced Milieu Teaching
Receives: Behavioral: Enhanced Milieu Teaching
Typically Developing Children Study 1 (TD1)OtherNo-intervention group for observational data comparison.
Receives: Other: no intervention comparison group
Children with Dev Language Disorder Study 1 (DLD1)OtherNo-intervention group for observational data comparison.
Receives: Other: no intervention comparison group

What is being measured

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

  1. Parental Language Stimulation Strategies (Study 2; Remote)

    The investigators will code the structured interaction task for parents' use of language stimulation strategies.The investigators will code use of trained strategies (i.e., responsive interaction, matched turns, language modeling, and expansions) and untrained generalization measures like constructive directives and scaffolds. This primary outcome will be a composite score of these language stimulation strategies (e.g., responsive interaction, matched turns, language modeling, expansions, constructive directives, and scaffolds). This composite will be measured at baseline and post-treatment during the structured interaction task, so the same amount of time will be given to each participant to interact. This is a continuous outcome variable, with values greater than or equal to zero. Higher values are generally representative of higher-quality language interactions.

    Measured: Baseline to Post-treatment (Five Weeks)

  2. Parental Language Stimulation Strategies (Study 1; Remote)

    The investigators will code the structured interaction task for parents' use of language stimulation strategies.The investigators will code use of trained strategies (i.e., responsive interaction, matched turns, language modeling, and expansions) and untrained generalization measures like constructive directives and scaffolds. This primary outcome will be a composite score of these language stimulation strategies (e.g., responsive interaction, matched turns, language modeling, expansions, constructive directives, and scaffolds). This composite will be measured once during the structured interaction task, so the same amount of time will be given to each participant to interact. This is a continuous outcome variable, with values greater than or equal to zero. Higher values are generally representative of higher-quality language interactions.

    Measured: Baseline (Single Timepoint)

Secondary outcomes (2)
  1. Adult-Child Conversational Turns (Study 2; Remote)

    The investigators will code the number of adult-child conversational turns during the structured language interactions. These turns will be measured at baseline and post-treatment during the structured interaction task, so the same amount of time will be given to each participant to interact. This is a continuous outcome variable, with values greater than or equal to zero. Higher values are generally representative or higher-quality language interactions.

    Measured: Baseline to Post-treatment (Five Weeks)

  2. Adult-Child Conversational Turns (Study 1; Remote)

    The investigators will code the number of adult-child conversational turns during the structured language interactions. These turns will be measured once during the structured interaction task, so the same amount of time will be given to each participant to interact. This is a continuous outcome variable, with values greater than or equal to zero. Higher values are generally representative or higher-quality language interactions.

    Measured: Baseline (Single Timepoint)

Timeline

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

  1. First posted16 May 2018
  2. Study start22 Mar 2021
  3. Primary completion18 Sep 2025
  4. Study completion18 Sep 2025

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
Non-randomised
Intervention model
Parallel groups
Model description
Study 1 (Remote) : Participants in the TD and DLD groups will receive no treatment; observational data only. Study 2 (Remote): Participants in the DLD and ASD+DLD groups will receive the Enhanced Milieu Teaching intervention. Participants in the TD will serve as the no-treatment comparison group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03525951
Sponsor's protocol ID
2023-0405
Other IDs
1K23DC017763-01A1, L&S/COMMUN SCI & DISORDERS, Protocol version 2/25/25
Status last verified
Nov 2025
First submitted
3 May 2018
Last updated
13 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators will make every effort to share the data and findings widely within the allowances of human subjects and other relevant regulations. The study protocol and deidentified data will be made available via clinicaltrials.gov in accordance with those policies. Dr. Alper is an approved PI through Databrary-a secure video data library for behavioral scientists. Participants will have the opportunity to consent to share their data with other approved researchers on Databrary. A variety of permission levels are allowed through Databrary (e.g., solely for approved researchers, for educational and research purposes, etc.).

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Milieu Teaching in people with Language Development Disorders and Autism Spectrum Disorder, run by University of Wisconsin, Madison 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 37 inclusion and 0 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: finished, as of the sponsor's last update on 13 Nov 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Parental Language Stimulation Strategies (Study 2; Remote) (time frame: Baseline to Post-treatment (Five Weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 13 Nov 2025.

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