Parent-Level Predictors of Early Language Interaction Quality and Intervention Outcomes
4 other identifiers
interventional
156
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2018
CompletedFirst Posted
Study publicly available on registry
May 16, 2018
CompletedStudy Start
First participant enrolled
March 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2025
CompletedNovember 13, 2025
November 1, 2025
4.5 years
May 3, 2018
November 10, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Baseline to Post-treatment (Five Weeks)
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.
Baseline (Single Timepoint)
Secondary Outcomes (2)
Adult-Child Conversational Turns (Study 2; Remote)
Baseline to Post-treatment (Five Weeks)
Adult-Child Conversational Turns (Study 1; Remote)
Baseline (Single Timepoint)
Study Arms (5)
Typically Developing Children Study 2 (TD2)
OTHERNo-intervention comparison group measured over time.
Children with Dev Language Disorder Study 2 (DLD2)
EXPERIMENTALEnhanced Milieu Teaching
Children with Autism Spectrum Disorders Study 2 (ASD+DLD 2)
EXPERIMENTALEnhanced Milieu Teaching
Typically Developing Children Study 1 (TD1)
OTHERNo-intervention group for observational data comparison.
Children with Dev Language Disorder Study 1 (DLD1)
OTHERNo-intervention group for observational data comparison.
Interventions
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 for observational (Study 1 and 2) and training (Study 2) data comparison.
Eligibility Criteria
You may qualify if:
- 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).
- 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
- 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:
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca M Alper, Ph.D., CCC-SLP
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The research team members doing the language sample analysis and behavioral coding will be blind to group membership (Study 1 and 2) and whether the session was recorded pre-test vs. posttest (Study 2).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2018
First Posted
May 16, 2018
Study Start
March 22, 2021
Primary Completion
September 18, 2025
Study Completion
September 18, 2025
Last Updated
November 13, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- All tasks (e.g., the behavioral awareness assessment), protocols (e.g., the parent-child interaction coding), and other research products developed as part of this study will be made available to other researchers upon request after publication of the findings.The parent-child interaction videos and deidentified data that have been released for Databrary will be shared to the repository after the publication of the findings. The consent form will be uploaded within 60 days of the last study visit. The analysis plan will be uploaded with the final results.
- Access Criteria
- Described above.
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.).