- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03525951
Parent-Level Predictors of Early Language Interaction Quality and Intervention Outcomes
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rebecca M Alper, Ph.D., CCC-SLP
- Phone Number: 608-890-2259
- Email: rebecca.alper@wisc.edu
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- Recruiting
- University of Wisconsin
-
Contact:
- Rebecca M Alper, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion - Parents
- 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)
a. 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)
- 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
Inclusion - Children, DLD Group (study 1 and 2)
- 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
Inclusion - Children, DLD+ASD Group (STUDY 2)
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Typically Developing Children Study 2 (TD2)
No-intervention comparison group measured over time.
|
No intervention for observational (Study 1 and 2) and training (Study 2) data comparison.
|
Experimental: Children with Dev Language Disorder Study 2 (DLD2)
Enhanced Milieu Teaching
|
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.
|
Experimental: Children with Autism Spectrum Disorders Study 2 (ASD+DLD 2)
Enhanced Milieu Teaching
|
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.
|
Other: Typically Developing Children Study 1 (TD1)
No-intervention group for observational data comparison.
|
No intervention for observational (Study 1 and 2) and training (Study 2) data comparison.
|
Other: Children with Dev Language Disorder Study 1 (DLD1)
No-intervention group for observational data comparison.
|
No intervention for observational (Study 1 and 2) and training (Study 2) data comparison.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental Language Stimulation Strategies (Study 1; Remote)
Time Frame: Baseline (Single Timepoint)
|
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)
|
Parental Language Stimulation Strategies (Study 2; Remote)
Time Frame: Baseline to Post-treatment (Five Weeks)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adult-Child Conversational Turns (Study 1; Remote)
Time Frame: Baseline (Single Timepoint)
|
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.
|
Baseline (Single Timepoint)
|
Adult-Child Conversational Turns (Study 2; Remote)
Time Frame: Baseline to Post-treatment (Five Weeks)
|
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.
|
Baseline to Post-treatment (Five Weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rebecca M Alper, Ph.D., CCC-SLP, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0405
- 1K23DC017763-01A1 (U.S. NIH Grant/Contract)
- L&S/COMMUN SCI & DISORDERS (Other Identifier: UW Madison)
- Protocol version 4/28/23 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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