Back to resultsParent-Level Predictors of Early Language Interaction Quality and Intervention Outcomes
Primary Purpose
Language Development Disorders, Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Milieu Teaching
no intervention comparison group
Sponsored by
About this trial
This is an interventional treatment trial for Language Development Disorders
Eligibility Criteria
Parents (STUDY 1 AND 2) a. Live in a Pennsylvania or New Jersey zip code that is within a 30-mile radius of Weiss Hall at Temple University.
b. Have access to the internet and willingness to videoconference. c. 18;0 or older d. Be an adult parent able to consent for the child to participate in the study e. English dominant (at least 80%) f. Pass hearing screening at 25 dB in best ear across 500, 1000, 2000, and 4000 Hz OR have no self-reported diagnosed hearing loss (or no concerns if they have not been tested).
g. 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).
- Children a. Typically Developing Group (TD) i. 1;4-1;8:30 at the start of testing (STUDY 1 AND 2) ii. English dominant (at least 80%; STUDY 1 AND 2) iii. Pass hearing screening at 25 dB in both ears across 500, 1000, 2000, and 4000 Hz OR no parent-reported diagnosed hearing loss (or no concerns if the child has not been tested; STUDY 1 AND 2).
iv. Have typical language abilities as evidenced by meeting two (STUDY 1) or three (STUDY 2) criteria 1. Score at or above -1 SD on the Auditory Comprehension and -1.25 SD on the Expressive Communication scales of the Preschool Language Scales-Fifth Edition (PLS-5; STUDY 2) 2. Score above the 10th percentile on the MacArthur Communicative Development Inventories-Words and Sentences (CDI-WS long form) Complexity section using sex-specific norms (STUDY 1 AND 2).
3. Score above the 10th percentile on the CDI-WS (long form) Words Produced using sex-specific norms (STUDY 1 AND 2).
v. 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 (STUDY 1).
- Score greater than or equal to 37.5 t-score (-1.25 SD) on the Visual Reception scale of the Mullen Scales of Early Learning (STUDY 2).
vi. 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; STUDY 1 AND 2).
vii. Pass the Modified Checklist for Autism in Toddlers-Revised with Follow-Up screener (STUDY 1 AND 2).
b. DLD Group i. 2;6-4;0:0 at the start of testing (STUDY 1 AND 2) ii. English dominant (at least 80%; STUDY 1 AND 2) iii. Pass hearing screening at 25 dB in both ears across 500, 1000, 2000, and 4000 Hz OR no parent-reported diagnosed hearing loss (or no concerns if the child has not been tested; STUDY 1 AND 2).
iv. Qualify as at risk for persistent language disorder by meeting two out of three criteria (STUDY 1 AND 2).
Score at or below the 10th percentile on the MacArthur-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.
AND
- 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).
OR 3. Score at or below -1.25 standard deviations on the Expressive Communication scales of the PLS-5 (STUDY 2).
v. Meet cognitive inclusion criteria.
- Score greater than or equal to 70 standard score (-2 SD) on the Cognition subtest of the DAYC-2 (STUDY 1)
- Score greater than or equal to 30 t-score (-2 SD) on the Visual Reception scale of the Mullen (STUDY 2).
vi. 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; STUDY 1 AND 2).
vii. Pass the Modified Checklist for Autism in Toddlers-Revised with Follow-Up screener (STUDY 1 AND 2) OR the Screening Tool for Autism in Toddlers and Young Children (STUDY 2).
c. DLD+ASD Group (STUDY 2) i. 2;6-4;0:0 at the start of testing ii. English dominant (at least 80%) iii. Pass hearing screening at 25 dB in both ears across 500, 1000, 2000, and 4000 Hz OR no parent-reported diagnosed hearing loss (or no concerns if the child has not been tested).
iv. Have received ASD diagnosis from a healthcare professional prior to beginning the study.
v. Qualify as at risk for persistent language disorder by meeting two out of three criteria.
Score at or below the 10th percentile on the MacArthur-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.
AND
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).
OR
- Score at or below -1.25 standard deviations on the Expressive Communication scales of the PLS-5.
vi. Score greater than or equal to 30 t-score (-2 SD) on the Visual Reception scale of the Mullen.
vii. 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).
Sites / Locations
- University of WisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Experimental
Experimental
Other
Other
Arm Label
Typically Developing Children Study 2 (TD2)
Children with Dev Language Disorder Study 2 (DLD2)
Children with Autism Spectrum Disorders Study 2 (ASD+DLD 2)
Typically Developing Children Study 1 (TD1)
Children with Dev Language Disorder Study 1 (DLD1)
Arm Description
No-intervention comparison group measured over time.
Enhanced Milieu Teaching
Enhanced Milieu Teaching
No-intervention group for observational data comparison.
No-intervention group for observational data comparison.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03525951
First Posted
May 3, 2018
Last Updated
June 22, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT03525951
Brief Title
Parent-Level Predictors of Early Language Interaction Quality and Intervention Outcomes
Official Title
Parent-Level Predictors of Early Language Interaction Quality and Intervention Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Development Disorders, Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
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).
Allocation
Non-Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Typically Developing Children Study 2 (TD2)
Arm Type
Other
Arm Description
No-intervention comparison group measured over time.
Arm Title
Children with Dev Language Disorder Study 2 (DLD2)
Arm Type
Experimental
Arm Description
Enhanced Milieu Teaching
Arm Title
Children with Autism Spectrum Disorders Study 2 (ASD+DLD 2)
Arm Type
Experimental
Arm Description
Enhanced Milieu Teaching
Arm Title
Typically Developing Children Study 1 (TD1)
Arm Type
Other
Arm Description
No-intervention group for observational data comparison.
Arm Title
Children with Dev Language Disorder Study 1 (DLD1)
Arm Type
Other
Arm Description
No-intervention group for observational data comparison.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Milieu Teaching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
no intervention comparison group
Intervention Description
No intervention for observational (Study 1 and 2) and training (Study 2) data comparison.
Primary Outcome Measure Information:
Title
Parental Language Stimulation Strategies (Study 2; Remote)
Description
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.
Time Frame
Baseline to Post-treatment (Five Weeks)
Title
Parental Language Stimulation Strategies (Study 1; Remote)
Description
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.
Time Frame
Baseline (Single Timepoint)
Secondary Outcome Measure Information:
Title
Adult-Child Conversational Turns (Study 2; Remote)
Description
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.
Time Frame
Baseline to Post-treatment (Five Weeks)
Title
Adult-Child Conversational Turns (Study 1; Remote)
Description
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.
Time Frame
Baseline (Single Timepoint)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca M Alper, Ph.D., CCC-SLP
Phone
608-890-2259
Email
rebecca.alper@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca M Alper, Ph.D., CCC-SLP
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca M Alper, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.).
IPD Sharing 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.
IPD Sharing Access Criteria
Described above.
Learn more about this trial
Parent-Level Predictors of Early Language Interaction Quality and Intervention Outcomes
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