Clinical trial NCT03525951: 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
Overall status: RECRUITING
Phase: NA
Conditions: Language Development Disorders
Autism Spectrum Disorder
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2018-05-16
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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:

  1. 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.
  2. 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:

  1. 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.
  2. 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:

  1. 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.
  2. 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).

Primary outcomes:
measure: Parental Language Stimulation Strategies (Study 2; Remote)
timeFrame: Baseline to Post-treatment (Five Weeks)
measure: Parental Language Stimulation Strategies (Study 1; Remote)
timeFrame: Baseline (Single Timepoint)
Secondary outcomes:
measure: Adult-Child Conversational Turns (Study 2; Remote)
timeFrame: Baseline to Post-treatment (Five Weeks)
measure: Adult-Child Conversational Turns (Study 1; Remote)
timeFrame: Baseline (Single Timepoint)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Rebecca M Alper, Ph.D., CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References: