Autism Spectrum Disorder Clinical Trial
Official title:
Parent-Level Predictors of Early Language Interaction Quality and Intervention Outcomes
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.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | November 30, 2025 |
Est. primary completion date | November 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Months and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Institute on Deafness and Other Communication Disorders (NIDCD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | 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. | Baseline to Post-treatment (Five Weeks) | |
Secondary | 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. | Baseline (Single Timepoint) |
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