NCT06649916

Brief Summary

The overall objective of this research is to determine whether parentese delivered in the video format (Aim 1) and in live interaction (Aim 2) facilitates novel word learning in autistic children and to investigate if there are factors that influence the effect of parentese on word learning (Aim 3).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress47%
Oct 2024Mar 2028

Study Start

First participant enrolled

October 4, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

3.4 years

First QC Date

October 17, 2024

Last Update Submit

October 21, 2025

Conditions

Keywords

autismword learninglanguage development

Outcome Measures

Primary Outcomes (1)

  • Proportion of time during which children's eye gaze is directed toward the target object

    Children's eye gaze is recorded as they look at images. The proportion of time during which gaze is directed to an image of the targeted word is the dependent measure.

    300 ms after the target words are introduced

Study Arms (2)

Parentese

EXPERIMENTAL

All participants will learn novel words in two conditions (parentese vs adult register) in each of the experiment (video and live word learning). In the Parentese condition, participants will listen to sentences that contain novel words in parentese.

Behavioral: Parentese Speech

Adult Register

ACTIVE COMPARATOR

All participants will learn novel words in two conditions (parentese vs adult register) in each of the experiment (video and live word learning). In the Adult Register condition, participants will listen to sentences that contain novel words in adult register speech.

Behavioral: Adult Registered Speech

Interventions

Novel words are introduced in parentese, a type of speech that is typically characterized by greater pitch variation, longer duration, and louder volume

Also known as: Infant-Directed Speech
Parentese

Novel words are introduced in standard adult register.

Also known as: Adult-Directed Speech
Adult Register

Eligibility Criteria

Age18 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children with or without a diagnosis of ASD between 18 and 59 months

You may not qualify if:

  • hears another language more than 10% of time based on parent report
  • has uncorrected visual impairment or hearing impairment
  • has developmental disorders or medical conditions other than ASD that affect language or cognition (excepting psychiatric conditions often comorbid with ASD such as ADHD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Dallas

Richardson, Texas, 75080, United States

RECRUITING

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum DisorderNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveMental Disorders

Study Officials

  • Pumpki L. Su, PhD

    The University of Texas at Dallas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pumpki L Su, PhD

CONTACT

McKenzie Cullinan, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 17, 2024

First Posted

October 21, 2024

Study Start

October 4, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

October 23, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

This was what was proposed in the study dissemination plan: Summary results of the primary outcomes for all aims will be uploaded to ClinicalTrials.gov within 12 months of the data collection for the final participants.

Locations