Telehealth Language Intervention for Children With Autism Ages 2-4 Years

NCT ID: NCT04675580

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-23

Study Completion Date

2022-07-15

Brief Summary

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The main goal of this intervention is to increase caregivers' use of interactive play and communication strategies to improve the child's early sentence development using telemedicine and video-based feedback.

Detailed Description

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Record was updated 11/2/2021 to include more detailed information about outcome measure time points. Specifically, secondary outcome measures will be collected more frequently over the course of the study (i.e., at baseline \[before starting intervention\], immediate follow-up \[week 12\], and long-term follow-up \[3 months after intervention\] assessments). No changes were made to outcome measures or how they are operationalized.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Tele Toy Talk

Caregivers of child participants receive 1-hour of telemedicine featuring parent-mediated naturalistic developmental behavioral intervention weekly for 10 weeks.

Group Type EXPERIMENTAL

Toy Talk

Intervention Type BEHAVIORAL

Language modeling strategy encouraging caregivers to (1) talk about the toys the child is playing with, including the states, actions, and properties of the toys and (2) give the object its name using a lexical noun phrase.

Multiple Baseline

Prior to receiving the intervention, participants will be randomized into one of three baseline conditions: a three-, four-, or five-week baseline period. At each weekly baseline session, caregivers will record the Tele-BOSCC (see Outcomes Measures section).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Toy Talk

Language modeling strategy encouraging caregivers to (1) talk about the toys the child is playing with, including the states, actions, and properties of the toys and (2) give the object its name using a lexical noun phrase.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of autism spectrum disorder (ASD) and/or communication disorder
* Child speaks at least 50 single words or uses emerging word combinations
* Caregivers have Internet availability from their home

Exclusion Criteria

* Child speaks using complex sentences
* Child is not within 2 to 4 years of age at time of enrollment
Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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So Hyun Kim, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Center for Autism and the Developing Brain/New York-Presbyterian Hospital

White Plains, New York, United States

Site Status

Countries

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United States

Other Identifiers

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19-07020518

Identifier Type: OTHER

Identifier Source: secondary_id

21-03023432

Identifier Type: -

Identifier Source: org_study_id

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