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

Weill Medical College of Cornell University14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Autism Spectrum Disorder

Interventions

Toy TalkBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 4 Years

Medical Language ↔ Plain English

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

Locations (1)

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

White Plains, New York, United States

Outcomes

Primary Outcomes

Change in number of unique combinations of subjects and verbs - caregiver

Number of unique combinations of subjects and verbs used by the caregiver at baseline, intervention midpoint, and post-evaluation. This will be calculated by transcribing 12-minute language samples from the BOSCC using Systematic Analysis of Language Transcripts (SALT) software.

Time frame: Baseline (Before starting intervention); Week 4; Week 8; Week 12

Change in number of unique combinations of subjects and verbs - child

Number of unique combinations of subjects and verbs used by the child at baseline, intervention midpoint, and post-evaluation. This will be calculated by transcribing 12-minute language samples from the BOSCC using Systematic Analysis of Language Transcripts (SALT) software.

Time frame: Baseline (Before starting intervention); Week 4; Week 8; Week 12

Change in caregiver mean length of utterance

Mean length of utterance used by caregiver at baseline, intervention midpoint, and post-evaluation. This will be calculated by transcribing 12-minute language samples from the BOSCC using Systematic Analysis of Language Transcripts (SALT) software.

Time frame: Baseline (before starting intervention); Week 4; Week 8; Week 12

Change in child mean length of utterance

Mean length of utterance used by child at baseline, intervention midpoint, and post-evaluation. This will be calculated by transcribing 12-minute language samples from the BOSCC using Systematic Analysis of Language Transcripts (SALT) software.

Time frame: Baseline (before starting intervention); Week 4; Week 8; Week 12

Change in Brief Observation of Social Communication Change (BOSCC) scores

Child's scores on the Brief Observation of Social Communication Change (BOSCC) at baseline, intervention midpoint, and post-evaluation. BOSCC scores are not linear. Each item is rated on a 6-point scale from 0 (abnormality is not present) to 5 (abnormality is present and significantly impairs functioning).

Data from ClinicalTrials.gov

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Secondary Outcomes

Change in scores on the Observation of Spontaneous Expressive Language (OSEL) - baseline

Child's scores on the Observation of Spontaneous Expressive Language at baseline, post-evaluation, and long-term follow-up evaluation (3 months after ending intervention). Scores on the OSEL are not linear. Scores range from 0 to 3, with higher scores indicating more impairment.

Time frame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention)

Change in scores on the Vineland-3

Scores on the Vineland-3 at baseline, post-evaluation, and long-term follow-up evaluation (3 months after ending intervention). The Vineland-3 provides norm-referenced scaled scores for 11 skill areas (M = 10; SD = 3) as well as standard scores (M =100, SD = 15) for three adaptive domains.

Time frame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention)