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

NCT04675580 | Completed

• 2 other identifiers: 21-0302343219-07020518
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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).

  Baseline (before starting intervention); Week 4; Week 8; Week 12

Secondary Outcomes (2)

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

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

• Change in scores on the Vineland-3

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

Other Outcomes (4)

• Change in scores on the Acceptance and Action Questionnaire, Second Version (AAQ-II)

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

• Change in scores on the Emotion Regulation Questionnaire (ERQ)

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

• Change in scores on the Caregiver Strain Questionnaire - Short Form 7 (CSQ-SF 7)

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

Study Arms (2)

Tele Toy Talk

EXPERIMENTAL

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

Behavioral: Toy Talk

Multiple Baseline

NO INTERVENTION

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).

Interventions

Toy Talk 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.

Tele Toy Talk

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Child speaks using complex sentences
• Child is not within 2 to 4 years of age at time of enrollment

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

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

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• So Hyun Kim, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 19, 2020
• Study Start: December 23, 2020
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)