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

• ClinicalTrials.gov Identifier: NCT04675580
• Recruitment Status: Recruiting
• First Posted: December 19, 2020
• Last Update Posted: December 30, 2020
• Sponsor: Weill Medical College of Cornell University
• Collaborator: Simons Foundation
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Autism Spectrum Disorder	Behavioral: Toy Talk	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluating BOSCC and ELSA as Outcome Measures in the Context of a JASPER Intervention Trial
• Actual Study Start Date: December 23, 2020
• Estimated Primary Completion Date: August 1, 2021
• Estimated Study Completion Date: August 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tele Toy Talk; Caregivers of child participants receive 1-hour of telemedicine featuring parent-mediated naturalistic developmental behavioral intervention weekly for 8 weeks, with additional 1-hour booster sessions at 10 weeks and 12 weeks.	Behavioral: 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.
No Intervention: 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).

Outcome Measures

Primary Outcome Measures :

1. Change in number of unique combinations of subjects and verbs - caregiver [ Time Frame: Baseline (Before starting intervention); Week 4; Week 8; Week 12 ]
   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.
2. Change in number of unique combinations of subjects and verbs - child [ Time Frame: Baseline (Before starting intervention); Week 4; Week 8; Week 12 ]
   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.
3. Change in caregiver mean length of utterance [ Time Frame: Baseline (before starting intervention); Week 4; Week 8; Week 12 ]
   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.
4. Change in child mean length of utterance [ Time Frame: Baseline (before starting intervention); Week 4; Week 8; Week 12 ]
   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.
5. Change in Brief Observation of Social Communication Change (BOSCC) scores [ Time Frame: Baseline (before starting intervention); Week 4; Week 8; Week 12 ]
   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).

Secondary Outcome Measures :

1. Change in scores on the Parent Motivation Inventory (PMI) [ Time Frame: Baseline (before starting intervention); Week 8; Week 12 ]
   Caregiver scores on the Parent Motivation Inventory (PMI) at baseline, intervention midpoint, and post-evaluation. The PMI is a 25-item self-report measure of parent treatment motivation on a five-point Likert-type scale (1=strongly disagree; 5=strongly agree).
2. Change in scores on the Observation of Spontaneous Expressive Language (OSEL) - baseline [ Time Frame: Baseline (before starting intervention); Week 12 ]
   Child's scores on the Observation of Spontaneous Expressive Language at baseline and post-evaluation. Scores on the OSEL are not linear. Scores range from 0 to 3, with higher scores indicating more impairment.
3. Change in scores on the Vineland-3 [ Time Frame: Baseline (before starting intervention); Week 8; Week 12 ]
   Scores on the Vineland-3 at baseline, intervention midpoint, and post-evaluation. 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.

Other Outcome Measures:

1. Change in scores on the Acceptance and Action Questionnaire, Second Version (AAQ-II) [ Time Frame: Baseline (before starting intervention); Week 8; Week 12 ]
   Caregiver scores on the Acceptance and Action Questionnaire, Second Version (AAQ-II) at baseline, intervention midpoint, and post-evaluation. Items are rated on a Likert-type scale of 1 through 7, and scores range from 7 to 49.
2. Change in scores on the Emotion Regulation Questionnaire (ERQ) [ Time Frame: Baseline (before starting intervention); Week 8; Week 12 ]
   Caregiver scores on the Emotion Regulation Questionnaire (ERQ) at baseline, intervention midpoint, and post-evaluation. The ERQ is a 10-item scale with each item consisting of a 7-point Likert-type scale ranging from 1 to 7.
3. Change in scores on the Caregiver Strain Questionnaire - Short Form 7 (CSQ-SF 7) [ Time Frame: Baseline (before starting intervention); Week 8; Week 12 ]
   Scores on the Caregiver Strain Questionnaire - Short Form 7 (CSQ-SF 7) at baseline, intervention midpoint, and post-evaluation. The CSQ-SF7 contains seven items, with response options on a five-point Likert-type scale.
4. Change in scores on the Parent Stress Index-4th Edition (PSI-4) [ Time Frame: Baseline (before starting intervention); Week 8; Week 12 ]
   Scores on the Parent Stress Index (PSI-4) at baseline, intervention midpoint, and post-evaluation. The PSI-4 is a 120-item inventory that provides two domain scores that are quantified using T scores (mean of 50; standard deviation of 10).

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 4 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Elizabeth P McKernan, Ph.D.; 9149975832 ext 9149975832; epm4001@med.cornell.edu

Locations

United States, New York

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

White Plains, New York, United States, 10605

Contact: Marcella Sanchez 914-997-5575 mab9254@med.cornell.edu

Sponsors and Collaborators

Weill Medical College of Cornell University

Simons Foundation

Investigators

• Principal Investigator: So Hyun Kim, Ph.D.; Weill Cornell Medicine

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT04675580
• Other Study ID Numbers: 19-07020518
• First Posted: December 19, 2020
• Last Update Posted: December 30, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders