Telehealth Language Intervention for Children With Autism Ages 2-4 Years
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Toy Talk
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility 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
Sites / Locations
- Center for Autism and the Developing Brain/New York-Presbyterian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tele Toy Talk
Multiple Baseline
Arm Description
Caregivers of child participants receive 1-hour of telemedicine featuring parent-mediated naturalistic developmental behavioral intervention weekly for 10 weeks.
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).
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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).
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04675580
First Posted
December 15, 2020
Last Updated
July 29, 2022
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT04675580
Brief Title
Telehealth Language Intervention for Children With Autism Ages 2-4 Years
Official Title
Tele Toy Talk: Telehealth Language Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 23, 2020 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tele Toy Talk
Arm Type
Experimental
Arm Description
Caregivers of child participants receive 1-hour of telemedicine featuring parent-mediated naturalistic developmental behavioral intervention weekly for 10 weeks.
Arm Title
Multiple Baseline
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Toy Talk
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in number of unique combinations of subjects and verbs - caregiver
Description
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
Title
Change in number of unique combinations of subjects and verbs - child
Description
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
Title
Change in caregiver mean length of utterance
Description
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
Title
Change in child mean length of utterance
Description
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
Title
Change in Brief Observation of Social Communication Change (BOSCC) scores
Description
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).
Time Frame
Baseline (before starting intervention); Week 4; Week 8; Week 12
Secondary Outcome Measure Information:
Title
Change in scores on the Observation of Spontaneous Expressive Language (OSEL) - baseline
Description
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)
Title
Change in scores on the Vineland-3
Description
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)
Other Pre-specified Outcome Measures:
Title
Change in scores on the Acceptance and Action Questionnaire, Second Version (AAQ-II)
Description
Caregiver scores on the Acceptance and Action Questionnaire, Second Version (AAQ-II) at baseline, post-evaluation, and long-term follow-up evaluation (3 months after end of intervention). Items are rated on a Likert-type scale of 1 through 7, and scores range from 7 to 49.
Time Frame
Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).
Title
Change in scores on the Emotion Regulation Questionnaire (ERQ)
Description
Caregiver scores on the Emotion Regulation Questionnaire (ERQ) at baseline, post-evaluation, and long-term follow-up evaluation (3 months after ending intervention). The ERQ is a 10-item scale with each item consisting of a 7-point Likert-type scale ranging from 1 to 7.
Time Frame
Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).
Title
Change in scores on the Caregiver Strain Questionnaire - Short Form 7 (CSQ-SF 7)
Description
Scores on the Caregiver Strain Questionnaire - Short Form 7 (CSQ-SF 7) at baseline, post-evaluation, and long-term follow-up evaluation (3 months after ending intervention). The CSQ-SF7 contains seven items, with response options on a five-point Likert-type scale.
Time Frame
Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).
Title
Change in scores on the Parent Stress Index-4th Edition (PSI-4)
Description
Scores on the Parent Stress Index (PSI-4) at baseline, post-evaluation, and long-term follow-up evaluation (3 months after ending intervention). 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).
Time Frame
Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
So Hyun Kim, Ph.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Autism and the Developing Brain/New York-Presbyterian Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telehealth Language Intervention for Children With Autism Ages 2-4 Years
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