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

Autism Spectrum Disorder Clinical Trial

Official title:

Tele Toy Talk: Telehealth Language Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04675580
• Other study ID #: 21-03023432
• Secondary ID: 19-07020518
• Status: Completed
• Phase: N/A
• Start date: December 23, 2020
• Est. completion date: July 15, 2022

Study information

• Verified date: July 2022
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Autism and the Developing Brain/New York-Presbyterian Hospital	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in scores on the Acceptance and Action Questionnaire, Second Version (AAQ-II)	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.	Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).
Other	Change in scores on the Emotion Regulation Questionnaire (ERQ)	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.	Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).
Other	Change in scores on the Caregiver Strain Questionnaire - Short Form 7 (CSQ-SF 7)	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.	Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).
Other	Change in scores on the Parent Stress Index-4th Edition (PSI-4)	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).	Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention)
Secondary	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.	Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention)