Telehealth Language Intervention for Children With Autism Ages 2-4 Years
- Conditions
- Autism Spectrum Disorder
- Interventions
- Behavioral: Toy Talk
- Registration Number
- NCT04675580
- Lead Sponsor
- Weill Medical College of Cornell University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- 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
- Child speaks using complex sentences
- Child is not within 2 to 4 years of age at time of enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tele Toy Talk Toy Talk Caregivers of child participants receive 1-hour of telemedicine featuring parent-mediated naturalistic developmental behavioral intervention weekly for 10 weeks.
- Primary Outcome Measures
Name Time Method Change in Brief Observation of Social Communication Change (BOSCC) scores 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).
Change in number of unique combinations of subjects and verbs - caregiver 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.
Change in child mean length of utterance 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.
Change in number of unique combinations of subjects and verbs - child 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.
Change in caregiver mean length of utterance 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.
- Secondary Outcome Measures
Name Time Method 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) 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 Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention) 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.
Trial Locations
- Locations (1)
Center for Autism and the Developing Brain/New York-Presbyterian Hospital
🇺🇸White Plains, New York, United States