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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tele Toy Talk: Telehealth Language Intervention

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Toy Talk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele Toy Talk<br>Caregivers of child participants receive 1-hour of telemedicine featuring parent-mediated naturalistic developmental behavioral intervention weekly for 10 weeks. | Behavioral: Toy Talk<br>* 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.<br>|
| No Intervention: Multiple Baseline<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) |