--- title: Telehealth Language Intervention for Children With Autism Ages 2-4 Years nct_id: NCT04675580 overall_status: COMPLETED phase: NA sponsor: Weill Medical College of Cornell University study_type: INTERVENTIONAL primary_condition: Autism Spectrum Disorder countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04675580.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04675580" ct_last_update_post_date: 2022-08-02 last_seen_at: "2026-05-12T06:58:51.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Telehealth Language Intervention for Children With Autism Ages 2-4 Years **Official Title:** Tele Toy Talk: Telehealth Language Intervention **NCT ID:** [NCT04675580](https://clinicaltrials.gov/study/NCT04675580) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 14 - **Lead Sponsor:** Weill Medical College of Cornell University - **Conditions:** Autism Spectrum Disorder - **Start Date:** 2020-12-23 - **Completion Date:** 2022-07-15 - **CT.gov Last Update:** 2022-08-02 ## 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. ## Eligibility - **Minimum age:** 2 Years - **Maximum age:** 4 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Tele Toy Talk** (EXPERIMENTAL) — Caregivers of child participants receive 1-hour of telemedicine featuring parent-mediated naturalistic developmental behavioral intervention weekly for 10 weeks. - **Multiple Baseline** (NO_INTERVENTION) — 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). ## Interventions - **Toy Talk** (BEHAVIORAL) — 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 Outcomes - **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. - **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. - **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. - **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. - **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 Outcomes - **Change in scores on the Observation of Spontaneous Expressive Language (OSEL) - baseline** _(time frame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention))_ - **Change in scores on the Vineland-3** _(time frame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention))_ ## Locations (1) - Center for Autism and the Developing Brain/New York-Presbyterian Hospital, White Plains, New York, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.center for autism and the developing brain/new york-presbyterian hospital|white plains|new york|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04675580.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04675580* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*