Clinical trial NCT04675580: Telehealth Language Intervention for Children With Autism Ages 2-4 Years
Official title: Tele Toy Talk: Telehealth Language Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 14
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Change in number of unique combinations of subjects and verbs - caregiver
timeFrame: Baseline (Before starting intervention); Week 4; Week 8; Week 12
measure: Change in number of unique combinations of subjects and verbs - child
timeFrame: Baseline (Before starting intervention); Week 4; Week 8; Week 12
measure: Change in caregiver mean length of utterance
timeFrame: Baseline (before starting intervention); Week 4; Week 8; Week 12
measure: Change in child mean length of utterance
timeFrame: Baseline (before starting intervention); Week 4; Week 8; Week 12
measure: Change in Brief Observation of Social Communication Change (BOSCC) scores
timeFrame: Baseline (before starting intervention); Week 4; Week 8; Week 12
Secondary outcomes:
measure: Change in scores on the Observation of Spontaneous Expressive Language (OSEL) - baseline
timeFrame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention)
measure: Change in scores on the Vineland-3
timeFrame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention)
Other outcomes:
measure: Change in scores on the Acceptance and Action Questionnaire, Second Version (AAQ-II)
timeFrame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).
measure: Change in scores on the Emotion Regulation Questionnaire (ERQ)
timeFrame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).
measure: Change in scores on the Caregiver Strain Questionnaire - Short Form 7 (CSQ-SF 7)
timeFrame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).
measure: Change in scores on the Parent Stress Index-4th Edition (PSI-4)
timeFrame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).
Locations:
city: White Plains
country: United States
facility: Center for Autism and the Developing Brain/New York-Presbyterian Hospital
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: So Hyun Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: