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| ID | Type | Description | Link |
|---|---|---|---|
| 19-07020518 | Other Identifier | Weill Cornell Medicine IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele Toy Talk | Experimental | Caregivers of child participants receive 1-hour of telemedicine featuring parent-mediated naturalistic developmental behavioral intervention weekly for 10 weeks. |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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). |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| So Hyun Kim, Ph.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Autism and the Developing Brain/New York-Presbyterian Hospital | White Plains | New York | 10605 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Baseline (before starting intervention); Week 4; Week 8; Week 12 |
| 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) |
| 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). |
| 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). |
| 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). |