An interventional study of Toy Talk in Autism Spectrum Disorder, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 2 Years to 4 Years. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment
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.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 14 is below the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
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Exclusion Criteria:
Caregivers of child participants receive 1-hour of telemedicine featuring parent-mediated naturalistic developmental behavioral intervention weekly for 10 weeks.
Behavioral: Toy Talk
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).
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline (before starting intervention); Week 4; Week 8; Week 12
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.
Time frame: 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.
Time frame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).
Plan to share: No
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Weill Medical College of Cornell University