Autism Spectrum DisorderNCT04675580
Telehealth Language Intervention for Children With Autism Ages 2-4 Years
A study testing Toy Talk in people with Autism Spectrum Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Toy Talk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2020to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Child speaks using complex sentences
- Child is not within 2 to 4 years of age at time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Autism and the Developing Brain/New York-Presbyterian Hospital
White Plains, New York, 10605
About this study
Official title: Tele Toy Talk: Telehealth Language Intervention
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Toy Talk
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toy TalkBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tele Toy Talk | Experimental | Caregivers of child participants receive 1-hour of telemedicine featuring parent-mediated naturalistic developmental behavioral intervention weekly for 10 weeks. Receives: Behavioral: Toy Talk |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline (before starting intervention); Week 4; Week 8; Week 12
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start23 Dec 2020
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- So Hyun Kim, Ph.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675580
- Sponsor's protocol ID
- 21-03023432
- Other IDs
- 19-07020518
- Status last verified
- Jul 2022
- First submitted
- 15 Dec 2020
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele Toy Talk: Telehealth Language Intervention
- ClinicalTrials.gov ID
- NCT04675580
- Acronym / sponsor ID
- 21-03023432
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele Toy Talk | Experimental | Behavioral: Toy TalkCaregivers 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). |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Child speaks using complex sentences
- Child is not within 2 to 4 years of age at time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toy TalkLanguage 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. | Behavioural | Tele Toy Talk |
Primary outcome
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).
2 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
So Hyun Kim, Ph.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toy Talk in people with Autism Spectrum Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of unique combinations of subjects and verbs - caregiver (time frame: Baseline (Before starting intervention); Week 4; Week 8; Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.