Autism Spectrum DisorderEBJNCT04146428
Evaluating BOSCC and ELSA as Outcome Measures in the Context of a JASPER Intervention Trial
A study testing clinician-mediated JASPER and parent-mediated JASPER in people with Autism Spectrum Disorder, run by University of California, Los Angeles at 4 sites in United States.
Trial summary
Research teams in Boston University, UCLA, and Weill Cornell will recruit 90 participants in 3 years (10 participants per site per year) and evaluate JASPER, play-based intervention, using the BOSCC and ELSA-T. Participants will be randomized to receive JASPER facilitated either by a clinician or the caregiver. Read more about this study
- Who is it for?
- Ages 18 months to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- clinician-mediated JASPER and parent-mediated JASPER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Apr 2021to 28 Oct 2025
- 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 18 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Minimally verbal children eligible for the ADOS Toddler Module or Module 1 (pre or minimally verbal) or those who have emerging phrases who may receive Module 2 (phrase speech) will be enrolled. The sample will be limited to children with confirmed diagnosis and nonverbal mental ages greater than or equal to 12 months. The child must be 18 months and 5 years of age.
Who cannot join
- Children that do not have a mental age greater than or equal to 12 months, don't have a confirmed diagnosis, are under the age of 18 months and older than 5 years of age.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Boston University
Boston, Massachusetts, 02215
UCLA
Los Angeles, California, 90095-1406
Semel Institute
Los Angeles, California, 90095
Weill Cornell Medical College/New York Presbyterian Hospital
White Plains, New York, 10605
About this study
Research teams in Boston University, UCLA, and Weill Cornell will recruit 90 participants in 3 years (10 participants per site per year) and evaluate JASPER, play-based intervention, using the BOSCC and ELSA-T. Participants will be randomized to receive JASPER facilitated either by a clinician or the caregiver. After 10 weeks, the participants will be evaluated using the CGI to determine if they are "responders" or "non-responders". Nonresponders will be given a mix of clinician and caregiver-facilitated JASPER and responders will remain the course for the following 10 weeks. Coding of the BOSCC and ELSA-T will be the outcome measures and change will be evaluated throughout the study.
Read the detailed description
Participants: 90 children with confirmed diagnoses of ASD (based on ADOS and clinical judgement) between 18 months and 5 years of age will be randomized into clinician-mediated vs. parent-mediated JASPER intervention at Weill Cornell (n=30; PI Dr. Kim), BU (n=30, PI Dr. Tager-Flusberg), and UCLA (n=30, PIs Drs. Lord \& Kasari). Minimally verbal children eligible for the ADOS Toddler Module or Module 1 (pre or minimally verbal) or those who have emerging phrases who may receive Module 2 (phrase speech) will be enrolled. The sample will be limited to children with nonverbal mental ages greater than or equal to 12 months.
Pre-Intervention Behavioral Testing: We will administer the ADOS and Mullen Scales of Early Learning (MSEL), ESCS, SPA, and CCX. Parents will complete the interview version of the Vineland Adaptive Behavior Scales -3rd edition. In addition, the investigators will administer ELSA-T (following the same procedures that we developed in the first phase of this project described above) as well as the BOSCC with clinicians and caregivers (independent, standardized administration by caregivers). A subset of children (n=20) will be invited within a week of the first assessment for another ELSA/BOSCC sessions for test-retest reliability.
Responder vs. non-responder criteria: Children who show improvements in core ASD symptoms based on the treating therapists' CGI-Improvement ratings will be considered as "responders." Children who show stability or worsening on the CGI-I will be considered as "non-responders." Children will be stratified based on age and language levels across sites, and randomized into 10-week clinician- vs. caregiver- mediated JASPER interventions initially by the statistician at BU who will not be directly involved in the data collection. Both "responders" and "non-responders" will have monthly check-ins (2 total) with the research staff for an additional 10 weeks. Both groups will proceed to T3 assessments following the 20 weeks of treatment and check-ins.
At T2 (after first 10 weeks) and T3 (after 20 weeks, end of study), the investigators will again administer ELSA-T, BOSCC, as well as CGI, ESCS, SPA, and CCX.
Coding ELSA: Naïve coders will be trained to use ELAN to mark the beginning and end of each child speech vocalization/utterance and each examiner/parent utterance, which are coded on separate tiers. Coders will be blind about which kind of intervention the child received and when the ELSA recording was collected pre- or post-intervention. ELAN provides as output frequency of child utterances and frequency of adult utterances (corrected per unit time). The investigators have developed an algorithm that takes ELAN exported files containing the start and end time of each utterance from each speaker to derive a measure of conversation turn-taking (number of consecutive utterances produced by same speaker).
Note that these two measures are not independent, but clinical trials could define either one as a primary outcome measure depending on whether the targeted outcome focuses on the child's communicative abilities or social engagement. ELSA-T recordings will be collected at three sites, but all ELSA coding will be completed at BU.
Coding BOSCC: PI Dr. Kim's research team has trained, blind coders who will score the BOSCC without previous knowledge of the child and the time points of interactions. Different coders will be assigned for the clinician vs. caregiver BOSCC videos and for the parent behavioral coding. BOSCC videos will be collected at three sites, but all BOSCC coding will be done at Weill Cornell.
The same research activities will be conducted at UCLA, Boston University, and Weill Cornell.
- Conditions
- Autism Spectrum Disorder
- Being tested
- clinician-mediated JASPER, parent-mediated JASPER
- Keywords
- BOSCC, ELSA-T, JASPER, autism
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinician-mediated JASPERBehavioural
JASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child. The adult referred in this condition is the clinician/therapist.
parent-mediated JASPERBehavioural
JASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child. The adult referred in this condition is the parent.
| Study group | Role | What they receive |
|---|---|---|
| clinician-mediated JASPER | Experimental | This group will consist of the child and therapist having one-on-one, JASPER sessions, twice a week. Receives: Behavioral: clinician-mediated JASPER |
| parent-mediated JASPER | Experimental | This group will consist of the therapist assisting the parent implement JASPER on the child twice a week. Receives: Behavioral: parent-mediated JASPER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of language utterances and number of conversation turns using the Elicitation of Language Samples for Analysis- Toddlers (ELSA-T)
Dr. Tager-Flusberg's team created the ELSA, for collecting natural language samples (NLSs) from minimally to low verbal school-aged children and adolescents with ASD and developed a novel approach for deriving quantitative measures of linguistic communication (frequency of child utterances and number of conversational turns), in real-time from the language samples that could be useful for a range of clinical intervention trials. In this study, ELSA will be used on toddlers in this study, which has already been piloted.
Measured: Entry (1st month of the study), T2 (10 weeks after entry), T3 (20 weeks after entry)
Change in social communication using the Brief Observation of Social Communication Change (BOSCC)
The BOSCC is a standardized measure of social communication change in children with ASD based on 12-minute videos of clinician- or caregiver-child interactions.
Measured: Entry (1st month of the study), T2 (10 weeks after entry), T3 (20 weeks after entry)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start27 Apr 2021
- Primary completion14 May 2025
- Study completion28 Oct 2025
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 University of California, Los AngelesThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Simons Foundation
- Responsible party
- Principal investigator, Connie Kasari, Ph.D., University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146428
- Sponsor's protocol ID
- 19-001638
- Acronym
- EBJ
- Status last verified
- Jan 2026
- First submitted
- 29 Oct 2019
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data will only be shared with researchers involved in the study.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating BOSCC and ELSA as Outcome Measures in the Context of a JASPER Intervention Trial
- ClinicalTrials.gov ID
- NCT04146428
- Acronym / sponsor ID
- EBJ / 19-001638
- Conditions
- Autism Spectrum Disorder
- Keywords
- BOSCC, ELSA-T, JASPER, autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Simons Foundation
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 31 Oct 2019 (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.
Research teams in Boston University, UCLA, and Weill Cornell will recruit 90 participants in 3 years (10 participants per site per year) and evaluate JASPER, play-based intervention, using the BOSCC and ELSA-T. Participants will be randomized to receive JASPER facilitated either by a clinician or the caregiver. After 10 weeks, the participants will be evaluated using the CGI to determine if they are "responders" or "non-responders". Nonresponders will be given a mix of clinician and caregiver-facilitated JASPER and responders will remain the course for the following 10 weeks. Coding of the BOSCC and ELSA-T will be the outcome measures and change will be evaluated throughout the study.
Detailed description
Participants: 90 children with confirmed diagnoses of ASD (based on ADOS and clinical judgement) between 18 months and 5 years of age will be randomized into clinician-mediated vs. parent-mediated JASPER intervention at Weill Cornell (n=30; PI Dr. Kim), BU (n=30, PI Dr. Tager-Flusberg), and UCLA (n=30, PIs Drs. Lord \& Kasari). Minimally verbal children eligible for the ADOS Toddler Module or Module 1 (pre or minimally verbal) or those who have emerging phrases who may receive Module 2 (phrase speech) will be enrolled. The sample will be limited to children with nonverbal mental ages greater than or equal to 12 months.
Pre-Intervention Behavioral Testing: We will administer the ADOS and Mullen Scales of Early Learning (MSEL), ESCS, SPA, and CCX. Parents will complete the interview version of the Vineland Adaptive Behavior Scales -3rd edition. In addition, the investigators will administer ELSA-T (following the same procedures that we developed in the first phase of this project described above) as well as the BOSCC with clinicians and caregivers (independent, standardized administration by caregivers). A subset of children (n=20) will be invited within a week of the first assessment for another ELSA/BOSCC sessions for test-retest reliability.
Responder vs. non-responder criteria: Children who show improvements in core ASD symptoms based on the treating therapists' CGI-Improvement ratings will be considered as "responders." Children who show stability or worsening on the CGI-I will be considered as "non-responders." Children will be stratified based on age and language levels across sites, and randomized into 10-week clinician- vs. caregiver- mediated JASPER interventions initially by the statistician at BU who will not be directly involved in the data collection. Both "responders" and "non-responders" will have monthly check-ins (2 total) with the research staff for an additional 10 weeks. Both groups will proceed to T3 assessments following the 20 weeks of treatment and check-ins.
At T2 (after first 10 weeks) and T3 (after 20 weeks, end of study), the investigators will again administer ELSA-T, BOSCC, as well as CGI, ESCS, SPA, and CCX.
Coding ELSA: Naïve coders will be trained to use ELAN to mark the beginning and end of each child speech vocalization/utterance and each examiner/parent utterance, which are coded on separate tiers. Coders will be blind about which kind of intervention the child received and when the ELSA recording was collected pre- or post-intervention. ELAN provides as output frequency of child utterances and frequency of adult utterances (corrected per unit time). The investigators have developed an algorithm that takes ELAN exported files containing the start and end time of each utterance from each speaker to derive a measure of conversation turn-taking (number of consecutive utterances produced by same speaker).
Note that these two measures are not independent, but clinical trials could define either one as a primary outcome measure depending on whether the targeted outcome focuses on the child's communicative abilities or social engagement. ELSA-T recordings will be collected at three sites, but all ELSA coding will be completed at BU.
Coding BOSCC: PI Dr. Kim's research team has trained, blind coders who will score the BOSCC without previous knowledge of the child and the time points of interactions. Different coders will be assigned for the clinician vs. caregiver BOSCC videos and for the parent behavioral coding. BOSCC videos will be collected at three sites, but all BOSCC coding will be done at Weill Cornell.
The same research activities will be conducted at UCLA, Boston University, and Weill Cornell.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clinician-mediated JASPER | Experimental | Behavioral: clinician-mediated JASPERThis group will consist of the child and therapist having one-on-one, JASPER sessions, twice a week. |
| parent-mediated JASPER | Experimental | Behavioral: parent-mediated JASPERThis group will consist of the therapist assisting the parent implement JASPER on the child twice a week. |
Who may qualify
- Ages
- 18 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Minimally verbal children eligible for the ADOS Toddler Module or Module 1 (pre or minimally verbal) or those who have emerging phrases who may receive Module 2 (phrase speech) will be enrolled. The sample will be limited to children with confirmed diagnosis and nonverbal mental ages greater than or equal to 12 months. The child must be 18 months and 5 years of age.
Key exclusion criteria (1 listed)
- Children that do not have a mental age greater than or equal to 12 months, don't have a confirmed diagnosis, are under the age of 18 months and older than 5 years of age.
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 |
|---|---|---|
| clinician-mediated JASPERJASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child. The adult referred in this condition is the clinician/therapist. | Behavioural | clinician-mediated JASPER |
| parent-mediated JASPERJASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child. The adult referred in this condition is the parent. | Behavioural | parent-mediated JASPER |
Primary outcome
Change in frequency of language utterances and number of conversation turns using the Elicitation of Language Samples for Analysis- Toddlers (ELSA-T)
Time frame: Entry (1st month of the study), T2 (10 weeks after entry), T3 (20 weeks after entry)
Dr. Tager-Flusberg's team created the ELSA, for collecting natural language samples (NLSs) from minimally to low verbal school-aged children and adolescents with ASD and developed a novel approach for deriving quantitative measures of linguistic communication (frequency of child utterances and number of conversational turns), in real-time from the language samples that could be useful for a range of clinical intervention trials. In this study, ELSA will be used on toddlers in this study, which has already been piloted.
Change in social communication using the Brief Observation of Social Communication Change (BOSCC)
Time frame: Entry (1st month of the study), T2 (10 weeks after entry), T3 (20 weeks after entry)
The BOSCC is a standardized measure of social communication change in children with ASD based on 12-minute videos of clinician- or caregiver-child interactions.
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 28 Jan 2026.
- Individual participant dataSharing planned: No. De-identified data will only be shared with researchers involved in the study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinician-mediated JASPER and parent-mediated JASPER in people with Autism Spectrum Disorder, run by University of California, Los Angeles at 4 sites 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 1 inclusion and 1 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 frequency of language utterances and number of conversation turns using the Elicitation of Language Samples for Analysis- Toddlers (ELSA-T) (time frame: Entry (1st month of the study), T2 (10 weeks after entry), T3 (20 weeks after entry)). The study lists 2 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 28 Jan 2026.