Evaluating BOSCC and ELSA as Outcome Measures in the Context of a JASPER Intervention Trial (NCT04146428) | Clinical Trial Compass
CompletedNot Applicable
Evaluating BOSCC and ELSA as Outcome Measures in the Context of a JASPER Intervention Trial
United States84 participantsStarted 2021-04-27
Plain-language 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. 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.
Who can participate
Age range
18 Months – 5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in frequency of language utterances and number of conversation turns using the Elicitation of Language Samples for Analysis- Toddlers (ELSA-T)
Timeframe: Entry (1st month of the study), T2 (10 weeks after entry), T3 (20 weeks after entry)
2
Change in social communication using the Brief Observation of Social Communication Change (BOSCC)
Timeframe: Entry (1st month of the study), T2 (10 weeks after entry), T3 (20 weeks after entry)