PRISM Intervention Study (NCT03883139) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PRISM Intervention Study
United States140 participantsStarted 2021-03-01
Plain-language summary
This research study, Personalized, Responsive Intervention Sequences for Minimally Verbal Children with Autism (PRISM), is designed to maximize language outcomes for limited-language preschoolers, thereby lowering the risk of being classified as "minimally verbal" at age 6, by empirically developing a two-stage, 20-week adaptive intervention approach in a real world community settings. If found efficacious, the adaptive intervention design will capitalize on the heterogeneity and evolving status of children with ASD by providing the best intervention (DTT, JASPER and CET) for children who need it (leading to individualized sequences of intervention), only when it is needed (potentially reducing burden on children).
Who can participate
Age range
36 Months – 59 Months
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:
* children meeting ADOS-2 criteria for ASD,
* age 36-59 months
* who have had \> 3 months early intervention/preschool (to ensure that children already have been exposed to some community interventions) and
* use \< 20 functional words (i.e., non-echoed, non-scripted).
Additional inclusion criteria are:
* stable medication over the past 6 months, and
* nonverbal mental age of \>12 months on the Mullen Scales of Early Learning (visual reception and fine motor subscales).
Exclusion Criteria:
* We will exclude children who have sensory and motor impairments (e.g., visual impairment, deaf or hard of hearing) and with known genetic syndromes (e.g., Down Syndrome).
* We will not exclude on the basis of AAC exposure, but expect few will be exposed at these ages.
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 of spontaneous utterances (SCU) from the Language Sample throughout the study.
Timeframe: baseline (entry), 10 weeks after entry, 20 weeks after entry, 30 weeks after entry, and when child turns 6