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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
children meeting ADOS-2 criteria for ASD
age 36-59 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (entry), week 10, week 20, week 30, age 6 (follow up)
Awards & highlights
Study Summary
This trial is designed to find the best way to help very young autistic children who have very little language. It will adapt to each child's needs, potentially reducing the burden on the children.
Who is the study for?
The PRISM study is for preschoolers aged 36-59 months with Autism Spectrum Disorder who speak less than 20 functional words. They must have had over 3 months of early intervention, stable medication for the past half year, and a nonverbal mental age above one year. Children with sensory/motor impairments or genetic syndromes like Down Syndrome are not eligible.Check my eligibility
What is being tested?
This trial tests an adaptive two-stage language development approach over 20 weeks for minimally verbal children with ASD in community settings. It aims to personalize treatment by choosing between DTT (Discrete Trial Training), JASPER, and CET interventions based on each child's needs.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected. However, there may be varying responses to therapy such as changes in behavior or emotional distress.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child has been diagnosed with autism.
Select...
I am between 3 and 5 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (entry), week 10, week 20, week 30, age 6 (follow up)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (entry), week 10, week 20, week 30, age 6 (follow up)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change of spontaneous utterances (SCU) from the Language Sample throughout the study.
Secondary outcome measures
Change in Joint Engagement on the Adult-Child Interaction (ACX) over the course of the study.
Change in receptive language using the Preschool Language Scales-5 (PLS-5) throughout the study.
Presence of word combinations in the Language Sample over the course of the study.
Other outcome measures
Determine eligibility on nonverbal mental age using the Mullen Scales of Early Learning (MSEL)
Presence of joint attention initiations using the Early Social-Communication Scales
Track the levels of spontaneous play acts using The Structured Play Assessment-R over the course of the study.
Trial Design
2Treatment groups
Active Control
Group I: JASPERActive Control1 Intervention
Child will spend 2 hours per week (2 days, 1 hour per day) for the first 10 weeks doing JASPER. If the child is an early responder, he/she will remain in the same course for the following 10 weeks.
If child is a slow responder, he/she will be randomized for either combined & enhanced treatment (CET) for 2 hours a week (2 days, 1 hour per day) or Intensified JASPER for 4 hours a week (4 days, 1 hour per day).
Group II: DTTActive Control1 Intervention
Child will spend 2 hours per week (2 days, 1 hour per day) for the first 10 weeks doing DTT. If the child is an early responder, he/she will remain in the same course for the following 10 weeks.
If child is a slow responder, he/she will be randomized for either combined & enhanced treatment (CET) for 2 hours a week (2 days, 1 hour per day) or Intensified DTT for 4 hours a week (4 days, 1 hour per day).
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,264,568 Total Patients Enrolled
24 Trials studying Autism Spectrum Disorder
4,209 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I likely haven't been exposed to AAC.My child has been diagnosed with autism.I am between 3 and 5 years old.I do not have sensory, motor impairments, or known genetic syndromes.You have certain changes in your genes that can be treated with medication.My child has been in early intervention or preschool for over 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: JASPER
- Group 2: DTT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots for participants in this trial?
"This clinical trial is still recruiting according to information on the website, clinicialtrials.gov. It was first posted in March 2021 and its most recent update was in August of this year."
Answered by AI
Is participation in this experiment open to individuals of all ages, or is there an age limitation?
"This research project permits individuals aged between 36 months and 59 months to sign up for the trial. There are 228 studies available for minors, whereas elderly persons can participate in 42 distinct trials."
Answered by AI
Is there any way for me to be included in this experiment?
"This autism spectrum disorder trial is seeking 140 children aged between 36-59 months and who have had more than 3 months of early interventions. The applicant must also use less than 20 functional words, maintain a stable medication regimen for the preceding 6 months and attain nonverbal mental age scores above 12 on the Mullen Scales of Early Learning (visual reception and fine motor subscales)."
Answered by AI
How many subjects are engaged in this medical trial?
"This trial necessitates an enrollment of 140 eligible patients from multiple medical sites, including University of Oregon in Eugene and UCLA in Los Angeles."
Answered by AI
Who else is applying?
What site did they apply to?
University of Rochester
What portion of applicants met pre-screening criteria?
Did not meet criteria
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