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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
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (entry), week 10, week 20, week 30, age 6 (follow up)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to improve language skills in preschool children with autism using a structured teaching and social interaction-based learning program. The program is adjusted based on each child's progress. The goal is to help these children develop better communication skills and avoid being minimally verbal by age 6.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have sensory, motor impairments, or known genetic syndromes.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change of spontaneous utterances (SCU) from the Language Sample throughout the study.
Secondary study objectives
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 study objectives
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.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Discrete Trial Training (DTT) is a structured behavioral intervention that breaks down skills into small, teachable components and uses reinforcement to encourage desired behaviors. JASPER focuses on improving joint attention and symbolic play skills, which are critical for social communication development.
Enhanced Milieu Teaching (EMT) combines behavioral and developmental principles to promote spontaneous communication in naturalistic settings. These treatments are important for ASD patients because they target specific deficits in communication and social interaction, which are core challenges in ASD.
By tailoring these interventions to individual needs, they can more effectively promote skill development and improve overall functioning.
Research-Based Intervention (RBI) for Autism Spectrum Disorder: Looking beyond Traditional Models and Outcome Measures for Clinical Trials.Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis.What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials.
Research-Based Intervention (RBI) for Autism Spectrum Disorder: Looking beyond Traditional Models and Outcome Measures for Clinical Trials.Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis.What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials.
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,560 Previous Clinical Trials
10,258,806 Total Patients Enrolled
25 Trials studying Autism Spectrum Disorder
4,259 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.
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