PRISM Intervention Study

NCT03883139 | Active Not Recruiting

• 1 other identifier: 19-000193
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Autism Spectrum Disorder

Keywords

autism; JASPER; DTT; ASD; Autism Spectrum Disorder; social and communication deficits

Outcome Measures

Primary Outcomes (1)

• Change of spontaneous utterances (SCU) from the Language Sample throughout the study.

  To determine which intervention for slower responding children (Intensify vs. CET) produces greater increases in socially communicative spontaneous utterances (SCU; primary outcome).

  baseline (entry), 10 weeks after entry, 20 weeks after entry, 30 weeks after entry, and when child turns 6

Secondary Outcomes (3)

• Change in Joint Engagement on the Adult-Child Interaction (ACX) over the course of the study.

  baseline (entry), 10 weeks after entry, 20 weeks after entry, 30 weeks after entry, and when child turns 6

• Change in receptive language using the Preschool Language Scales-5 (PLS-5) throughout the study.

  baseline (entry), 20 weeks, and when child turns 6

• Presence of word combinations in the Language Sample over the course of the study.

  baseline (entry), 10 weeks after entry, 20 weeks after entry, 30 weeks after entry, and when child turns 6

Other Outcomes (3)

• Presence of joint attention initiations using the Early Social-Communication Scales

  baseline (entry), week 10, week 20, week 30, age 6 (follow up)

• Track the levels of spontaneous play acts using The Structured Play Assessment-R over the course of the study.

  baseline (entry), 10 weeks after entry, 20 weeks after entry, 30 weeks after entry, and when child turns 6

• Determine eligibility on nonverbal mental age using the Mullen Scales of Early Learning (MSEL)

  baseline (entry), week 20, and age 6 (follow up)

Study Arms (2)

JASPER

ACTIVE COMPARATOR

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).

Behavioral: JASPER

DTT

ACTIVE COMPARATOR

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).

Behavioral: DTT (Discrete Trial Training)

Interventions

JASPER BEHAVIORAL

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.

JASPER

DTT (Discrete Trial Training) BEHAVIORAL

DTT is an adult-led, highly structured, behavioral teaching approach, is considered to have the strongest evidence as a "standard of care" for young children with autism. DTT emphasizes didactic, adult-led instruction.

DTT

Eligibility Criteria

• Age: 36 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (3)

UCLA

Los Angeles, California, 90095, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

University of Oregon

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Activator Appliances

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, Functional; Orthodontic Appliances; Orthodontics; Dentistry; Orthodontic Appliances, Removable

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 20, 2019
• Study Start: March 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (3)