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Clinical Trials/NCT03883139
NCT03883139Active, not recruitingNot Applicable

Personalized, Responsive Intervention Sequences for Minimally Verbal Children With Autism

University of California, Los Angeles3 sites in 1 country140 target enrollmentStarted: March 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
140
Locations
3
Primary Endpoint
Change of spontaneous utterances (SCU) from the Language Sample throughout the study.

Study Overview

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).

Detailed Description

This study will use a Sequential Multiple Assignment Randomized Trial (SMART) design to examine key scientific questions for assembling an optimal adaptive intervention for preschoolers with ASD .

Children will first be recruited through local school districts and early intervention service providers, approximately 35 children per year across all three sites (UCLA will have 15 per year, University of Oregon will have 10 per year, and University of Rochester will have 10 per year) for a total of 140 children.

Based on early intervention research conducted by this research team over the past 15 years, we are proposing a first stage treatment decision comparing the commonly applied ABA method of Discrete Trial Teaching or an NDBI approach of JASPER focused on social communication and play targets specifically. The dose of each intervention is delivered at a research dose of 2 hours per week (consistent with previous JASPER studies. All children are expected to receive federally subsidized early intervention services which we will track for dose and type (to be considered in analyses). The interventions are described below: Stage 1 DTT Intervention (2x60 minute sessions per week in community setting): Discrete Trial Training (DTT), 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. This approach relies on teaching discriminations between stimuli, responses to stimuli, and providing systematic reinforcement for correct responses. The goals of DTT are to teach specific skills, to accelerate overall development and increase school readiness. In order to meet these goals the interventionist works to create an engaging environment to support the child's ability to attend to the instruction and demonstrate the skills correctly. Recently, DTT interventions have begun to teach skills to address early core social communication deficits such as joint attention in order to promote better language and communication outcomes. While many children will have been exposed to DTT prior to entering this trial as part of business as usual community treatment, community intervention quality and dosage can vary widely. It is important to insure that children (a) receive quality DTT, and (b) have exposure to elements related to language learning, specifically engagement in instruction, and joint attention and requesting gestures, in order to make the comparison with JASPER in stage 1. Thus, in addition to the expected ABA approach used in their early intervention preschool program (which in the sites we are located also includes DTT during the day), we will insure high quality DTT carried out by research staff in order to adequately make the comparison between models for children with ASD in this project.

Stage 1 JASPER Intervention (2x60 minute sessions per week in community setting): 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 uses the child's current play level to choose appropriate toys and materials to create a context for learning. Developmental principles of following the child's attentional focus, balancing imitation and modeling to create and expand play routines, supporting children's regulation and engagement, as well as responding to and expanding children's communication/language targets are used. The goal of JASPER is to increase (a) joint engagement, (b) initiations of joint attention and requesting skills, (c) diversity in social play involving objects and persons, and (d) verbal and nonverbal communication by facilitating meaningful social interactions. The social interaction foundation of JASPER is critical. Modeling and expansions of communicative behaviors and play are used strategically within the interactions with an adult. For children at risk of minimally verbal status, meaningful social interaction is essential for establishing the platform on which language input and development will be built. Unlike DTT, JASPER is likely to be a novel intervention to which few children will have had previous exposure through business as usual treatment.

Stage 2: Responders (2x60 minute sessions per week): Responders in stage 1 stay the course in the same intervention at the same dose.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
36 Months to 59 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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).

Intervention: JASPER (Behavioral)

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).

Intervention: DTT (Discrete Trial Training) (Behavioral)

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Connie Kasari, Ph.D.

Principal Investigator

University of California, Los Angeles

Study Sites (3)

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