Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03883139 |
| Other study ID # |
19-000193 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
March 31, 2026 |
Study information
| Verified date |
November 2023 |
| Source |
University of California, Los Angeles |
| Contact |
Connie Kasari, PhD |
| Phone |
310-825-8342 |
| Email |
kasari[@]gseis.ucla.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
Stage 2: Intensify (4x60 minute sessions per week): Slower responders in stage 1 may be
rerandomized to continue the stage 1 intervention. In this Stage 2 choice, we will follow the
same procedures outlined in the stage 1 interventions to provide the child with more time to
make gains with consistent high quality intervention, but add an additional session, as
increased dose is usual practice in the community.
Stage 2 intervention Combined & Enhanced Treatment (CET: 2x60 minute sessions per week): CET
is 2 sessions per week. Using the dashboard approach pioneered by Chorpita, child needs are
matched to potentially effective intervention modules (e.g., behavior challenges that may
indicate more time spent in DTT type intervention). We have used this approach with older
minimally verbal children with ASD, and are proposing to use this model here with preschool
aged children who respond slowly to first stage intervention.
Our prior trials exploring supports for slowly responding school age children have shown us
that children are typically showing some response rather than no response. Therefore, CET
will combine a balance of initial treatment augmented with additional treatment type. Our
options for enhancing intervention include a) primarily direct instruction (75% DTT with
JASPER strategies embedded within play based breaks), b)primarily JASPER (75% JASPER, with
DTT priming on specific language or play targets at the beginning of the session and trials
embedded briefly within JASPER routines), c) add SGD, child will receive access to a tablet
with a speech generating application to teach the child to communicate using both augmented
and spoken language using either JASPER or direct instruction strategies. When the SGD is
added, this will provide another mode for children to communicate as well to model and teach
expressive communication. The SGD will be added to DTT to provide instruction (e.g.,
discriminative stimulus) and for the child to use to respond and spontaneously communicate
across programs. In JASPER, the adult will model both augmented words using the SGD and
spoken words as well as respond and expand child communication with both spoken and augmented
words.
The tablet will be programmed to meet the developmental level of the child (e.g., number of
symbols, type of symbol- real image, symbol). Children randomized to CET will be reviewed by
the study team (site leads, coordinators, and interventionist) to plan the CET program
components to cross site consensus. Plans and components will be tracked using the CET
Dashboard tracking form.
Intervention Dose and Duration: In stage 1, all children receive 2 hours per week of JASPER
or DTT.
The total duration of treatment is 20 weeks This dose is based on (i) ongoing and previous
research conducted by our team concerning feasible doses of stage 1 DTT or JASPER in actual
practice settings (RO1 # R01HD073975); and (ii) our previous efficacy studies of JASPER.
Concomitant Intervention: Children can receive concomitant intervention, which will be
measured for dose and type (and considered in analyses). For example, many (or all) children
are expected to receive federally subsidized early intervention services.
Fidelity and Quality Assurance. Interventionists at all 3 recruitment sites will be trained
together to high fidelity levels (>90% on all elements of intervention components) with 2-3
children prior to carrying out the intervention for this study. The PI and Coordinator at
each site will supervise interventionists weekly in individual and group meetings.
Coordinators will rate fidelity for each site for 20% of all sessions, selected randomly. If
low levels of fidelity are observed, the poor-performing interventionist will receive
additional training until fidelity exceeds 90%. Weekly conference calls will be conducted to
monitor cross-site fidelity for each intervention.
Video-recorded sessions of each interventionist will be reviewed on a rotating basis by the
interventionists and supervisors during these calls. In prior studies we have successfully
used this approach in which videos are uploaded to our password-protected, HIPAA-compliant
Data Coordinating site to calibrate reliability ratings and intervention fidelity and to
initiate discussion of difficult or problematic cases in prior studies. Quality assurance
checks at each site will occur monthly on 10% of randomly selected sessions by Coordinators
and/or PIs.
Randomization. Authorized personnel at each site will randomize participants via the
centralized database using a customized system tailored for the SMART design. The project
statistician will generate the randomization sequence, with allocation sequence concealed
from all other study personnel. The first randomization at baseline is to stage 1 treatment
(JASPER or DTT) with equal assignment probability to each group. For the first randomization,
the system will make a treatment assignment only if the participant meets study criteria and
only after the screening and stratification data are entered. For the second randomization,
once the variables necessary for determining early response status (as well as the
stratification variables) are entered, slower responders will be automatically re-randomized
to Stage 2 treatment.
All randomizations will occur within sites and will be further stratified using a
minimization allocation method. This procedure will ensure that treatment groups are balanced
for variables that may correlate highly with outcomes. The first randomization will be
stratified on 1 baseline measure, initiating joint attention (JA gestures and/or JA language
>0 vs ≤0) based on the Early Social Communication Scales (ESCS). The second randomization
among slow responders will be stratified on whether or not the child has made 0.2 gains (2
minutes) in joint engagement from baseline to week 10 based on the Adult-Child Interaction
Play Interaction.
SMART Design:
Early Assessments, Randomize to Stage 1 Treatment
Stage 1: JASPER
Decision Point: Early Response Assessments
Early Responders/Re-Randomize JASPER (slow responders)
Stage 2: Stay the course (Early Responders only)- (A; look at 6.0) Stage 2:CET - (B; look at
6.0) or Stage 2: JASPER -intensify (Randomized for slow responders)- (C; look at 6.0)
Exit assessments and Follow up assessments at 10 weeks post treatment and 6 years of age
Early Assessments, Randomize to Stage 1 Treatment
Stage 1: DTT Decision Point: Early Response Assessments
Early Responders/Re-Randomize DTT (slow responders)
Stage 2: Stay the course (Early Responders only) -(D; look at 6.0) Stage 2:CET -(E; look at
6.0) or Stage 2: DTT -intensify (Randomized for slow responders) - (F; look at 6.0)
Exit assessments and Follow up assessments at 10 weeks post treatment and 6 years of age
