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
