Results of an RCT for Project DATA (Developmental Appropriate Treatment for Autism),

an inclusive community based treatment model for toddlers with ASD.

Bonnie J. McBride, PhD, BCBA-D, University of Oklahoma Health Sciences Center
Ilene S. Schwartz, PhD, BCBA-D, University of Washington

Introduction Results Conclusions

Comprehensive treatment programs delivered early, intensive in design and that The overall results of study showed significant effects Project DATA for Toddler is an effective intervention model for
incorporate behavioral learning principles have been effective in improving outcomes for cognitive ability and reduced autism young children with ASD with demonstrated findings similar to
for a significant number of children with ASD. However, scalability of these intensive symptomology after 2 years of intervention for other studies with fewer hours of intervention.
behavioral programs is a challenge. children receiving the Project DATA Toddler model. Unlike in previous EIBI studies, the services as usual
Project DATA for Toddlers is an early intensive behavioral intervention model that Effect size estimates of .87 for Project DATA (SAU) group showed large improvements in Year 2 when they
is built on behavior analytic principles with a developmental and social emphasis. The model were similar to other EIBI studies and ESDM turned 3. Factors that may have affected these outcomes include
children receive intensive instruction on core treatment areas for autism such as outcomes on overall measures of development a high rate of additional services received by these children. For
imitation, social responsiveness, communication and play, but also have opportunities (Dawson et al., 2010; Odom et al., 2010; Sallows, example 85% of the children in the SAU group were enrolled in
to interact successfully in the same setting as their peers from the first day of Graupner, 2005). These gains were shown with far a public school developmental preschool for more than 10 hours
intervention. fewer hours than other traditional EIBI programs (i.e., per week. More than half of SAU participants also received
15-17 hours compared to 25-40 hours).
private services for SLP, OT or BCBA.
This compares favorably to the average effect
Since these gains in the SAU group coincided with entry
Extended, Technical and sizes for EIBI using all accessible pre-post IQ data
Intensive Social Support into developmental preschools in local school districts this
Instruction for Families from studies cited in known early intervention for
Figure 1. autism in meta-analytic and systematic reviews
could simply indicate improvement in community ECSE
Integrated Early
Improved
Outcomes for
Project DATA (Reichow, 2012; Odom et al., 2010). programs, but could also give cause for re-evaluation our
Childhood
Experience Children and intervention model The DATA group showed the most significant assumptions regarding the effects of EIBI when compared to
Families
components. improvements in autism symptomology (ADOS other available high quality services. We also noted that
Collaboration Quality of Life
Severity Scores) and overall, fine motor, receptive retention of participants, particularly in the SAU group, was
and Influenced
Coordination Curriculum language, visual cognitive development (Mullen non-random and may have been correlated with childs response
Scales of Early Learning). The SAU control group also ADOS to services, potentially increasing mean gains in the SAU group
Baseline 2-year Outcome Effect Size compared to the DATA group.
saw gains in the same areas, to a lesser degree than the
Mean SD Mean SD Becker g Cohens d
DATA group but also much larger compared to control A consistent finding across all EIBI studies is the fact that
Model Components:
groups in previous RCT trials of EIBI for autism. only about 50% of the children show dramatic improvement or
Behavioral teaching strategies DATA 6.8 1.5 5.4 2.0 0.80 0.85
Specialized curriculum intervention effects. There is still a great deal that is unknown
SAU 6.8 1.5 6.0 1.9 0.53 0.46
14-17 hours/week intervention at center about the significant population of low responders. Future
Weekly 2 hour home visit Figure 4. Changes in autism research should focus on what we can learn from this effect as
Access to typically developing peers symptomology as measured well as explore methods for predicting and adapting to
Figure 3. Changes in by Autism Diagnostic variability in response to intervention.
Family support and education
cognitive function as observation Schedule Severity An addition related phenomenon we observed in the study
measured by the Mullen Scores (Gotham, Pickles, relates to outcome measurements and the influence of floor and
Scales of Early Learning. The Lord, 2009). ceiling effects. We found floor effects to be pervasive in some
broad curving lines illustrate
measurement domains (e.g. 87% of participants were at floor on
greater mean improvement in
at least one Mullen subscale). In other instances, particularly in
Methods and Participants the DATA participants. The
Mullen Visual Reception scores, we found that late in study
overlaid individual participant
This study was a 2-arm, multi-site, cross-state RCT (4 OK counties and King County, many children were scoring at the maximum level and we
line plots show great variation
WA) of Project DATA. Major aims of the study included improved ASD symptom potentially lost some of our ability to accurately measure their
and floor effects within both
outcomes, improved parenting outcomes, and acceptability to participating families. gains through the course of the intervention.
groups.
We were able to secure a comparatively large sample of 78 childrenprevious ASD continues to have a substantial public health and
RCTs for autism EIBIs had samples sizes between 40 and 50. All children included in economic impact on society. The suggestion that early intensive
the study were 30 months or younger, had failed an M-CHAT screening, had scored in intervention can avert a substantial portion of these public
1-year Outcome 2-year Outcome 1-year 2-year 1-year 2-year
the ASD range on the ADOS, had qualified for early intervention services, and had at DATA - DATA Figure 5. Cognitive function health and economic consequences makes the development of
Control (n =39 ) DATA (n =39 ) Control (n = 39) DATA (n =39 ) SAU SAU Becker g Becker g
least one parent who spoke English and could provide for transportation. Children outcome data as measured by effective intervention models that are potentially deliverable in
diagnosed with a chronic or serious health or medical issue, neurological disorder of Mean SE SAU Mean SE DATA Mean SE SAU Mean SE DATA Est. 95% C.I. Est. 95% C.I. gSAU gDATA gSAU gDATA
the Mullen Scales of Early scaled-up service environments even more pressing. The fact
Mullen/MSEL
known etiology, or seizure disorder did not qualify for the study. Composite
62.6 3.7 4.3 73.3 3.4 11.7 70.5 5 12.6 76.2 4.6 14.8 7.4 [1.1,13.5] 2.2 [-7.9,12.7] 0.25 0.69 0.74 0.87 Learning. The most significant that there continues to be a generally poor prognosis for
T-score
Expressive
language T-score
30.8 2.4 4.7 34.4 2.1 6.2 33.9 3.2 7.8 32.7 2.8 4.5 1.5 [-2.7,5.8] -3.3 [-9.4,2.7] 0.46 0.61 0.77 0.44 gains for DATA participants children with ASD despite the progress made in identifying
DATA Group SAU Group
Receptive
27.9 1.9 2.9 34.2 2.4 9 31.9 3.2 6.9 34.4 2.4 9.2 6.1 [1.8,10.6] 2.3 [-4.9,9.4] 0.27 0.83 0.64 0.85
were in Fine Motor skills, effective treatment strategies could be attributable to the context
Figure 2. Age language T-score
Receptive Language, and
Mean SD N Mean SD N Visual in which EIBI is most often delivered (e.g., segregated autism
Age at entry in years 2.55 0.30 39 2.53 0.30 39 and gender of T-score
28.8 2.7 1 39.7 2.4 9.4 35 3.7 7.1 40.7 3.2 10.6 8.4 [3.1,13.9] 3.4 [-5.6,12.4] 0.08 0.72 0.55 0.82
Visual skills domains.
participants by
Fine Motor T-
27.6 1.9 3.3 31.4 1.6 4.9 31 3 6.7 36.5 2.6 9.9 [-2.0,5.1] 3.2 [-4.0,10.4] 0.29 0.43 0.59 0.88 only ; 1:1 models). This issue of context could prove to be
score 1.6
Gender Male Female Total Male Female Total group. important for scalability of early behavioral interventions.
32 7 39 32 7 39

After participants were recruited (through state-sponsored early intervention

services, pediatric services, and diagnostic clinics) each was randomly assigned to
either the Project DATA or services as usual (SAU), utilizing adaptive randomization.
Covariate analysis found no statistically significant differences between groups, both
in demographic and in baseline outcome measures or sub-domains of these measures.
This parity also applied across the sites and regions participating in the study.
Children assigned to the DATA Model received 15-17 hours weekly including
parent education and weekly home visit. All participants received quarterly
assessments in order to assess nonlinearity of growth over time and to provide a more
reliable measurement of ability at young ages. Children in both groups also received
intervention recommendations and progress reports from study staff. Analysis of
outcome date utilized latent growth curve modeling (i.e., change in outcomes over
time using random effects, multilevel analysis).
Literature cited
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Gotham, K., Pickles, A., & Lord, C. (2009). Standardizing ADOS scores for
a measure of severity in autism spectrum disorders. Journal of Autism
and Developmental Disorders, 39(5), 693705.
Odom, S. L., Boyd, B. A., Hall, L. J., & Hume, K. (2010). Evaluation of
Comprehensive Treatment Models for Individuals with Autism
Spectrum Disorders. Journal of Autism and Developmental Disorders,
40(4), 425436.
Reichow, B. (2012). Overview of Meta-Analyses on Early Intensive
Behavioral Intervention for Young Children with Autism Spectrum
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520.
Sallows, G. O., & Graupner, T. D. (2005). Intensive Behavioral Treatment
for Children With Autism: Four-Year Outcome and Predictors. American
Journal on Mental Retardation, 110(6), 417438.
Smith, T., Groen, A. D., & Wynn, J. W. (2000). Randomized trial of intensive
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Acknowledgments
OUHSC Team: Bonnie McBride, PhD; David Bard, PhD; Michael Hunter, PhD;
Kendra Murrill, MEd; Donna Wells, MEd; Lauren Ethridge, PhD; Mark Chaffin,
PhD
University of WA Team: Ilene Schwartz, PhD; Jennifer Fung, PhD; Ariane Gavreau,
PhD; Katy Batemen,BCBA; Yevgeniya Veverka,BCBA; Mary Cusic, MS/CCCSLP
The information reported here was supported in part by a grant from the Institute of
Education Sciences, U.S. Department of Education, through Grant R324A120232
to University of Oklahoma Health Sciences Center and University of Washington .
The opinions expressed are those of the authors and do not represent views of the
Institute or the U.S. Department of Education.