Randomized Controlled Trial of the P.L.A.Y. (Play and Language for Autistic Youngsters) Project Intervention for Autism

A growing number of children (1 in 88) with autistic spectrum disorders ASD need intensive
intervention (25 hours/week, 1:1 or 1:2 teacher to pupil ratio), which most states do not
provide because a) there is a national shortage of trained personnel, b) such interventions
are very expensive and c) an evidence-based, cost-effective model has not yet been developed
for national dissemination. The unmet national need is enormous.

The P.L.A.Y. (Play and Language for Autistic Youngsters) Project Home Consultation model
(PLAY), under the direction of developmental and behavioral pediatrician Richard Solomon MD,
is an innovative train-the-trainer solution that could potentially address this national
need.

Since publication of the pilot study in 2007*, PLAY was awarded a $1.8 million 3 year NIH
SBIR (Small Business Innovations Research) grant in 2009 to implement a randomized,
multi-site, blinded, controlled effectiveness study. This study compares control children
receiving Community Standard Services (CSS)—12-14 hours of special education pre-school—to
intervention children receiving CSS plus the PLAY Project—a once a month (3 hour),
home-based, parent training program using trained masters level home consultants (HCs). PLAY
operationalizes Greenspan's DIR theoretical framework into a practical approach to help
parents be more sensitive, responsive, and effective in interacting with their children with
ASD.

With Easter Seals National as our clinical partner and and Michigan State University (Hiram
Fitzgerald PhD) as our evaluation partner, the PLAY Project NIH Grant successfully recruited
112, 3-5 year old children with autism spectrum disorders, at 5 Easter Seals sites. Each year
a cohort of 30 families received monthly 3-hour PLAY Project home visits for 12 months. Thus
a total of 60 intervention families and 60 control families were recruited.

Final results from both cohorts (n = 112) confirm that PLAY intervention children improved
when compared to the control group with clinically and statistically significant less severe
autism as measured by the ADOS, better language scores as measured by the MacArthur Child
Development Inventories and improved ability to interact as scored by blinded raters using
Mahoney's Child Behavior (Video) Rating Scale. PLAY parents, after a year of intervention,
were markedly more sensitive, responsive, and effective during interactions with their
children as scored by blinded raters using Mahoney's Child Behavior (Video) Rating Scale.
When compared to control parents, PLAY Parents showed significantly less depression over the
year of intervention. Despite asking parents to provide 2 hours per day of intervention at
home parent stress was not increased. Home consultants show fidelity to the model.

The PLAY Project shows promise as a replicable developmental model of autism intervention
using an efficient train-the-trainer model at relatively low cost to parents and society that
can be broadly and quickly disseminated to serve a growing, unmet national need.

* Solomon R, Necheles J, Ferch C, Bruckman D, (2007) Pilot study of a parent training program
for young children with autism: The PLAY Project Home Consultation program. Autism Vol 11(3)
205-224.

Inclusion Criteria: Children ages 3-5 years 11 months old diagnosed with autism.

Exclusion Criteria:

We excluded children if they had been diagnosed with Asperger's Syndrome, had identifiable
genetic disorders, severe medical conditions, a parent with severe psychiatric disorder or
cognitive impairment, and/or families who did not speak English with their child. Families
in the CS group who reported receiving intensive intervention (>10 hours/week of a
programmatic approach to ASD—check this) were excluded from the study.