Development of an Intervention for Preschoolers With Autism

This study is enrolling participants by invitation only.
U.S. Department of Education
Information provided by (Responsible Party):
Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Identifier:
First received: April 30, 2012
Last updated: January 15, 2016
Last verified: January 2016
The purpose of this study is to test the effectiveness of a school-based treatment aimed at increasing language and social skills in preschool-aged children with autism spectrum disorder (ASD). Through interactive development (continually seeking educator feedback for intervention improvement) and implementation of the intervention, the investigators hope to provide a feasible and practical means for educators to work with children with ASD in real world, large scale settings. ASD preschool educators, the children enrolled in their classes, between the ages of 3 and 6 years and their families may join.

Condition Intervention
Autism Spectrum Disorder
Behavioral: ISC+PRT Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of a Social and Communication Intervention for Preschoolers With Autism

Resource links provided by NLM:

Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:
  • Change in educator instruction to meet fidelity of intervention. [ Time Frame: approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention ] [ Designated as safety issue: No ]
    Fidelity will be monitored throughout the duration of the intervention by KKI staff to assess the quality and consistency with which educators implement the intervention.

Secondary Outcome Measures:
  • Change in Baseline Autism Diagnostic Observation Schedule [ Time Frame: 9 months into treatment ] [ Designated as safety issue: No ]
  • Change in Baseline Mullen Scales of Early Learning [ Time Frame: 9 months into treatment ] [ Designated as safety issue: No ]
  • Change in Child's Baseline Spontaneous Imitation Task [ Time Frame: 9 months into treatment ] [ Designated as safety issue: No ]
  • Change in Child Classroom-based Social Communication Performance [ Time Frame: 9 months into treatment ] [ Designated as safety issue: No ]
  • Change in parent perception of child behavior as recorded by the Autism Composite score of the PDDBI (parent version) [ Time Frame: 9 months into treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ISC+PRT Intervention
For the duration of at least one school year children will receive 45-90 minutes of intervention in the classroom in an attempt to increase social and communication skills.
Behavioral: ISC+PRT Intervention
Teachers will be trained to implement an intervention in preschool ASD classrooms that provides a learning environment in which social and communication skills are focused on.
No Intervention: Instruction As Usual
For the duration of at least one year children will receive the typical classroom instruction

Detailed Description:
For this most recent cohort, KKI staff will train Delaware preschool teachers to serve as model coaches and educators through the Delaware Autism Program. Families whose children are enrolled in participating classrooms have been consented through DAP using the school's consent to be videotaped. Any families who did not consent for their child to be videotaped for this training will receive the nonparticipant consent form currently utilized in this study and staff videotaping will take every effort to keep those children out of frame when taping. This cohort will involve KKI study team members training 1-2 coaches, who will then train five Delaware school teachers. The IES model will be implemented in the teacher's classrooms (n= 5-10 students participating in each classroom; 20-40 children total).

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

For Teachers:

- Work in an ASD preschool classroom within a cooperating Baltimore County Public School.

For Children:

  • Meet Autism Diagnostic Observation Schedule-Generic (ADOS; Lord et al., 2002) and expert clinical judgment criteria for ASD
  • Have an IQ or Developmental Quotient of at least 40 based on the Early Learning Composite from the Mullen Scales of Early Learning (Mullen, 1995)
  • Be enrolled in a participating Baltimore County Public School ASD preschool classroom
  • Be between the ages of 3 and 6 and enrolled in a participating ASD preschool classroom.

Exclusion Criteria:

Children and educators may be taken out of the study if they:

  • Are unable to comply with the study protocol
  • Change schools due to relocation

Children may also be taken out of this study if they:

  • Sustain a head injury or other serious physical injury during the study
  • Are not being brought in for testing as designated in the protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01591707

United States, Delaware
Brennen School
Newark, Delaware, United States, 19713
United States, Maryland
Kennedy Krieger Institute/Baltimore County Public Schools
Baltimore City/County, Maryland, United States
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
U.S. Department of Education
Principal Investigator: Rebecca Landa, PhD, CCC-SLP Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  More Information

Responsible Party: Rebecca Landa, Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Identifier: NCT01591707     History of Changes
Other Study ID Numbers: NA_00073501 
Study First Received: April 30, 2012
Last Updated: January 15, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
autism spectrum disorders

Additional relevant MeSH terms:
Autism Spectrum Disorder
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Neurodevelopmental Disorders processed this record on May 26, 2016