Development of an Intervention for Preschoolers With Autism

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01591707
First received: April 30, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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: 152
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01591707

Contacts
Contact: Rebecca Landa, PhD, CCC-SLP 443-923-7680 landa@kennedykrieger.org

Locations
United States, Maryland
Kennedy Krieger Institute/Baltimore County Public Schools Recruiting
Baltimore City/County, Maryland, United States
Contact: Rebecca Landa, Phd, CCC-SLP    443-923-7680    landa@kennedykrieger.org   
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
U.S. Department of Education
Investigators
Principal Investigator: Rebecca Landa, PhD, CCC-SLP Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  More Information

No publications provided

Responsible Party: Rebecca Landa, Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01591707     History of Changes
Other Study ID Numbers: NA_00073501
Study First Received: April 30, 2012
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014