Development of an Intervention for Preschoolers With Autism
This study is currently recruiting participants.
Verified January 2013 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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: January 4, 2013
Last verified: January 2013
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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 |
|---|---|
|
Experimental: ISC+PRT Intervention Instruction As Usual |
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 ]
- Change in Educators' scores on the Perception of Barriers [ Time Frame: approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention ] [ 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 and older |
| 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 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
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: | January 4, 2013 |
| 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 May 23, 2013