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Evaluating a Social and Communication Intervention for Preschoolers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01591707
Recruitment Status : Recruiting
First Posted : May 4, 2012
Last Update Posted : December 23, 2019
U.S. Department of Education
Information provided by (Responsible Party):
Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: ISC+PRT Intervention Not Applicable

Detailed Description:

In Phase 4, KKI staff trained Delaware preschool teachers to serve as model coaches and educators through the Delaware Autism Program. Families whose children were enrolled in participating classrooms were 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 received the nonparticipant consent form currently utilized in this study and staff videotaping took every effort to keep those children out of frame when taping. This cohort involved KKI study team members training 1-2 coaches, who then trained five Delaware school teachers. The IES model was implemented in the teacher's classrooms (n= 5-10 students participating in each classroom; 20-40 children total).

In the current phase of the study, Phase 5 and 6, KKI study team members will continue the evaluation of the IES model, by testing the efficacy of the intervention model in a larger sample (Phase 5) and then analyzing the corresponding data (Phase 6). The larger efficacy study (phase 5) will be conducted on teachers and students recruited from public school districts in Maryland, Delaware, and Pennsylvania using the same IES model and recruitment methods in the previous phases.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating a Social and Communication Intervention for Preschoolers
Study Start Date : July 2012
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Change in Baseline Autism Diagnostic Observation Schedule [ Time Frame: 9 months into treatment ]
  2. Change in Baseline Mullen Scales of Early Learning [ Time Frame: 9 months into treatment ]
  3. Change in Child's Baseline Spontaneous Imitation Task [ Time Frame: 9 months into treatment ]
  4. Change in Child Classroom-based Social Communication Performance [ Time Frame: 9 months into treatment ]
  5. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01591707

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Contact: Rebecca Landa, PhD, CCC-SLP 443-923-7680

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United States, Delaware
Brennen School Enrolling by invitation
Newark, Delaware, United States, 19713
United States, Maryland
Kennedy Krieger Institute/Howard County Public Schools Recruiting
Baltimore, Maryland, United States, 21211
Contact: Rebecca Landa, Phd, CCC-SLP    443-923-7680   
United States, Pennsylvania
Elwyn Early Childhood Services Recruiting
Media, Pennsylvania, United States, 19063
Contact: Kyu Hwang    610-891-2196   
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
U.S. Department of Education
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Principal Investigator: Rebecca Landa, PhD, CCC-SLP Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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Responsible Party: Rebecca Landa, Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Identifier: NCT01591707    
Other Study ID Numbers: NA_00073501
First Posted: May 4, 2012    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data for teachers will be shared with the Delaware Autism Program to determine feasibility of model implementation. Child participant data will not be shared.
Keywords provided by Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
autism spectrum disorders
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders