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Evaluating a Social and Communication Intervention for Preschoolers

Primary Purpose

Autism Spectrum Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ISC+PRT Intervention
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism spectrum disorders, school, language, social

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brennen School
  • Kennedy Krieger Institute/Howard County Public Schools
  • Elwyn Early Childhood Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ISC+PRT Intervention

Instruction As Usual

Arm Description

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.

For the duration of at least one year children will receive the typical classroom instruction

Outcomes

Primary Outcome Measures

Change in educator instruction to meet fidelity of 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

Change in Baseline Autism Diagnostic Observation Schedule
Change in Baseline Mullen Scales of Early Learning
Change in Child's Baseline Spontaneous Imitation Task
Change in Child Classroom-based Social Communication Performance
Change in parent perception of child behavior as recorded by the Autism Composite score of the PDDBI (parent version)

Full Information

First Posted
April 30, 2012
Last Updated
April 21, 2023
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT01591707
Brief Title
Evaluating a Social and Communication Intervention for Preschoolers
Official Title
Evaluating a Social and Communication Intervention for Preschoolers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
U.S. Department of Education

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
autism spectrum disorders, school, language, social

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ISC+PRT Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Instruction As Usual
Arm Type
No Intervention
Arm Description
For the duration of at least one year children will receive the typical classroom instruction
Intervention Type
Behavioral
Intervention Name(s)
ISC+PRT Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in educator instruction to meet fidelity of intervention.
Description
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.
Time Frame
approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention
Secondary Outcome Measure Information:
Title
Change in Baseline Autism Diagnostic Observation Schedule
Time Frame
9 months into treatment
Title
Change in Baseline Mullen Scales of Early Learning
Time Frame
9 months into treatment
Title
Change in Child's Baseline Spontaneous Imitation Task
Time Frame
9 months into treatment
Title
Change in Child Classroom-based Social Communication Performance
Time Frame
9 months into treatment
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Landa, PhD, CCC-SLP
Organizational Affiliation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brennen School
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Kennedy Krieger Institute/Howard County Public Schools
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21211
Country
United States
Facility Name
Elwyn Early Childhood Services
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Evaluating a Social and Communication Intervention for Preschoolers

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