Evaluating a Social and Communication Intervention for Preschoolers

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: ISC+PRT Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • Brennen School
  • Maryland
    • Baltimore, Maryland, United States, 21211
      • Kennedy Krieger Institute/Howard County Public Schools
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Elwyn Early Childhood Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Baseline Autism Diagnostic Observation Schedule	9 months into treatment
Change in Baseline Mullen Scales of Early Learning	9 months into treatment
Change in Child's Baseline Spontaneous Imitation Task	9 months into treatment
Change in Child Classroom-based Social Communication Performance	9 months into treatment
Change in parent perception of child behavior as recorded by the Autism Composite score of the PDDBI (parent version)	9 months into treatment

Collaborators and Investigators

• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Collaborators: U.S. Department of Education

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: April 30, 2012
• First Submitted That Met QC Criteria: May 2, 2012
• First Posted (Estimate): May 4, 2012

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: language; autism spectrum disorders; social; school
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: NA_00073501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.