Evaluating a Social and Communication Intervention for Preschoolers

NCT01591707 | Completed

• 1 other identifier: NA_00073501
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 3

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.

Conditions

Autism Spectrum Disorder

Keywords

autism spectrum disorders; school; language; social

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

ISC+PRT Intervention

EXPERIMENTAL

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

Instruction As Usual

NO INTERVENTION

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

Interventions

ISC+PRT Intervention BEHAVIORAL

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.

ISC+PRT Intervention

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Brennen School

Newark, Delaware, 19713, United States

Location

Kennedy Krieger Institute/Howard County Public Schools

Baltimore, Maryland, 21211, United States

Location

Elwyn Early Childhood Services

Media, Pennsylvania, 19063, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Language

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication; Behavior

Study Officials

• Rebecca Landa, PhD, CCC-SLP

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 4, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2020
• Study Completion: December 15, 2020
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (3)