Evaluating a Social and Communication Intervention for Preschoolers

NCT ID: NCT01591707

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2026-05-31

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.

Conditions

Autism Spectrum Disorder

Keywords

autism spectrum disorders; school; language; social

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

ISC+PRT Intervention

Intervention Type: 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.

Instruction As Usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Department of Education

FED

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Landa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Landa, PhD, CCC-SLP

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Brennen School

Newark, Delaware, United States

Kennedy Krieger Institute/Howard County Public Schools

Baltimore, Maryland, United States

Elwyn Early Childhood Services

Media, Pennsylvania, United States

Countries

United States

Other Identifiers

NA_00073501

Identifier Type: -

Identifier Source: org_study_id