Evaluating a Social and Communication Intervention for Preschoolers

Not Applicable

Active, not recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: ISC+PRT Intervention

• Registration Number: NCT01591707
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-04
• Study Start: 2012-07
• Status Verified: 2024-06
• Primary Completion: 2025-03
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ISC+PRT Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in educator instruction to meet fidelity of intervention.	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

Name	Time	Method
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 Baseline Autism Diagnostic Observation Schedule	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

Trial Locations

Locations (3)

Kennedy Krieger Institute/Howard County Public Schools; 🇺🇸 Baltimore, Maryland, United States

Elwyn Early Childhood Services; 🇺🇸 Media, Pennsylvania, United States

Brennen School; 🇺🇸 Newark, Delaware, United States