Skip to main content
OpenTrials
Completed

NCT Number: NCT01591707

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Communication Language Mental Disorders Neurodevelopmental Disorders

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brennen School, Newark, Delaware, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in educator instruction to meet fidelity of intervention.

    Time frame: 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 outcomes

  1. Change in Baseline Autism Diagnostic Observation Schedule

    Time frame: 9 months into treatment

  2. Change in Baseline Mullen Scales of Early Learning

    Time frame: 9 months into treatment

  3. Change in Child's Baseline Spontaneous Imitation Task

    Time frame: 9 months into treatment

  4. Change in Child Classroom-based Social Communication Performance

    Time frame: 9 months into treatment

  5. 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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • U.S. Department of Education

Registry information

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
May 4, 2012
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.