Evaluating a Social and Communication Intervention for Preschoolers

Autism Spectrum Disorder Clinical Trial

Official title:

Evaluating a Social and Communication Intervention for Preschoolers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01591707
• Other study ID #: NA_00073501
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2012
• Est. completion date: March 2025

Study information

• Verified date: April 2023
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute/Howard County Public Schools	Baltimore	Maryland
United States	Elwyn Early Childhood Services	Media	Pennsylvania
United States	Brennen School	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

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