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Evaluating a Social and Communication Intervention for Preschoolers

Evaluating a Social and Communication Intervention for Preschoolers

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01591707
Enrollment
700
Registered
2012-05-04
Start date
2012-07-01
Completion date
2020-12-15
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

autism spectrum disorders, school, language, social

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.

Interventions

BEHAVIORALISC+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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in educator instruction to meet fidelity of intervention.approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the interventionFidelity 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

MeasureTime frame
Change in Baseline Autism Diagnostic Observation Schedule9 months into treatment
Change in Baseline Mullen Scales of Early Learning9 months into treatment
Change in Child's Baseline Spontaneous Imitation Task9 months into treatment
Change in Child Classroom-based Social Communication Performance9 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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRebecca Landa, PhD, CCC-SLP

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026