Clinical trial NCT01591707: Evaluating a Social and Communication Intervention for Preschoolers
Official title: Evaluating a Social and Communication Intervention for Preschoolers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism spectrum disorders
school
language
social
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2012-05-04
Enrollment: 700
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in educator instruction to meet fidelity of intervention.
timeFrame: approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention
Secondary outcomes:
measure: Change in Baseline Autism Diagnostic Observation Schedule
timeFrame: 9 months into treatment
measure: Change in Baseline Mullen Scales of Early Learning
timeFrame: 9 months into treatment
measure: Change in Child's Baseline Spontaneous Imitation Task
timeFrame: 9 months into treatment
measure: Change in Child Classroom-based Social Communication Performance
timeFrame: 9 months into treatment
measure: Change in parent perception of child behavior as recorded by the Autism Composite score of the PDDBI (parent version)
timeFrame: 9 months into treatment
Other outcomes:
Locations:
city: Newark
country: United States
facility: Brennen School
state: Delaware
city: Baltimore
country: United States
facility: Kennedy Krieger Institute/Howard County Public Schools
state: Maryland
city: Media
country: United States
facility: Elwyn Early Childhood Services
state: Pennsylvania
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Rebecca Landa, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References: