Clinical trial NCT01724047: Autism Intervention Research Network for Behavioral Health (AIR-B II): Deployment Into Elementary Schools
Official title: Autism Intervention Research Network for Behavioral Health (AIR-B II): Network Activity A: Conduct Research on Evidence-Based Practices.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: Autism
School Based Intervention
Lead sponsor: Health Resources and Services Administration (HRSA)
Sponsor class: FED
Collaborators: name: University of Rochester
name: University of Pennsylvania
First posted: 2012-11-09
Enrollment: 250
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to identify efficacious and cost effective intervention strategies that can improve academic and psychological outcomes for children with ASD, and can be feasibly be implemented at fidelity by school personnel in under served elementary schools. Two simultaneous interventions will occur.

In intervention 1, students with ASD in inclusion classrooms will be randomized to the Playground Intervention or a waitlist control group. In the Playground Intervention, UCLA/ROC/UPENN staff will work with school personals (teachers, paraprofessionals) to increase peer engagement on the yard.

In intervention 2, students in special day classes will be randomized to the 'Schedule Tools Activities Transitions' Intervention (STAT) or wait-list control. In the STAT Intervention, UCLA/ROC/UPENN staff will work with teachers to implement behavioral strategies in the classrooms.

In both interventions, the conditions are: 1) Immediate treatment, where the training will begin immediately after baseline measures are completed. 2) Wait-list treatment, where the training will begin the follow school year.


Eligibility criteria: Inclusion Criteria:

1. Child: Child has to meet the following criteria: 1) Child's primary classroom teacher has consented to participate, 2) Child meets ADOS research criteria for autism spectrum disorder, 3) Child is between 5-11 years old, 4) Child's parents consented to have child participate, and 5) Child is placed in inclusion classroom or self-contained special education classroom for a minimum of 50% of the school day.
2. Adult: School teachers and paraprofessionals working with children with ASD.

Exclusion Criteria:

1. Child: Participants will be excluded from the study if child has co-morbid disorders such as cerebral palsy, Fragile X, Down syndrome. Child has profound vision or hearing lose.
2. Adult: Participants will be excluded from the study if the adult is not a teacher, administrator, teaching assistant, yard attendant, related services provider, or a paraprofessional.

Primary outcomes:
measure: Playground Intervention: Playground Peer Engagement
timeFrame: Change from baseline to exit (12 weeks later) in the POPE
measure: Playground Intervention: Playground Peer Engagement
timeFrame: Change from exit to follow up (3 months later) in the POPE
measure: Playground Intervention: Social Network Salience
timeFrame: Change from baseline to exit (12 weeks later) in Playground Intervention Social Network
measure: Playground Intervention: Social Network Salience
timeFrame: Change from exit to follow up (3 months later) in Playground Intervention Social Network
measure: STAT Intervention: Teacher Behaviors and Student's Engagement in the Classrooms
timeFrame: Change from Baseline to Exit (6 weeks later) in STAT Intervention: Classroom Observational Measure
measure: STAT Intervention: Teacher Behaviors and Student's Engagement in the Classrooms
timeFrame: Change from Exit to Follow Up (3 months later) in STAT Intervention: Classroom Observational Measure
Secondary outcomes:
measure: Playground Intervention: Teachers Ratings of Intervention Implementation
timeFrame: Exit (12 weeks from Baseline)
measure: Playground Intervention: Teacher's Perceptions of Intervention
timeFrame: Change from baseline to exit (12 weeks later) in Playground Intervention Teacher Perception of Intervention
measure: STAT Intervention: Teacher Nominated Target Behaviors
timeFrame: Change from baseline to exit (6 weeks later) in STAT Intervention: Teacher Nominated Target Behaviors
measure: STAT Intervention: Teacher Nominated Target Behaviors
timeFrame: Change from Exit to Follow Up (3 months later) in STAT Intervention Classroom Observational Measure
measure: Playground Intervention Teacher's Perceptions of Intervention
timeFrame: Change from exit to follow up (3 months later) in Playground Intervention Teacher Perception of Intervention
measure: STAT Intervention: Teacher Nominated Target Behaviors
timeFrame: Change from exit to follow up (3 months later) in STAT Intervention: Teacher Nominated Target Behaviors
measure: Playground Intervention: Coach Ratings of Aide Implementation
timeFrame: Change from Baseline to Exit (12 weeks later) in Playground Intervention Coach Rated Aide Fidelity
measure: Playground Intervention: Coach Ratings of Aide Implementation
timeFrame: Change from Exit to Follow Up (3 months follow up) in Playground Intervention Coach Rated Aide Fidelity
measure: Playground Intervention: Observer Ratings of Aide Implementation
timeFrame: Change from baseline to exit (12 weeks later)
measure: Playground Intervention: Observer Ratings of Aides Implementation
timeFrame: Change from exit to follow up (3 months later)
measure: STAT Intervention: Coach Rated Teacher Implementation
timeFrame: Change from baseline to exit (6 weeks)
measure: STAT Intervention: Coach Rated Teacher Implementation
timeFrame: Change from exit to follow up (3 months)
measure: STAT Intervention: Teacher Ratings of Implementation
timeFrame: Exit (12 weeks from Baseline)
measure: Playground Intervention: Aides Ratings of Effectiveness of Intervention
timeFrame: Change from Baseline to Exit (12 weeks later) in Playground Intervention Aide Rated Fidelity
measure: STAT Intervention: Teachers Ratings of Effectiveness of Intervention
timeFrame: Change from Baseline to Exit (12 weeks later) in STAT Intervention in Teacher Fidelity
measure: Playground Intervention: Aides Ratings of Effectiveness of Intervention
timeFrame: Change from Exit to Follow Up (3 months later) in Playground Intervention Aide Rated Fidelity
measure: STAT Intervention: Teachers Ratings of Effectiveness of Intervention
timeFrame: Change from Exit to Follow up (3 months later) in STAT Intervention in Teacher Fidelity
Other outcomes:
measure: Playground Intervention School Personnel Acceptability
timeFrame: Change from Baseline to Exit (12 weeks later) in Acceptability of Playground Intervention
measure: Playground Intervention: School Personnel Buy In of Intervention
timeFrame: Exit (12 weeks from baseline)
measure: Playground Intervention: School Personnel Acceptability of Intervention
timeFrame: Change from Exit to Follow Up (3 months later) in Acceptability of Playground Intervention
measure: STAT Intervention Teacher Buy In of Intervention
timeFrame: Exit (6 weeks from baseline)
measure: Playground Intervention: Teacher's Social Opportunities Interview
timeFrame: At Baseline
Locations:
city: Los Angeles
country: United States
facility: UCLA Semel Institute
state: California
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Philadelphia
country: United States
facility: UPENN Map Center for Mental Health Policy and Services Research
state: Pennsylvania
Study officials:
affiliation: University of California, Los Angeles
name: Connie Kasari, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: David Mandell, Sc.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Tristram Smith, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: