- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01724047
Autism Intervention Research Network for Behavioral Health (AIR-B II): Deployment Into Elementary Schools (AIR-B II)
Autism Intervention Research Network for Behavioral Health (AIR-B II): Network Activity A: Conduct Research on Evidence-Based Practices.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90024
- UCLA Semel Institute
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New York
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104-2648
- UPENN Map Center for Mental Health Policy and Services Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- Adult: School teachers and paraprofessionals working with children with ASD.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Playground Intervention
Schools will be randomized to one of two conditions.
The conditions are: 1) Immediate treatment, where the training will begin immediately after baseline measures are completed 2) Waitlist treatment, where the training will begin the following school year.
The initial delivery will occur for 30 minutes three times for a period of two to three weeks, then 30 minutes two times for a period of two weeks, then 30 minutes once a week for up to 16 sessions, within a period of 3 months, then a 30 minute follow up will occur 3 months later.
A systematic fading of intervention using performance feedback, coaching, and consultation.
Outcome measures will be administered at entry, end of treatment, and 3-month follow-up.
Entry diagnostic, exit and follow up assessments will last 1.5- 2 hours and participants will be assessed after school or in their homes.
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Intervention is designed for children diagnosed with an autism spectrum disorder (ASD) included in a regular education k through fifth grade classroom for at least 50% of the school day.
Schools will be randomized to one of two conditions.
The conditions are: 1) Immediate treatment, where the training will begin immediately after baseline measures are completed.
2) Waitlist treatment, where the training will begin the following school year.
This study will take place at school.
All intervention activities will be conducted during recess or lunch where children with autism may have the most difficulty interacting with peers.
A total of 14-16 intervention sessions will be held with the child with autism, school personnel, and the child's classmates.
The intervention will last approximately 3 months with a 3-month follow-up.
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Experimental: STAT Intervention
Classrooms will be randomized to one of two conditions.
The conditions are: 1) Immediate treatment, where the training will begin immediately after baseline measures are completed.
2) Waitlist treatment, where the training will begin the following school year.
The intervention will be over a period of 6 weeks, with baseline, treatment, and a follow up visit totaling 18 weeks at the school site.
Each visit is approximately 30 minutes.
A systematic fading of intervention using performance feedback, coaching, and consultation.
Outcome measures will be administered at entry, end of treatment.
Entry diagnostic, exit and follow up assessments will last 1.5- 2 hours and participants will be assessed after school or in their homes.
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This study will track the behavioral progress of children whose teachers receive training in these instructional methods.
This study also will examine the ability and willingness of teachers to use these methods as they were designed.
The study will last approximately 18 weeks (6 weeks of intervention, and a 3 month follow up visit).
This study will take place at school.
Classrooms will be randomized to one of two conditions.
The conditions are: 1) Immediate treatment, where the training will begin immediately after baseline measures are completed.
2) Waitlist treatment, where the training will begin the following school year.
All intervention activities will be conducted with a teacher during the school day but not during instructional time.
Study staff will visit the school on a weekly basis to train your child's teacher on evidence-based strategies for teaching children with autism.
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No Intervention: Playground Waitlist Control
Waitlist Control
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No Intervention: STAT Waitlist Control
Waitlist Control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Playground Intervention: Playground Peer Engagement
Time Frame: Change from baseline to exit (12 weeks later) in the POPE
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Playground Intervention: Peer Observation of Playground Engagement (POPE) measure.
Peer interactions on the playground will be coded using an interval-observation schedule of every 40 seconds (with 20 second coding intervals).
Interactive levels or states will be noted along with the presence or absence of discrete interactive behaviors during each coding interval.
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Change from baseline to exit (12 weeks later) in the POPE
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Playground Intervention: Playground Peer Engagement
Time Frame: Change from exit to follow up (3 months later) in the POPE
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Playground Intervention: Peer Observation of Playground Engagement (POPE) measure.
Peer interactions on the playground will be coded using an interval-observation schedule of every 40 seconds (with 20 second coding intervals).
Interactive levels or states will be noted along with the presence or absence of discrete interactive behaviors during each coding interval.
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Change from exit to follow up (3 months later) in the POPE
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Playground Intervention: Social Network Salience
Time Frame: Change from baseline to exit (12 weeks later) in Playground Intervention Social Network
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Playground Intervention: Social Network measure.
Based on the Cairns' (1994) method, participants will be asked to list all the names of children in their class who hang out together; this free-recall method is used rather than asking respondents to place each peer's name in a group, because the relative strength of students' tendency to recall classmates is an important indicator of the peers' prominence in the social structure.
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Change from baseline to exit (12 weeks later) in Playground Intervention Social Network
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Playground Intervention: Social Network Salience
Time Frame: Change from exit to follow up (3 months later) in Playground Intervention Social Network
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Playground Intervention: Social Network Measure.
Based on the Cairns' (1994) method, participants will be asked to list all the names of children in their class who hang out together; this free-recall method is used rather than asking respondents to place each peer's name in a group, because the relative strength of students' tendency to recall classmates is an important indicator of the peers' prominence in the social structure.
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Change from exit to follow up (3 months later) in Playground Intervention Social Network
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STAT Intervention: Teacher Behaviors and Student's Engagement in the Classrooms
Time Frame: Change from Baseline to Exit (6 weeks later) in STAT Intervention: Classroom Observational Measure
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STAT Intervention: The Classroom Observational Measure is an adaptive observational measure designed to capture teacher behaviors and student behaviors in the classroom that includes teacher's praises, behavioral control and student's on/off task behaviors.
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Change from Baseline to Exit (6 weeks later) in STAT Intervention: Classroom Observational Measure
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STAT Intervention: Teacher Behaviors and Student's Engagement in the Classrooms
Time Frame: Change from Exit to Follow Up (3 months later) in STAT Intervention: Classroom Observational Measure
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STAT Intervention: The Classroom Observational Measure is an adaptive observational measure designed to capture teacher behaviors and student behaviors in the classroom that includes teacher's praises, behavioral control and student's on/off task behaviors.
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Change from Exit to Follow Up (3 months later) in STAT Intervention: Classroom Observational Measure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Playground Intervention: Teachers Ratings of Intervention Implementation
Time Frame: Exit (12 weeks from Baseline)
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Playground Intervention Teacher Implementation Climate Measure.
Climate for Implementation Measure is a 17-item questionnaire to measure the climate of each classroom.
The survey asks teachers and aides to rate their perception of program quality and ease of use, and global perceptions of staff climate.
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Exit (12 weeks from Baseline)
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Playground Intervention: Teacher's Perceptions of Intervention
Time Frame: Change from baseline to exit (12 weeks later) in Playground Intervention Teacher Perception of Intervention
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The teacher perception of social skill (TPSS) is a 26-item questionnaire that uses a 3-point Likert scale to rate 12 items regarding teachers' perceptions of participants' social skills (1 = never, 2 = sometimes and 3 = very often).
The social skills domain describes the child's strengths, such as adaptability to the school classroom and environment, quality of interactions with peers, and popularity or likeability among peers (Sorongon, Kim, & Zill, 2000).
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Change from baseline to exit (12 weeks later) in Playground Intervention Teacher Perception of Intervention
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STAT Intervention: Teacher Nominated Target Behaviors
Time Frame: Change from baseline to exit (6 weeks later) in STAT Intervention: Teacher Nominated Target Behaviors
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Teacher report of student's behavioral problems in the classroom.
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Change from baseline to exit (6 weeks later) in STAT Intervention: Teacher Nominated Target Behaviors
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STAT Intervention: Teacher Nominated Target Behaviors
Time Frame: Change from Exit to Follow Up (3 months later) in STAT Intervention Classroom Observational Measure
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STAT Intervention: Classroom Observational Measure is an adaptive observational measure designed to capture teacher behaviors and student behaviors in the classroom.
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Change from Exit to Follow Up (3 months later) in STAT Intervention Classroom Observational Measure
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Playground Intervention Teacher's Perceptions of Intervention
Time Frame: Change from exit to follow up (3 months later) in Playground Intervention Teacher Perception of Intervention
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The teacher perception of social skill (TPSS) is a 26-item questionnaire that uses a 3-point Likert scale to rate 12 items regarding teachers' perceptions of participants' social skills (1 = never, 2 = sometimes and 3 = very often).
The social skills domain describes the child's strengths, such as adaptability to the school classroom and environment, quality of interactions with peers, and popularity or likeability among peers (Sorongon, Kim, & Zill, 2000).
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Change from exit to follow up (3 months later) in Playground Intervention Teacher Perception of Intervention
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STAT Intervention: Teacher Nominated Target Behaviors
Time Frame: Change from exit to follow up (3 months later) in STAT Intervention: Teacher Nominated Target Behaviors
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Teacher report of student's behavioral problems in the classroom.
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Change from exit to follow up (3 months later) in STAT Intervention: Teacher Nominated Target Behaviors
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Playground Intervention: Coach Ratings of Aide Implementation
Time Frame: Change from Baseline to Exit (12 weeks later) in Playground Intervention Coach Rated Aide Fidelity
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Playground Intervention-Coach Rated Aide Fidelity.
Fidelity forms will measure implementation mastery of interventionists and school personnel.
This is to ensure that interventionists are teaching and conveying strategies at a high standard and school personnel are delivery strategies at a high level.
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Change from Baseline to Exit (12 weeks later) in Playground Intervention Coach Rated Aide Fidelity
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Playground Intervention: Coach Ratings of Aide Implementation
Time Frame: Change from Exit to Follow Up (3 months follow up) in Playground Intervention Coach Rated Aide Fidelity
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Playground Intervention: Coach Rated Aide Fidelity.
Fidelity forms will measure implementation mastery of interventionists and school personnel.
This is to ensure that interventionists are teaching and conveying strategies at a high standard and school personnel are delivery strategies at a high level.
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Change from Exit to Follow Up (3 months follow up) in Playground Intervention Coach Rated Aide Fidelity
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Playground Intervention: Observer Ratings of Aide Implementation
Time Frame: Change from baseline to exit (12 weeks later)
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Playground Intervention: Observer Rated Aide Fidelity.
Fidelity forms will measure implementation mastery of interventionists and school personnel.
This is to ensure that interventionists are teaching and conveying strategies at a high standard and school personnel are delivery strategies at a high level.
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Change from baseline to exit (12 weeks later)
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Playground Intervention: Observer Ratings of Aides Implementation
Time Frame: Change from exit to follow up (3 months later)
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Playground Intervention: Observer Rated Aide fidelity.
Fidelity forms will measure implementation mastery of interventionists and school personnel.
This is to ensure that interventionists are teaching and conveying strategies at a high standard and school personnel are delivery strategies at a high level.
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Change from exit to follow up (3 months later)
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STAT Intervention: Coach Rated Teacher Implementation
Time Frame: Change from baseline to exit (6 weeks)
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STAT Intervention: Coach Rated Teacher Fidelity.
Fidelity forms will measure implementation mastery of interventionists and school personnel.
This is to ensure that interventionists are teaching and conveying strategies at a high standard and school personnel are delivery strategies at a high level.
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Change from baseline to exit (6 weeks)
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STAT Intervention: Coach Rated Teacher Implementation
Time Frame: Change from exit to follow up (3 months)
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STAT Intervention: Coach Rated Teacher Fidelity.
Fidelity forms will measure implementation mastery of interventionists and school personnel.
This is to ensure that interventionists are teaching and conveying strategies at a high standard and school personnel are delivery strategies at a high level.
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Change from exit to follow up (3 months)
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STAT Intervention: Teacher Ratings of Implementation
Time Frame: Exit (12 weeks from Baseline)
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Climate for Implementation Measure is a 17-item questionnaire to measure the climate of each classroom.
The survey asks teachers and aides to rate their perception of program quality and ease of use, and global perceptions of staff climate.
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Exit (12 weeks from Baseline)
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Playground Intervention: Aides Ratings of Effectiveness of Intervention
Time Frame: Change from Baseline to Exit (12 weeks later) in Playground Intervention Aide Rated Fidelity
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Playground Intervention Aide Rate Fidelity.
Fidelity forms will measure implementation mastery of interventionists and school personnel.
This is to ensure that interventionists are teaching and conveying strategies at a high standard and school personnel are delivery strategies at a high level.
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Change from Baseline to Exit (12 weeks later) in Playground Intervention Aide Rated Fidelity
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STAT Intervention: Teachers Ratings of Effectiveness of Intervention
Time Frame: Change from Baseline to Exit (12 weeks later) in STAT Intervention in Teacher Fidelity
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STAT Intervention Teacher Fidelity.
Fidelity forms will measure implementation mastery of interventionists and school personnel.
This is to ensure that interventionists are teaching and conveying strategies at a high standard and school personnel are delivery strategies at a high level.
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Change from Baseline to Exit (12 weeks later) in STAT Intervention in Teacher Fidelity
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Playground Intervention: Aides Ratings of Effectiveness of Intervention
Time Frame: Change from Exit to Follow Up (3 months later) in Playground Intervention Aide Rated Fidelity
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Playground Intervention Aide Rated Fidelity.
Fidelity forms will measure implementation mastery of interventionists and school personnel.
This is to ensure that interventionists are teaching and conveying strategies at a high standard and school personnel are delivery strategies at a high level.
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Change from Exit to Follow Up (3 months later) in Playground Intervention Aide Rated Fidelity
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STAT Intervention: Teachers Ratings of Effectiveness of Intervention
Time Frame: Change from Exit to Follow up (3 months later) in STAT Intervention in Teacher Fidelity
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STAT Intervention Teacher's Fidelity.
Fidelity forms will measure implementation mastery of interventionists and school personnel.
This is to ensure that interventionists are teaching and conveying strategies at a high standard and school personnel are delivery strategies at a high level.
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Change from Exit to Follow up (3 months later) in STAT Intervention in Teacher Fidelity
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Playground Intervention School Personnel Acceptability
Time Frame: Change from Baseline to Exit (12 weeks later) in Acceptability of Playground Intervention
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Playground Acceptability Scale is a 7-item questionnaire that uses a 5 point Likert Scale to rate acceptability
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Change from Baseline to Exit (12 weeks later) in Acceptability of Playground Intervention
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Playground Intervention: School Personnel Buy In of Intervention
Time Frame: Exit (12 weeks from baseline)
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The rate in which teachers and school personnel are accepting of the playground interventions strategies.
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Exit (12 weeks from baseline)
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Playground Intervention: School Personnel Acceptability of Intervention
Time Frame: Change from Exit to Follow Up (3 months later) in Acceptability of Playground Intervention
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Playground Acceptability Scale is a 7-item questionnaire that uses a 5 point Likert Scale to assess acceptability of intervention.
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Change from Exit to Follow Up (3 months later) in Acceptability of Playground Intervention
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STAT Intervention Teacher Buy In of Intervention
Time Frame: Exit (6 weeks from baseline)
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The rate in which teachers and school personnel are accepting of the STAT interventions.
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Exit (6 weeks from baseline)
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Playground Intervention: Teacher's Social Opportunities Interview
Time Frame: At Baseline
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This interview captures the daily activities (and amount of time spent in those activities) of children with ASD in inclusive settings as well as the number of social opportunities children with ASD have with their peers throughout the school day (despite level of engagement in those activities).
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At Baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Connie Kasari, Ph.D, University of California, Los Angeles
- Principal Investigator: David Mandell, Sc.D, University of Pennsylvania
- Principal Investigator: Tristram Smith, Ph.D, University of Rochester
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-001120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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