Autism Intervention Research Network for Behavioral Health (AIR-B II): Deployment Into Elementary Schools (AIR-B II)

September 22, 2014 updated by: Connie Kasari, Ph.D., Health Resources and Services Administration (HRSA)

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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90024
        • UCLA Semel Institute
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-2648
        • UPENN Map Center for Mental Health Policy and Services Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.
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.
No Intervention: Playground Waitlist Control
Waitlist Control
No Intervention: STAT Waitlist Control
Waitlist Control

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
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.
Change from baseline to exit (12 weeks later) in the POPE
Playground Intervention: Playground Peer Engagement
Time Frame: Change from exit to follow up (3 months later) in the POPE
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.
Change from exit to follow up (3 months later) in the POPE
Playground Intervention: Social Network Salience
Time Frame: Change from baseline to exit (12 weeks later) in Playground Intervention Social Network
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.
Change from baseline to exit (12 weeks later) in Playground Intervention Social Network
Playground Intervention: Social Network Salience
Time Frame: Change from exit to follow up (3 months later) in Playground Intervention Social Network
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.
Change from exit to follow up (3 months later) in Playground Intervention Social Network
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
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.
Change from Baseline to Exit (6 weeks later) in STAT Intervention: Classroom Observational Measure
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
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.
Change from Exit to Follow Up (3 months later) in STAT Intervention: Classroom Observational Measure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Playground Intervention: Teachers Ratings of Intervention Implementation
Time Frame: Exit (12 weeks from Baseline)
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.
Exit (12 weeks from Baseline)
Playground Intervention: Teacher's Perceptions of Intervention
Time Frame: Change from baseline to exit (12 weeks later) in Playground Intervention Teacher Perception of Intervention
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).
Change from baseline to exit (12 weeks later) in Playground Intervention Teacher Perception of Intervention
STAT Intervention: Teacher Nominated Target Behaviors
Time Frame: Change from baseline to exit (6 weeks later) in STAT Intervention: Teacher Nominated Target Behaviors
Teacher report of student's behavioral problems in the classroom.
Change from baseline to exit (6 weeks later) in STAT Intervention: Teacher Nominated Target Behaviors
STAT Intervention: Teacher Nominated Target Behaviors
Time Frame: Change from Exit to Follow Up (3 months later) in STAT Intervention Classroom Observational Measure
STAT Intervention: Classroom Observational Measure is an adaptive observational measure designed to capture teacher behaviors and student behaviors in the classroom.
Change from Exit to Follow Up (3 months later) in STAT Intervention Classroom Observational Measure
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
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).
Change from exit to follow up (3 months later) in Playground Intervention Teacher Perception of Intervention
STAT Intervention: Teacher Nominated Target Behaviors
Time Frame: Change from exit to follow up (3 months later) in STAT Intervention: Teacher Nominated Target Behaviors
Teacher report of student's behavioral problems in the classroom.
Change from exit to follow up (3 months later) in STAT Intervention: Teacher Nominated Target Behaviors
Playground Intervention: Coach Ratings of Aide Implementation
Time Frame: Change from Baseline to Exit (12 weeks later) in Playground Intervention Coach Rated Aide Fidelity
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.
Change from Baseline to Exit (12 weeks later) in Playground Intervention Coach Rated Aide Fidelity
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
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.
Change from Exit to Follow Up (3 months follow up) in Playground Intervention Coach Rated Aide Fidelity
Playground Intervention: Observer Ratings of Aide Implementation
Time Frame: Change from baseline to exit (12 weeks later)
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.
Change from baseline to exit (12 weeks later)
Playground Intervention: Observer Ratings of Aides Implementation
Time Frame: Change from exit to follow up (3 months later)
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.
Change from exit to follow up (3 months later)
STAT Intervention: Coach Rated Teacher Implementation
Time Frame: Change from baseline to exit (6 weeks)
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.
Change from baseline to exit (6 weeks)
STAT Intervention: Coach Rated Teacher Implementation
Time Frame: Change from exit to follow up (3 months)
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.
Change from exit to follow up (3 months)
STAT Intervention: Teacher Ratings of Implementation
Time Frame: Exit (12 weeks from Baseline)
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.
Exit (12 weeks from Baseline)
Playground Intervention: Aides Ratings of Effectiveness of Intervention
Time Frame: Change from Baseline to Exit (12 weeks later) in Playground Intervention Aide Rated Fidelity
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.
Change from Baseline to Exit (12 weeks later) in Playground Intervention Aide Rated Fidelity
STAT Intervention: Teachers Ratings of Effectiveness of Intervention
Time Frame: Change from Baseline to Exit (12 weeks later) in STAT Intervention in Teacher Fidelity
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.
Change from Baseline to Exit (12 weeks later) in STAT Intervention in Teacher Fidelity
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
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.
Change from Exit to Follow Up (3 months later) in Playground Intervention Aide Rated Fidelity
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
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.
Change from Exit to Follow up (3 months later) in STAT Intervention in Teacher Fidelity

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
Playground Acceptability Scale is a 7-item questionnaire that uses a 5 point Likert Scale to rate acceptability
Change from Baseline to Exit (12 weeks later) in Acceptability of Playground Intervention
Playground Intervention: School Personnel Buy In of Intervention
Time Frame: Exit (12 weeks from baseline)
The rate in which teachers and school personnel are accepting of the playground interventions strategies.
Exit (12 weeks from baseline)
Playground Intervention: School Personnel Acceptability of Intervention
Time Frame: Change from Exit to Follow Up (3 months later) in Acceptability of Playground Intervention
Playground Acceptability Scale is a 7-item questionnaire that uses a 5 point Likert Scale to assess acceptability of intervention.
Change from Exit to Follow Up (3 months later) in Acceptability of Playground Intervention
STAT Intervention Teacher Buy In of Intervention
Time Frame: Exit (6 weeks from baseline)
The rate in which teachers and school personnel are accepting of the STAT interventions.
Exit (6 weeks from baseline)
Playground Intervention: Teacher's Social Opportunities Interview
Time Frame: At Baseline
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).
At Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 6, 2012

First Posted (Estimate)

November 9, 2012

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 22, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

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.

Clinical Trials on Autism

Clinical Trials on Playground Intervention

3
Subscribe