<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01724047</url>
  </required_header>
  <id_info>
    <org_study_id>12-001120</org_study_id>
    <nct_id>NCT01724047</nct_id>
  </id_info>
  <brief_title>Autism Intervention Research Network for Behavioral Health (AIR-B II): Deployment Into Elementary Schools</brief_title>
  <acronym>AIR-B II</acronym>
  <official_title>Autism Intervention Research Network for Behavioral Health (AIR-B II): Network Activity A: Conduct Research on Evidence-Based Practices.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Health Resources and Services Administration (HRSA)</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Health Resources and Services Administration (HRSA)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of this study is to identify efficacious and cost effective intervention&#xD;
      strategies that can improve academic and psychological outcomes for children with ASD, and&#xD;
      can be feasibly be implemented at fidelity by school personnel in under served elementary&#xD;
      schools. Two simultaneous interventions will occur.&#xD;
&#xD;
      In intervention 1, students with ASD in inclusion classrooms will be randomized to the&#xD;
      Playground Intervention or a waitlist control group. In the Playground Intervention,&#xD;
      UCLA/ROC/UPENN staff will work with school personals (teachers, paraprofessionals) to&#xD;
      increase peer engagement on the yard.&#xD;
&#xD;
      In intervention 2, students in special day classes will be randomized to the 'Schedule Tools&#xD;
      Activities Transitions' Intervention (STAT) or wait-list control. In the STAT Intervention,&#xD;
      UCLA/ROC/UPENN staff will work with teachers to implement behavioral strategies in the&#xD;
      classrooms.&#xD;
&#xD;
      In both interventions, the conditions are: 1) Immediate treatment, where the training will&#xD;
      begin immediately after baseline measures are completed. 2) Wait-list treatment, where the&#xD;
      training will begin the follow school year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Playground Intervention: Playground Peer Engagement</measure>
    <time_frame>Change from baseline to exit (12 weeks later) in the POPE</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Playground Intervention: Playground Peer Engagement</measure>
    <time_frame>Change from exit to follow up (3 months later) in the POPE</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Playground Intervention: Social Network Salience</measure>
    <time_frame>Change from baseline to exit (12 weeks later) in Playground Intervention Social Network</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Playground Intervention: Social Network Salience</measure>
    <time_frame>Change from exit to follow up (3 months later) in Playground Intervention Social Network</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>STAT Intervention: Teacher Behaviors and Student's Engagement in the Classrooms</measure>
    <time_frame>Change from Baseline to Exit (6 weeks later) in STAT Intervention: Classroom Observational Measure</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>STAT Intervention: Teacher Behaviors and Student's Engagement in the Classrooms</measure>
    <time_frame>Change from Exit to Follow Up (3 months later) in STAT Intervention: Classroom Observational Measure</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Playground Intervention: Teachers Ratings of Intervention Implementation</measure>
    <time_frame>Exit (12 weeks from Baseline)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Playground Intervention: Teacher's Perceptions of Intervention</measure>
    <time_frame>Change from baseline to exit (12 weeks later) in Playground Intervention Teacher Perception of Intervention</time_frame>
    <description>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, &amp; Zill, 2000).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STAT Intervention: Teacher Nominated Target Behaviors</measure>
    <time_frame>Change from baseline to exit (6 weeks later) in STAT Intervention: Teacher Nominated Target Behaviors</time_frame>
    <description>Teacher report of student's behavioral problems in the classroom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STAT Intervention: Teacher Nominated Target Behaviors</measure>
    <time_frame>Change from Exit to Follow Up (3 months later) in STAT Intervention Classroom Observational Measure</time_frame>
    <description>STAT Intervention: Classroom Observational Measure is an adaptive observational measure designed to capture teacher behaviors and student behaviors in the classroom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Playground Intervention Teacher's Perceptions of Intervention</measure>
    <time_frame>Change from exit to follow up (3 months later) in Playground Intervention Teacher Perception of Intervention</time_frame>
    <description>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, &amp; Zill, 2000).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STAT Intervention: Teacher Nominated Target Behaviors</measure>
    <time_frame>Change from exit to follow up (3 months later) in STAT Intervention: Teacher Nominated Target Behaviors</time_frame>
    <description>Teacher report of student's behavioral problems in the classroom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Playground Intervention: Coach Ratings of Aide Implementation</measure>
    <time_frame>Change from Baseline to Exit (12 weeks later) in Playground Intervention Coach Rated Aide Fidelity</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Playground Intervention: Coach Ratings of Aide Implementation</measure>
    <time_frame>Change from Exit to Follow Up (3 months follow up) in Playground Intervention Coach Rated Aide Fidelity</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Playground Intervention: Observer Ratings of Aide Implementation</measure>
    <time_frame>Change from baseline to exit (12 weeks later)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Playground Intervention: Observer Ratings of Aides Implementation</measure>
    <time_frame>Change from exit to follow up (3 months later)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STAT Intervention: Coach Rated Teacher Implementation</measure>
    <time_frame>Change from baseline to exit (6 weeks)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STAT Intervention: Coach Rated Teacher Implementation</measure>
    <time_frame>Change from exit to follow up (3 months)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STAT Intervention: Teacher Ratings of Implementation</measure>
    <time_frame>Exit (12 weeks from Baseline)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Playground Intervention: Aides Ratings of Effectiveness of Intervention</measure>
    <time_frame>Change from Baseline to Exit (12 weeks later) in Playground Intervention Aide Rated Fidelity</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STAT Intervention: Teachers Ratings of Effectiveness of Intervention</measure>
    <time_frame>Change from Baseline to Exit (12 weeks later) in STAT Intervention in Teacher Fidelity</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Playground Intervention: Aides Ratings of Effectiveness of Intervention</measure>
    <time_frame>Change from Exit to Follow Up (3 months later) in Playground Intervention Aide Rated Fidelity</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STAT Intervention: Teachers Ratings of Effectiveness of Intervention</measure>
    <time_frame>Change from Exit to Follow up (3 months later) in STAT Intervention in Teacher Fidelity</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Playground Intervention School Personnel Acceptability</measure>
    <time_frame>Change from Baseline to Exit (12 weeks later) in Acceptability of Playground Intervention</time_frame>
    <description>Playground Acceptability Scale is a 7-item questionnaire that uses a 5 point Likert Scale to rate acceptability</description>
  </other_outcome>
  <other_outcome>
    <measure>Playground Intervention: School Personnel Buy In of Intervention</measure>
    <time_frame>Exit (12 weeks from baseline)</time_frame>
    <description>The rate in which teachers and school personnel are accepting of the playground interventions strategies.</description>
  </other_outcome>
  <other_outcome>
    <measure>Playground Intervention: School Personnel Acceptability of Intervention</measure>
    <time_frame>Change from Exit to Follow Up (3 months later) in Acceptability of Playground Intervention</time_frame>
    <description>Playground Acceptability Scale is a 7-item questionnaire that uses a 5 point Likert Scale to assess acceptability of intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>STAT Intervention Teacher Buy In of Intervention</measure>
    <time_frame>Exit (6 weeks from baseline)</time_frame>
    <description>The rate in which teachers and school personnel are accepting of the STAT interventions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Playground Intervention: Teacher's Social Opportunities Interview</measure>
    <time_frame>At Baseline</time_frame>
    <description>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).</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Playground Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>STAT Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Playground Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Waitlist Control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>STAT Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Waitlist Control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Playground Intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>Playground Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>STAT Intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>STAT Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Child: Child has to meet the following criteria: 1) Child's primary classroom teacher&#xD;
             has consented to participate, 2) Child meets ADOS research criteria for autism&#xD;
             spectrum disorder, 3) Child is between 5-11 years old, 4) Child's parents consented to&#xD;
             have child participate, and 5) Child is placed in inclusion classroom or&#xD;
             self-contained special education classroom for a minimum of 50% of the school day.&#xD;
&#xD;
          2. Adult: School teachers and paraprofessionals working with children with ASD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Child: Participants will be excluded from the study if child has co-morbid disorders&#xD;
             such as cerebral palsy, Fragile X, Down syndrome. Child has profound vision or hearing&#xD;
             lose.&#xD;
&#xD;
          2. Adult: Participants will be excluded from the study if the adult is not a teacher,&#xD;
             administrator, teaching assistant, yard attendant, related services provider, or a&#xD;
             paraprofessional.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Connie Kasari, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Mandell, Sc.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tristram Smith, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Semel Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPENN Map Center for Mental Health Policy and Services Research</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104-2648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>September 22, 2014</last_update_submitted>
  <last_update_submitted_qc>September 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Connie Kasari, Ph.D.</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Autism</keyword>
  <keyword>School Based Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01724047
org study id: 12-001120
nct id: NCT01724047
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Playground Intervention: Playground Peer Engagement
time frame: Change from baseline to exit (12 weeks later) in the POPE
description: 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.
measure: Playground Intervention: Playground Peer Engagement
time frame: Change from exit to follow up (3 months later) in the POPE
description: 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.
measure: Playground Intervention: Social Network Salience
time frame: Change from baseline to exit (12 weeks later) in Playground Intervention Social Network
description: 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.
measure: Playground Intervention: Social Network Salience
time frame: Change from exit to follow up (3 months later) in Playground Intervention Social Network
description: 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.
measure: 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
description: 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.
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
description: 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.
measure: Playground Intervention: Teachers Ratings of Intervention Implementation
time frame: Exit (12 weeks from Baseline)
description: 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.
measure: Playground Intervention: Teacher's Perceptions of Intervention
time frame: Change from baseline to exit (12 weeks later) in Playground Intervention Teacher Perception of Intervention
description: 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).
measure: STAT Intervention: Teacher Nominated Target Behaviors
time frame: Change from baseline to exit (6 weeks later) in STAT Intervention: Teacher Nominated Target Behaviors
description: Teacher report of student's behavioral problems in the classroom.
measure: STAT Intervention: Teacher Nominated Target Behaviors
time frame: Change from Exit to Follow Up (3 months later) in STAT Intervention Classroom Observational Measure
description: STAT Intervention: Classroom Observational Measure is an adaptive observational measure designed to capture teacher behaviors and student behaviors in the classroom.
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
description: 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).
measure: STAT Intervention: Teacher Nominated Target Behaviors
time frame: Change from exit to follow up (3 months later) in STAT Intervention: Teacher Nominated Target Behaviors
description: Teacher report of student's behavioral problems in the classroom.
measure: Playground Intervention: Coach Ratings of Aide Implementation
time frame: Change from Baseline to Exit (12 weeks later) in Playground Intervention Coach Rated Aide Fidelity
description: 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.
measure: 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
description: 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.
measure: Playground Intervention: Observer Ratings of Aide Implementation
time frame: Change from baseline to exit (12 weeks later)
description: 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.
measure: Playground Intervention: Observer Ratings of Aides Implementation
time frame: Change from exit to follow up (3 months later)
description: 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.
measure: STAT Intervention: Coach Rated Teacher Implementation
time frame: Change from baseline to exit (6 weeks)
description: 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.
measure: STAT Intervention: Coach Rated Teacher Implementation
time frame: Change from exit to follow up (3 months)
description: 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.
measure: STAT Intervention: Teacher Ratings of Implementation
time frame: Exit (12 weeks from Baseline)
description: 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.
measure: Playground Intervention: Aides Ratings of Effectiveness of Intervention
time frame: Change from Baseline to Exit (12 weeks later) in Playground Intervention Aide Rated Fidelity
description: 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.
measure: STAT Intervention: Teachers Ratings of Effectiveness of Intervention
time frame: Change from Baseline to Exit (12 weeks later) in STAT Intervention in Teacher Fidelity
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: Playground Intervention School Personnel Acceptability
time frame: Change from Baseline to Exit (12 weeks later) in Acceptability of Playground Intervention
description: Playground Acceptability Scale is a 7-item questionnaire that uses a 5 point Likert Scale to rate acceptability
measure: Playground Intervention: School Personnel Buy In of Intervention
time frame: Exit (12 weeks from baseline)
description: The rate in which teachers and school personnel are accepting of the playground interventions strategies.
measure: Playground Intervention: School Personnel Acceptability of Intervention
time frame: Change from Exit to Follow Up (3 months later) in Acceptability of Playground Intervention
description: Playground Acceptability Scale is a 7-item questionnaire that uses a 5 point Likert Scale to assess acceptability of intervention.
measure: STAT Intervention Teacher Buy In of Intervention
time frame: Exit (6 weeks from baseline)
description: The rate in which teachers and school personnel are accepting of the STAT interventions.
measure: Playground Intervention: Teacher's Social Opportunities Interview
time frame: At Baseline
description: 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).
arm group label: Playground Intervention
arm group type: Experimental
description: 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.
arm group label: STAT Intervention
arm group type: Experimental
description: 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.
arm group label: Playground Waitlist Control
arm group type: No Intervention
description: Waitlist Control
arm group label: STAT Waitlist Control
arm group type: No Intervention
description: Waitlist Control
intervention type: Behavioral
intervention name: Playground Intervention
description: 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.
arm group label: Playground Intervention
intervention type: Behavioral
intervention name: STAT Intervention
description: 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.
arm group label: STAT Intervention
criteria: 
gender: All
minimum age: 4 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Connie Kasari, Ph.D
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: David Mandell, Sc.D
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Tristram Smith, Ph.D
role: Principal Investigator
affiliation: University of Rochester
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Connie Kasari, Ph.D.
investigator title: Professor
mesh term: Autistic Disorder