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Completed

NCT Number: NCT01724047

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

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Semel Institute, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Playground Intervention

Behavioral

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.

STAT Intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

Other outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

Health Resources and Services Administration (HRSA)

Fed

Collaborators

  • University of Pennsylvania
  • University of Rochester

Registry information

Official study title

Autism Intervention Research Network for Behavioral Health (AIR-B II): Network Activity A: Conduct Research on Evidence-Based Practices.

Acronym: AIR-B II

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 9, 2012
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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