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

Study Overview
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Brief Summary
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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.

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

Conditions
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Autism

Intervention / Treatment
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* Behavioral: Playground Intervention
* Behavioral: STAT Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Playground Intervention<br>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. | Behavioral: Playground Intervention<br>* 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.<br>|
| Experimental: STAT Intervention<br>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. | Behavioral: STAT Intervention<br>* 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.<br>|
| No Intervention: Playground Waitlist Control<br>Waitlist Control | |
| No Intervention: STAT Waitlist Control<br>Waitlist Control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Playground Intervention: Playground Peer Engagement | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, School Based Intervention