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

Autism Clinical Trial

— AIR-B II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724047
• Other study ID #: 12-001120
• Status: Completed
• Phase: N/A
• First received: November 5, 2012
• Last updated: September 22, 2014
• Start date: November 2012
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Health Resources and Services Administration (HRSA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Behavioral:
• Playground Intervention
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
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.

Locations

Country	Name	City	State
United States	UCLA Semel Institute	Los Angeles	California
United States	UPENN Map Center for Mental Health Policy and Services Research	Philadelphia	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
Health Resources and Services Administration (HRSA)	University of Pennsylvania, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Playground Intervention School Personnel Acceptability	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	No
Other	Playground Intervention: School Personnel Buy In of Intervention	The rate in which teachers and school personnel are accepting of the playground interventions strategies.	Exit (12 weeks from baseline)	No
Other	Playground Intervention: School Personnel Acceptability of 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	No
Other	STAT Intervention Teacher Buy In of Intervention	The rate in which teachers and school personnel are accepting of the STAT interventions.	Exit (6 weeks from baseline)	No
Other	Playground Intervention: Teacher's Social Opportunities Interview	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Autism Intervention Research Network on Behavioral Health