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

NCT01724047 | Completed

• 1 other identifier: 12-001120
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Autism

Keywords

Autism; School Based Intervention

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (17)

• Playground Intervention: Teachers Ratings of Intervention Implementation

  Exit (12 weeks from Baseline)

• Playground Intervention: Teacher's Perceptions of Intervention

  Change from baseline to exit (12 weeks later) in Playground Intervention Teacher Perception of Intervention

• STAT Intervention: Teacher Nominated Target Behaviors

  Change from baseline to exit (6 weeks later) in STAT Intervention: Teacher Nominated Target Behaviors

• STAT Intervention: Teacher Nominated Target Behaviors

  Change from Exit to Follow Up (3 months later) in STAT Intervention Classroom Observational Measure

• Playground Intervention Teacher's Perceptions of Intervention

  Change from exit to follow up (3 months later) in Playground Intervention Teacher Perception of Intervention

Other Outcomes (5)

• Playground Intervention School Personnel Acceptability

  Change from Baseline to Exit (12 weeks later) in Acceptability of Playground Intervention

• Playground Intervention: School Personnel Buy In of Intervention

  Exit (12 weeks from baseline)

• Playground Intervention: School Personnel Acceptability of Intervention

  Change from Exit to Follow Up (3 months later) in Acceptability of Playground Intervention

Study Arms (4)

Playground Intervention

EXPERIMENTAL

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

STAT Intervention

EXPERIMENTAL

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

Playground Waitlist Control

NO INTERVENTION

Waitlist Control

STAT Waitlist Control

NO INTERVENTION

Waitlist Control

Interventions

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.

Playground Intervention

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.

STAT Intervention

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult: School teachers and paraprofessionals working with children with ASD.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Health Resources and Services Administration (HRSA): lead
• University of Rochester: collaborator
• University of Pennsylvania: collaborator

Study Sites (3)

UCLA Semel Institute

Los Angeles, California, 90024, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

UPENN Map Center for Mental Health Policy and Services Research

Philadelphia, Pennsylvania, 19104-2648, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

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

Study Officials

• Connie Kasari, Ph.D

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• David Mandell, Sc.D

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Tristram Smith, Ph.D

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 9, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

US (3)