AutismAIR-B IINCT01724047
Autism Intervention Research Network for Behavioral Health (AIR-B II): Deployment Into Elementary Schools
A study testing Playground Intervention and STAT Intervention in people with Autism, run by Health Resources and Services Administration (HRSA) at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- Playground Intervention and STAT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UCLA Semel Institute
Los Angeles, California, 90024
UPENN Map Center for Mental Health Policy and Services Research
Philadelphia, Pennsylvania, 19104-2648
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Autism Intervention Research Network for Behavioral Health (AIR-B II): Network Activity A: Conduct Research on Evidence-Based Practices.
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.
Read more
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
- Being tested
- Playground Intervention, STAT Intervention
- Keywords
- Autism, School Based Intervention
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Playground InterventionBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: STAT Intervention |
| Playground Waitlist Control | No intervention | Waitlist Control |
| STAT Waitlist Control | No intervention | Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Exit to Follow up (3 months later) in STAT Intervention in Teacher Fidelity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Resources and Services Administration (HRSA)
- Sponsor type
- US federal agency
- Collaborators
- University of Rochester, University of Pennsylvania
- Responsible party
- Principal investigator, Connie Kasari, Ph.D., University of California, Los Angeles
- Investigators
- Connie Kasari, Ph.D, Principal investigator, University of California, Los AngelesDavid Mandell, Sc.D, Principal investigator, University of PennsylvaniaTristram Smith, Ph.D, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724047
- Sponsor's protocol ID
- 12-001120
- Acronym
- AIR-B II
- Status last verified
- Sep 2014
- First submitted
- 5 Nov 2012
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Intervention Research Network for Behavioral Health (AIR-B II): Network Activity A: Conduct Research on Evidence-Based Practices.
- ClinicalTrials.gov ID
- NCT01724047
- Acronym / sponsor ID
- AIR-B II / 12-001120
- Conditions
- Autism
- Keywords
- Autism, School Based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Health Resources and Services Administration (HRSA)US federal agency
- Collaborators
- University of Rochester, University of Pennsylvania
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Playground Intervention | Experimental | Behavioral: Playground InterventionSchools 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. |
| STAT Intervention | Experimental | Behavioral: STAT InterventionClassrooms 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. |
| Playground Waitlist Control | No intervention | –Waitlist Control |
| STAT Waitlist Control | No intervention | –Waitlist Control |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Playground InterventionIntervention 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. | Behavioural | Playground Intervention |
| STAT InterventionThis 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. | Behavioural | STAT Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
17 secondary outcomes
Playground Intervention: Teachers Ratings of Intervention Implementation
Time frame: Exit (12 weeks from Baseline)
Playground Intervention: Teacher's Perceptions of Intervention
Time frame: Change from baseline to exit (12 weeks later) in Playground Intervention Teacher Perception of Intervention
STAT Intervention: Teacher Nominated Target Behaviors
Time frame: Change from baseline to exit (6 weeks later) in STAT Intervention: Teacher Nominated Target Behaviors
STAT Intervention: Teacher Nominated Target Behaviors
Time frame: Change from Exit to Follow Up (3 months later) in STAT Intervention Classroom Observational 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
STAT Intervention: Teacher Nominated Target Behaviors
Time frame: Change from exit to follow up (3 months later) in STAT Intervention: Teacher Nominated Target Behaviors
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 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: Observer Ratings of Aide Implementation
Time frame: Change from baseline to exit (12 weeks later)
Playground Intervention: Observer Ratings of Aides Implementation
Time frame: Change from exit to follow up (3 months later)
STAT Intervention: Coach Rated Teacher Implementation
Time frame: Change from baseline to exit (6 weeks)
STAT Intervention: Coach Rated Teacher Implementation
Time frame: Change from exit to follow up (3 months)
STAT Intervention: Teacher Ratings of Implementation
Time frame: Exit (12 weeks from Baseline)
Playground Intervention: Aides Ratings of Effectiveness of Intervention
Time frame: Change from Baseline to Exit (12 weeks later) in Playground Intervention Aide Rated Fidelity
STAT Intervention: Teachers Ratings of Effectiveness of Intervention
Time frame: Change from Baseline to Exit (12 weeks later) in STAT Intervention in Teacher Fidelity
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Kasari, Ph.D principal investigator
University of California, Los Angeles
David Mandell, Sc.D principal investigator
University of Pennsylvania
Tristram Smith, Ph.D principal investigator
University of Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Playground Intervention and STAT Intervention in people with Autism, run by Health Resources and Services Administration (HRSA) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Playground Intervention: Playground Peer Engagement (time frame: Change from baseline to exit (12 weeks later) in the POPE). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.