Condition category
Not Applicable
Date applied
13/05/2019
Date assigned
16/05/2019
Last edited
16/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
School safety is fundamental to fostering positive outcomes for children and youth, such as academic achievement, well-being, and prosocial behavior. A safe school is defined as one that minimizes violence, promotes student mental health, and fosters a positive climate. Violence remains a pressing concern in American schools: in 2013, nearly 20% of high school students were bullied at school, while 8% had been in a physical fight on school property. Even by ages 10-11, more than half of boys and one-third of girls are either victims of or engage in delinquent behaviors. Among girls, victimization and delinquency increase significantly between ages 11 and 12; among boys, a corresponding jump occurs between ages 13 and 14. Similarly, over half of lifetime mental health concerns become evident before age 14. Thus, interventions to promote safety likely need to focus as early as elementary school. Such interventions should emphasize a positive school climate, which includes the appropriate connections, support, and commitment to promote positive outcomes. This study will examine a comprehensive multi-component intervention targeted to fourth through sixth graders (i.e. 9–12 year olds), using primary and secondary prevention approaches.

Who can participate?
Students in 4th- 6th grade (i.e. 9–12 year olds) and school staff and teachers at participating schools in Michigan (USA)

What does the study involve?
Participating schools are randomly allocated to either the treatment group or the control group. The ten treatment schools receive interventions in restorative justice practices and mental health first aid. These schools also receive a physical assessment and work to make physical changes to improve school safety. At each school, a three-person leadership team, led by a mental health professional and comprised of one police officer and one school staff member, makes decisions and guides the intervention. The control schools do not receive these interventions. The research involves an evaluation of the effectiveness of the interventions on school climate, classroom management and student behavioral outcomes. Students in 4th, 5th and 6th grades at the intervention schools and the control schools are invited to complete a survey. Teachers and school staff at the intervention schools are also invited to take a survey. Students receive a follow-up survey at the end of the school year. The researchers use data currently collected by Genesee Intermediate School District (GISD) schools, including the School Wide Information System (SWIS) database, to record behavioral referrals and truancy, and the MiPHY (Michigan Profile for Healthy Youth). The researchers also survey teachers regarding their perceptions of school climate and safety. The teachers at intervention schools can benefit by enhancing their classroom management skills. The study also looks at how different schools implement the interventions and ways to keep these programs going by doing focus groups with key stakeholders, teachers, and students. Finally, a cost-benefit analysis is conducted with regard to violence outcomes.

What are the possible benefits and risks of participating?
There are no personal benefits to participants. Results from this study, however, will help to determine whether a comprehensive school climate initiative can improve the learning environment in Genesee County, MI schools, and how local school districts can improve school climate. There are no foreseeable risks associated with student’s participation in this study because the information is protected by Federal statute; that is, his/her answers cannot be shared with anyone.

Where is the study run from?
Michigan State University and the University of Michigan partners with the Genesee Intermediate School District for this study

When is the study starting and how long is it expected to run for?
September 2017 to June 2020

Who is funding the study?
National Institute of Justice (USA)

Who are the main contacts for this study?
1. Edmund McGarrell
mcgarrel@msu.edu
2. Justin Heinze
jheinze@umich.edu

Trial website

Contact information

Type

Public

Primary contact

Dr Edmund McGarrell

ORCID ID

Contact details

Professor School of Criminal Justice
Michigan State University
Baker Hall
Room 441
655 Auditorium Road
East Lansing
48824-1118
United States of America
+1 (0)517/355 6649
mcgarrel@msu.edu

Type

Scientific

Additional contact

Dr Edmund McGarrell

ORCID ID

Contact details

Professor School of Criminal Justice
Michigan State University
Baker Hall
Room 441
655 Auditorium Road
East Lansing
48824-1118
United States of America
+1 (0)517/355 6649
mcgarrel@msu.edu

Type

Public

Additional contact

Dr Justin Heinze

ORCID ID

Contact details

HBHE
3818 SPH I
Ann Arbor
48109-2929
United States of America
+1 (0)734- 615 4992
jheinze@umich.edu

Type

Scientific

Additional contact

Dr Justin Henize

ORCID ID

Contact details

HBHE
3818 SPH I
Ann Arbor
MI
48109-2029
United States of America
+1 (0)734 615 4992
jheize@umich.edu

Type

Public

Additional contact

Dr Andria Eisman

ORCID ID

Contact details

Health Behavior Health Education
1415 Washington Hts #3706
Ann Arbor
48109-2029
United States of America
+1 (0)734 763 1989
aeisman@umich.edu

Type

Scientific

Additional contact

Dr Andria Eisman

ORCID ID

Contact details

Health Behavior Health Education
1415 Washington Hts #3706
Ann Arbor
MI
48109-2029
United States of America
+1 (0)734 763 1989
aeisman@umich.edu

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IP #00118484 verify

Study information

Scientific title

Comprehensive approaches to addressing mental health needs and enhancing school security: a cluster randomized controlled trial

Acronym

CSSI

Study hypothesis

1.1 Do students in schools receiving the intervention report less violence (over time) compared with students in the control group? Do the intervention schools have an overall lower rate of violence over the school year compared with control schools?
1.2 Are there fewer records of truancy and behavioral referrals in the intervention schools as compared with change among the control school records over time?
2. Mediation effects of school climate and mental health:
2.1 Do intervention school students report more positive school climate and mental health compared with students in control schools over time? Does change of positive school climate predict change toward positive mental health and reduced violence?
2.2 Do teachers in the intervention schools report more positive school climate compared with teachers in control schools control over time? Is greater teacher-reported school climate associated with more positive student mental health and reduced violence?
3. Implementation evaluation
3.1 Is the intervention able to be implemented as planned as reported by school staff (including the 3-PLT) and students in each year of the program?
3.2 Is there evidence that the three intervention components are implemented in an integrated fashion as reported by school staff and students as well as by activity logs and observation (e.g., environmental design components)?
4. Cost-Benefit Analysis:
4.1 How do the costs of the intervention compare with benefits associated with less violence?

Ethics approval

1. Approved 27/09/2017, Michigan State University Institutional Review Board (4000 Collins Rd., Suite 136, Lansing, MI 48910; Tel: +1 (0)517 355 2180; Email: irb@ora.msu.edu), IRB# x15-1129e Category: EXEMPT 1
2. Approved 19/12/2017, University of Michigan Health Science and Behavioral Science Institutional Review Board (2800 Plymouth Rd, Bldg. 520, Rm. 1169, Ann Arbor, MI 48109, Tel: +1 (0)734 936 0933; Email: irbhsbs@umich.edu), HUM00139400, EXEMPT
3. Approved 22/12/2017, University of Michigan Health Science and Behavioral Science Institutional Review Board (2800 Plymouth Rd, Bldg. 520, Rm. 1169, Ann Arbor, MI 48109, Tel: +1 (0)734 936 0933; Email: irbhsbs@umich.edu), HUM00114385, EXEMPT

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Condition

School safety

Intervention

The overarching framework for the intervention is guided by the premise that elementary school safety can be promoted through a positive school climate, which in turn is associated with better mental health and less violence. The researchers propose to implement a comprehensive intervention using a compilation of evidence-based approaches tailored to individual school contexts by a leadership team within each school, led by a climate specialist. The approach centers around fostering positive school climate among elementary-aged students, targeting change early and building support systems.

The intervention will be implemented over three years to facilitate change in school climate. The intervention will be staggered (5 intervention schools starting in Year 1; 5 additional schools in Year 2) in order to maximize the likelihood of intensive implementation. The intervention centers on three key areas: (i) at a universal prevention level, focusing on changes to the physical school environment (environmental design) and promoting consistent and fair discipline and reward practices (restorative justice); (ii) a more targeted approach, to help those with early signs of mental health problems (mental health first aid); and (iii) engaging those involved in violent or aggressive situations at school through restorative justice practices. Each school will recruit a three-person leadership team (3-PLT) comprised of a school resource officer (police), a school staff member, and led by a full-time mental health expert (who will hold an advanced degree in counseling/social work) employed for this project.

All eligible schools (N = 35) in the county were listed in an Excel file. Each school was assigned a random number through the Microsoft Excel random number generator between 1 and 1,000. The schools were then sorted from highest random number to lowest random number. The first ten schools were identified as treatment schools, and the second ten were identified as control schools to initially approach for inclusion in the study. The remaining schools were assigned as replacement treatment or control schools on an every other case basis (i.e., alternative treatment, alternative control, alternative treatment, alternative control). If an initially identified treatment or control school declined participation, the researchers would select the next alternative treatment or control school in the list to approach for participation. The cohort in which they were assigned was not random. Rather, that process was dictated through a negotiation with the GISD and the school district.

Although the framework and underlying foundational principles for interventions can be consistent, intervention delivery will vary across individual schools, making complete standardization difficult. The proposed study seeks to standardize processes and components where feasible, and account for differences in school readiness, practices, and resources differ; the researchers therefore seek to evaluate the feasibility of district-wide (yet individualized) implementation of the three school safety components using the implementation facilitation strategy. Facilitation includes diverse, implementation-science informed, tailored activities that enhance intervention delivery (e.g., stakeholder engagement), and identify and solve implementation challenges. Facilitation will be delivered via regular contact with the school staff and other 3-PLT members by the climate specialist (CS) trained in program implementation and use of RJ, MHFA and CPTED in schools. The CS will support the school staff and 3-PLT in strategic thinking and program specific skills to address barriers related to the context, innovation, provider and recipients.

The 3-PLT will be provided with a comprehensive set of resources and training for components of MHFA, restorative justice, and environmental design planning. The 3-PLT will be trained to deliver MHFA training to all school staff, deliver restorative justice efforts (e.g., be trained in peer mediation and similar restorative processes and facilitate this within schools), and liaise with expert consultants of environmental design. Environmental design components will be tailored for each school's unique physical and social structures; in general, aspects of the school's image/management, and increasing ownership of undefined spaces will be emphasized. The intervention will not be entirely or minutely prescribed; rather, the 3-PLT, led by the climate specialist, will guide school-wide delivery using their knowledge of each school’s culture. The climate specialist will coordinate the activities and will facilitate efforts between the 3-PLT, PTA representatives, and students. The climate specialist will also help develop processes based on local evidence, thus necessitating improved data systems and procedures management. This component stems from the evidence-based School Wide Positive Behavioral Interventions and Supports program (SWIS). Expectations for discipline and reinforcement of positive behaviors are developed and communicated to staff and students with SWIS. Also key is a formal system to collect, analyze, and use data on disciplinary infringements for data-based decision-making. This includes data self-reported in the MiPHY (Michigan Profile for Healthy Youth) survey and from the Internet-based system SWIS, where disciplinary data (e.g., suspensions, behavior management referrals) are systematically collected (entered by an administrator) and summarized for the 3-PLT.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

1. Student school-climate perceptions are measured by students self-reporting on the Student Climate Reflection Scale in the MiPHY Survey at baseline and 9 months (beginning and end of school year)
2. Emotional functioning (anxiety and depression symptoms) data are measured by students self-reporting in the MiPHY Survey at baseline and 9 months (beginning and end of school year)
3. Aggression is measured by students self-reporting in the MiPHY Survey at baseline and 9 months (beginning and end of school year)
4. Violence, victimization, and bullying are measured by students self-reporting on the School Victimization Scale and Outside Victimization Scale in the MiPHY Survey at baseline and 9 months (beginning and end of school year)
5. School violence perceptions are measured by students self-reporting on the School Perceived Risk Scale in the MiPHY Survey at baseline and 9 months (beginning and end of school year)
6. Student violations and truancy are measured by data reported and abstracted from school records at the end of the school year, annually
7. Student discipline and behavioral referrals are measured by data reported and abstracted from school records at the end of the school year, annually

Secondary outcome measures

1. Student discipline is measured by data reported by the school Climate Specialist in a monthly school audit
2. Teacher and staff climate and safety perceptions are measured by teachers self-reporting in the Teacher and Staff Survey at baseline and 9 months (beginning and end of school year)
3. Feasibility of the implementation strategy is assessed using from qualitative process evaluation data. The researchers will obtain input from teachers of senior elementary students at each intervention school through focus groups and interviews and focus groups conducted with 3-PLT members annually
4. Intervention costs are tabulated by GISD staff on an ongoing basis
5. Implementation costs are tabulated by GISD staff on an ongoing basis

Overall trial start date

27/09/2017

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Students:
1. Enrolled in intervention or control schools
2. All genders
3. 4th- 6th grade

School staff and teachers:
1. Working at intervention schools
2. All genders
3. All ages

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

300

Participant exclusion criteria

Students:
1. Non-students
2. Not enrolled in intervention or control schools
3. Not in 4th- 6th grade

School staff and teachers:
1. Not working at intervention schools

Recruitment start date

01/09/2017

Recruitment end date

15/06/2020

Locations

Countries of recruitment

United States of America

Trial participating centre

Genesee Intermediate School District
2413 W Maple Ave
FLINT
48507
United States of America

Trial participating centre

Atherton Elementary
3444 S Genesee Rd,
Burton
48519
United States of America

Trial participating centre

Richfield Academy
3807 Center Rd
Flint
48506
United States of America

Trial participating centre

Feidler Elementary
6137 Nightingale Dr
FLINT
48506
United States of America

Trial participating centre

Grand Blanc Academy
5135 Hill Rd,
Grand Blanc
48439
United States of America

Trial participating centre

Northridge Academy
4100 Coldwater Rd,
Flint
48504
United States of America

Trial participating centre

Dailey Elementary
6236 Neff Rd,
Mt. Morris
48458
United States of America

Trial participating centre

Dye Elementary
1174 S Graham Rd
Flint
48532
United States of America

Trial participating centre

Rankin Elemntary
3459 Mundy Ave G
Swartz Creek,
48473
United States of America

Trial participating centre

Montague Elementary
344 W Mt Morris St,
Mt Morris
48458
United States of America

Trial participating centre

McGrath Elementary
5288 Todd St
Grand Blanc
48439
United States of America

Trial participating centre

Columbiaville Elementary
4775 Pine St
Columbiaville
48421
United States of America

Trial participating centre

McMonagle Elementary
3484 N Jennings Rd
Flint
48504
United States of America

Trial participating centre

Moore Elementary
1201 Wisner St
Mt Morris
48458
United States of America

Trial participating centre

Elms Road Elementary
3259 Elms Rd
Swartz Creek
48473
United States of America

Trial participating centre

Randels Elementary
6022 Brobeck St
Flint
48532
United States of America

Trial participating centre

Lakeville Middle School
11107 Washburn Rd
Otisville
48463
United States of America

Trial participating centre

Barhitte Elementary
6080 Roberta St
Burton
48509
United States of America

Trial participating centre

Greater Heights Academy
3196 Pasadena Ave
Flint
48504
United States of America

Trial participating centre

Haas Elementary
7347 N Genesee Rd
Genesee
48437
United States of America

Trial participating centre

Kuehn Haven Middle School
303 Ray St
Montrose
48457
United States of America

Trial participating centre

Woodland Park Academy
2083 E Grand Blanc Rd
Grand Blanc
48439
United States of America

Sponsor information

Organisation

MIchigan State University

Sponsor details

Contract and Grant Administration
301 Administration Building
East Lansing
517.355.5040
United States of America
+1 (0)517 355 5040
help@cga.msu.edu

Sponsor type

University/education

Website

Organisation

University of Michigan Office of Research and Sponsored Projects

Sponsor details

3003 South State Street
First Floor
Wolverine Tower
Ann Arbor
48109
United States of America
+1 (0)734 763 5500
orsp-info@umich.edu

Sponsor type

University/education

Website

https://orsp.umich.edu/

Funders

Funder type

Government

Funder name

National Institute of Justice

Alternative name(s)

NIJ

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United States of America

Results and Publications

Publication and dissemination plan

The researchers also have existing mechanisms for dissemination to both research and practice communities. The Michigan Youth Violence Prevention Center (MI-YVPC), housed at UM, is part of the CDC-funded network of National Centers of Excellence in Youth Violence Prevention, which may serve as an additional venue for disseminating results to researchers and practice professionals. MSU houses Bureau of Justice Assistance training and technical assistance programs for Project Safe Neighborhoods, the Violence Reduction Assessment Tool, and the Smart Suite Research Practitioner Fellows Academy that provide outstanding mechanisms for the dissemination of findings to teams of practitioners and researchers across the US. Finally, we will aim to disseminate results and lessons learned to practitioners (including school administrators and resource officers) at conferences such as Michigan’s SEPLA conference (http://www.seplainstitute.org/index.htm) and the conferences of the Michigan Chiefs of Police and Sheriffs Associations. We plan to publish outcome and implementation findings in peer reviewed journals.

In addition, the researchers aim to make information about this research available to a broader audience including the GISD community (students, families, staff, and local residents); local, state, and national policy makers; and the general public. Upon study completion, they will feed back results to the GISD community via newsletters, town halls, and presentations to school administrators, district officials, and the Genesee Intermediate Board of Education. They will create a page on the MI-YVPC website (http://yvpc.sph.umich.edu) to communicate information about their research and house links to reports, publications, or any media coverage. Similar information and links to the MI-YVPC website will also be available through the Michigan Justice Statistics Center, the Statistical Analysis Center for the state of Michigan (housed at MSU). The researchers will also make this information available for a common NIJ-sponsored school safety website. Finally, they will work with the UM School of Public Health’s Office of Communications to prepare press releases for state and national print, radio, and television outlets.

IPD sharing statement
De-identified quantitative survey data, notes from qualitative interviews and transcripts from focus-group data will be provided to the National Archive of Criminal Justice Data (NACJD) at ICPSR at the University of Michigan within two years after the completion of the project. The NACJD will make the final determination of whether or not the data are suitable for public release, as well as the conditions associated with the release of the data if it is deemed appropriate for public use. Requests for the data can be made through their online data portal found at: https://www.icpsr.umich.edu/icpsrweb/content/NACJD/index.html.
All adults participants provided informed consent, while youth provided their assent, and their parents were offered the opportunity to refuse their child’s participation through a passive parental consent process given data is not identifiable at the individual level. No individual identifying information was collected as part of the survey data collection process.

Intention to publish date

01/01/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/05/2019: Trial's existence confirmed by funder.