Clinical trial NCT05196893: Link for Schools: an Evaluation of a Tiered Staff Training Program and Student Intervention to Prevent Violence
Official title: Link for Schools: A System to Prevent Violence and Its Adverse Impacts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Reduction Behavior
Keywords: School violence prevention
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: U.S. Department of Justice
name: University of Minnesota
name: Cedar Rapids Community School District
First posted: 2022-01-19
Enrollment: 863
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a two-level randomized intervention trial of students from 12 schools in three clusters.
Primary purpose: PREVENTION

Brief summary: The University of Iowa in collaboration with the Cedar Rapids Community School District (CRCSD) conducted an effectiveness study to test a theory-based system, called Link, that trained school staff to provide a sustainable infrastructure of support for youth at-risk of violence. Our purpose was to prevent and intervene in violence that impacts students, and to adopt cost-effective school-based violence prevention strategies.

The research team conducted a randomized intervention trial with three "clusters" of within the CRCSD using the procedures described in the following paragraph. Each cluster consisted of a middle school and three "feeder" elementary schools. Implementation of the program began in Fall 2017 at Cluster 1, Fall 2018 at Cluster 2, and Cluster 3 remained a control site and received no intervention.

Program Implementation, by Cluster:

A series of videos were produced by the University of Iowa team in conjunction with the CRCSD, and were offered as a training opportunity to school staff. The series of video trainings include: Trauma Informed Care (TIC) video to be viewed by all staff; and a Link Program training video for select staff.

TIC video instructions was required of all staff during a workshop session. Participants were invited to complete a post-training evaluation survey following the viewing of the TIC video, for research.

Concurrent with the delivery of the Trauma Informed Care video training, select staff were identified by the CRCSD research team to become Link interventionists, by participating in specialized training of the Link system using the Link Program video and in-person trainings. These interventionists had a dual role as a study participant and as a member of the research team. These interventionists were provided 4 in-person trainings throughout the school year that included training in child assent procedures, and Link Program training. These interventionists were invited to complete pre/post evaluation surveys at each training session, for research.

Targeted Research Intervention:

Following the Link Program Training, the CRCSD research team randomly assigned a case load of students to the Link interventionists with whom they used the Link Program skills. Following each student encounter, the interventionist completed a Link Case Management Tool for process evaluation. Link interventionists were also invited to complete a pre-evaluation survey prior to Link Program training, and post-evaluation surveys following training sessions.

Data collected for the targeted student intervention included: primary data in the form of a Link Case Management Tool completed by a Link interventionist following each student encounter; secondary data in the form of existing school administrative data sources (i.e., enrollment and office referrals).

Detailed description: Program implementation and the targeted student intervention were implemented using a staggered approach.

Cluster 1 began study procedure in 2017, and the process is outlined below.

Program Implementation:

Trauma Informed Care Training: Following consent, staff participants viewed a Trauma Informed Care (TIC) training video (TIC video available for review at: https://publichealth.uicapture.uiowa.edu/Panopto/Pages/Sessions/List.aspx?folderID=e4d017e6-6133-4d0b-819d-495f72c74284) that was delivered at a staff in-service session organized by the school district. All participants were invited to complete an anonymous "TIC post-training evaluation" survey immediately following TIC video viewing; those participating in in-person training will complete a paper survey.The survey took approximately 5-10 minutes to complete.

Specialized Link Interventionist Training- Session 1: Identified Link Interventionists were provided training by UI IRB and the UI Research team, for their role as research team members for purposes of assenting students participants, and to be trained in study protocol. The research team presented a group presentation about the research study, and following consent, participants were invited to complete an anonymous "Link_pre-program evaluation" survey. The survey took approximately 5-10 minutes to complete.

Session 2: The Link Program training session consisted of a combination of Link video training (Link training video available for viewing at: https://publichealth.uicapture.uiowa.edu/Panopto/Pages/Sessions/List.aspx?folderID=e4d017e6-6133-4d0b-819d-495f72c74284) and in-person training conducted by the UI research team. Participants were invited to complete an anonymous "Link_post training evaluation_initial" survey at the end of the session. The survey took approximately 5-10 minutes to complete. This training session lasted approximately 2 hours and occurred during an in-service training session scheduled by the school district. Following this training session, participants were randomly assigned a case load of students with which they used the Link Program skills. Following each student encounter, the interventionist completed a "Link Case Management Tool" for process evaluation. This tool took approximately 5-10 minutes to complete.

Session 3: Approximately 6 weeks following the initial training session, a follow-up training session was conducted. This training session consisted of video training and in-person training. Additional video training consisted of reviewing specific student scenario videos and other additional videos developed by the research team (7 scenarios and "Tools for You" are available for review at: https://publichealth.uicapture.uiowa.edu/Panopto/Pages/Sessions/List.aspx?folderID=e4d017e6-6133-4d0b-819d-495f72c74284). Participants were invited to complete an anonymous "Link_post training evaluation_follow up" survey at the end of the session. The survey took approximately 5-10 minutes to complete. This training session will last approximately 2 hours and occurred during an in-service training session scheduled by the school district.

Session 4: At the end of the school year, a final training session was conducted. This training session consisted of a de-briefing discussion about challenges, successes, and future implementation. Participants were invited to complete an anonymous "Link_post program evaluation" survey at the end of the session. The survey took approximately 5-10 minutes to complete. This training session lasted approximately 1 hour and occurred during an in-service training session scheduled by the school district. Due to school cancellation because of the COVID-19 response, this training session was conducted remotely via zoom during the final year of the study; participants were able to join the training session using a laptop or phone. The research team provided a zoom link to the school district project manager, who emailed a meeting invitation to all program interventionists/participants. Following the training session, a survey link to the evaluation survey was emailed to participants via REDCap's automated survey function and completed electronically. Data was stored in a REDCap database maintained by the University of Iowa.

These Link interventionist training sessions were audio recorded for training content analysis.

Targeted Student Intervention The school district research team maintained a list of students in Clusters 1, 2, and 3 schools whose parents have provided consent for participation, and met eligibility criteria. Students were then assigned to randomization arms by the research team.

Immediate intervention group: Following assent by the Link Interventionist, the student had a conversation with the interventionist in which the interventionist used specific communication skills they learned through their training described above. The interventionist may or may not have used specific tools they were exposed to during the training sessions (stress screener, etc.) and referred the child to additional resources as necessary. The student subject was invited to meet with the interventionist several times (up to 2 times per week) during the remainder of the school year. These encounters were approximately 10-30 minutes in length, and occurred during the school day in a private location determined by the interventionist and the school district research team. The student was referred to additional resources, as necessary, and as a result of the meetings.

Wait-list control: These students were approached for intervention the semester following the implementation of the intervention, and interventionists used the same procedures described for the immediate intervention group. While on the wait-list, students assigned to this intervention arm received the same standard services offered by the school district to students at control group schools. This multi-level wait-list design (both at Cluster and student level) is ideal for evaluating the effectiveness of a program that is realistically rolled out over time. The wait-list also allows for comparisons between students who receive support vs. those who do not, and comparisons of students in a mature program vs. newly implemented program. The wait-list is an ethical approach used in other intervention evaluation studies of mental health treatment programs for at-risk children exposed to violence. Due to school cancellation due to COVID-19 response, interventionists contacted parents via phone (numbers are available to school staff in PowerSchool) to check-in with the family and student. During this phone call, the interventionists assessed whether the student was interested in continuing the intervention electronically (phone or web meeting). Depending on the students' preference, the interventionist then conducted any future session via phone (using the phone number listed in PowerSchool) or web meeting (an email invitation was sent to the student participant's school-based email address from the interventionist).

Cluster 2: Same procedures as Cluster 1, but commencing the following school year

Cluster 3: Control group, did not receive any training or intervention. During registration at the beginning of the school year, parents were provided a letter via PowerSchool/school district website notifying them that the district will be providing de-identified student data to University of Iowa researchers for research purposes. If parents objected, they were instructed to contact a school district official (listed on the letter), and their student's data would be removed from the data set shared with investigators.

For all clusters, the school district research team provided individual-level data (identified with a student ID number only), sorted by intervention arm, about these students to the UI research team for analysis. This data was in the form of administrative student records (i.e., enrollment, office referrals). The UI research team was not provided a key code for these data.

Eligibility criteria: Inclusion Criteria:

1. Elementary and middle school students in grades 3- 8 from clusters 1 and 2, who:

1. Have one or more behavioral referrals in the previous academic year, or
2. Have at least 2 of the following indicators in the previous academic year:

   * attended 80% or less of enrolled school days,
   * were in the 90th percentile and above on tardies,
   * had changed schools since the previous year,
   * were not proficient in ELA (tested only in 6th and 7th grade),
   * were in the 10th percentile or below on math performance,
   * were in the 90th percentile or above on health office visits, or
   * scored positive on the district-administered Pediatric Symptom Checklist.

Exclusion Criteria:

* Students unable to proficiently communicate in English

Primary outcomes:
measure: Change in weekly rate of student office referrals (overall)
timeFrame: weekly, up to 3 academic years
measure: Change in weekly rate of student office referrals (physical aggression)
timeFrame: weekly, up to 3 academic years
measure: Change in student K-6 stress screener score
timeFrame: every two weeks, up to 3 academic years
Secondary outcomes:
Other outcomes:
Locations:
city: Cedar Rapids
country: United States
facility: Cedar Rapids Community School District
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Iowa
name: Karen Heimer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Marizen R Ramirez, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: