Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05196893 |
Other study ID # |
201705712 |
Secondary ID |
2016-CK-BX-0006 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 1, 2017 |
Est. completion date |
June 1, 2021 |
Study information
Verified date |
January 2022 |
Source |
University of Iowa |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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).
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=e4d017e6-6
133-4d0b-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=e4d017e6-6
133-4d0b-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=e4d017e6-6
133-4d0b-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.