NCT05196893

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
863

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

2.9 years

First QC Date

December 7, 2021

Last Update Submit

January 18, 2022

Conditions

Keywords

School violence prevention

Outcome Measures

Primary Outcomes (3)

  • Change in weekly rate of student office referrals (overall)

    A mean weekly rate of overall disciplinary office referrals was calculated using counts of student disciplinary office referrals received per academic week, for all referral types. To determine the effectiveness of the intervention in reducing the rate of referrals, negative binomial models were fitted using Generalized Estimating Equations (GEEs); the first model focused on the amount of time each student was in the study and the second model determined if there was a dosage effect with the number of intervention sessions received. Each of these models included covariates (sex, race, and grade level) to account for the differences between the students' demographic groups.

    weekly, up to 3 academic years

  • Change in weekly rate of student office referrals (physical aggression)

    A mean weekly rate of physical aggression office referrals was calculated using counts of student office referrals related to physical aggression, received per academic week. To determine the effectiveness of the intervention in reducing the rate of referrals, negative binomial models were fitted using Generalized Estimating Equations (GEEs); the first model focused on the amount of time each student was in the study and the second model determined if there was a dosage effect with the number of intervention sessions received. Each of these models included covariates (sex, race, and grade level) to account for the differences between the students' demographic groups.

    weekly, up to 3 academic years

  • Change in student K-6 stress screener score

    Score of individual student stress, measured using the Kessler-6 (K-6) "Six Simple Questions" stress screener. Interventionists were trained to assess student stress on an as needed basis during intervention sessions, and on at least two occasions: 1) at the start of the student's intervention (during first session), and 2) prior to ending or tapering intervention sessions.

    every two weeks, up to 3 academic years

Study Arms (3)

Immediate Student Intervention Group

EXPERIMENTAL

Eligible students who were randomized into an immediate intervention group, and received intervention from school staff who received specialized intervention training starting in the fall semester of the academic year. Students from two clusters of schools received staggered intervention (Cluster 1 starting in year 1, and Cluster 2 starting in year 2). School staff recorded details of intervention sessions in a case management tool, and administrative records were maintained by the school district, for evaluation purposes.

Behavioral: Link Intervention

Wait-list Student Intervention Group

EXPERIMENTAL

Eligible students who were randomized into a wait-list intervention group, and received intervention from school staff who received specialized intervention training starting in the spring semester of the academic year. Students from two clusters of schools received staggered intervention (Cluster 1 starting in year 1, and Cluster 2 starting in year 2). School staff recorded details of intervention sessions in a case management tool, and administrative records were maintained by the school district, for evaluation purposes.

Behavioral: Link Intervention

Within School Student Control Group

NO INTERVENTION

Eligible students who were randomized into either the immediate or wait-list intervention groups, but did not receive intervention from school staff. This was used as a control group instead of an intended 3rd Cluster, which ultimately was not a comparable control based on enrollment and demographic characteristics.

Interventions

Eligible students met with staff trained in specialize intervention skills. Staff met with students multiple times per month, for approximately 10-30 minutes. During these sessions, staff had conversations with students, using intervention communication skills, assessed student stress, and implemented strategies for behavior change. Details of the sessions were recorded in a case management tool. Students were referred to additional resources, as necessary, and these referrals were also recorded. Rates of student office referrals were assessed over time.

Immediate Student Intervention GroupWait-list Student Intervention Group

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \. Elementary and middle school students in grades 3- 8 from clusters 1 and 2, who:
  • Have one or more behavioral referrals in the previous academic year, or
  • 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.

You may not qualify if:

  • Students unable to proficiently communicate in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cedar Rapids Community School District

Cedar Rapids, Iowa, 52405, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Karen Heimer, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR
  • Marizen R Ramirez, PhD, MPH

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is a two-level randomized intervention trial of students from 12 schools in three clusters.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2021

First Posted

January 19, 2022

Study Start

August 1, 2017

Primary Completion

July 1, 2020

Study Completion

June 1, 2021

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Datasets will be archived with the National Archive of Criminal Justice Data (NACJD). Datasets archived include: all training evaluation datasets, case management data, a dataset about linkages to student supports, secondary student administrative data, and cost data.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
Data will be made publicly available upon successful curation by NACJD.
Access Criteria
Data will be publicly available.

Locations