Clinical trial NCT06608173: Evaluation of radKIDS 2.0, a Multi-media Training Program for Elementary School Bullying and Abuse Prevention
Official title: Development and Evaluation of a Multi-media Training Program for Elementary School Bullying and Abuse Prevention: radKIDS 2.0
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Self Esteem
Self Efficacy
Knowledge
Keywords: radKIDS
school-based intervention
bullying
victimization
self-esteem
self-efficacy
safety knowledge
prevention
Lead sponsor: Saavsus, Inc.
Sponsor class: OTHER
Collaborators: name: Oregon Research Institute
name: National Institute on Minority Health and Health Disparities (NIMHD)
name: National Institutes of Health (NIH)
First posted: 2024-09-23
Enrollment: 656
Sex: ALL
Minimum age (years): 9
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to evaluate an adapted version of the radKIDS® Personal Empowerment and Safety Education Program in randomly assigned 4th grade classrooms.

The primary hypothesis is that students in the radKIDS study arm will have significantly higher growth in safety knowledge, safety skill self-efficacy, confidence in help-seeking and in maintaining personal safety, and self-esteem compared to classrooms in the business as usual condition.

At the student level, researchers will compare 4th grade students in classrooms randomized to receive the radKIDS program to those in classrooms receiving their regular instruction.

Student participants will complete two surveys a few months apart assessing safety knowledge, self-efficacy, and self-esteem. In the radKIDS2.0 arm, students will receive the radKIDS program between the two surveys. In the control arm, students will receive instruction as usual.

Detailed description: Child victimization and injury continue to be major public health challenges, jeopardizing the healthy development of millions of American children every day. Child victimization by peers is linked to poorer mental health in later childhood and adolescence, impacting school outcomes due to higher absenteeism, reduced classroom attentiveness, increased school drop-out, and greater risk for substance abuse, delinquency, and violent behavior. Most successful bullying prevention programs do not align with nationally recommended safety guidelines deemed essential for effectively protecting children from victimization and violence. The radKIDS® Personal Empowerment and Safety Education Program is a school-based program developed in response to these national recommendations. radKIDS® uses activity-based skill training to help elementary aged children develop personal safety boundaries, critical thinking skills for responding to threats of danger, age-appropriate coping strategies for dealing with current and past victimization, self-assertiveness and physical skills for self-defense, communication skills for reporting incidences to parents/adults, and increasing child self-worth-the program's cornerstone for personal safety and healthy development for elementary students. To effectively bring the radKIDS® program to more schools across the country, the National Institute on Minority Health and Health Disparities funded this study to adapt the radKIDS® instructor training and student instruction into a blended online/in-person instructor training and instructional delivery system. To evaluate this new instructor training model, the investigators are inviting 40 schools to participate in a randomized trial, with one 4th grade classroom per school participating in the study. Participating classrooms will be randomly assigned, with half of the classrooms getting the radKIDS® program, and half in the "control" condition, receiving instruction as usual. All participating students will complete two surveys a few months apart, assessing growth in knowledge, safety skill self-efficacy, confidence in help-seeking and in maintaining personal safety, and self-esteem. For schools receiving the program, instructors will be trained with the newly adapted curriculum, and will rate the usability and acceptability of the program. If the modified program is effective and practical for use in schools, wide-spread implementation of radKIDS® could have a large impact on public health by decreasing incidents and risks of victimization and reducing child trauma due to preventable violence, abuse, and injury.

Eligibility criteria: Inclusion Criteria:

* A student in a participating 4th grade class
* Able to read and understand English
* Able to understand the study
* Able to assent to participate

Exclusion Criteria:

* Not a student in a participating 4th grade class

Primary outcomes:
measure: Piers-Harris Self-Concept Scale
timeFrame: Asked twice, at baseline and about three months after baseline
measure: radKIDS Safety Knowledge
timeFrame: This is done by students twice, at baseline and about three months later.
measure: Self-efficacy with safety skills
timeFrame: This survey is done twice, once at baseline and once about 3 months later.
measure: Child Rosenberg Self-esteem Scale
timeFrame: This is done twice, at baseline and about three months later.
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Saavsus, Inc.
state: Oregon
city: Springfield
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Saavsus, Inc.
name: Deborah Johnson-Shelton, PhD
role: PRINCIPAL_INVESTIGATOR
References: