Evaluation of radKIDS 2.0, a Multi-media Training Program for Elementary School Bullying and Abuse Prevention

NCT06608173 | Active Not Recruiting

• 1 other identifier: R43MD015695
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy; Self Esteem; Self Efficacy; Knowledge

Keywords

radKIDS; school-based intervention; bullying; victimization; self-esteem; self-efficacy; safety knowledge; prevention

Outcome Measures

Primary Outcomes (4)

• Piers-Harris Self-Concept Scale

  Provides a complete picture of self-concept using a simple yes-or-no response format. Students will complete three sub-scales: (1) Happiness and Satisfaction (10 items), (2) Freedom from Anxiety (14 items), and (3) Behavioral Adjustment (14 items). Response options are No = 1 and Yes = 2. Items will be scored and summed such that a higher score indicates a higher self-concept. The summed score range on the Happiness and Satisfaction sub-scale is 10 (min) to 20 (max) and the summed score range on both the Freedom from Anxiety and Behavioral Adjustment sub-scales are 14 (min) to 28 (max).

  Asked twice, at baseline and about three months after baseline

• radKIDS Safety Knowledge

  The investigators developed this survey to assess student safety knowledge. It consists of 15 safety knowledge questions in a multiple choice format. There is one correct answer to each question, with higher scores indicating more safety knowledge. The correct number of items will be summed, divided by 15, and multiplied by 100 to reflect the percent of items answered correctly. The scores can range from 0 to 100.

  This is done by students twice, at baseline and about three months later.

• Self-efficacy with safety skills

  The investigators adapted a self-efficacy scale to apply to child safety skills. Self-efficacy reflects confidence in the ability to exert control over ones own motivation, behavior, and social environment. This scale has 12 items with response options from 1 = Not well at all to 5 = Very well. A mean score will be computed with a possible range of 1 to 5, with higher scores indicating more self-efficacy.

  This survey is done twice, once at baseline and once about 3 months later.

• Child Rosenberg Self-esteem Scale

  This 10 item self-esteem scale is validated for children ages 7-12 and assesses a positive or negative attitude toward the self. Response options are from 1 - definitely not true, to 4, very true. The investigators will compute a mean score such that higher scores indicate higher self-esteem. The scores can range from 1 to 4.

  This is done twice, at baseline and about three months later.

Study Arms (2)

Control

NO INTERVENTION

Classrooms randomly assigned to this arm will receive instruction as usual, with no intervention

radKIDS program

EXPERIMENTAL

This is the intervention arm, with the radKIDS2.0 program delivered across 20 weeks.

Behavioral: radKIDS2.0 Safety and Empowerment Education Program

Interventions

radKIDS2.0 Safety and Empowerment Education Program BEHAVIORAL

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.

radKIDS program

Eligibility Criteria

• Age: 9 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not a student in a participating 4th grade class

Sponsors & Collaborators

• Saavsus, Inc.: lead
• Oregon Research Institute: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Saavsus, Inc.

Eugene, Oregon, 97401, United States

Location

Oregon Research Institute

Springfield, Oregon, 97477, United States

Location

MeSH Terms

Conditions

Bullying

Condition Hierarchy (Ancestors)

Aggression; Behavioral Symptoms; Behavior; Harassment, Non-Sexual; Social Behavior

Study Officials

• Deborah Johnson-Shelton, PhD

  Saavsus, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: June 4, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 30, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: It will be available within one year of the end of this study, by August 31, 2026. It will be available in perpetuity.
• Access Criteria: It will be made publicly available in the openICPSR database, with open access.

Locations

US (2)