radKIDS Program for Bullying Prevention

(radKIDS2 Trial)

Recruiting at 1 trial location

Overseen By Erika Westling, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Saavsus, Inc.

Disqualifiers: Not in 4th grade class

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

656 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the radKIDS2.0 treatment for bullying prevention?

The research suggests that complex, whole-school interventions can effectively reduce bullying, and targeted prevention programs may help support vulnerable children. Additionally, school-based mentoring has shown promise in reducing peer victimization, indicating that similar approaches could be beneficial in bullying prevention. ^{1 2 3 4 5}

Research Team

Deborah Johnson-Shelton, PhD

Principal Investigator

Saavsus, Inc.

Eligibility Criteria

This trial is for 4th grade students. It aims to see if a program called radKIDS 2.0 can help them feel more confident, know how to stay safe, and deal with bullying better than usual school lessons.

Inclusion Criteria

I am willing and able to agree to participate.

I understand the details of the study.

Able to read and understand English

Exclusion Criteria

Not a student in a participating 4th grade class

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Students complete initial surveys assessing safety knowledge, self-efficacy, and self-esteem

1 week

1 visit (in-person)

Intervention

radKIDS2.0 program delivered to students in the intervention arm over 20 weeks

20 weeks

Follow-up Assessment

Students complete follow-up surveys assessing growth in safety knowledge, self-efficacy, and self-esteem

1 week

1 visit (in-person)

Follow-up

Participants are monitored for long-term effectiveness of the radKIDS program

3 months

Treatment Details

Interventions

• radKIDS2.0

Trial Overview The study tests the radKIDS 2.0 Safety and Empowerment Education Program by comparing two groups of students: one learns through this new program and the other follows regular school instruction.

Participant Groups

Group I: radKIDS program Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Saavsus, Inc.

Lead Sponsor

Trials

1

Recruited

660+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Oregon Research Institute

Collaborator

Trials

87

Recruited

62,600+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Editorial: Selective Prevention in Anti-Bullying Programs: Could Targeting Personality Be the Answer? [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Identifying children at risk for being bullies in the United States. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The Child Adolescent Bullying Scale (CABS): Psychometric evaluation of a new measure. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Factors Associated With Bullying Victimization and Bullying Perpetration in Children and Adolescents With ADHD: 2016 to 2017 National Survey of Children's Health. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

School-based mentoring as selective prevention for bullied children: a preliminary test. [2021]