HealthyradKIDS2NCT06608173
Evaluation of radKIDS 2.0, a Multi-media Training Program for Elementary School Bullying and Abuse Prevention
A study testing radKIDS2.0 Safety and Empowerment Education Program in people with Healthy and Self Esteem, run by Saavsus, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Self Esteem, Self Efficacy
- What is being tested?
- radKIDS2.0 Safety and Empowerment Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jun 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A student in a participating 4th grade class
- Able to read and understand English
- Able to understand the study
- Able to assent to participate
Who cannot join
- Not a student in a participating 4th grade class
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Saavsus, Inc.
Eugene, Oregon, 97401
Oregon Research Institute
Springfield, Oregon, 97477
About this study
Official title: Development and Evaluation of a Multi-media Training Program for Elementary School Bullying and Abuse Prevention: radKIDS 2.0
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.
Read more
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.
Read the 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.
- Conditions
- Healthy, Self Esteem, Self Efficacy, Knowledge
- Being tested
- radKIDS2.0 Safety and Empowerment Education Program
- Keywords
- radKIDS, school-based intervention, bullying, victimization, self-esteem, self-efficacy, safety knowledge, prevention
- Medical subject headings
- Bullying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radKIDS2.0 Safety and Empowerment Education ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: radKIDS2.0 Safety and Empowerment Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This is done twice, at baseline and about three months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start4 Jun 2024
- Primary completion30 Jun 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 656 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saavsus, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Research Institute, National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Deborah Johnson-Shelton, PhD, Principal investigator, Saavsus, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608173
- Sponsor's protocol ID
- R43MD015695
- Other IDs
- R43MD015695
- Acronym
- radKIDS2
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data deposited in openICPSR will be available to the research community free of charge and in perpetuity. Study data will be findable by searching for the project title on the openICPSR database.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Multi-media Training Program for Elementary School Bullying and Abuse Prevention: radKIDS 2.0
- ClinicalTrials.gov ID
- NCT06608173
- Acronym / sponsor ID
- radKIDS2 / R43MD015695
- Conditions
- Healthy, Self Esteem, Self Efficacy, Knowledge
- Keywords
- radKIDS, school-based intervention, bullying, victimization, self-esteem, self-efficacy, safety knowledge, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 656 participants (actual)
- Lead sponsor
- Saavsus, Inc.University, hospital or other
- Collaborators
- Oregon Research Institute, National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Classrooms randomly assigned to this arm will receive instruction as usual, with no intervention |
| radKIDS program | Experimental | Behavioral: radKIDS2.0 Safety and Empowerment Education ProgramThis is the intervention arm, with the radKIDS2.0 program delivered across 20 weeks. |
Who may qualify
- Ages
- 9 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- A student in a participating 4th grade class
- Able to read and understand English
- Able to understand the study
- Able to assent to participate
Key exclusion criteria (1 listed)
- Not a student in a participating 4th grade class
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radKIDS2.0 Safety and Empowerment Education ProgramradKIDS® 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. | Behavioural | radKIDS program |
Primary outcome
Piers-Harris Self-Concept Scale
Time frame: Asked twice, at baseline and about three months after baseline
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).
radKIDS Safety Knowledge
Time frame: This is done by students twice, at baseline and about three months later.
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.
Self-efficacy with safety skills
Time frame: This survey is done twice, once at baseline and once about 3 months later.
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.
Child Rosenberg Self-esteem Scale
Time frame: This is done twice, at baseline and about three months later.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. Study data deposited in openICPSR will be available to the research community free of charge and in perpetuity. Study data will be findable by searching for the project title on the openICPSR database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Johnson-Shelton, PhD principal investigator
Saavsus, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radKIDS2.0 Safety and Empowerment Education Program in people with Healthy and Self Esteem, run by Saavsus, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Piers-Harris Self-Concept Scale (time frame: Asked twice, at baseline and about three months after baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.