Violence PreventionYES-IDEASNCT05337410
YES: Innovative Discussion for Engagement, Achievement, and Service
A study testing YES IDEAS in people with Violence Prevention, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of YES-IDEAS (YES: Innovative Discussion for Engagement, Achievement, and Service)compared to regular after school programming in increasing youth empowerment, promoting positive behaviors, and decreasing youth violence. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence Prevention
- What is being tested?
- YES IDEAS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students enrolled in afterschool programs at multiple middle schools in Counties across south-east Michigan
- Students in 6th through 8th grade
- Students who assent
Who cannot join
- Non-students
- Students who do not assent or whose parents notify us of their refusal
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy of YES-IDEAS (YES: Innovative Discussion for Engagement, Achievement, and Service)compared to regular after school programming in increasing youth empowerment, promoting positive behaviors, and decreasing youth violence.
Through the evidence-based YES (Youth Empowerment Solutions) program, youth design and implement projects to help improve their communities. In the current study, investigators adapted the existing YES curriculum to empower youth from diverse backgrounds to reduce violent behavior. The adapted curriculum, YES-IDEAS, focus on middle school students.
The investigators test the effects of YES-IDEAS curriculum on youths' sense of empowerment, attitudes, and violent behavior. They designed the study to be a group-randomized trial in after-school programs across multiple middle schools in south-east Michigan, but issues that arose due to the COVID-19 pandemic and other practical issues with the schools we modified the design to be a matched control group design at the school level. Matching variables included size, geographic locations, race/ethnicity, free/reduced lunch status. Dose-response and sustainability of YES-IDEAS effects are also examined.
Read the detailed description
Youth violence is a significant public health concern, as over 20% report being in a fight, 19% reported bullying someone, and 16% reported weapon carriage. Violent victimization among youth includes mental health sequelae in addition to the physical injury caused by violent behavior.
Positive development can be achieved by engaging youth in community improvement activities designed to empower them to avoid risky behaviors. Building on prior research and guided by previous studies of empowerment processes, the investigators developed an afterschool violence prevention program for middle-school students called Youth Empowerment Solutions (YES) for Peaceful Communities. Prior studies have described how YES engages youth in assessing neighborhood assets and liabilities for violence prevention and designing and implementing neighborhood or school projects to reduce violence. Results from prior YES evaluations found the YES program reduced violent behavior and increased positive behaviors in a comparison group design through the process of empowering youth to think critically about their community, develop plans for change, and implement their plans (i.e., program effects were mediated through empowered outcomes).
The existing YES curriculum was adapted to empower youth from various backgrounds to address to address bullying and promote positive behaviors as a way to reduce violent behavior. YES for Engaging Youth for Innovative Discussion for Engagement, Achievement and Service (YES-IDEAS) will focus on middle school students because this is a developmental period when independence from parents begins, their own ideas about peer relationships are formative, and when bullying behavior is at its peak. Empowering children to address violence at this critical developmental period may enable them to resist negative attitudes and behaviors. Working with an advisory board of experts and youth, we will develop and integrate lessons that address these behaviors into the existing YES curriculum.
The study includes two phases: 1) adapting YES and 2) testing YES IDEAS effects. Phase 1 included piloting and evaluating curriculum revisions through testing new modules and obtaining feedback from youth and teachers. Phase 2 tests the effects of YES IDEAS using a matched control trial in after-school programs across multiple middle schools across south-east Michigan. The investigators examine the effects of the curriculum on individual youths' sense of empowerment, attitudes, and violent behavior. Finally, dose-response and sustainability of YES IDEAS effects are examined.
The Specific Aims are:
AIM 1: adapt the YES curriculum to integrate several modules that address youth violence and study the adaptation and implementation process for the new curriculum for middle school students.
AIM 2: Test the efficacy of the YES-IDEAS curriculum in a matched control design on empowered outcomes which will mediate the effects of YES-IDEAS on violent attitudes and behavior.
AIM 3: Investigate if empowered outcomes are the mechanism by which the YES-IDEAS curriculum reduces aggressive and violent behavior over time.
AIM 4: study the effects of dose-response over time on the outcomes from AIMS 2 and 3.
- Conditions
- Violence Prevention
- Being tested
- YES IDEAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YES IDEASBehavioural
Also called YES: Innovative Discussion for Engagement, Achievement, and Service (YES-IDEAS)
YES IDEAS is an adapted version of the evidence based YES (Youth Empowerment Solutions) program. Through the YES program, youth design and implement their own projects to help improve their own communities. The adapted YES IDEAS curriculum empowers youth from various backgrounds to address bullying and promote positive behaviors as a way to reduce violent behavior. Over the course of the program, youth carry out a community change project aimed at promoting non-violence in their community.
| Study group | Role | What they receive |
|---|---|---|
| YES IDEAS | Experimental | Students participate in the YES IDEAS program. Receives: Behavioral: YES IDEAS |
| Control | No intervention | Students participate in the regular after-school programming. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Violence Perpetration
6 items on a 4 point Likert scale ranging from 1 (never) to 4 (3 or more times) assess the frequency of physical violence perpetration in the past 30 days. A sample item is "In the past 30 days, how often have you hit someone with your fists or beat up someone?" A higher score indicates more instances of violence perpetration in the past 30 days. Items were adapted for the current study from Hurd et al. (2011).
Measured: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
Change in Targeted Aggression
5 items on a 6-point Likert Scale ranging from 1 (never) to 6 (5 or more times) measure frequency of aggression targeted toward specific group in the past 30 days. A sample item includes "In the past 30 days, how often have you told lies or spread false rumors about someone because of their race?" Higher scores indicate more instances of targeted aggression perpetration. Items were adapted for the current study from the Multisite Violence Prevention Project (2004) and Brondolo et al. (2005).
Measured: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
Change in Prosocial behaviors
3 items on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) measure students' prosocial behavior. A sample item is "I am kind to other people." Higher scores indicate more prosocial behavior. Items were adapted for the current study from Nielsen et al., 2015.
Measured: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
Change in Bystander behaviors
6 items on a 2-point scale from 0 (no) to 1 (yes) assess youths' bystander behaviors. A sample item is "Have you called out someone who says something bad about another race or makes a racial joke?" Higher scores indicate youth engage in more positive bystander behaviors. Items were adapted for the current study from Salmivalli et al., 1996.
Measured: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
Change in Social action for promoting equity
3 items on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) assess students' behaviors related to social action for promoting equity. A sample item is "I ask questions if people aren't being treated fairly." Higher scores mean more social action. Items were developed for the current study.
Measured: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
Change in Self Efficacy for Inclusion, Diversity, Equity, Acceptance, Solidarity
5 items on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) measure youths' beliefs about their abilities to promote inclusion, diversity, equity, acceptance, and solidarity. A sample item is "I can accept all different types of people." Higher scores indicate more self-efficacy. Items were developed for the current study.
Measured: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
Change in Privilege awareness
4 items on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) measure youths' privilege awareness. A sample item is "Not all racial or ethnic groups have the same chance to get ahead in life." Higher scores indicate greater privilege awareness. Items were developed for the current study.
Measured: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
Change in Recognizing strengths in people
3 items on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) assess youths' recognition of strengths in people. A sample item is "Everyone has something to offer." Higher scores indicate more recognition of strengths in people. Items were developed for the current study.
Measured: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
Change in Social connections across diverse groups
8 items on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) assess youths' social connections across diverse groups of people. A sample item is: "I can be friends with someone from a different racial group." Higher scores indicate more social connections across diverse groups. Items were developed for the current study.
Measured: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Apr 2022
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Violence PreventionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Students enrolled in the YES IDEAS program comprise the treatment group. Students enrolled in other after-school programs (not YES IDEAS) comprise the control group.
- Masking
- None (open label)
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Marc A. Zimmerman, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337410
- Sponsor's protocol ID
- HUM00190523
- Other IDs
- R01MD015024
- Acronym
- YES-IDEAS
- Status last verified
- Oct 2026
- First submitted
- 21 Mar 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miao TA, Umemoto K, Gonda D, Hishinuma ES. Essential elements for community engagement in evidence-based youth violence prevention. Am J Community Psychol. 2011 Sep;48(1-2):120-32. doi: 10.1007/s10464-010-9418-6.
PubMed 21203825Zimmerman MA. Psychological empowerment: issues and illustrations. Am J Community Psychol. 1995 Oct;23(5):581-99. doi: 10.1007/BF02506983.
PubMed 8851341Zimmerman MA, Stewart SE, Morrel-Samuels S, Franzen S, Reischl TM. Youth Empowerment Solutions for Peaceful Communities: combining theory and practice in a community-level violence prevention curriculum. Health Promot Pract. 2011 May;12(3):425-39. doi: 10.1177/1524839909357316. Epub 2010 Nov 8.
PubMed 21059871Kellett M. Small shoes, big steps! Empowering children as active researchers. Am J Community Psychol. 2010 Sep;46(1-2):195-203. doi: 10.1007/s10464-010-9324-y.
PubMed 20524150
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YES: Innovative Discussion for Engagement, Achievement, and Service
- ClinicalTrials.gov ID
- NCT05337410
- Acronym / sponsor ID
- YES-IDEAS / HUM00190523
- Conditions
- Violence Prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 20 Apr 2022 (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 purpose of this study is to evaluate the efficacy of YES-IDEAS (YES: Innovative Discussion for Engagement, Achievement, and Service)compared to regular after school programming in increasing youth empowerment, promoting positive behaviors, and decreasing youth violence.
Through the evidence-based YES (Youth Empowerment Solutions) program, youth design and implement projects to help improve their communities. In the current study, investigators adapted the existing YES curriculum to empower youth from diverse backgrounds to reduce violent behavior. The adapted curriculum, YES-IDEAS, focus on middle school students.
The investigators test the effects of YES-IDEAS curriculum on youths' sense of empowerment, attitudes, and violent behavior. They designed the study to be a group-randomized trial in after-school programs across multiple middle schools in south-east Michigan, but issues that arose due to the COVID-19 pandemic and other practical issues with the schools we modified the design to be a matched control group design at the school level. Matching variables included size, geographic locations, race/ethnicity, free/reduced lunch status. Dose-response and sustainability of YES-IDEAS effects are also examined.
Detailed description
Youth violence is a significant public health concern, as over 20% report being in a fight, 19% reported bullying someone, and 16% reported weapon carriage. Violent victimization among youth includes mental health sequelae in addition to the physical injury caused by violent behavior.
Positive development can be achieved by engaging youth in community improvement activities designed to empower them to avoid risky behaviors. Building on prior research and guided by previous studies of empowerment processes, the investigators developed an afterschool violence prevention program for middle-school students called Youth Empowerment Solutions (YES) for Peaceful Communities. Prior studies have described how YES engages youth in assessing neighborhood assets and liabilities for violence prevention and designing and implementing neighborhood or school projects to reduce violence. Results from prior YES evaluations found the YES program reduced violent behavior and increased positive behaviors in a comparison group design through the process of empowering youth to think critically about their community, develop plans for change, and implement their plans (i.e., program effects were mediated through empowered outcomes).
The existing YES curriculum was adapted to empower youth from various backgrounds to address to address bullying and promote positive behaviors as a way to reduce violent behavior. YES for Engaging Youth for Innovative Discussion for Engagement, Achievement and Service (YES-IDEAS) will focus on middle school students because this is a developmental period when independence from parents begins, their own ideas about peer relationships are formative, and when bullying behavior is at its peak. Empowering children to address violence at this critical developmental period may enable them to resist negative attitudes and behaviors. Working with an advisory board of experts and youth, we will develop and integrate lessons that address these behaviors into the existing YES curriculum.
The study includes two phases: 1) adapting YES and 2) testing YES IDEAS effects. Phase 1 included piloting and evaluating curriculum revisions through testing new modules and obtaining feedback from youth and teachers. Phase 2 tests the effects of YES IDEAS using a matched control trial in after-school programs across multiple middle schools across south-east Michigan. The investigators examine the effects of the curriculum on individual youths' sense of empowerment, attitudes, and violent behavior. Finally, dose-response and sustainability of YES IDEAS effects are examined.
The Specific Aims are:
AIM 1: adapt the YES curriculum to integrate several modules that address youth violence and study the adaptation and implementation process for the new curriculum for middle school students.
AIM 2: Test the efficacy of the YES-IDEAS curriculum in a matched control design on empowered outcomes which will mediate the effects of YES-IDEAS on violent attitudes and behavior.
AIM 3: Investigate if empowered outcomes are the mechanism by which the YES-IDEAS curriculum reduces aggressive and violent behavior over time.
AIM 4: study the effects of dose-response over time on the outcomes from AIMS 2 and 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Students enrolled in the YES IDEAS program comprise the treatment group. Students enrolled in other after-school programs (not YES IDEAS) comprise the control group.
| Arm | Type | Receives |
|---|---|---|
| YES IDEAS | Experimental | Behavioral: YES IDEASStudents participate in the YES IDEAS program. |
| Control | No intervention | –Students participate in the regular after-school programming. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Students enrolled in afterschool programs at multiple middle schools in Counties across south-east Michigan
- Students in 6th through 8th grade
- Students who assent
Key exclusion criteria (2 listed)
- Non-students
- Students who do not assent or whose parents notify us of their refusal
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 |
|---|---|---|
| YES IDEASAlso: YES: Innovative Discussion for Engagement, Achievement, and Service (YES-IDEAS)YES IDEAS is an adapted version of the evidence based YES (Youth Empowerment Solutions) program. Through the YES program, youth design and implement their own projects to help improve their own communities. The adapted YES IDEAS curriculum empowers youth from various backgrounds to address bullying and promote positive behaviors as a way to reduce violent behavior. Over the course of the program, youth carry out a community change project aimed at promoting non-violence in their community. | Behavioural | YES IDEAS |
Primary outcome
Change in Violence Perpetration
Time frame: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
6 items on a 4 point Likert scale ranging from 1 (never) to 4 (3 or more times) assess the frequency of physical violence perpetration in the past 30 days. A sample item is "In the past 30 days, how often have you hit someone with your fists or beat up someone?" A higher score indicates more instances of violence perpetration in the past 30 days. Items were adapted for the current study from Hurd et al. (2011).
Change in Targeted Aggression
Time frame: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
5 items on a 6-point Likert Scale ranging from 1 (never) to 6 (5 or more times) measure frequency of aggression targeted toward specific group in the past 30 days. A sample item includes "In the past 30 days, how often have you told lies or spread false rumors about someone because of their race?" Higher scores indicate more instances of targeted aggression perpetration. Items were adapted for the current study from the Multisite Violence Prevention Project (2004) and Brondolo et al. (2005).
Change in Prosocial behaviors
Time frame: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
3 items on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) measure students' prosocial behavior. A sample item is "I am kind to other people." Higher scores indicate more prosocial behavior. Items were adapted for the current study from Nielsen et al., 2015.
Change in Bystander behaviors
Time frame: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
6 items on a 2-point scale from 0 (no) to 1 (yes) assess youths' bystander behaviors. A sample item is "Have you called out someone who says something bad about another race or makes a racial joke?" Higher scores indicate youth engage in more positive bystander behaviors. Items were adapted for the current study from Salmivalli et al., 1996.
Change in Social action for promoting equity
Time frame: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
3 items on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) assess students' behaviors related to social action for promoting equity. A sample item is "I ask questions if people aren't being treated fairly." Higher scores mean more social action. Items were developed for the current study.
Change in Self Efficacy for Inclusion, Diversity, Equity, Acceptance, Solidarity
Time frame: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
5 items on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) measure youths' beliefs about their abilities to promote inclusion, diversity, equity, acceptance, and solidarity. A sample item is "I can accept all different types of people." Higher scores indicate more self-efficacy. Items were developed for the current study.
Change in Privilege awareness
Time frame: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
4 items on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) measure youths' privilege awareness. A sample item is "Not all racial or ethnic groups have the same chance to get ahead in life." Higher scores indicate greater privilege awareness. Items were developed for the current study.
Change in Recognizing strengths in people
Time frame: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
3 items on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) assess youths' recognition of strengths in people. A sample item is "Everyone has something to offer." Higher scores indicate more recognition of strengths in people. Items were developed for the current study.
Change in Social connections across diverse groups
Time frame: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months
8 items on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) assess youths' social connections across diverse groups of people. A sample item is: "I can be friends with someone from a different racial group." Higher scores indicate more social connections across diverse groups. Items were developed for the current study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 21203825Miao TA, Umemoto K, Gonda D, Hishinuma ES. Essential elements for community engagement in evidence-based youth violence prevention. Am J Community Psychol. 2011 Sep;48(1-2):120-32. doi: 10.1007/s10464-010-9418-6.
- Background: PubMed 8851341Zimmerman MA. Psychological empowerment: issues and illustrations. Am J Community Psychol. 1995 Oct;23(5):581-99. doi: 10.1007/BF02506983.
- Background: PubMed 21059871Zimmerman MA, Stewart SE, Morrel-Samuels S, Franzen S, Reischl TM. Youth Empowerment Solutions for Peaceful Communities: combining theory and practice in a community-level violence prevention curriculum. Health Promot Pract. 2011 May;12(3):425-39. doi: 10.1177/1524839909357316. Epub 2010 Nov 8.
- Background: PubMed 20524150Kellett M. Small shoes, big steps! Empowering children as active researchers. Am J Community Psychol. 2010 Sep;46(1-2):195-203. doi: 10.1007/s10464-010-9324-y.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YES IDEAS in people with Violence Prevention, run by University of Michigan at 1 site 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 23 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Violence Perpetration (time frame: Baseline (0 months), End of Program (3 months), 6 months, 9 months, 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05337410, which also lists 4 linked publications.
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 23 Oct 2026.