ViolencePhase 2NCT02458365
A Stage-Based Expert System for Teen Dating Violence Prevention
A Phase 2 study testing Teen Choices: A Program for Healthy Nonviolent Relationships and Health In Motion in people with Violence and Bullying, run by Pro-Change Behavior Systems.
Trial summary
Male-to-female intimate partner violence accounts for 26% of violence-related injuries in women presenting in hospital emergency departments and 33% of all female homicides. Adolescence provides an excellent "window of opportunity" for the prevention of intimate partner violence. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Teen Choices: A Program for Healthy Nonviolent Relationships and Health In Motion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,901 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Attending one of 20 participating schools
- In grade 9, 10, or 11
Who cannot join
- Parent submitted opt-out form
About this study
Male-to-female intimate partner violence accounts for 26% of violence-related injuries in women presenting in hospital emergency departments and 33% of all female homicides. Adolescence provides an excellent "window of opportunity" for the prevention of intimate partner violence. Patterns of relating in intimate relationships are still relatively undifferentiated and open to influence. However, the evidence supporting traditional, school-based programs for the prevention of teen dating violence is mixed. A major problem with existing programs is that they are "one size fits all," making it difficult to meet the diverse needs of students-boys and girls, individuals who are dating and those who are not, individuals who have experienced dating violence as a victim, perpetrator, or both, and those who have not. Perhaps most importantly, these interventions neglect individual differences in readiness to use healthy, non-violent ways of relating to stay violence-free. In Phase I the objective was to use expert system technology to integrate best practices for teen dating violence prevention with the Transtheoretical Model of Behavior Change (TTM), the "stage model," to develop an interactive, multimedia computer-administered change program that delivers individualized intervention sessions and exercises tailored to stage of change and other individual characteristics. In Phase II, the objective was to complete development of the intervention package and assess its efficacy in a randomized clinical trial involving 3,901 teens from 20 Rhode Island high schools randomly assigned to intervention or comparison. Among youth exposed to risk for dating violence, efficacy was assessed by comparing the intervention and comparison groups on dating violence perpetration and victimization at follow-up. Among youth not exposed to risk for dating violence, efficacy was assessed by comparing intervention and comparison on peer violence perpetration and victimization.
Read the detailed description
Twenty Rhode Island high schools agreed to participate in the study. A Multiattribute Utility Measurement Approach (Graham, Flay, Johnson, Hansen, \& Collins, 1984) was used to ensure that schools assigned to the intervention and comparison conditions were approximately equivalent on school size, student ethnicity, socioeconomic status (SES, percent receiving free or reduced-price lunch), attendance, mobility, truancy, dropout, and standardized test performance. The most similar schools were paired, and one school within each pair was randomly assigned to intervention, and the other to comparison.
The intervention trial was launched in the Fall of 2009. Both the intervention and comparison groups completed a computerized baseline assessment and two follow-up assessments approximately 6 and 12 months later-in the Spring and Fall of 2010. Students assigned to the intervention condition completed their first Teen Choices intervention session immediately following their baseline assessment. The second and third intervention sessions were administered at approximately 1 and 2 months follow-up. Students assigned to the comparison condition completed an alternative evidence-based online TTM-based intervention, Health In Motion, which targets physical activity, screen time, and healthy eating for obesity prevention (Mauriello et al., 2010). Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for comparison schools and students. Online assessment and intervention sessions were overseen by project research assistants with the assistance of school personnel.
Dating violence outcomes at one year follow-up were were examined in intervention and comparison participants who completed the final assessment and were exposed to risk for dating violence-that is, students who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period. Peer violence outcomes were examined in participants who completed the final assessment and were not exposed to risk for dating violence.
- Being tested
- Teen Choices: A Program for Healthy Nonviolent Relationships, Health In Motion
- Keywords
- Violence, Bullying, Social skills, Prevention & control, Adolescent
- Medical subject headings
- Bullying, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen Choices: A Program for Healthy Nonviolent RelationshipsBehavioural
A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
Health In MotionBehavioural
A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
| Study group | Role | What they receive |
|---|---|---|
| Teen Choices | Experimental | Teen Choices: A Program for Healthy Nonviolent Relationships Receives: Behavioral: Teen Choices: A Program for Healthy Nonviolent Relationships |
| Comparison | Other | Health In Motion Receives: Behavioral: Health In Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Perpetrating Physical Dating Violence During Follow-up
A 30-item measure assessing five types of dating violence perpetration and victimization was developed to meet specific needs of this research (Levesque, 2007). Alphas for the five 3-item perpetrator scales are: .88 for emotional mistreatment, .87 for controlling behavior, .91 for threats, .92 for physical violence, and .94 for sexual coercion. At follow-up, in the spring and fall of 2010, the measure assessed dating violence perpetrated and experienced since January 1, 2010. Given the hierarchical structure of the perpetration measure, the emotional mistreatment and controlling behavior scales were combined to represent emotional dating violence perpetration, and the threats, physical violence, and sexual coercion scales were combined to represent physical perpetration. Given extreme non-normal distributions, the two measures were then dichotomized. One or more incidents of physical perpetration during the period in question were coded as "yes," and no incidents as "no".
Measured: One year
Secondary outcomes (3)
Number of Participants Experiencing Physical Dating Violence During Follow-up
See above. Cronbach's Alphas for the five victimization scales were .87 for emotional mistreatment, .86 for controlling behavior, .83 for threats, .76 for physical violence, and .90 for sexual coercion. One or more incidents of physical dating violence victimization during the period in question were coded as "yes," and no incidents coded as "no").
Measured: One year
Number of Participants Perpetrating Emotional Dating Violence During Follow-up
See above.One or more incidents of emotional dating violence perpetration during the period in question were coded as "yes," and no incidents coded as "no").
Measured: One year
Number of Participants Experiencing Emotional Dating Violence During Follow-up
See above.One or more incidents of emotional dating violence victimization during the period in question were coded as "yes," and no incidents coded as "no").
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ViolenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pro-Change Behavior Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah A Levesque, Ph.D., Principal investigator, Pro-Change Behavior Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458365
- Sponsor's protocol ID
- R44MH086129
- Status last verified
- Jul 2015
- First submitted
- 26 May 2015
- Last updated
- 21 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stage-Based Expert System for Teen Dating Violence Prevention
- ClinicalTrials.gov ID
- NCT02458365
- Acronym / sponsor ID
- R44MH086129
- Keywords
- Violence, Bullying, Social skills, Prevention & control, Adolescent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,901 participants (actual)
- Lead sponsor
- Pro-Change Behavior SystemsUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Posted 9 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Male-to-female intimate partner violence accounts for 26% of violence-related injuries in women presenting in hospital emergency departments and 33% of all female homicides. Adolescence provides an excellent "window of opportunity" for the prevention of intimate partner violence. Patterns of relating in intimate relationships are still relatively undifferentiated and open to influence. However, the evidence supporting traditional, school-based programs for the prevention of teen dating violence is mixed. A major problem with existing programs is that they are "one size fits all," making it difficult to meet the diverse needs of students-boys and girls, individuals who are dating and those who are not, individuals who have experienced dating violence as a victim, perpetrator, or both, and those who have not. Perhaps most importantly, these interventions neglect individual differences in readiness to use healthy, non-violent ways of relating to stay violence-free. In Phase I the objective was to use expert system technology to integrate best practices for teen dating violence prevention with the Transtheoretical Model of Behavior Change (TTM), the "stage model," to develop an interactive, multimedia computer-administered change program that delivers individualized intervention sessions and exercises tailored to stage of change and other individual characteristics. In Phase II, the objective was to complete development of the intervention package and assess its efficacy in a randomized clinical trial involving 3,901 teens from 20 Rhode Island high schools randomly assigned to intervention or comparison. Among youth exposed to risk for dating violence, efficacy was assessed by comparing the intervention and comparison groups on dating violence perpetration and victimization at follow-up. Among youth not exposed to risk for dating violence, efficacy was assessed by comparing intervention and comparison on peer violence perpetration and victimization.
Detailed description
Twenty Rhode Island high schools agreed to participate in the study. A Multiattribute Utility Measurement Approach (Graham, Flay, Johnson, Hansen, \& Collins, 1984) was used to ensure that schools assigned to the intervention and comparison conditions were approximately equivalent on school size, student ethnicity, socioeconomic status (SES, percent receiving free or reduced-price lunch), attendance, mobility, truancy, dropout, and standardized test performance. The most similar schools were paired, and one school within each pair was randomly assigned to intervention, and the other to comparison.
The intervention trial was launched in the Fall of 2009. Both the intervention and comparison groups completed a computerized baseline assessment and two follow-up assessments approximately 6 and 12 months later-in the Spring and Fall of 2010. Students assigned to the intervention condition completed their first Teen Choices intervention session immediately following their baseline assessment. The second and third intervention sessions were administered at approximately 1 and 2 months follow-up. Students assigned to the comparison condition completed an alternative evidence-based online TTM-based intervention, Health In Motion, which targets physical activity, screen time, and healthy eating for obesity prevention (Mauriello et al., 2010). Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for comparison schools and students. Online assessment and intervention sessions were overseen by project research assistants with the assistance of school personnel.
Dating violence outcomes at one year follow-up were were examined in intervention and comparison participants who completed the final assessment and were exposed to risk for dating violence-that is, students who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period. Peer violence outcomes were examined in participants who completed the final assessment and were not exposed to risk for dating violence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teen Choices | Experimental | Behavioral: Teen Choices: A Program for Healthy Nonviolent RelationshipsTeen Choices: A Program for Healthy Nonviolent Relationships |
| Comparison | Other | Behavioral: Health In MotionHealth In Motion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Attending one of 20 participating schools
- In grade 9, 10, or 11
Key exclusion criteria (1 listed)
- Parent submitted opt-out form
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 |
|---|---|---|
| Teen Choices: A Program for Healthy Nonviolent RelationshipsA 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships. | Behavioural | Teen Choices |
| Health In MotionA 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students. | Behavioural | Comparison |
Primary outcome
Number of Participants Perpetrating Physical Dating Violence During Follow-up
Time frame: One year
A 30-item measure assessing five types of dating violence perpetration and victimization was developed to meet specific needs of this research (Levesque, 2007). Alphas for the five 3-item perpetrator scales are: .88 for emotional mistreatment, .87 for controlling behavior, .91 for threats, .92 for physical violence, and .94 for sexual coercion. At follow-up, in the spring and fall of 2010, the measure assessed dating violence perpetrated and experienced since January 1, 2010. Given the hierarchical structure of the perpetration measure, the emotional mistreatment and controlling behavior scales were combined to represent emotional dating violence perpetration, and the threats, physical violence, and sexual coercion scales were combined to represent physical perpetration. Given extreme non-normal distributions, the two measures were then dichotomized. One or more incidents of physical perpetration during the period in question were coded as "yes," and no incidents as "no".
3 secondary outcomes
Number of Participants Experiencing Physical Dating Violence During Follow-up
Time frame: One year
Number of Participants Perpetrating Emotional Dating Violence During Follow-up
Time frame: One year
Number of Participants Experiencing Emotional Dating Violence During Follow-up
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Deborah A Levesque, Ph.D. principal investigator
Pro-Change Behavior Systems, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teen Choices: A Program for Healthy Nonviolent Relationships and Health In Motion in people with Violence and Bullying, run by Pro-Change Behavior Systems.
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 2 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 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Perpetrating Physical Dating Violence During Follow-up (time frame: One year). 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 21 Apr 2016.