- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02458365
A Stage-Based Expert System for Teen Dating Violence Prevention
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Attending one of 20 participating schools
- In grade 9, 10, or 11
Exclusion Criteria:
- Parent submitted opt-out form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Teen Choices
Teen Choices: A Program for Healthy Nonviolent Relationships
|
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.
|
Other: Comparison
Health In Motion
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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".
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Experiencing Physical Dating Violence During Follow-up
Time Frame: One year
|
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").
|
One year
|
Number of Participants Perpetrating Emotional Dating Violence During Follow-up
Time Frame: One year
|
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").
|
One year
|
Number of Participants Experiencing Emotional Dating Violence During Follow-up
Time Frame: One year
|
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").
|
One year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Perpetrating Physical Peer Violence During Follow-up
Time Frame: One year
|
Among participants not exposed to risk for dating violence, an 18-item measure assessed three types of peer violence perpetration and victimization (Levesque, 2007).
Alphas for the three 3-item perpetrator scales are: .89
for emotional mistreatment, .89
for physical violence, and .94
for sexual coercion.
At follow-up, in the spring and fall of 2010, the measure assessed peer violence experienced and perpetrated since January 1, 2010.
Given the hierarchical structure of the perpetration measure, the physical violence and sexual coercion scales were combined to represent physical perpetration.
One or more incidents of physical perpetration during the period in question were coded as "yes," and no incidents coded as "no".
|
One year
|
Number of Participants Experiencing Physical Peer Violence During Follow-up
Time Frame: One year
|
See above.
Cronbach's Alphas for the three victimization scales were .89
for emotional mistreatment, .89
for physical violence, and .93 for sexual coercion.
One or more incidents of physical peer violence victimization during the period in question were coded as "yes," and no incidents coded as "no").
|
One year
|
Number of Participants Perpetrating Emotional Peer Violence During Follow-up
Time Frame: One year
|
See above.
One or more incidents of peer emotional mistreatment perpetrated during the period in question were coded as "yes," and no incidents coded as "no").
|
One year
|
Number of Participants Experiencing Emotional Peer Violence During Follow-up
Time Frame: One year
|
See above.
One or more incidents of peer emotional mistreatment experienced during the period in question were coded as "yes," and no incidents coded as "no").
|
One year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R44MH086129 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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