Clinical trial NCT02458365: A Stage-Based Expert System for Teen Dating Violence Prevention
Official title: A Stage-Based Expert System for Teen Dating Violence Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Violence
Bullying
Keywords: Violence
Bullying
Social skills
Prevention & control
Adolescent
Lead sponsor: Pro-Change Behavior Systems
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 3901
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Attending one of 20 participating schools
* In grade 9, 10, or 11

Exclusion Criteria:

* Parent submitted opt-out form

Primary outcomes:
measure: Number of Participants Perpetrating Physical Dating Violence During Follow-up
timeFrame: One year
Secondary outcomes:
measure: Number of Participants Experiencing Physical Dating Violence During Follow-up
timeFrame: One year
measure: Number of Participants Perpetrating Emotional Dating Violence During Follow-up
timeFrame: One year
measure: Number of Participants Experiencing Emotional Dating Violence During Follow-up
timeFrame: One year
Other outcomes:
measure: Number of Participants Perpetrating Physical Peer Violence During Follow-up
timeFrame: One year
measure: Number of Participants Experiencing Physical Peer Violence During Follow-up
timeFrame: One year
measure: Number of Participants Perpetrating Emotional Peer Violence During Follow-up
timeFrame: One year
measure: Number of Participants Experiencing Emotional Peer Violence During Follow-up
timeFrame: One year
Locations:
Study officials:
affiliation: Pro-Change Behavior Systems, Inc.
name: Deborah A Levesque, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: