NCT02458365

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,901

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
1 month until next milestone

Results Posted

Study results publicly available

July 9, 2015

Completed
Last Updated

April 21, 2016

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

May 26, 2015

Results QC Date

May 29, 2015

Last Update Submit

March 23, 2016

Conditions

Keywords

ViolenceBullyingSocial skillsPrevention & controlAdolescent

Outcome Measures

Primary Outcomes (1)

  • 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".

    One year

Secondary Outcomes (3)

  • Number of Participants Experiencing Physical Dating Violence During Follow-up

    One year

  • Number of Participants Perpetrating Emotional Dating Violence During Follow-up

    One year

  • Number of Participants Experiencing Emotional Dating Violence During Follow-up

    One year

Other Outcomes (4)

  • Number of Participants Perpetrating Physical Peer Violence During Follow-up

    One year

  • Number of Participants Experiencing Physical Peer Violence During Follow-up

    One year

  • Number of Participants Perpetrating Emotional Peer Violence During Follow-up

    One year

  • +1 more other outcomes

Study Arms (2)

Teen Choices

EXPERIMENTAL

Teen Choices: A Program for Healthy Nonviolent Relationships

Behavioral: Teen Choices: A Program for Healthy Nonviolent Relationships

Comparison

OTHER

Health In Motion

Behavioral: Health In Motion

Interventions

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.

Teen Choices

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.

Comparison

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Parent submitted opt-out form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BullyingSocial Skills

Interventions

HealthMotion

Condition Hierarchy (Ancestors)

AggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial Behavior

Intervention Hierarchy (Ancestors)

Population CharacteristicsPhysical Phenomena

Results Point of Contact

Title
Deborah Levesque, Ph.D.
Organization
Pro-Change Behavior Systems, Inc.

Study Officials

  • Deborah A Levesque, Ph.D.

    Pro-Change Behavior Systems, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 1, 2015

Study Start

September 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 21, 2016

Results First Posted

July 9, 2015

Record last verified: 2015-07

Data Sharing

IPD Sharing
Will not share