Development and Pilot Trial of an Intervention to Reduce Disclosure Recipients Negative Social Reactions and Victims Psychological Distress and Problem Drinking
Primary Purpose
Social Skills, Self-Criticism, Post-traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS)
Sponsored by
About this trial
This is an interventional prevention trial for Social Skills focused on measuring Sexual Violence, Interpersonal Violence, Prevention, Mixed-Methods, Randomized Controlled Trial, Outcome Evaluation, College Students, Post-traumatic Stress Disorder, Alcohol, Sexual Assault, Disclosure, Social Reactions, Coping, Depression, Intervention
Eligibility Criteria
Inclusion Criteria:
- undergraduate student at University of New Hampshire
- read and understand English
- able to independently complete online surveys
Sites / Locations
- University of New Hampshire
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Wait-list Control
Arm Description
This arm will receive the intervention, followed by a six-month follow-up evaluation.
This arm will receive the intervention after a six-month follow-up evaluation.
Outcomes
Primary Outcome Measures
Negative Social Reactions
As measured by the Social Reactions Questionnaire (at six month follow-up). This scale is measured from 1 to 6, with higher mean scores representing a less desirable outcome.
Secondary Outcome Measures
Positive Social Reactions
As measured by the Social Reactions Questionnaire (at six month follow-up). This scale is measured from 1 to 6, with higher mean scores representing a less desirable outcome.
Full Information
NCT ID
NCT03488927
First Posted
March 29, 2018
Last Updated
September 24, 2020
Sponsor
University of New Hampshire
Collaborators
University of Illinois at Chicago, University of South Florida, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT03488927
Brief Title
Development and Pilot Trial of an Intervention to Reduce Disclosure Recipients Negative Social Reactions and Victims Psychological Distress and Problem Drinking
Official Title
Development and Pilot Trial of an Intervention to Reduce Disclosure Recipients Negative Social Reactions and Victims Psychological Distress and Problem Drinking
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
June 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Hampshire
Collaborators
University of Illinois at Chicago, University of South Florida, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this randomized controlled trial is to evaluate an intervention, Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS). SSS trains potential recipients of IPV or SA disclosure on the best methods of responding to a victim's disclosure. Consenting college students will be randomized into the SSS intervention or a wait-list control condition. Evaluation data will be multi-informant (i.e., data from both informal supports and victims) and multi-method (i.e., qualitative and quantitative). The investigators hypothesize that individuals receiving the SSS intervention, compared to individuals in the wait-list control condition, will provide less negative and more positive social reactions to victims' disclosure.
Detailed Description
Intimate partner violence (IPV) and sexual assault (SA) are public health issues that impact the vast majority of college students in some capacity (as a victim and/or disclosure recipient). Most (75+%) victims disclose to informal supports, such as friends. Unfortunately, over 80% of victims' disclosures are met with negative social reactions (e.g., blame) from informal supports (used interchangeably with disclosure recipients). Negative social reactions predict deleterious psychological (e.g., posttraumatic stress disorder) and behavioral (e.g., problem drinking) health outcomes in victims. Although recent research has shed light on the factors (e.g., victim attributions) that predict informal supports' negative (e.g., egocentric and blaming statements) and positive (e.g., providing emotional support) social reactions, there is no intervention to date that targets potential recipients of IPV and SA disclosure to inform these individuals of the best methods of responding to an IPV or SA disclosure. This type of intervention, if effective in reducing negative social reactions in informal supports, could reduce problem drinking and related outcomes in victims.
Thus, in the current study, the investigators evaluate an intervention (i.e., Supporting Survivors and Self [SSS]) created for potential informal support disclosure recipients. College students are the target population for the initial version of the SSS intervention given the high rates of SA, IPV, and alcohol misuse among this demographic. The interactive, two-session intervention teaches potential disclosure recipients what to say and not to say and ways to promote healthy coping and discourage unhealthy coping in victims. The role of alcohol in risk for and outcomes associated with IPV and SA as well as alcohol-specific social reactions are addressed in the SSS intervention because alcohol is involved in most situations of IPV and SA among college students, and drinking to cope is common among victims.
This study is a small-scale, yet rigorous, initial evaluation of the SSS intervention that includes a prospective (i.e., intervention prior to potential disclosure) and experimental (i.e., randomized control trial) methodology. Outcome data will be multi-informant (i.e., data from both informal supports and victims) and multi-method (i.e., qualitative and quantitative). The investigators will:
Implement and evaluate the effectiveness of the SSS intervention compared to a wait-list control condition among potential informal supports. Hypothesis 1a: Individuals receiving the SSS intervention (N=450) compared to individuals in the wait-list control condition (N=450) will report fewer IPV and SA rape myths as well as greater intentions to provide positive social reactions and fewer intentions to provide negative social reactions. Hypothesis 1b: Individuals who receive SSS intervention and are subsequent disclosure recipients (n=100) will report providing less negative social reactions and more positive social reactions than individuals in the control condition who are subsequent disclosure recipients (n=100); mediators (e.g., low victim blame) and moderators (e.g., victim alcohol use at time of assault) of outcomes will be examined. Hypothesis 1c: Individuals who receive the SSS intervention and are subsequent victims of IPV and/or SA (n=60) will report less self-blame, PTSD, depression, drinking to cope, and problem drinking compared to individuals in the control condition who are subsequent victims of IPV and/or SA (n=60); mediators (e.g., engagement in healthy coping) and moderators (e.g., gender) will be explored. Methodology: A random sample of college students from a public university will be invited to participate in a pre-test (all participants), SSS intervention (only participants randomly assigned to this condition), and six-month post-test (all participants). A subsample of disclosure recipients in the SSS intervention condition will be invited to participate in a qualitative exit interviews (after the post-test) to enrich findings and inform SSS revisions.
Determine the feasibility in recruiting victims who disclosed to individuals in the SSS and control conditions to complete outcome surveys and gather preliminary effectiveness data on the SSS intervention. Hypothesis 2a: Victims who disclose to an individual in the SSS intervention (n=50) will report trends towards receiving more positive social reactions to disclosure, less negative social reactions to disclosure, and fewer symptoms of PTSD, depression, drinking to cope, and negative alcohol-related consequences compared to individuals who disclose to an individual in the control condition (n=50).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Skills, Self-Criticism, Post-traumatic Stress Disorder, Depression, Alcohol Abuse, Drinking, College, Alcohol Drinking, Alcohol; Harmful Use, Social Stigma, Social Norms, Social Responsibility, Social Behavior, Empathy, Coping Skills, Coping Behavior
Keywords
Sexual Violence, Interpersonal Violence, Prevention, Mixed-Methods, Randomized Controlled Trial, Outcome Evaluation, College Students, Post-traumatic Stress Disorder, Alcohol, Sexual Assault, Disclosure, Social Reactions, Coping, Depression, Intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control intervention trial with a wait-list control condition, randomized at the individual level
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1268 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
This arm will receive the intervention, followed by a six-month follow-up evaluation.
Arm Title
Wait-list Control
Arm Type
No Intervention
Arm Description
This arm will receive the intervention after a six-month follow-up evaluation.
Intervention Type
Behavioral
Intervention Name(s)
Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS)
Intervention Description
The SSS intervention consists of a two-hour session followed by a 90-minute booster session a month following the initial program session. The SSS intervention is delivered in groups of approximately 20 students facilitated by peer educators. The SSS intervention provides participants with specific information on the reasons why positive social reactions are important and negative social reactions can be harmful, examples of what to say and what not to say (including ways to promote healthy coping and discourage unhealthy coping, e.g., drinking to cope), opportunities for roleplay, and an emphasis on the importance of self-care and ways in which self-care can be balanced with the needs of IPV and SA victims.
Primary Outcome Measure Information:
Title
Negative Social Reactions
Description
As measured by the Social Reactions Questionnaire (at six month follow-up). This scale is measured from 1 to 6, with higher mean scores representing a less desirable outcome.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Positive Social Reactions
Description
As measured by the Social Reactions Questionnaire (at six month follow-up). This scale is measured from 1 to 6, with higher mean scores representing a less desirable outcome.
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
undergraduate student at University of New Hampshire
read and understand English
able to independently complete online surveys
Facility Information:
Facility Name
University of New Hampshire
City
Durham
State/Province
New Hampshire
ZIP/Postal Code
03824
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Development and Pilot Trial of an Intervention to Reduce Disclosure Recipients Negative Social Reactions and Victims Psychological Distress and Problem Drinking
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