ClinicalTrials.gg
CompletedNCT03488927Updated Oct 19, 2020Results posted

Development and Pilot Trial of an Intervention to Reduce Disclosure Recipients Negative Social Reactions and Victims Psychological Distress and Problem Drinking

An interventional study of Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS) in Social Skills, Self-Criticism and Post-traumatic Stress Disorder, sponsored by University of New Hampshire. Completed at 1 site in United States. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by University of New Hampshire · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,268
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Study 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.

Read the 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:

  1. 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.
  2. 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).
02

Conditions studied

  • 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
03

In context

Social Skills

120 studies on the registry are indexed under Social Skills; 31 are open to participants now.

This study's enrollment of 1,268 is above the median of 78 across 110 interventional studies indexed under Social Skills.

Browse Social Skills studies →

Lead sponsor

University of New Hampshire is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • undergraduate student at University of New Hampshire
  • read and understand English
  • able to independently complete online surveys
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,268 participants (actual)

Study arms

  • Experimental
    Intervention

    This arm will receive the intervention, followed by a six-month follow-up evaluation.

    Behavioral: Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS)

  • No intervention
    Wait-list Control

    This arm will receive the intervention after a six-month follow-up evaluation.

Interventions

  • BehavioralSupporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS)

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Six months

Secondary outcomes

  1. 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.

    Time frame: Six months

07

Results

Posted Oct 19, 2020

Participant flow

Participant flow — Overall Study
MilestoneIntervention-AttendWait-list ControlIntervention-Nonattend
Started305432531
Completed261314314
Not completed44118217
Withdrew: Withdrawal by subject44118217

Outcome measures

PrimaryNegative 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.

Time frame:
Six months
Reported as:
Mean · Mean of actual negative reactions scale
Negative Social Reactions
Mean of actual negative reactions scaleIntervention-AttendWait-list ControlIntervention-Nonattend
Negative Social Reactions1.25 ± 0.371.28 ± 0.401.35 ± 0.56
SecondaryPositive 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.

Time frame:
Six months
Reported as:
Mean · score on a scale
Positive Social Reactions
score on a scaleIntervention-AttendWait-list ControlIntervention-Nonattend
Positive Social Reactions4.05 ± 0.683.87 ± 0.823.87 ± 0.74

Adverse events

Collected over Six months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention-Attend0/305 (0%)0/305 (0%)0/305 (0%)
Wait-list Control0/432 (0%)0/432 (0%)0/432 (0%)
Intervention-Nonattend0/531 (0%)0/531 (0%)0/531 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Intervention-AttendWait-list ControlIntervention-NonattendTotal
<=18 years0000
Between 18 and 65 years3054325311268
>=65 years0000
Age, Continuous
Age, Continuous(Years)Intervention-AttendWait-list ControlIntervention-NonattendTotal
Mean19.50 ± 1.1719.51 ± 1.2719.64 ± 1.2319.56 ± 1.23
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Intervention-AttendWait-list ControlIntervention-NonattendTotal
Woman239276351866
Man63154174391
Self-identify or No answer32611
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Intervention-AttendWait-list ControlIntervention-NonattendTotal
Hispanic or Latino10203363
Not Hispanic or Latino2944094891192
Unknown or Not Reported13913
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention-AttendWait-list ControlIntervention-NonattendTotal
American Indian or Alaska Native1113
Asian18152457
Native Hawaiian or Other Pacific Islander0000
Black or African American29718
White2733934781144
More than one race9111333
Unknown or Not Reported23813
Region of Enrollment
Region of Enrollment(participants)Intervention-AttendWait-list ControlIntervention-NonattendTotal
United States3054325311268
08

Study locations

1 site
  • University of New Hampshire
    Durham, New Hampshire 03824, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03488927
Lead sponsor
University of New Hampshire
Responsible party
Katie Edwards (Associate Professor of Psychology, University of New Hampshire) — Principal investigator
First posted
Apr 5, 2018
Start date
Sep 10, 2018
Primary completion
Jun 10, 2019
Completion
Jun 10, 2019
Results posted
Oct 19, 2020
Last update
Oct 19, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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