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Social SkillsNCT03488927

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

A study testing Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS) in people with Social Skills and Self-Criticism, run by University of New Hampshire at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 24 yearsHealthy volunteers can take part
What is being tested?
Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,268 participants
Where
1 siteUnited States
Study dates
10 Sep 2018to 10 Jun 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of New Hampshire

    Durham, New Hampshire, 03824

Other trials in United States

About this study

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).
Being tested
Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS)
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
Medical subject headings
Social Skills, Stress Disorders, Post-Traumatic, Depression, Alcoholism, Alcohol Drinking in College, Alcohol Drinking, Social Stigma, Social Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT03488927
Study groupRoleWhat they receive
InterventionExperimentalThis arm will receive the intervention, followed by a six-month follow-up evaluation.
Receives: Behavioral: Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS)
Wait-list ControlNo interventionThis arm will receive the intervention after a six-month follow-up evaluation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Six months

Secondary outcomes (1)
  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.

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2018
  2. Study start10 Sep 2018
  3. Primary completion10 Jun 2019
  4. Study completion10 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized control intervention trial with a wait-list control condition, randomized at the individual level
Masking
None (open label)
Enrolment
1,268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03488927
Sponsor's protocol ID
UNewHampshire
Status last verified
Sep 2020
First submitted
29 Mar 2018
Last updated
19 Oct 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS) in people with Social Skills and Self-Criticism, run by University of New Hampshire at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Negative Social Reactions (time frame: Six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

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