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.
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
- Conditions the study is for
- Social Skills, Self-Criticism, Post-traumatic Stress Disorder
- What is being tested?
- Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS)
- Type of treatment
- Lifestyle or therapy programme
- 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
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:
- 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).
- Conditions
- Social Skills, Self-Criticism, Post-traumatic Stress Disorder, Depression, Alcohol Abuse, Drinking, College
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This 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 Control | No intervention | This 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.
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)
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.
- First posted5 Apr 2018
- Study start10 Sep 2018
- Primary completion10 Jun 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Social SkillsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of New Hampshire
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, University of South Florida, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Katie Edwards, University of New Hampshire
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Trial of an Intervention to Reduce Disclosure Recipients Negative Social Reactions and Victims Psychological Distress and Problem Drinking
- ClinicalTrials.gov ID
- NCT03488927
- Acronym / sponsor ID
- UNewHampshire
- Conditions
- Social Skills, Self-Criticism, Post-traumatic Stress Disorder, Depression, Alcohol Abuse, Drinking, College
- Keywords
- Sexual Violence, Interpersonal Violence, Prevention, Mixed-Methods, Randomized Controlled Trial, Outcome Evaluation, College Students, Post-traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,268 participants (actual)
- Lead sponsor
- University of New HampshireUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, University of South Florida, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control intervention trial with a wait-list control condition, randomized at the individual level
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS)This arm will receive the intervention, followed by a six-month follow-up evaluation. |
| Wait-list Control | No intervention | –This arm will receive the intervention after a six-month follow-up evaluation. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- undergraduate student at University of New Hampshire
- read and understand English
- able to independently complete online surveys
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supporting 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. | Behavioural | Intervention |
Primary outcome
Negative Social Reactions
Time frame: Six months
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.
1 secondary outcome
Positive Social Reactions
Time frame: Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.