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

• Sponsor: University of New Hampshire (Other)
• Overall Status: Completed
• CT.gov ID: NCT03488927
• Collaborator: University of Illinois at Chicago (Other), University of South Florida (Other), National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 1,268
• Location: 1
• Arms: 2
• Actual Duration (Months): 9
• Patients Per Site Per Month: 141.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	Behavioral: Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS)	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 1268 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized control intervention trial with a wait-list control condition, randomized at the individual levelRandomized control intervention trial with a wait-list control condition, randomized at the individual level
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Development and Pilot Trial of an Intervention to Reduce Disclosure Recipients Negative Social Reactions and Victims Psychological Distress and Problem Drinking
• Actual Study Start Date: Sep 10, 2018
• Actual Primary Completion Date: Jun 10, 2019
• Actual Study Completion Date: Jun 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
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); 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.
No Intervention: Wait-list Control This arm will receive the intervention after a six-month follow-up evaluation.

Outcome Measures

Primary Outcome Measures

1. Negative Social Reactions [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.

Secondary Outcome Measures

1. Positive Social Reactions [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• undergraduate student at University of New Hampshire

• read and understand English

• able to independently complete online surveys

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of New Hampshire	Durham	New Hampshire	United States	03824

Sponsors and Collaborators

• University of New Hampshire
• University of Illinois at Chicago
• University of South Florida
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Aug 25, 2020
• Statistical Analysis Plan - Aug 25, 2020
• Informed Consent Form - Apr 1, 2019

More Information

Publications

None provided.

• Responsible Party: Katie Edwards, Associate Professor of Psychology, University of New Hampshire
• ClinicalTrials.gov Identifier: NCT03488927
• Other Study ID Numbers: UNewHampshire
• First Posted: Apr 5, 2018
• Last Update Posted: Oct 19, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Katie Edwards, Associate Professor of Psychology, University of New Hampshire: 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
• Additional relevant MeSH terms: Alcoholism; Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Alcohol Drinking; Alcohol Drinking in College

Study Results

Participant Flow

Arm/Group Title	Intervention-Attend	Wait-list Control	Intervention-Nonattend
Arm/Group Description	This arm was invited to and attended the intervention, followed by a six-month follow-up evaluation. 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.	This arm was be invited to attend the intervention after a six-month follow-up evaluation.	This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.
Period Title: Overall Study
STARTED	305	432	531
COMPLETED	261	314	314
NOT COMPLETED	44	118	217

Baseline Characteristics

Arm/Group Title	Intervention-Attend	Wait-list Control	Intervention-Nonattend	Total
Arm/Group Description	This arm was invited to and attended the intervention, followed by a six-month follow-up evaluation. 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.	This arm was be invited to attend the intervention after a six-month follow-up evaluation.	This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.	Total of all reporting groups
Overall Participants	305	432	531	1268
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	305 100%	432 100%	531 100%	1268 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	19.50 (1.17)	19.51 (1.27)	19.64 (1.23)	19.56 (1.23)
Sex/Gender, Customized (Count of Participants)
Woman	239 78.4%	276 63.9%	351 66.1%	866 68.3%
Man	63 20.7%	154 35.6%	174 32.8%	391 30.8%
Self-identify or No answer	3 1%	2 0.5%	6 1.1%	11 0.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 3.3%	20 4.6%	33 6.2%	63 5%
Not Hispanic or Latino	294 96.4%	409 94.7%	489 92.1%	1192 94%
Unknown or Not Reported	1 0.3%	3 0.7%	9 1.7%	13 1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.3%	1 0.2%	1 0.2%	3 0.2%
Asian	18 5.9%	15 3.5%	24 4.5%	57 4.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	2 0.7%	9 2.1%	7 1.3%	18 1.4%
White	273 89.5%	393 91%	478 90%	1144 90.2%
More than one race	9 3%	11 2.5%	13 2.4%	33 2.6%
Unknown or Not Reported	2 0.7%	3 0.7%	8 1.5%	13 1%
Region of Enrollment (participants) [Number]
United States	305 100%	432 100%	531 100%	1268 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention-Attend	Wait-list Control	Intervention-Nonattend
Arm/Group Description	This arm was invited to and attended the intervention, followed by a six-month follow-up evaluation. 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.	This arm was be invited to attend the intervention after a six-month follow-up evaluation.	This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.
Measure Participants	130	164	159
Mean (Standard Deviation) [Mean of actual negative reactions scale]	1.25 (0.37)	1.28 (0.40)	1.35 (0.56)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention-Attend	Wait-list Control	Intervention-Nonattend
Arm/Group Description	This arm was invited to and attended the intervention, followed by a six-month follow-up evaluation. 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.	This arm was be invited to attend the intervention after a six-month follow-up evaluation.	This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.
Measure Participants	129	160	158
Mean (Standard Deviation) [score on a scale]	4.05 (0.68)	3.87 (0.82)	3.87 (0.74)

Adverse Events

Time Frame	Six months.
Adverse Event Reporting Description	No adverse events to report.
Arm/Group Title	Intervention-Attend		Wait-list Control		Intervention-Nonattend
Arm/Group Description	This arm was invited to and attended the intervention, followed by a six-month follow-up evaluation. 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.		This arm was be invited to attend the intervention after a six-month follow-up evaluation.		This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.
All Cause Mortality
	Intervention-Attend		Wait-list Control		Intervention-Nonattend
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/305 (0%)		0/432 (0%)		0/531 (0%)
Serious Adverse Events
	Intervention-Attend		Wait-list Control		Intervention-Nonattend
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/305 (0%)		0/432 (0%)		0/531 (0%)
Other (Not Including Serious) Adverse Events
	Intervention-Attend		Wait-list Control		Intervention-Nonattend
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/305 (0%)		0/432 (0%)		0/531 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.