Trial Outcomes & Findings for Development and Pilot Trial of an Intervention to Reduce Disclosure Recipients Negative Social Reactions and Victims Psychological Distress and Problem Drinking (NCT NCT03488927)
NCT ID: NCT03488927
Last Updated: 2020-10-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1268 participants
Primary outcome timeframe
Six months
Results posted on
2020-10-19
Participant Flow
Participant milestones
| Measure |
Intervention-Attend
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.
|
Wait-list Control
This arm was be invited to attend the intervention after a six-month follow-up evaluation.
|
Intervention-Nonattend
This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
305
|
432
|
531
|
|
Overall Study
COMPLETED
|
261
|
314
|
314
|
|
Overall Study
NOT COMPLETED
|
44
|
118
|
217
|
Reasons for withdrawal
| Measure |
Intervention-Attend
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.
|
Wait-list Control
This arm was be invited to attend the intervention after a six-month follow-up evaluation.
|
Intervention-Nonattend
This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
44
|
118
|
217
|
Baseline Characteristics
Development and Pilot Trial of an Intervention to Reduce Disclosure Recipients Negative Social Reactions and Victims Psychological Distress and Problem Drinking
Baseline characteristics by cohort
| Measure |
Intervention-Attend
n=305 Participants
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.
|
Wait-list Control
n=432 Participants
This arm was be invited to attend the intervention after a six-month follow-up evaluation.
|
Intervention-Nonattend
n=531 Participants
This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.
|
Total
n=1268 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
305 Participants
n=5 Participants
|
432 Participants
n=7 Participants
|
531 Participants
n=5 Participants
|
1268 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
19.50 Years
STANDARD_DEVIATION 1.17 • n=5 Participants
|
19.51 Years
STANDARD_DEVIATION 1.27 • n=7 Participants
|
19.64 Years
STANDARD_DEVIATION 1.23 • n=5 Participants
|
19.56 Years
STANDARD_DEVIATION 1.23 • n=4 Participants
|
|
Sex/Gender, Customized
Woman
|
239 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
866 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Man
|
63 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
391 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Self-identify or No answer
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
294 Participants
n=5 Participants
|
409 Participants
n=7 Participants
|
489 Participants
n=5 Participants
|
1192 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
273 Participants
n=5 Participants
|
393 Participants
n=7 Participants
|
478 Participants
n=5 Participants
|
1144 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
305 participants
n=5 Participants
|
432 participants
n=7 Participants
|
531 participants
n=5 Participants
|
1268 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Six monthsAs 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.
Outcome measures
| Measure |
Intervention-Attend
n=130 Participants
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.
|
Wait-list Control
n=164 Participants
This arm was be invited to attend the intervention after a six-month follow-up evaluation.
|
Intervention-Nonattend
n=159 Participants
This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.
|
|---|---|---|---|
|
Negative Social Reactions
|
1.25 Mean of actual negative reactions scale
Standard Deviation 0.37
|
1.28 Mean of actual negative reactions scale
Standard Deviation 0.40
|
1.35 Mean of actual negative reactions scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Six monthsAs 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.
Outcome measures
| Measure |
Intervention-Attend
n=129 Participants
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.
|
Wait-list Control
n=160 Participants
This arm was be invited to attend the intervention after a six-month follow-up evaluation.
|
Intervention-Nonattend
n=158 Participants
This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.
|
|---|---|---|---|
|
Positive Social Reactions
|
4.05 score on a scale
Standard Deviation 0.68
|
3.87 score on a scale
Standard Deviation 0.82
|
3.87 score on a scale
Standard Deviation 0.74
|
Adverse Events
Intervention-Attend
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-list Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention-Nonattend
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place