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

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

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

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=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Age, Categorical
Between 18 and 65 years
305 Participants
n=99 Participants
432 Participants
n=107 Participants
531 Participants
n=206 Participants
1268 Participants
n=7 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Age, Continuous
19.50 Years
STANDARD_DEVIATION 1.17 • n=99 Participants
19.51 Years
STANDARD_DEVIATION 1.27 • n=107 Participants
19.64 Years
STANDARD_DEVIATION 1.23 • n=206 Participants
19.56 Years
STANDARD_DEVIATION 1.23 • n=7 Participants
Sex/Gender, Customized
Woman
239 Participants
n=99 Participants
276 Participants
n=107 Participants
351 Participants
n=206 Participants
866 Participants
n=7 Participants
Sex/Gender, Customized
Man
63 Participants
n=99 Participants
154 Participants
n=107 Participants
174 Participants
n=206 Participants
391 Participants
n=7 Participants
Sex/Gender, Customized
Self-identify or No answer
3 Participants
n=99 Participants
2 Participants
n=107 Participants
6 Participants
n=206 Participants
11 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants
n=99 Participants
20 Participants
n=107 Participants
33 Participants
n=206 Participants
63 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
294 Participants
n=99 Participants
409 Participants
n=107 Participants
489 Participants
n=206 Participants
1192 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
3 Participants
n=107 Participants
9 Participants
n=206 Participants
13 Participants
n=7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
3 Participants
n=7 Participants
Race (NIH/OMB)
Asian
18 Participants
n=99 Participants
15 Participants
n=107 Participants
24 Participants
n=206 Participants
57 Participants
n=7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=99 Participants
9 Participants
n=107 Participants
7 Participants
n=206 Participants
18 Participants
n=7 Participants
Race (NIH/OMB)
White
273 Participants
n=99 Participants
393 Participants
n=107 Participants
478 Participants
n=206 Participants
1144 Participants
n=7 Participants
Race (NIH/OMB)
More than one race
9 Participants
n=99 Participants
11 Participants
n=107 Participants
13 Participants
n=206 Participants
33 Participants
n=7 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=99 Participants
3 Participants
n=107 Participants
8 Participants
n=206 Participants
13 Participants
n=7 Participants
Region of Enrollment
United States
305 participants
n=99 Participants
432 participants
n=107 Participants
531 participants
n=206 Participants
1268 participants
n=7 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

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 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.

Outcome measures

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

Katie Edwards

University of Nebraska-Lincoln

Phone: 402-472-2223

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place