Trial Outcomes & Findings for Strength for U in Relationship Empowerment (NCT NCT04218864)
NCT ID: NCT04218864
Last Updated: 2025-08-01
Results Overview
The frequency of IPV will be measured using the Composite Abuse Scale. The Composite Abuse Scale is a 30-item scale with 4 subscales that measure severe combined abuse, emotional abuse, physical abuse, and harassment. Items are scored between 0 and 5, with Never=0 and Daily=5. Scale range is from 0-150. The lower the score, the better or less victimization. Change scores will be used to estimate differences within and between groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
Baseline, 6-week follow-up, 3, 6, and 12-month follow-up.
Results posted on
2025-08-01
Participant Flow
Participant milestones
| Measure |
Strength for U in Relationship Empowerment (SURE)
Theory-driven and derived from empirical support
Strength for U in Relationship Empowerment (SURE): A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
|
Attention, Time, and Information Matched Control
Well-validated
Attention, time, and information matched control: A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
57
|
|
Overall Study
COMPLETED
|
56
|
50
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
Strength for U in Relationship Empowerment (SURE)
Theory-driven and derived from empirical support
Strength for U in Relationship Empowerment (SURE): A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
|
Attention, Time, and Information Matched Control
Well-validated
Attention, time, and information matched control: A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Strength for U in Relationship Empowerment
Baseline characteristics by cohort
| Measure |
Strength for U in Relationship Empowerment (SURE)
n=65 Participants
Theory-driven and derived from empirical support
Strength for U in Relationship Empowerment (SURE): A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
|
Attention, Time, and Information Matched Control
n=57 Participants
Well-validated
Attention, time, and information matched control: A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows
|
Total
n=122 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
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
65 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
45 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Bi-Racial or Multi-Ethnic
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American or Native Alaskan
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6-week follow-up, 3, 6, and 12-month follow-up.Population: All baseline outcome measures were missing for one subject due to a software issue. As a consequence, the outcome analysis was carried out with data from 121 participants.
The frequency of IPV will be measured using the Composite Abuse Scale. The Composite Abuse Scale is a 30-item scale with 4 subscales that measure severe combined abuse, emotional abuse, physical abuse, and harassment. Items are scored between 0 and 5, with Never=0 and Daily=5. Scale range is from 0-150. The lower the score, the better or less victimization. Change scores will be used to estimate differences within and between groups.
Outcome measures
| Measure |
Strength for U in Relationship Empowerment (SURE)
n=64 Participants
Theory-driven and derived from empirical support
Strength for U in Relationship Empowerment (SURE): A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
|
Attention, Time, and Information Matched Control
n=57 Participants
Well-validated
Attention, time, and information matched control: A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows
|
|---|---|---|
|
Composite Abuse Scale (CAS)
6-week follow-up
|
10.54 units on a scale
Standard Deviation 12.02
|
10.02 units on a scale
Standard Deviation 12.78
|
|
Composite Abuse Scale (CAS)
Baseline
|
29.13 units on a scale
Standard Deviation 20.92
|
27.01 units on a scale
Standard Deviation 20.65
|
|
Composite Abuse Scale (CAS)
3-month follow-up
|
9.69 units on a scale
Standard Deviation 10.39
|
8.27 units on a scale
Standard Deviation 11.06
|
|
Composite Abuse Scale (CAS)
6-month follow-up
|
8.89 units on a scale
Standard Deviation 12.06
|
8.7 units on a scale
Standard Deviation 10.95
|
|
Composite Abuse Scale (CAS)
12-month follow-up
|
11.45 units on a scale
Standard Deviation 14.56
|
7.5 units on a scale
Standard Deviation 12.02
|
SECONDARY outcome
Timeframe: Baseline, 6-week follow-up, 3, 6, and 12-month follow-upPopulation: All baseline outcome measures were missing for one subject due to a software issue. As a consequence, the outcome analysis was carried out with data from 121 participants.
Positive affect and well-being will be measured by using the National Institutes of Health Quality of Life in Neurological Disorders scale for Positive Affect and Well-being a computerized adaptive test 9-item scale. This scale is scored between 1 and 5, with Never=1 and Always=5. Scale range is from 9-45. Higher scores indicate higher positive affect, life satisfaction, or an overall sense of purpose and meaning. Change scores will be used to estimate differences within and between groups.
Outcome measures
| Measure |
Strength for U in Relationship Empowerment (SURE)
n=64 Participants
Theory-driven and derived from empirical support
Strength for U in Relationship Empowerment (SURE): A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
|
Attention, Time, and Information Matched Control
n=57 Participants
Well-validated
Attention, time, and information matched control: A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows
|
|---|---|---|
|
The Positive Affect and Well-being Scale (PAW)
12-month follow-up
|
33.59 units on a scale
Standard Deviation 5.75
|
32.93 units on a scale
Standard Deviation 6.64
|
|
The Positive Affect and Well-being Scale (PAW)
Baseline
|
29.39 units on a scale
Standard Deviation 7.32
|
29.95 units on a scale
Standard Deviation 7.17
|
|
The Positive Affect and Well-being Scale (PAW)
6-week follow-up
|
31.68 units on a scale
Standard Deviation 6.43
|
32.05 units on a scale
Standard Deviation 6.68
|
|
The Positive Affect and Well-being Scale (PAW)
3-month follow-up
|
33.21 units on a scale
Standard Deviation 5.91
|
31.4 units on a scale
Standard Deviation 6.84
|
|
The Positive Affect and Well-being Scale (PAW)
6-month follow-up
|
32.64 units on a scale
Standard Deviation 6.08
|
30.84 units on a scale
Standard Deviation 6.51
|
SECONDARY outcome
Timeframe: Baseline, 6-week follow-up, 3, 6, and 12-month follow-upPopulation: All baseline outcome measures were missing for one subject due to a software issue. As a consequence, the outcome analysis was carried out with data from 121 participants.
Perceived emotional support will be measured using a 4-item scale developed by the Patient-Reported Outcomes Measurement Information System . Patient-Reported Outcomes Measurement Information System is a National Institutes of Health Roadmap initiative that provides precise, reliable, valid, and standardized questionnaires measuring patient-reported outcomes across the domains of physical, mental, and social health. The Patient-Reported Outcomes Measurement Information System .Emotional Support item bank specifically aims to measure perceived feelings of being cared for and valued as a person. This scale is scored between 1 and 5, with Never=1 and Always=5. Scale range is from 4-20. A higher Patient-Reported Outcomes Measurement Information System score represents increased emotional support. Change scores will be used to estimate differences within and between groups.
Outcome measures
| Measure |
Strength for U in Relationship Empowerment (SURE)
n=64 Participants
Theory-driven and derived from empirical support
Strength for U in Relationship Empowerment (SURE): A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
|
Attention, Time, and Information Matched Control
n=57 Participants
Well-validated
Attention, time, and information matched control: A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows
|
|---|---|---|
|
Perceived Emotional Support (PES)
Baseline
|
14.61 units on a scale
Standard Deviation 4.15
|
14.89 units on a scale
Standard Deviation 4.16
|
|
Perceived Emotional Support (PES)
6- Week
|
15.41 units on a scale
Standard Deviation 3.63
|
15.32 units on a scale
Standard Deviation 4.23
|
|
Perceived Emotional Support (PES)
3- Month
|
15.75 units on a scale
Standard Deviation 3.45
|
14.77 units on a scale
Standard Deviation 4.46
|
|
Perceived Emotional Support (PES)
6- Month
|
15.15 units on a scale
Standard Deviation 3.54
|
15.12 units on a scale
Standard Deviation 3.49
|
|
Perceived Emotional Support (PES)
12-Month
|
16.02 units on a scale
Standard Deviation 3.67
|
15.58 units on a scale
Standard Deviation 4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6-week follow-up, 3, 6, and 12-month follow-upPopulation: All baseline outcome measures were missing for one subject due to a software issue. As a consequence, the outcome analysis was carried out with data from 121 participants.
Empowerment will be measured using the Personal Progress Scale-Revised for measuring skills, social supports, and resources to cope more effectively with relationship stress and trauma. The Personal Progress Scale-Revised is a 28-item scale scored between 1 and 7, with 1=Almost Never and 7=Almost Always. Scale range is from 28-196. Higher scores indicating higher empowerment. Change scores will be used to estimate differences within and between groups.
Outcome measures
| Measure |
Strength for U in Relationship Empowerment (SURE)
n=64 Participants
Theory-driven and derived from empirical support
Strength for U in Relationship Empowerment (SURE): A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
|
Attention, Time, and Information Matched Control
n=57 Participants
Well-validated
Attention, time, and information matched control: A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows
|
|---|---|---|
|
Personal Progress Scale-Revised (PPS-R)
3-Month
|
111.4 units on a scale
Standard Deviation 13.4
|
113.74 units on a scale
Standard Deviation 14.11
|
|
Personal Progress Scale-Revised (PPS-R)
Baseline
|
129.53 units on a scale
Standard Deviation 21.66
|
132.56 units on a scale
Standard Deviation 22.62
|
|
Personal Progress Scale-Revised (PPS-R)
6-Week
|
109.08 units on a scale
Standard Deviation 14.39
|
113.66 units on a scale
Standard Deviation 11.72
|
|
Personal Progress Scale-Revised (PPS-R)
6-Month
|
111.42 units on a scale
Standard Deviation 14.01
|
113.84 units on a scale
Standard Deviation 14.11
|
|
Personal Progress Scale-Revised (PPS-R)
12-Month
|
114.1 units on a scale
Standard Deviation 16.44
|
110.87 units on a scale
Standard Deviation 12.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6-week follow-up, 3, 6, and 12-month follow-upPopulation: All baseline outcome measures were missing for one subject due to a software issue. As a consequence, the outcome analysis was carried out with data from 121 participants.
Self-efficacy will be measured using the General Self-Efficacy Scale a 10-item self-report measure. It measures personal competence to deal effectively with a variety of stressful situations. The General Self-Efficacy Scale is scored from 10-40, with 1=Not at all true and 4=Exactly true. A higher score indicates more self-efficacy. Change scores will be used to estimate differences within and between groups.
Outcome measures
| Measure |
Strength for U in Relationship Empowerment (SURE)
n=64 Participants
Theory-driven and derived from empirical support
Strength for U in Relationship Empowerment (SURE): A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
|
Attention, Time, and Information Matched Control
n=57 Participants
Well-validated
Attention, time, and information matched control: A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows
|
|---|---|---|
|
Self-efficacy (GSE)
Baseline
|
28.45 units on a scale
Standard Deviation 4.57
|
27.34 units on a scale
Standard Deviation 4.8
|
|
Self-efficacy (GSE)
6- Week
|
28.71 units on a scale
Standard Deviation 4.17
|
28.68 units on a scale
Standard Deviation 5.23
|
|
Self-efficacy (GSE)
3- Month
|
29.67 units on a scale
Standard Deviation 3.82
|
29.57 units on a scale
Standard Deviation 5.32
|
|
Self-efficacy (GSE)
6- Month
|
29.49 units on a scale
Standard Deviation 4.23
|
28.84 units on a scale
Standard Deviation 4.58
|
|
Self-efficacy (GSE)
12-Month
|
30.72 units on a scale
Standard Deviation 3.94
|
29.79 units on a scale
Standard Deviation 4.7
|
Adverse Events
Strength for U in Relationship Empowerment (SURE)
Serious events: 24 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention, Time, and Information Matched Control
Serious events: 17 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Strength for U in Relationship Empowerment (SURE)
n=65 participants at risk
Theory-driven and derived from empirical support
Strength for U in Relationship Empowerment (SURE): A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
|
Attention, Time, and Information Matched Control
n=57 participants at risk
Well-validated
Attention, time, and information matched control: A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Hospitalization
|
4.6%
3/65 • Number of events 3 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
1.8%
1/57 • Number of events 1 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
|
Renal and urinary disorders
Hospitalization
|
3.1%
2/65 • Number of events 2 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
1.8%
1/57 • Number of events 1 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
|
Social circumstances
IPV Altercation (non-study related)
|
23.1%
15/65 • Number of events 37 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
15.8%
9/57 • Number of events 19 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
|
Psychiatric disorders
Hospitalization
|
3.1%
2/65 • Number of events 3 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
7.0%
4/57 • Number of events 4 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
|
Social circumstances
Housing
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
1.8%
1/57 • Number of events 1 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
|
Infections and infestations
Hospitalization
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
0.00%
0/57 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
|
Ear and labyrinth disorders
Hospitalization
|
0.00%
0/65 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
1.8%
1/57 • Number of events 1 • Adverse event data were collected at 6-weeks, 3-months, 6 months , and 12-months after baseline assessment
Systematic assessment: The study research staff conducted a standard structured interview at each follow-up period. Specific pregnancy-related medical conditions resulting in hospitalization were not evaluated.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place