Trial Outcomes & Findings for Alabama Community Healthy Marriage Initiative Evaluation Project for Couples (NCT NCT03158714)
NCT ID: NCT03158714
Last Updated: 2025-02-19
Results Overview
Couple satisfaction was measured using an abbreviated version of the Couple Satisfaction Index utilized in previously published studies. The 3 items (rated from 1 \[Not at all\] to 6 \[Completely\]) are: "I have a warm and comfortable relationship with my partner," "How rewarding is your relationship with your partner?" and "In general, how satisfied are you with your relationship?" Mean composites were calculated, and the total scale ranges from 1 to 6. Higher scores indicate higher couple satisfaction.
COMPLETED
NA
1858 participants
6 months
2025-02-19
Participant Flow
Participant milestones
| Measure |
Couples Connecting Mindfully Curriculum
Receives the Couples Connecting Mindfully curriculum over a 6 week period.
Couples Connecting Mindfully
|
ELEVATE Curriculum
Receives the ELEVATE curriculum over a 6 week period.
ELEVATE
|
Control
No programming is offered.
|
|---|---|---|---|
|
Overall Study
STARTED
|
626
|
626
|
606
|
|
Overall Study
COMPLETED
|
445
|
398
|
606
|
|
Overall Study
NOT COMPLETED
|
181
|
228
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some participants did not fill out complete age information on the baseline survey, so we are missing this demographic data on a few participants for each group (ELEVATE, CCM, and Control)
Baseline characteristics by cohort
| Measure |
Couples Connecting Mindfully Curriculum
n=626 Participants
Receives the Couples Connecting Mindfully curriculum over a 6 week period.
Couples Connecting Mindfully
|
ELEVATE Curriculum
n=626 Participants
Receives the ELEVATE curriculum over a 6 week period.
ELEVATE
|
Control
n=606 Participants
No programming is offered.
|
Total
n=1858 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.17 Years
STANDARD_DEVIATION 12.85 • n=607 Participants • Some participants did not fill out complete age information on the baseline survey, so we are missing this demographic data on a few participants for each group (ELEVATE, CCM, and Control)
|
37.23 Years
STANDARD_DEVIATION 11.70 • n=607 Participants • Some participants did not fill out complete age information on the baseline survey, so we are missing this demographic data on a few participants for each group (ELEVATE, CCM, and Control)
|
36.46 Years
STANDARD_DEVIATION 11.19 • n=584 Participants • Some participants did not fill out complete age information on the baseline survey, so we are missing this demographic data on a few participants for each group (ELEVATE, CCM, and Control)
|
37.30 Years
STANDARD_DEVIATION 11.30 • n=1798 Participants • Some participants did not fill out complete age information on the baseline survey, so we are missing this demographic data on a few participants for each group (ELEVATE, CCM, and Control)
|
|
Sex: Female, Male
Female
|
312 Participants
n=626 Participants
|
316 Participants
n=626 Participants
|
308 Participants
n=606 Participants
|
936 Participants
n=1858 Participants
|
|
Sex: Female, Male
Male
|
314 Participants
n=626 Participants
|
310 Participants
n=626 Participants
|
298 Participants
n=606 Participants
|
922 Participants
n=1858 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=626 Participants
|
36 Participants
n=626 Participants
|
31 Participants
n=606 Participants
|
97 Participants
n=1858 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
573 Participants
n=626 Participants
|
568 Participants
n=626 Participants
|
550 Participants
n=606 Participants
|
1691 Participants
n=1858 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=626 Participants
|
22 Participants
n=626 Participants
|
25 Participants
n=606 Participants
|
70 Participants
n=1858 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=626 Participants
|
2 Participants
n=626 Participants
|
1 Participants
n=606 Participants
|
8 Participants
n=1858 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=626 Participants
|
6 Participants
n=626 Participants
|
4 Participants
n=606 Participants
|
17 Participants
n=1858 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=626 Participants
|
0 Participants
n=626 Participants
|
1 Participants
n=606 Participants
|
1 Participants
n=1858 Participants
|
|
Race (NIH/OMB)
Black or African American
|
212 Participants
n=626 Participants
|
201 Participants
n=626 Participants
|
207 Participants
n=606 Participants
|
620 Participants
n=1858 Participants
|
|
Race (NIH/OMB)
White
|
364 Participants
n=626 Participants
|
372 Participants
n=626 Participants
|
351 Participants
n=606 Participants
|
1087 Participants
n=1858 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=626 Participants
|
0 Participants
n=626 Participants
|
0 Participants
n=606 Participants
|
0 Participants
n=1858 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
38 Participants
n=626 Participants
|
45 Participants
n=626 Participants
|
42 Participants
n=606 Participants
|
125 Participants
n=1858 Participants
|
|
Education Level
No degree or diploma earned
|
33 Participants
n=626 Participants
|
36 Participants
n=626 Participants
|
33 Participants
n=606 Participants
|
102 Participants
n=1858 Participants
|
|
Education Level
General Education Development (GED)
|
48 Participants
n=626 Participants
|
55 Participants
n=626 Participants
|
39 Participants
n=606 Participants
|
142 Participants
n=1858 Participants
|
|
Education Level
High School Diploma
|
70 Participants
n=626 Participants
|
84 Participants
n=626 Participants
|
83 Participants
n=606 Participants
|
237 Participants
n=1858 Participants
|
|
Education Level
Vocational/Technical Certification
|
29 Participants
n=626 Participants
|
17 Participants
n=626 Participants
|
23 Participants
n=606 Participants
|
69 Participants
n=1858 Participants
|
|
Education Level
Some college but no degree completion
|
142 Participants
n=626 Participants
|
117 Participants
n=626 Participants
|
108 Participants
n=606 Participants
|
367 Participants
n=1858 Participants
|
|
Education Level
Associate's Degree
|
52 Participants
n=626 Participants
|
53 Participants
n=626 Participants
|
49 Participants
n=606 Participants
|
154 Participants
n=1858 Participants
|
|
Education Level
Bachelor's Degree
|
129 Participants
n=626 Participants
|
126 Participants
n=626 Participants
|
142 Participants
n=606 Participants
|
397 Participants
n=1858 Participants
|
|
Education Level
Advanced Degree
|
103 Participants
n=626 Participants
|
116 Participants
n=626 Participants
|
106 Participants
n=606 Participants
|
325 Participants
n=1858 Participants
|
|
Education Level
Not Reported
|
20 Participants
n=626 Participants
|
22 Participants
n=626 Participants
|
23 Participants
n=606 Participants
|
65 Participants
n=1858 Participants
|
|
Relationship Status
Committed (not engaged/married)
|
131 Participants
n=626 Participants
|
119 Participants
n=626 Participants
|
137 Participants
n=606 Participants
|
387 Participants
n=1858 Participants
|
|
Relationship Status
Engaged to be married
|
50 Participants
n=626 Participants
|
45 Participants
n=626 Participants
|
66 Participants
n=606 Participants
|
161 Participants
n=1858 Participants
|
|
Relationship Status
Married
|
413 Participants
n=626 Participants
|
424 Participants
n=626 Participants
|
376 Participants
n=606 Participants
|
1213 Participants
n=1858 Participants
|
|
Relationship Status
Separated
|
6 Participants
n=626 Participants
|
5 Participants
n=626 Participants
|
0 Participants
n=606 Participants
|
11 Participants
n=1858 Participants
|
|
Relationship Status
Not Reported
|
26 Participants
n=626 Participants
|
33 Participants
n=626 Participants
|
27 Participants
n=606 Participants
|
86 Participants
n=1858 Participants
|
|
Parent Status
Parent
|
431 Participants
n=626 Participants
|
432 Participants
n=626 Participants
|
428 Participants
n=606 Participants
|
1291 Participants
n=1858 Participants
|
|
Parent Status
Not a parent
|
164 Participants
n=626 Participants
|
167 Participants
n=626 Participants
|
140 Participants
n=606 Participants
|
471 Participants
n=1858 Participants
|
|
Parent Status
Not reported
|
31 Participants
n=626 Participants
|
27 Participants
n=626 Participants
|
38 Participants
n=606 Participants
|
96 Participants
n=1858 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 406 ELEVATE respondents, 432 CCM respondents, and 426 Control respondents completed baseline, immediate follow-up, and 6-month follow-up surveys and completed all of the CSI items.
Couple satisfaction was measured using an abbreviated version of the Couple Satisfaction Index utilized in previously published studies. The 3 items (rated from 1 \[Not at all\] to 6 \[Completely\]) are: "I have a warm and comfortable relationship with my partner," "How rewarding is your relationship with your partner?" and "In general, how satisfied are you with your relationship?" Mean composites were calculated, and the total scale ranges from 1 to 6. Higher scores indicate higher couple satisfaction.
Outcome measures
| Measure |
Couples Connecting Mindfully Curriculum
n=432 Participants
Receives the Couples Connecting Mindfully curriculum over a 6 week period.
Couples Connecting Mindfully
|
ELEVATE Curriculum
n=406 Participants
Receives the ELEVATE curriculum over a 6 week period.
ELEVATE
|
Control
n=426 Participants
No programming is offered.
|
|---|---|---|---|
|
Couple Satisfaction Index
|
4.82 score on a scale
Standard Deviation 1.11
|
4.90 score on a scale
Standard Deviation 1.17
|
4.78 score on a scale
Standard Deviation 1.16
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: 497 ELEVATE respondents, 520 CCM respondents, and 521 Control respondents completed both baseline \& immediate follow-up surveys, as well as 80% of the CRSI items.
Couple relationship skills were measured using 32 items from the Couple Relationship Skills Inventory (CRSI). This measure was constructed to match the core relationship skills and predictors of couple quality emphasized in the HMRE programs provided. Items were taken from established and validated social science measures assessing commitment, intimate partner knowledge, friendship, caring behaviors, conflict management, and external support. Example items include, "I commit effort every day to making my relationship work," "I know my partner's current life stresses," "When things 'get heated' I suggest we take a break to calm down," and "I initiate physical affection with my partner." Items ranged from 1 (Very strongly disagree) to 7 (Very strongly agree). Composite sum scores were created at the individual level and the total scale ranges from 1-224 (i.e., 32\*7 = 224). Higher scores indicate greater couple relationship skills.
Outcome measures
| Measure |
Couples Connecting Mindfully Curriculum
n=520 Participants
Receives the Couples Connecting Mindfully curriculum over a 6 week period.
Couples Connecting Mindfully
|
ELEVATE Curriculum
n=497 Participants
Receives the ELEVATE curriculum over a 6 week period.
ELEVATE
|
Control
n=521 Participants
No programming is offered.
|
|---|---|---|---|
|
The Couple Relationship Skills Inventory
|
171.14 score on a scale
Standard Deviation 24.23
|
170.73 score on a scale
Standard Deviation 24.33
|
167.64 score on a scale
Standard Deviation 22.85
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 389 ELEVATE participants, 423 CCM participants, and 416 control respondents completed baseline, immediate post-program, and 6-month follow-up surveys, as well as 100% of the items of the SF-12 measure.
Individual mental health was measured using the SF-12 Mental Component Summary score assessing anxiety, depression, sense of wellbeing, and social/emotional functioning. Per the measure's design, items were asked on differing scales (e.g., 1 to 3 or 1 to 5) with different anchor responses (e.g., all of the time to none of the time, or not at all to extremely). Example items include, "During the past month how much of the time have you accomplished less than you would like" or "During the past month how often have you felt downhearted and depressed?" The SF-12 Mental Component Summary score has shown scale reliability and validity in empirical studies. Scores range from 0 to 100 with a mean of 50 and SD of 10 in the general U.S. population. Higher scores indicate better individual mental health.
Outcome measures
| Measure |
Couples Connecting Mindfully Curriculum
n=423 Participants
Receives the Couples Connecting Mindfully curriculum over a 6 week period.
Couples Connecting Mindfully
|
ELEVATE Curriculum
n=389 Participants
Receives the ELEVATE curriculum over a 6 week period.
ELEVATE
|
Control
n=416 Participants
No programming is offered.
|
|---|---|---|---|
|
Individual Mental Health
|
43.63 score on a scale
Standard Deviation 10.16
|
43.16 score on a scale
Standard Deviation 10.28
|
43.95 score on a scale
Standard Deviation 10.32
|
Adverse Events
Couples Connecting Mindfully Curriculum
ELEVATE Curriculum
Control
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