Trial Outcomes & Findings for Reproductive Life Planning for Women With Mental Illness (NCT NCT03969589)
NCT ID: NCT03969589
Last Updated: 2022-04-22
Results Overview
The Reproductive Life Goal Behavioral Intentions scale was used to measure self-reported intentions to engage in behavior to address one's reproductive life goals. A total score was calculated by taking the sum of the responses to the items. The average total score across participants is reported (range = 1 to 5) with higher scores indicating greater intentions to engage in behaviors to address one's reproductive life goals.
COMPLETED
NA
40 participants
Baseline to 2-Month Post-Intervention (~2 months)
2022-04-22
Participant Flow
Participant milestones
| Measure |
Reproductive Life Planning-Mental Health Intervention
Reproductive Life Planning-Mental Health (RLP-MH) intervention is comprised of two parts: 1) an in-person interactive session in which the participant works with an RLP-MH facilitator to explore pregnancy intentions and RLP goals, consider important factors that impact those goals (e.g. mental health and physical health conditions, psychosocial and lifestyle factors, values, preferences), and identify personal action steps to address RLP goals and 2) a 15-20 minute follow-up session in person or by phone one month later to discuss progress in addressing RLP goals.
|
Written Materials on Reproductive Life Planning
Participants will receive written materials on reproductive life planning, contraception, and VA resources. Participants will be given the materials and study staff will briefly discuss the content with the participant.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Reproductive Life Planning-Mental Health Intervention
Reproductive Life Planning-Mental Health (RLP-MH) intervention is comprised of two parts: 1) an in-person interactive session in which the participant works with an RLP-MH facilitator to explore pregnancy intentions and RLP goals, consider important factors that impact those goals (e.g. mental health and physical health conditions, psychosocial and lifestyle factors, values, preferences), and identify personal action steps to address RLP goals and 2) a 15-20 minute follow-up session in person or by phone one month later to discuss progress in addressing RLP goals.
|
Written Materials on Reproductive Life Planning
Participants will receive written materials on reproductive life planning, contraception, and VA resources. Participants will be given the materials and study staff will briefly discuss the content with the participant.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Declined Follow-Up
|
0
|
1
|
Baseline Characteristics
Reproductive Life Planning for Women With Mental Illness
Baseline characteristics by cohort
| Measure |
Reproductive Life Planning-Mental Health Intervention
n=20 Participants
Reproductive Life Planning-Mental Health (RLP-MH) intervention is comprised of two parts: 1) an in-person interactive session in which the participant works with an RLP-MH facilitator to explore pregnancy intentions and RLP goals, consider important factors that impact those goals (e.g. mental health and physical health conditions, psychosocial and lifestyle factors, values, preferences), and identify personal action steps to address RLP goals and 2) a 15-20 minute follow-up session in person or by phone one month later to discuss progress in addressing RLP goals.
|
Written Materials on Reproductive Life Planning
n=20 Participants
Participants will receive written materials on reproductive life planning, contraception, and VA resources. Participants will be given the materials and study staff will briefly discuss the content with the participant.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 3.9 • n=39 Participants
|
34.1 years
STANDARD_DEVIATION 4.7 • n=41 Participants
|
35.0 years
STANDARD_DEVIATION 4.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2-Month Post-Intervention (~2 months)Population: Number analyzed in the rows differ from overall because 3 participants in RLP-MH and 3 in the written materials condition did not complete the 2 month post-treatment assessment
The Reproductive Life Goal Behavioral Intentions scale was used to measure self-reported intentions to engage in behavior to address one's reproductive life goals. A total score was calculated by taking the sum of the responses to the items. The average total score across participants is reported (range = 1 to 5) with higher scores indicating greater intentions to engage in behaviors to address one's reproductive life goals.
Outcome measures
| Measure |
Reproductive Life Planning-Mental Health Intervention
n=20 Participants
Reproductive Life Planning-Mental Health (RLP-MH) intervention is comprised of two parts: 1) an in-person interactive session in which the participant works with an RLP-MH facilitator to explore pregnancy intentions and RLP goals, consider important factors that impact those goals (e.g. mental health and physical health conditions, psychosocial and lifestyle factors, values, preferences), and identify personal action steps to address RLP goals and 2) a 15-20 minute follow-up session in person or by phone one month later to discuss progress in addressing RLP goals.
|
Written Materials on Reproductive Life Planning
n=20 Participants
Participants will receive written materials on reproductive life planning, contraception, and VA resources. Participants will be given the materials and study staff will briefly discuss the content with the participant.
|
|---|---|---|
|
Reproductive Life Goal Behavioral Intentions
Baseline
|
3.6 score on scale
Standard Deviation 1.3
|
2.7 score on scale
Standard Deviation 1.5
|
|
Reproductive Life Goal Behavioral Intentions
2-Month Post Intervention
|
3.3 score on scale
Standard Deviation 1.4
|
3.0 score on scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Baseline to 2-Month Post-Intervention (~2 months)Population: Number analyzed in the rows differ from overall because 3 participants in RLP-MH and 3 in the written materials condition did not complete the 2-month post-treatment assessment
The Reproductive Health Decisional Self-Efficacy scale was used to measures expectations or beliefs about one's ability to engage in behaviors that help in making reproductive life decisions. A total score is calculated by taking the sum of response to the items (range = 0 to 44) with higher scores indicating greater decisional self-efficacy.
Outcome measures
| Measure |
Reproductive Life Planning-Mental Health Intervention
n=20 Participants
Reproductive Life Planning-Mental Health (RLP-MH) intervention is comprised of two parts: 1) an in-person interactive session in which the participant works with an RLP-MH facilitator to explore pregnancy intentions and RLP goals, consider important factors that impact those goals (e.g. mental health and physical health conditions, psychosocial and lifestyle factors, values, preferences), and identify personal action steps to address RLP goals and 2) a 15-20 minute follow-up session in person or by phone one month later to discuss progress in addressing RLP goals.
|
Written Materials on Reproductive Life Planning
n=20 Participants
Participants will receive written materials on reproductive life planning, contraception, and VA resources. Participants will be given the materials and study staff will briefly discuss the content with the participant.
|
|---|---|---|
|
Reproductive Health Decisional Self-Efficacy
Baseline
|
35.7 score on a scale
Standard Deviation 11.9
|
33.9 score on a scale
Standard Deviation 8.8
|
|
Reproductive Health Decisional Self-Efficacy
2-Month Post Intervention
|
40.7 score on a scale
Standard Deviation 3.4
|
38.7 score on a scale
Standard Deviation 6.0
|
PRIMARY outcome
Timeframe: Baseline to 2-Month Post-Intervention (~2 months)Population: Number analyzed in the rows differ from overall because 3 participants in RLP-MH and 3 in the written materials condition did not complete the 2-month post-treatment assessment
The Attitudes Towards Reproductive Life Planning developed for this study will be used to measure attitudes towards reproductive life planning and goal setting across several domains key to effective reproductive life planning. A total score is calculated by taking the sum of responses to the items (range = 7 to 49) with higher scores indicating more positive/favorable attitudes towards reproductive life planning.
Outcome measures
| Measure |
Reproductive Life Planning-Mental Health Intervention
n=20 Participants
Reproductive Life Planning-Mental Health (RLP-MH) intervention is comprised of two parts: 1) an in-person interactive session in which the participant works with an RLP-MH facilitator to explore pregnancy intentions and RLP goals, consider important factors that impact those goals (e.g. mental health and physical health conditions, psychosocial and lifestyle factors, values, preferences), and identify personal action steps to address RLP goals and 2) a 15-20 minute follow-up session in person or by phone one month later to discuss progress in addressing RLP goals.
|
Written Materials on Reproductive Life Planning
n=20 Participants
Participants will receive written materials on reproductive life planning, contraception, and VA resources. Participants will be given the materials and study staff will briefly discuss the content with the participant.
|
|---|---|---|
|
Attitudes Towards Reproductive Life Planning
Baseline
|
38.1 score on a scale
Standard Deviation 12.5
|
42.2 score on a scale
Standard Deviation 10.6
|
|
Attitudes Towards Reproductive Life Planning
2-Month Post Intervention
|
38.9 score on a scale
Standard Deviation 10.8
|
39.4 score on a scale
Standard Deviation 11.6
|
Adverse Events
Reproductive Life Planning-Mental Health Intervention
Written Materials on Reproductive Life Planning
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