Trial Outcomes & Findings for Bringing Education Through Technology, Empathic Listening, and Research (NCT NCT05214118)
NCT ID: NCT05214118
Last Updated: 2025-07-18
Results Overview
Participants will complete a survey about the feasibility of the intervention consisting of 4 items rated on a 0 to 6 scale. Scores will be summed to yield a final feasibility score ranging from 0 to 24. Higher scores indicate higher feasibility.
COMPLETED
NA
29 participants
Within 2 weeks of completing the intervention
2025-07-18
Participant Flow
Participant milestones
| Measure |
Brochure
No intervention, brochure
|
Technology-based Program
technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
16
|
|
Overall Study
COMPLETED
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Brochure
No intervention, brochure
|
Technology-based Program
technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
delivered late preterm 34 wks gestation
|
1
|
1
|
|
Overall Study
moved
|
1
|
0
|
Baseline Characteristics
Bringing Education Through Technology, Empathic Listening, and Research
Baseline characteristics by cohort
| Measure |
Brochure
n=13 Participants
No intervention, brochure
|
Technology-based Program
n=16 Participants
technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.
|
Total
n=29 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
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.3 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
29.7 years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
30 years
STANDARD_DEVIATION 4.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 2 weeks of completing the interventionPopulation: Participants will complete a survey about the feasibility of the intervention consisting of 4 items rated on a 0 to 6 scale. Scores will be summed to yield a final feasibility score ranging from 0 to 24. Higher scores indicate higher feasibility.
Participants will complete a survey about the feasibility of the intervention consisting of 4 items rated on a 0 to 6 scale. Scores will be summed to yield a final feasibility score ranging from 0 to 24. Higher scores indicate higher feasibility.
Outcome measures
| Measure |
Brochure
n=11 Participants
No intervention, brochure
|
Technology-based Program
n=13 Participants
technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.
|
|---|---|---|
|
Feasibility of the Intervention
|
21.5 score on a scale
Standard Deviation 2.3
|
21.2 score on a scale
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: Within 2 weeks of completing the interventionPopulation: Participants will complete a survey about the acceptability of the intervention consisting of 10 items rated on a 1 to 5 scale. Scores will be summed to yield a final feasibility score ranging from 10 to 50. Higher scores indicated higher acceptability.
Participants will complete a survey about the acceptability of the intervention consisting of 10 items rated on a 1 to 5 scale. Higher scores indicated higher acceptability.
Outcome measures
| Measure |
Brochure
n=11 Participants
No intervention, brochure
|
Technology-based Program
n=13 Participants
technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.
|
|---|---|---|
|
Acceptability of the Intervention
|
47.6 score on a scale
Standard Deviation 5.5
|
48.3 score on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline to within 2 weeks of completing the intervention, up to 5 weeksPopulation: Participants will complete 12 items (4 items per 3 content areas) assessing their feelings of competence related to the information covered by the intervention. The items will be rated on a 1 to 7 scale. Higher scores indicated higher perceived competence.
Participants will complete a survey assessing their feelings of competence related to the information covered by the intervention. The items will be rated on a 1 to 7 scale. Higher scores indicated higher perceived competence. An increase in perceived competence suggests a greater sense of confidence, mastery, and belief in one's ability to achieve goals within that area. This can be linked to positive outcomes like improved performance, motivation, and goal attainment. A decrease in perceived competence indicates a diminished sense of self-efficacy and belief in one's abilities, potentially leading to reduced motivation, avoidance of challenges, and lower engagement.
Outcome measures
| Measure |
Brochure
n=12 Participants
No intervention, brochure
|
Technology-based Program
n=9 Participants
technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.
|
|---|---|---|
|
Change in Perceived Competence
|
.75 mean score on a scale
Standard Deviation 9.7
|
.3 mean score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Baseline to within 2 weeks of completing the intervention, up to 5 weeksPopulation: Participants will complete a 16-item survey assessing their feelings of competence related to the parenting. The items will be rated on a 1 to 6 scale. Higher scores indicated higher perceived parental competence.
Participants will complete a survey assessing their feelings of competence related to the parenting. The items will be rated on a 1 to 6 scale. An increase in perceived competence suggests a greater sense of confidence, mastery, and belief in one's ability to achieve goals within that area. This can be linked to positive outcomes like improved performance, motivation, and goal attainment. A decrease in perceived competence indicates a diminished sense of self-efficacy and belief in one's abilities, potentially leading to reduced motivation, avoidance of challenges, and lower engagement.
Outcome measures
| Measure |
Brochure
n=12 Participants
No intervention, brochure
|
Technology-based Program
n=10 Participants
technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.
|
|---|---|---|
|
Change in Parental Competence
|
3.3 mean score on a scale
Standard Deviation 9
|
-1.5 mean score on a scale
Standard Deviation 11.5
|
Adverse Events
Brochure
Technology-based Program
Serious adverse events
| Measure |
Brochure
n=13 participants at risk
No intervention, brochure
|
Technology-based Program
n=16 participants at risk
technology-based program: Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
7.7%
1/13 • Number of events 1 • February 2022-October 2023 overall for the study. During the duration of study involvement individually for each subject which is Baseline to within 2 weeks of completing the intervention, up to 5 weeks.
|
0.00%
0/16 • February 2022-October 2023 overall for the study. During the duration of study involvement individually for each subject which is Baseline to within 2 weeks of completing the intervention, up to 5 weeks.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Caitlin E. Martin
Virginia Commonwealth University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place