An interventional study of technology-based program in Pregnancy Related, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care
The purpose of this study is to test a new educational technology-based program and brochure as a supplement to prenatal education from providers. The program provides education about common challenges that pregnant and parenting women receiving medication for Opioid Use Disorder (OUD) often face. Specifically, it addresses the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.
Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
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Exclusion Criteria:
Behavioral: 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
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.
Time frame: Within 2 weeks of completing the intervention
Acceptability of the Intervention
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.
Time frame: Within 2 weeks of completing the intervention
Change in 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.
Time frame: Baseline to within 2 weeks of completing the intervention, up to 5 weeks
Change in 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.
Time frame: Baseline to within 2 weeks of completing the intervention, up to 5 weeks
| Milestone | Brochure | Technology-based Program |
|---|---|---|
| Started | 13 | 16 |
| Completed | 11 | 13 |
| Not completed | 2 | 3 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Delivered late preterm 34 wks gestation | 1 | 1 |
| Withdrew: Moved | 1 | 0 |
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.
| score on a scale | Brochure | Technology-based Program |
|---|---|---|
| Feasibility of the Intervention | 21.5 ± 2.3 | 21.2 ± 2.9 |
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.
| score on a scale | Brochure | Technology-based Program |
|---|---|---|
| Acceptability of the Intervention | 47.6 ± 5.5 | 48.3 ± 7.6 |
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.
| mean score on a scale | Brochure | Technology-based Program |
|---|---|---|
| Change in Perceived Competence | .75 ± 9.7 | .3 ± 8.5 |
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.
| mean score on a scale | Brochure | Technology-based Program |
|---|---|---|
| Change in Parental Competence | 3.3 ± 9 | -1.5 ± 11.5 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brochure | 0/13 (0%) | 1/13 (7.7%) | 0/13 (0%) |
| Technology-based Program | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Event | Brochure | Technology-based Program |
|---|---|---|
| Cardiac disordersCardiac disorders | 1/13 | 0/16 |
| Age, Categorical(Participants) | Brochure | Technology-based Program | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 16 | 29 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Brochure | Technology-based Program | Total |
|---|---|---|---|
| Mean | 30.3 ± 5.3 | 29.7 ± 3.6 | 30 ± 4.45 |
| Sex: Female, Male(Participants) | Brochure | Technology-based Program | Total |
|---|---|---|---|
| Female | 13 | 16 | 29 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Brochure | Technology-based Program | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 12 | 16 | 28 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Brochure | Technology-based Program | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 6 | 9 |
| White | 10 | 9 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Brochure | Technology-based Program | Total |
|---|---|---|---|
| United States | 13 | 16 | 29 |
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Virginia Commonwealth University