Pregnancy Related
Conditions
Brief summary
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.
Interventions
BEHAVIORALtechnology-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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female 2. ≥18 years of age 3. Meet criteria for Opioid Use Disorder 4. Currently receiving MOUD pharmacotherapy (including buprenorphine, buprenorphine/naloxone, or methadone) 5. Pregnant (\<34 weeks EGA) 6. Initial in-person visit at OB MOTIVATE clinic for the current pregnancy ≤10 weeks ago
Exclusion criteria
1. Considering/planning adoption 2. Present with a serious cognitive/psychiatric impairment 3. Existing language barriers making true informed consent impossible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Intervention | Within 2 weeks of completing 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. |
| Acceptability of the Intervention | Within 2 weeks of completing 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Competence | Baseline to within 2 weeks of completing the intervention, up to 5 weeks | 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. |
| Change in Parental Competence | Baseline to within 2 weeks of completing the intervention, up to 5 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brochure No intervention, brochure | 13 |
| 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. | 16 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | delivered late preterm 34 wks gestation | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | moved | 1 | 0 |
Baseline characteristics
| Characteristic | Brochure | Technology-based Program | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 16 Participants | 29 Participants |
| Age, Continuous | 30.3 years STANDARD_DEVIATION 5.3 | 29.7 years STANDARD_DEVIATION 3.6 | 30 years STANDARD_DEVIATION 4.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 16 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 9 Participants | 19 Participants |
| Region of Enrollment United States | 13 participants | 16 participants | 29 participants |
| Sex: Female, Male Female | 13 Participants | 16 Participants | 29 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 16 |
| other Total, other adverse events | 0 / 13 | 0 / 16 |
| serious Total, serious adverse events | 1 / 13 | 0 / 16 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brochure | Acceptability of the Intervention | 47.6 score on a scale | Standard Deviation 5.5 |
| Technology-based Program | Acceptability of the Intervention | 48.3 score on a scale | Standard Deviation 7.6 |
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brochure | Feasibility of the Intervention | 21.5 score on a scale | Standard Deviation 2.3 |
| Technology-based Program | Feasibility of the Intervention | 21.2 score on a scale | Standard Deviation 2.9 |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brochure | Change in Parental Competence | 3.3 mean score on a scale | Standard Deviation 9 |
| Technology-based Program | Change in Parental Competence | -1.5 mean score on a scale | Standard Deviation 11.5 |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brochure | Change in Perceived Competence | .75 mean score on a scale | Standard Deviation 9.7 |
| Technology-based Program | Change in Perceived Competence | .3 mean score on a scale | Standard Deviation 8.5 |