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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brochure | No Intervention | ||
| Technology-based program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| technology-based program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Within 2 weeks of completing the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant females
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| Name | Affiliation | Role |
|---|---|---|
| Caitlin E Martin, MD, MPH | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42008128 | Derived | Eglovitch M, Martin S, Thumma L, Svikis DS, Tyson K, Pearson K, Martin CE, Parlier-Ahmad AB. Project BETTER: Outcomes at the pregnancy-to-postpartum transition from a pilot clinical trial of a technology-delivered intervention for birthing people receiving medication for opioid use disorder. Fam Syst Health. 2025 Dec;43(4):758-763. doi: 10.1037/fsh0001030. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brochure | No intervention, brochure |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brochure | No intervention, brochure |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Within 2 weeks of completing the intervention |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brochure | No intervention, brochure | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | Systematic Assessment | Participant was placed on extracorporeal membrane oxygenation and had to be ventilated, participants fetus did not survive. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Caitlin E. Martin | Virginia Commonwealth University | (804) 628-7023 | caitlin.martin@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2021 | Jun 2, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 7, 2022 | Jun 30, 2025 | ICF_001.pdf |
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| 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. | Baseline to within 2 weeks of completing the intervention, up to 5 weeks |
| moved |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Within 2 weeks of completing the intervention |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mean score on a scale | Baseline to within 2 weeks of completing the intervention, up to 5 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mean score on a scale | Baseline to within 2 weeks of completing the intervention, up to 5 weeks |
|
|
|
| 13 |
| 1 |
| 13 |
| 0 |
| 13 |
| EG001 | 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. | 0 | 16 | 0 | 16 | 0 | 16 |
|
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