Pregnancy RelatedBETTERNCT05214118
Bringing Education Through Technology, Empathic Listening, and Research
A study testing technology-based program in people with Pregnancy Related, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- technology-based program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to 22 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- ≥18 years of age
- Meet criteria for Opioid Use Disorder
- Currently receiving MOUD pharmacotherapy (including buprenorphine, buprenorphine/naloxone, or methadone)
- Pregnant (<34 weeks EGA)
- Initial in-person visit at OB MOTIVATE clinic for the current pregnancy ≤10 weeks ago
Who cannot join
- Considering/planning adoption
- Present with a serious cognitive/psychiatric impairment
- Existing language barriers making true informed consent impossible
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Project BETTER: Bringing Education Through Technology, Empathic Listening, and Research - A Feasibility Randomized Controlled Trial
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.
- Conditions
- Pregnancy Related
- Being tested
- technology-based program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
technology-based programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brochure | No intervention | Not described |
| Technology-based program | Experimental | Not described Receives: Behavioral: technology-based program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 2 weeks of completing the intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline to within 2 weeks of completing the intervention, up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start2 Feb 2022
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caitlin E Martin, MD, MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214118
- Sponsor's protocol ID
- HM20023314
- Acronym
- BETTER
- Status last verified
- Jun 2025
- First submitted
- 10 Jan 2022
- Last updated
- 18 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42008128
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project BETTER: Bringing Education Through Technology, Empathic Listening, and Research - A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05214118
- Acronym / sponsor ID
- BETTER / HM20023314
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Posted 18 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brochure | No intervention | – |
| Technology-based program | Experimental | Behavioral: technology-based program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- ≥18 years of age
- Meet criteria for Opioid Use Disorder
- Currently receiving MOUD pharmacotherapy (including buprenorphine, buprenorphine/naloxone, or methadone)
- Pregnant (<34 weeks EGA)
Key exclusion criteria (3 listed)
- Considering/planning adoption
- Present with a serious cognitive/psychiatric impairment
- Existing language barriers making true informed consent impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| technology-based programParticipants 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. | Behavioural | Technology-based program |
Primary outcome
Feasibility of the Intervention
Time frame: 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
Time frame: 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.
2 secondary outcomes
Change in Perceived Competence
Time frame: Baseline to within 2 weeks of completing the intervention, up to 5 weeks
Change in Parental Competence
Time frame: Baseline to within 2 weeks of completing the intervention, up to 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42008128Eglovitch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caitlin E Martin, MD, MPH principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing technology-based program in people with Pregnancy Related, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention (time frame: Within 2 weeks of completing the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05214118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.