Digital InterventionEarly Phase 1PARENTSSNCT06652880
Digital Support Intervention for Pregnant People with Opioid Use Disorders
A Early Phase 1 study testing Digital technology and Bibliotherapy in people with Digital Intervention and Bibliotherapy, run by University of South Carolina at 1 site in United States.
Trial summary
The goal of this pilot randomized feasibility study is to explore the benefits of providing parenting and recovery support for pregnant people with Opioid Use Disorders through digital technology (e.g. smartphones). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Digital Intervention, Bibliotherapy
- What is being tested?
- Digital technology and Bibliotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2024to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, pregnant, greater 13 weeks gestational age
- Opioid Dominant Use Disorder and Primary Phenotype
- Residing in natural home environment
- minimum of 18 years of age
- Able to speak and understand English
- Able to understand and provide informed consent
Who cannot join
- Not pregnant, has active illicit opioid use and not currently in treatment
- a violent criminal history
- cannot read and communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site
MUSC Health Institute of Psychiatry
Charleston, South Carolina, 29425
About this study
Official title: Exploring the Preliminary Effects of a Digital Parenting and Recovery Support Intervention for Pregnant People Seeking Recovery from Opioid Use Disorders: a Pilot Randomized Control Trial
The goal of this pilot randomized feasibility study is to explore the benefits of providing parenting and recovery support for pregnant people with Opioid Use Disorders through digital technology (e.g. smartphones). The main question it aims to answer is:
- What is the feasibility of providing customized digital parenting and recovery supports to pregnant people with Opioid Use Disorders residing in natural communities?
- Feasibility data includes data on study interest, eligibility, time to enroll, participant training on digital app usage, attrition;
Read more
Secondary outcome exploratory data will include MOUD treatment retention, missed follow up prenatal and early postpartum appointments, drug usage, and parenting outcomes (i.e., scores on the Parental sense of competency scale, Self-rated abilities for health practices scale, and Self-efficacy in infant care scale) through self-report; The intervention group only will also be observed regarding app usage, frequency of use, resources accessed, thoughts about the app, and what was found to be helpful.
Researchers will compare the bibliotherapy control group to determine clinical differences in secondary outcomes.
Participants will complete the following tasks:
- Schedule an online meeting with the research team to receive more information about the study. Once consented to participate, the participant will be randomly assigned to one of the groups.
- Complete survey questions within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about drug usage, missed follow-up medical appointments, and parenting outcomes. The total time to complete the survey after consenting to be in the study will take approximately 40 minutes. The total time to complete the surveys after the six week and 12-week study period should take no more than 30 minutes.
- Complete a one-hour virtual interview at three months post-delivery (by phone or computer) about the study experience.
- Conditions
- Digital Intervention, Bibliotherapy
- Being tested
- Digital technology, Bibliotherapy
- Keywords
- PARENTSS project, Opioid Use Disorders, Pregnancy, Postpartum, Methadone, Buprenorphine, Digital technology, digital apps
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital technologyDevice
Also called digital app
The digital app is a customized comprehensive self-management platform designed to provide recovery and parenting support for individuals with substance use disorders.
BibliotherapyOther
Also called book
Bibliotherapy control group will receive parenting book what to expect the first year.
| Study group | Role | What they receive |
|---|---|---|
| Customized Digital Application group (Intervention) | Experimental | Participants are assigned to one of two groups where they will receive one type of parenting support. The intervention group will receive a smartphone app which provides access to comprehensive resources related to parenting and recovery.
The intervention group will be observed to determine how frequently they use the digital app, thoughts about it, and what was found to be helpful. This will occur over a 12-week period.
The intervention group will complete surveys over the study period through the digital app. The times for survey completion are within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about personal history, drug usage and cravings, missed follow-up medical appointments, and parenting outcomes. An interview with the PI at 12 weeks post-delivery. Receives: Device: Digital technology |
| Parenting book as support for control group | Active comparator | The bibliotherapy control group will receive a book on what to expect as a parent the first year after delivery.
The control group will complete surveys over the study period and are given the option to complete surveys by phone or videoconference with a Team member. The times for survey completion are within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about personal history, drug usage and cravings, missed follow-up medical appointments, and parenting outcomes. An interview with the PI at 12 weeks post-delivery. Receives: Other: Bibliotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and Retention: Number of communications regarding study interest, number of interested persons eligible/ineligible, No. of study refusals; study attrition rates
Recruitment - recruitment measures (e.g., total time, direct calls regarding interest, number eligible/ineligible, refusals) (Qualitative) Qualitative data via interviews at the end of the study period with each participant in the Intervention group regarding type of smart phone used/model; overall experience using the app, times and situations when participants were more likely to use app as a resource, app features most helpful in supporting recovery from OUD, app features most helpful in supporting parenting, and preferences regarding initiation of intervention. Attrition data --duration of time that individuals engaged with the app; participated in the study
Measured: 12 week study period; final data collection (qualitative interview) at 3 months post-delivery
Secondary outcomes (5)
Treatment retention: Qualitative interview 3 months post delivery: responses to questions regarding status in treatment for Opioid Use Disorder, attendance to postpartum appointments, scheduled baby visits.
Participants will be asked to participate in an interview at 3 months post-delivery with a research team member. Information regarding medical appointments will be collected.
Measured: Qualitative interview at 3 months post-delivery
Recovery Capital: Quantitative measure: Total scores on the Brief Assessment of Recovery Capital scale.
Participants will be asked to complete the Brief Assessment of Recovery Capital (BARC-10) scale at certain timepoints during the 12 week study period, at the end of the 12 week study period and at 3 months post-delivery. Brief Recovery capital scale is designed to evaluate a person's resources and strengths (i.e., recovery capital) that can support their recovery from substance use disorders. Participants rate their agreement with each statement in the BARC-10 from "Strongly Disagree" (with a value of 1) to "Strongly Agree" (with a value of 6). The score for each question is added together to create the participant's total score. Total scores can range from 10 to 60, with higher scores indicating greater recovery capital.
Measured: 12 week study period; final data collection (qualitative interview) at 3 months post-delivery
Parenting outcomes: Quantitative measures: Total scores on the self-rated abilities for health practices scale (SRAHP)
Participants will be asked to complete surveys at baseline, 6 weeks and at 12 weeks. The SRAHP is a 28-item, 5-point scale to measure self-perceived ability to implement health-promoting behaviors. SRAHP contains four subscales. Items are rated from 0 (not at all) to 4 (completely). Total scores range from 0-112. Higher scores indicate greater self-efficacy.
Measured: 12 week study period
Parenting outcomes: Quantitative measures: Total scores on the parental sense of competence scale (PSOC)
Participants will be asked to complete surveys at baseline, 6 weeks and at 12 weeks. The PSOC is a self-report measure that aims to assess one's perceived efficacy and satisfaction with parenting. The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6-point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree". A higher score indicates a higher parenting sense of competency.
Measured: 12 week study period
Parenting outcomes: Quantitative measures: Total scores on the self-efficacy in infant care scale (SICS)
Participants will be asked to complete surveys at baseline, 6 weeks and at 12 weeks. SICS is a 44 item questionnaire s a self-administered to assess maternal judgments about the ability to care for the baby during the first year of life. Each item is rated on a 5 point Likert scale anchored by 1 = "strongly disagree" and 6 = "strongly agree". Higher scores indicate higher self-efficacy.
Measured: 12 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start4 Jun 2024
- Primary completion28 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital InterventionStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention is access to a digital application that provides parenting and recovery support on the participant\'s smartphone.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phyllis Raynor, University of South Carolina
- Investigators
- Phyllis A Raynor, PHD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652880
- Sponsor's protocol ID
- Pro00136341
- Acronym
- PARENTSS
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: primary feasibility outcome data and secondary treatment retention data will be shared in aggregate to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Preliminary Effects of a Digital Parenting and Recovery Support Intervention for Pregnant People Seeking Recovery from Opioid Use Disorders: a Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06652880
- Acronym / sponsor ID
- PARENTSS / Pro00136341
- Conditions
- Digital Intervention, Bibliotherapy
- Keywords
- PARENTSS project, Opioid Use Disorders, Pregnancy, Postpartum, Methadone, Buprenorphine, Digital technology, digital apps
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 28 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot randomized feasibility study is to explore the benefits of providing parenting and recovery support for pregnant people with Opioid Use Disorders through digital technology (e.g. smartphones). The main question it aims to answer is:
- What is the feasibility of providing customized digital parenting and recovery supports to pregnant people with Opioid Use Disorders residing in natural communities?
- Feasibility data includes data on study interest, eligibility, time to enroll, participant training on digital app usage, attrition;
Secondary outcome exploratory data will include MOUD treatment retention, missed follow up prenatal and early postpartum appointments, drug usage, and parenting outcomes (i.e., scores on the Parental sense of competency scale, Self-rated abilities for health practices scale, and Self-efficacy in infant care scale) through self-report; The intervention group only will also be observed regarding app usage, frequency of use, resources accessed, thoughts about the app, and what was found to be helpful.
Researchers will compare the bibliotherapy control group to determine clinical differences in secondary outcomes.
Participants will complete the following tasks:
- Schedule an online meeting with the research team to receive more information about the study. Once consented to participate, the participant will be randomly assigned to one of the groups.
- Complete survey questions within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about drug usage, missed follow-up medical appointments, and parenting outcomes. The total time to complete the survey after consenting to be in the study will take approximately 40 minutes. The total time to complete the surveys after the six week and 12-week study period should take no more than 30 minutes.
- Complete a one-hour virtual interview at three months post-delivery (by phone or computer) about the study experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The intervention is access to a digital application that provides parenting and recovery support on the participant\'s smartphone.
| Arm | Type | Receives |
|---|---|---|
| Customized Digital Application group (Intervention) | Experimental | Device: Digital technologyParticipants are assigned to one of two groups where they will receive one type of parenting support. The intervention group will receive a smartphone app which provides access to comprehensive resources related to parenting and recovery. The intervention group will be observed to determine how frequently they use the digital app, thoughts about it, and what was found to be helpful. This will occur over a 12-week period. The intervention group will complete surveys over the study period through the digital app. The times for survey completion are within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about personal history, drug usage and cravings, missed follow-up medical appointments, and parenting outcomes. An interview with the PI at 12 weeks post-delivery. |
| Parenting book as support for control group | Active comparator | Other: BibliotherapyThe bibliotherapy control group will receive a book on what to expect as a parent the first year after delivery. The control group will complete surveys over the study period and are given the option to complete surveys by phone or videoconference with a Team member. The times for survey completion are within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about personal history, drug usage and cravings, missed follow-up medical appointments, and parenting outcomes. An interview with the PI at 12 weeks post-delivery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female, pregnant, greater 13 weeks gestational age
- Opioid Dominant Use Disorder and Primary Phenotype
- Residing in natural home environment
- minimum of 18 years of age
- Able to speak and understand English
Key exclusion criteria (3 listed)
- Not pregnant, has active illicit opioid use and not currently in treatment
- a violent criminal history
- cannot read and communicate in English
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 |
|---|---|---|
| Digital technologyAlso: digital appThe digital app is a customized comprehensive self-management platform designed to provide recovery and parenting support for individuals with substance use disorders. | Device | Customized Digital Application group (Intervention) |
| BibliotherapyAlso: bookBibliotherapy control group will receive parenting book what to expect the first year. | Other | Parenting book as support for control group |
Primary outcome
Recruitment and Retention: Number of communications regarding study interest, number of interested persons eligible/ineligible, No. of study refusals; study attrition rates
Time frame: 12 week study period; final data collection (qualitative interview) at 3 months post-delivery
Recruitment - recruitment measures (e.g., total time, direct calls regarding interest, number eligible/ineligible, refusals) (Qualitative) Qualitative data via interviews at the end of the study period with each participant in the Intervention group regarding type of smart phone used/model; overall experience using the app, times and situations when participants were more likely to use app as a resource, app features most helpful in supporting recovery from OUD, app features most helpful in supporting parenting, and preferences regarding initiation of intervention. Attrition data --duration of time that individuals engaged with the app; participated in the study
5 secondary outcomes
Treatment retention: Qualitative interview 3 months post delivery: responses to questions regarding status in treatment for Opioid Use Disorder, attendance to postpartum appointments, scheduled baby visits.
Time frame: Qualitative interview at 3 months post-delivery
Recovery Capital: Quantitative measure: Total scores on the Brief Assessment of Recovery Capital scale.
Time frame: 12 week study period; final data collection (qualitative interview) at 3 months post-delivery
Parenting outcomes: Quantitative measures: Total scores on the self-rated abilities for health practices scale (SRAHP)
Time frame: 12 week study period
Parenting outcomes: Quantitative measures: Total scores on the parental sense of competence scale (PSOC)
Time frame: 12 week study period
Parenting outcomes: Quantitative measures: Total scores on the self-efficacy in infant care scale (SICS)
Time frame: 12 week study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No. primary feasibility outcome data and secondary treatment retention data will be shared in aggregate to protect participant confidentiality.
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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.
Phyllis A Raynor, PHD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Digital technology and Bibliotherapy in people with Digital Intervention and Bibliotherapy, run by University of South Carolina 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: status not confirmed, as of the sponsor's last update on 17 Feb 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Recruitment and Retention: Number of communications regarding study interest, number of interested persons eligible/ineligible, No. of study refusals; study attrition rates (time frame: 12 week study period; final data collection (qualitative interview) at 3 months post-delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2025.