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Active, Not Recruiting

NCT Number: NCT06652880

Digital Support Intervention for Pregnant People with Opioid Use Disorders

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?

o 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

MUSC Health Institute of Psychiatry

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not pregnant, has active illicit opioid use and not currently in treatment
  • a violent criminal history
  • cannot read and communicate in English

Treatment and study plan

Digital technology

Device

The digital app is a customized comprehensive self-management platform designed to provide recovery and parenting support for individuals with substance use disorders.

Other names: digital app

Bibliotherapy

Other

Bibliotherapy control group will receive parenting book what to expect the first year.

Other names: book

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. Parenting outcomes: Quantitative measures: Total scores on the self-rated abilities for health practices scale (SRAHP)

    Time frame: 12 week study period

    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.

  4. Parenting outcomes: Quantitative measures: Total scores on the parental sense of competence scale (PSOC)

    Time frame: 12 week study period

    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.

  5. Parenting outcomes: Quantitative measures: Total scores on the self-efficacy in infant care scale (SICS)

    Time frame: 12 week study period

    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.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study 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

Acronym: PARENTSS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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