Digital Support Intervention for Pregnant People with Opioid Use Disorders (PARENTSS)

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?

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bibliotherapy; Digital Intervention
• Intervention / Treatment: Device: Digital technology; Other: Bibliotherapy

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC Health Institute of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Customized Digital Application group (Intervention); 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.	Device: Digital technology; 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
Active Comparator: Parenting book as support for control group; 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.	Other: Bibliotherapy; Bibliotherapy control group will receive parenting book what to expect the first year.; Other Names: book

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 week study period; final data collection (qualitative interview) at 3 months post-delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	12 week study period

Collaborators and Investigators

• Sponsor: University of South Carolina
• Investigators: Principal Investigator: Phyllis A Raynor, PHD, University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Estimated): August 28, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy; Postpartum; Methadone; Buprenorphine; Digital technology; Opioid Use Disorders; PARENTSS project; digital apps
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: Pro00136341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: primary feasibility outcome data and secondary treatment retention data will be shared in aggregate to protect participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No