Digital Support Intervention for Pregnant People with Opioid Use Disorders

NCT06652880 | Active Not Recruiting Early Phase 1

• 1 other identifier: Pro00136341
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Digital Intervention; Bibliotherapy

Keywords

PARENTSS project; Opioid Use Disorders; Pregnancy; Postpartum; Methadone; Buprenorphine; Digital technology; digital apps

Outcome Measures

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

  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 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.

  Qualitative interview at 3 months post-delivery

• Recovery Capital: Quantitative measure: Total scores on the Brief Assessment of Recovery Capital scale.

  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)

  12 week study period

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

  12 week study period

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

  12 week study period

Study Arms (2)

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.

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.

Other: Bibliotherapy

Interventions

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.

Also known as: digital app

Customized Digital Application group (Intervention)

Bibliotherapy OTHER

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

Also known as: book

Parenting book as support for control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

MUSC Health Institute of Psychiatry

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Bibliotherapy

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Phyllis A Raynor, PHD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: The intervention is access to a digital application that provides parenting and recovery support on the participant\'s smartphone.

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: October 22, 2024
• Study Start: June 4, 2024
• Primary Completion: August 28, 2025
• Study Completion: December 31, 2025
• Last Updated: February 17, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)