Clinical trial NCT06652880: Digital Support Intervention for Pregnant People with Opioid Use Disorders
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Digital Intervention
Bibliotherapy
Keywords: PARENTSS project
Opioid Use Disorders
Pregnancy
Postpartum
Methadone
Buprenorphine
Digital technology
digital apps
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention is access to a digital application that provides parenting and recovery support on the participant\&#39;s smartphone.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment and Retention: Number of communications regarding study interest, number of interested persons eligible/ineligible, No. of study refusals; study attrition rates
timeFrame: 12 week study period; final data collection (qualitative interview) at 3 months post-delivery
Secondary outcomes:
measure: 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.
timeFrame: Qualitative interview at 3 months post-delivery
measure: Recovery Capital: Quantitative measure: Total scores on the Brief Assessment of Recovery Capital scale.
timeFrame: 12 week study period; final data collection (qualitative interview) at 3 months post-delivery
measure: Parenting outcomes: Quantitative measures: Total scores on the self-rated abilities for health practices scale (SRAHP)
timeFrame: 12 week study period
measure: Parenting outcomes: Quantitative measures: Total scores on the parental sense of competence scale (PSOC)
timeFrame: 12 week study period
measure: Parenting outcomes: Quantitative measures: Total scores on the self-efficacy in infant care scale (SICS)
timeFrame: 12 week study period
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC Health Institute of Psychiatry
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Phyllis A Raynor, PHD
role: PRINCIPAL_INVESTIGATOR
References: