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
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Recruitment and Retention: Number of communications regarding study interest, number of interested persons eligible/ineligible, No. of study refusals; study attrition rates
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Not pregnant, has active illicit opioid use and not currently in treatment
- •a violent criminal history
- •cannot read and communicate in English
结局指标
主要结局
Recruitment and Retention: Number of communications regarding study interest, number of interested persons eligible/ineligible, No. of study refusals; study attrition rates
时间窗: 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
次要结局
- 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)
研究者
Phyllis Raynor
Clinical Assistant Professor
University of South Carolina