Improving Maternal Mental Health & Substance Use Disorder Screening and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10,470
- 试验地点
- 2
- 主要终点
- Change in Retention in Treatment
研究概览
简要总结
The purpose of the study is to compare a text message-based mental health and substance use screening and referral to a treatment program, called Listening to Women and Pregnant and Postpartum People (LTWP), to standard of care in-person mental health and substance use screening to look at rates of treatment attendance and retention in treatment. Participation would involve completing online questionnaires. You may be eligible to participate if you are age 18-45 years, are pregnant and entering prenatal care in one of MUSC's OB clinics, and attended a prenatal appointment at an MUSC clinic.
详细描述
Aim 1: To determine differences in rates of treatment attendance and retention for Perinatal Mood and Anxiety Disorders (PMADs) and Perinatal Substance Use Disorders (PSUDs) between participants assigned to LTWP, compared to SBIRT.
Aim 2: To determine differences in Patient-Reported Outcomes (PROs) including depressive symptoms, quality of life, substance use, and maternal functioning and well-being measured at baseline and 2, 5, 8, and 11 months postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •This study is a cluster RCT step wedge design so we are randomizing on the clinic level, not the individual level. The clinics are made up of 4 "wedges" (3 clinics/wedge). Pregnant women receiving prenatal care in these clinics will receive SBIRT as part of usual care. Clusters of clinics will be randomized to an LTWP start date where they will transition from SBIRT to LTWP for the purposes of screening and referral to treatment.
- •EHR Data Collection (PPP):
- •pregnant and entering prenatal care in one of MUSC's OB clinics
- •attended a prenatal appointment at an MUSC clinic
排除标准
- •a.) primary language is not English or Spanish
- •Study Assessments at baseline and 2, 5, 8, and 11 months postpartum (PPP):
- •Age 18-45 years
- •attended an initial prenatal appointment at an MUSC OB clinic
- •Unable to complete study assessments
- •primary language is not English or Spanish
研究组 & 干预措施
Screening Brief Intervention & Referral to Treatment (SBIRT)
This group will receive in-person screening and referral to treatment assessment.
Listening to Women & Pregnant & Postpartum People (LTWP)
This group will receive text-message-based SBIRT with phone-based assessment and referral to treatment. The SBIRT is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, and other drugs including prescription medication), and domestic violence.
干预措施: Listening to Women & Pregnant and Postpartum People (Behavioral)
结局指标
主要结局
Change in Retention in Treatment
时间窗: Through participants baseline prenatal care appointment and pregnancy and the postpartum year for participants, approximately 21 months
Retention in treatment for PMADs: defined as 6 or more psychotherapy visits and/or 4 or more medication management visits; and PSUDs: are defined as continuous pharmacological and/or behavioral treatment \> 2 months.
Change in Treatment Attendance
时间窗: Through participants baseline prenatal care appointment and pregnancy and the postpartum year for participants, approximately 21 months
Treatment attendance is defined as attending at least 1 or more visits with a mental health or substance use disorder treatment provider.
次要结局
- Change in Maternal Functioning and Wellbeing(Change from baseline maternal functioning to follow-up maternal functioning during the postpartum year, approximately over 21 months.)
- Change in depressive symptoms(Change from baseline depression screening symptoms to follow-up depression screening symptoms during the postpartum year, approximately over 21 months.)
- Change in Substance Use(Change from baseline substance use to follow-up substance use during the postpartum year, approximately over 21 months.)
研究者
Constance Guille
Professor
Medical University of South Carolina