PDF(Pubmed)
Abstract：
BACKGROUND: Perinatal substance use can have significant adverse effects on maternal and child health and family stability. Few interventions are specifically designed to address this significant public health problem. The Parent-Child Assistance Program (PCAP) is a 3-year case management and home-visiting intervention that seeks to help birthing persons with at-risk substance use during pregnancy to achieve and maintain substance use disorder recovery and avoid exposing future children to substances prenatally. At-risk refers to a level of substance use that creates problems in the individuals\' lives or puts them or their children at risk of harm either prenatally or postnatally. Although the program has consistently shown substantial pre- to post-intervention improvements in its participants, PCAP remains to be tested with a rigorous randomized controlled trial (RCT). This study protocol describes a randomized controlled trial that aims to examine the effectiveness of the intervention compared to services as usual in affecting primary outcomes related to substance use and family planning. Secondary outcomes will concern connection to recovery support services and family preservation.
METHODS: Using an intent-to-treat design, the study will recruit from two metro areas in Oklahoma and enroll 200 birthing individuals who are pregnant or up to 24 months postpartum with at-risk substance use during their current or most recent pregnancy. Participants will be randomly assigned, stratified by location, to receive either PCAP or services as usual for 3 years. Participants in the PCAP condition will meet with their case manager approximately biweekly over the course of the intervention period, in their local communities or in their own homes whenever possible. Case managers will assist with goal setting and provide practical assistance in support of participants\' goals. Primary and secondary outcomes will be assessed at baseline and 12, 24, and 36 months post-baseline using the Addiction Severity Index interview and a self-administered survey.
CONCLUSIONS: Results from this trial will help to gauge the effectiveness of PCAP in improving parent and child well-being. Results will be reviewed by federal clearinghouses on home-visiting and foster care prevention to determine the strength of evidence of effectiveness with implications for federal financing of this program model at the state level.
BACKGROUND: ClinicalTrials.gov NCT05534568. Registered on 6/8/2022.
METHODS: Using an intent-to-treat design, the study will recruit from two metro areas in Oklahoma and enroll 200 birthing individuals who are pregnant or up to 24 months postpartum with at-risk substance use during their current or most recent pregnancy. Participants will be randomly assigned, stratified by location, to receive either PCAP or services as usual for 3 years. Participants in the PCAP condition will meet with their case manager approximately biweekly over the course of the intervention period, in their local communities or in their own homes whenever possible. Case managers will assist with goal setting and provide practical assistance in support of participants\' goals. Primary and secondary outcomes will be assessed at baseline and 12, 24, and 36 months post-baseline using the Addiction Severity Index interview and a self-administered survey.
CONCLUSIONS: Results from this trial will help to gauge the effectiveness of PCAP in improving parent and child well-being. Results will be reviewed by federal clearinghouses on home-visiting and foster care prevention to determine the strength of evidence of effectiveness with implications for federal financing of this program model at the state level.
BACKGROUND: ClinicalTrials.gov NCT05534568. Registered on 6/8/2022.
摘要：
背景：围产期物质使用会对母婴健康和家庭稳定产生重大不利影响。很少有专门设计来解决这一重大公共卫生问题的干预措施。亲子援助计划（PCAP）是一项为期3年的病例管理和家庭访问干预措施，旨在帮助在怀孕期间分娩有危险物质使用的人实现并维持物质使用障碍的恢复，并避免使未来的孩子暴露于产前物质。风险是指物质使用的水平，在个人生活中造成问题，或使他们或他们的孩子在产前或产后受到伤害的风险。尽管该计划一直在参与者中显示出干预前和干预后的实质性改善，PCAP仍有待严格的随机对照试验（RCT）进行测试。该研究方案描述了一项随机对照试验，旨在检查干预措施与通常服务相比在影响与药物使用和计划生育相关的主要结局方面的有效性。次要结果将涉及与恢复支持服务和家庭保护的联系。
方法：使用意图处理设计，该研究将从俄克拉荷马州的两个都会区招募,纳入200名怀孕或产后24个月内在当前或最近一次怀孕期间使用危险物质的分娩者.参与者将被随机分配，按位置分层，照常接受PCAP或服务3年。PCAP条件的参与者将在干预期间大约每两周与他们的病例经理会面，尽可能在当地社区或自己的家中。案例经理将协助制定目标，并为参与者的目标提供实际帮助。主要和次要结果将在基线和基线后12、24和36个月使用成瘾严重程度指数访谈和自我管理调查进行评估。
结论：这项试验的结果将有助于评估PCAP在改善父母和儿童福祉方面的有效性。结果将由联邦信息交换所对家庭访问和寄养预防进行审查，以确定有效性证据的强度，并对该计划模型在州一级的联邦资助产生影响。
背景：ClinicalTrials.govNCT05534568。2022年6月8日注册。
方法：使用意图处理设计，该研究将从俄克拉荷马州的两个都会区招募,纳入200名怀孕或产后24个月内在当前或最近一次怀孕期间使用危险物质的分娩者.参与者将被随机分配，按位置分层，照常接受PCAP或服务3年。PCAP条件的参与者将在干预期间大约每两周与他们的病例经理会面，尽可能在当地社区或自己的家中。案例经理将协助制定目标，并为参与者的目标提供实际帮助。主要和次要结果将在基线和基线后12、24和36个月使用成瘾严重程度指数访谈和自我管理调查进行评估。
结论：这项试验的结果将有助于评估PCAP在改善父母和儿童福祉方面的有效性。结果将由联邦信息交换所对家庭访问和寄养预防进行审查，以确定有效性证据的强度，并对该计划模型在州一级的联邦资助产生影响。
背景：ClinicalTrials.govNCT05534568。2022年6月8日注册。
