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.
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。