Parlier-Ahmad Anna Beth, Thumma Lillia, Martin Sarah, Eglovitch Michelle, Simmons Kameron, Kimbrough Tiffany, Svikis Dace S, Martin Caitlin E
Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.
Department of Obstetrics and Gynecology, Virginia Commonwealth University, Richmond, VA, USA.
J Child Adolesc Subst Abuse. 2025;30(2):52-63. doi: 10.1080/1067828x.2024.2447774. Epub 2025 Feb 7.
This randomized feasibility trial aimed to 1) assess methodology for a subsequent efficacy trial and 2) examine the usability and acceptability of Project BETTER's hybrid technology-delivered educational intervention for pregnant people receiving medication for opioid use disorder within a perinatal addiction treatment clinic. Participants were randomized to the technology-delivered educational intervention or standard practice control (brochure). Project BETTER's intervention offers three modules (pregnancy-to-postpartum transition, Neonatal Opioid Withdrawal Syndrome, child welfare interactions) via Computerized Intervention Authoring System (CIAS 3.0). Inclusion criteria were: ≥18 years of age, <34 weeks pregnant, currently receiving medication for opioid use disorder (MOUD), and had engaged in care ≤10 weeks during their current pregnancy. Study visits included an online survey, brief interview, and medical record review. Mean perceived helpfulness scores were compared by study condition using independent samples t-test. The screening process identified 49 potential participants, n=31 (63%) of whom were recruited. Twenty-nine participants were randomized (intervention: n=16, control: n=13). Participants (n=29) were reproductive age [M = 30.0 years (SD = 4.4)], 66% white and 31% Black with a median estimated gestational age of 24 weeks. Most participants (69%) received buprenorphine. Study completion rate was 83%. Most participants completed study components remotely. Among participants in the intervention group, 56% completed at least one module. Participants perceived the intervention to be as helpful as the brochure (intervention: 5.28 ± 0.98, control: 5.39 ± 0.56, p=0.387) and highly acceptable. With protocol modifications, scale up to a larger clinical trial is feasible and acceptable to pregnant people receiving MOUD.
1）评估后续疗效试验的方法；2）在围产期成瘾治疗诊所中，检验“改善计划”（Project BETTER）通过混合技术提供的教育干预措施，对于正在接受阿片类药物使用障碍治疗的孕妇的可用性和可接受性。参与者被随机分配到通过技术提供的教育干预组或标准实践对照组（宣传册）。“改善计划”的干预措施通过计算机化干预创作系统（CIAS 3.0）提供三个模块（从怀孕到产后过渡、新生儿阿片类药物戒断综合征、儿童福利互动）。纳入标准为：年龄≥18岁，怀孕<34周，目前正在接受阿片类药物使用障碍药物治疗（MOUD），且在本次怀孕期间接受护理≤10周。研究访视包括在线调查、简短访谈和病历审查。使用独立样本t检验，按研究条件比较平均感知帮助得分。筛查过程确定了49名潜在参与者，其中n = 31名（63%）被招募。29名参与者被随机分组（干预组：n = 16，对照组：n = 13）。参与者（n = 29）为育龄期[平均年龄M = 30.0岁（标准差SD = 4.4）]，66%为白人，31%为黑人，估计孕周中位数为24周。大多数参与者（69%）接受丁丙诺啡治疗。研究完成率为83%。大多数参与者通过远程方式完成研究组件。在干预组的参与者中，56%完成了至少一个模块。参与者认为干预措施与宣传册一样有帮助（干预组：5.28±0.98，对照组：5.39±0.56，p = 0.387），并且高度可接受。通过方案修改，扩大到更大规模的临床试验对于接受MOUD治疗的孕妇是可行且可接受的。
