Reducing alcohol-exposed pregnancy risk

描述(由申请人提供)： 这个1b阶段行为疗法开发项目的目的是开发和测试一种简短的、基于理论的干预措施的可行性和前景，以降低高危社区妇女酒精暴露怀孕(AEP)的风险。在第一阶段，研究人员将把一个有希望的干预措施改编成一个单一的延长会话模式，然后对9名参与者进行预试，反复修订治疗手册。此外，还将制定和完善治疗师忠诚度和能力评定表。在第二阶段，将对过程测量的治疗师和评分员进行培训。在第三阶段，该团队将实施一项双臂随机对照试验。第一组将接受早期干预，而第二组，即对照组，将接受信息/注意干预。早期干预以社会学习理论和跨理论变革模型为基础，采用激励性访谈咨询方式，包括与饮酒和无效避孕有关的风险的个性化反馈、信息、决策平衡练习、关于变革准备情况的讨论、目标陈述和制定变革计划。参与者将是一个高危社区样本，其中包括152名经常饮酒或酗酒、避孕效果不佳的生育女性，她们来自性病和公共卫生诊所以及酒精/药物治疗机构。参与者将完成一组基线评估，测量人口统计学、酒精和药物使用、产科/妇科病史、情绪困扰、变化的阶段和过程、自我效能和个性。参与者和治疗师将提供行为干预课程的过程评级。质量保证将通过持续的监督来实现。独立评分者将对治疗师对治疗方案的遵守程度和提供干预的能力进行评级。随访评估分别为3个月和6个月。主要结果将通过饮酒和性行为/避孕行为的90天时间线随访来衡量。由于任何一种风险行为的改变都将导致AEP风险的降低，因此将评估三种主要结果。这些是在6个月的随访中不再有AEP风险的女性比例，不再被归类为高风险饮酒者的女性比例，以及不再被归类为避孕无效使用者的女性比例。二次分析将确定改变的相关因素，包括酒精严重程度、药物使用和严重程度、精神疾病的共同发病率、改变的动机、个性和自我效能，并将检查AEP风险降低的中介和调节模型。在第四阶段，将开发为更大的第二阶段疗效试验做准备所需的产品。长期目标是确定更简短的干预措施，有效减少AEP的危险行为，这些行为可以转移到各种公共卫生治疗和干预环境中。

DESCRIPTION (provided by applicant): The purpose of this Stage 1 b behavior therapy development project is to develop and test the feasibility and promise of a brief, theory-based intervention to reduce the risk of alcohol-exposed pregnancy (AEP) in high-risk community women. During Phase 1, the investigators will adapt a promising intervention to a single extended session model, then pre-pilot test the intervention with 9 participants, iteratively revising the treatment manual. In addition, therapist adherence and competence rating forms will be developed and refined. During Phase 2, therapists and raters of process measures will be trained. During Phase 3, the team will implement a two-arm randomized controlled trial. Group 1 will receive the EARLY intervention, and Group 2, the comparison group, will receive an information/ attention intervention. The EARLY intervention, based on social learning theory and the Transtheoretical model of change, uses the motivational interviewing counseling style, and includes personalized feedback of risks related to drinking and ineffective contraception, information, decisional balance exercises, discussion of readiness to change, eliciting of goal statements, and development of change plans. Participants will be a high-risk community sample of 152 fertile women who drink frequently or who binge, and who use contraception ineffectively, drawn from STD and public health clinics and alcohol/drug treatment settings. Participants will complete a baseline assessment battery measuring demographics, alcohol and drug use, obstetrical/gynecological history, emotional distress, stages and processes of change, self-efficacy, and personality. Participants and therapists will provide process ratings of the behavioral intervention sessions. Quality assurance will be achieved through continuous supervision. Independent raters will rate therapist adherence to the protocol and competence in delivering the intervention. Follow-up assessments are at 3 and 6 months. Primary outcomes will be measured by a 90-day timeline follow-back for drinking and sexual activity/ contraceptive behavior. Because change in either risk behavior will lead to a reduction of AEP risk, three primary outcomes will be evaluated. These are the proportion of women no longer at risk for AEP at 6-month followup, the proportion of women no longer classified as risky drinkers, and the proportion of women no longer classified as ineffective users of contraception. Secondary analyses will identify correlates of change, including alcohol severity, drug use and severity, psychiatric co-morbidity, motivation for change, personality, and self-efficacy, and will examine mediator and moderator models of AEP risk reduction. During Phase 4, products needed to prepare for a larger Stage 2 efficacy trial will be developed. The long-term goal is to identify briefer interventions that effectively reduce the risk behaviors for AEP that could be transferred to a variety of public health treatment and intervention settings.