Reducing alcohol-exposed pregnancy risk

降低酒精暴露怀孕风险

• 批准号: 7072245
• 负责人: KAREN S INGERSOLL
• 金额: $ 33.29万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-02-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7072245
• 关键词: alcoholism /alcohol abuse; behavior therapy; behavioral /social science research tag; clinical research; clinical trials; community health services; contraceptives; disease /disorder proneness /risk; embryo /fetus toxicology; female; high risk behavior /lifestyle; human subject; human therapy evaluation; pregnancy; sex behavior; therapy compliance; therapy design /development; training

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.

描述（由申请人提供）： 第一阶段B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妊娠（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调整为一个单一的扩展会话模型，然后用9名参与者对干预措施进行预试测试，反复修改治疗手册。此外，还将制定和完善治疗师依从性和能力评级表。在第2阶段，将对治疗师和过程测量评分员进行培训。在第3阶段，该团队将实施一项双臂随机对照试验。第1组将接受早期干预，第2组（对照组）将接受信息/注意力干预。早期干预，基于社会学习理论和跨理论模型的变化，使用动机访谈咨询风格，并包括个性化的反馈有关饮酒和无效避孕的风险，信息，决策平衡练习，讨论准备改变，引出的目标陈述，并制定改变计划。参与者将是一个高风险的社区样本的152名育龄妇女谁经常喝酒或谁狂欢，谁使用避孕无效，从性病和公共卫生诊所和酒精/药物治疗设置。参与者将完成基线评估电池测量人口统计学，酒精和药物使用，产科/妇科史，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会议的过程评级。我们会透过持续的监察，确保服务质素。独立评估者将评估治疗师对方案的依从性和提供干预的能力。在3个月和6个月时进行随访评估。将通过90天时间轴随访饮酒和性活动/避孕行为来测量主要结局。由于任何一种风险行为的改变都会导致AEP风险的降低，因此将评估三个主要结局。这些是在6个月随访时不再有AEP风险的女性比例，不再被归类为危险饮酒者的女性比例，以及不再被归类为避孕无效者的女性比例。二次分析将确定变化的相关性，包括酒精的严重程度，药物使用和严重程度，精神病共病，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4阶段，将开发为更大规模的第2阶段疗效试验做准备所需的产品。长期目标是确定有效减少AEP风险行为的简短干预措施，这些干预措施可以转移到各种公共卫生治疗和干预环境中。