1/2-Maternal HIV: Multisite Trial to Assist Disclosure to Children

描述(由申请人提供)：根据计划公告PAR-09-153，本协作R01的目的是进行一项干预措施的全面试验，以帮助感染艾滋病毒(MLH)的母亲向其年幼(6-14岁)、健康的孩子披露其血清状态。干预的初步研究最近已经完成(R01MH077493)，并达到了主要目标。试点干预措施的开发基础是从三个R01开始的工作(MH057207，目前是。14)旨在纵向评估MLH及其子女。在这项工作中，进行了几项关于母亲披露的研究(例如，Murphy，Marelich，&Hoffman，2002；Murphy，Roberts，&Hoffman，2002；Murphy，Roberts，&Hoffman，2003；Murphy，Roberts，&Hoffman，2006；Murphy，Steers，&Dello Stritto，2001)，表明披露是困难的，MLH和儿童的结果可以通过干预得到改善。这项试点研究在社区中被称为教学、抚养和与儿童沟通(TRACE)，是基于综合披露理论(Derlega等人，2004年)。试点试验的结果表明，干预组的发病率是对照组的6倍以上。 在9个月的随访期内，MLH披露的33%的干预措施中，有可能向孩子披露自己的艾滋病毒/艾滋病状况的比例高于对照组(O.R.6.33)，而对照组的这一比例仅为7.3%。也许更重要的是，干预后干预组儿童的情绪功能及其满意度显著提高，与对照组相比，MLH干预组儿童的心理健康指标在随访时显著优于对照组儿童。在这项名为Track II的研究中，我们建议在两个地点进行一次全面的干预试验：(1)洛杉矶县(地点1，进行Pilo试验)，其中将包括高比例的拉丁裔家庭，以及较小比例的非裔美国人和白人家庭；(2)佐治亚州亚特兰大(地点2，试点试验的主要顾问进行研究)，其中将包括比例较高的南部非洲裔家庭和白人家庭。MLH及其子女(共440人；每个地点110名母亲和110名儿童，每个地点n=220人)将在基线以及3、9和15个月的随访时进行评估。MLH将被随机分配到干预或对照中。目的是：1.促进向儿童披露母亲的艾滋病毒状况，这将包括以下次要目标：a.提高母亲的自我效能，以披露和回应有关艾滋病毒的儿童问题；b.减少母亲对披露和羞辱的恐惧；c.提高母亲对儿童发展的知识，以及如何根据孩子的年龄提供适当水平的信息；2.随着时间的推移改善MLH精神健康指标(即抑郁、焦虑、生活质量)；3.随着时间的推移改善儿童精神健康指标(即抑郁、焦虑、行为不端)；4.改善家庭功能指标(例如，亲密度、母子之间的亲密感)。 公共卫生相关性：本协作性R01的目的是测试对有6-14岁孩子的艾滋病毒感染母亲进行披露干预的全面试验的有效性。此干预措施的开发基础是前两个R01(MH057207，目前为年)的工作14)旨在对艾滋病毒阳性母亲及其子女进行纵向评估。根据这项观察工作，制定了披露干预措施，并进行了干预措施的试点试验。在初步研究中，干预组的母亲更有可能向孩子披露她们的血清状况，并且干预组的母亲和儿童在披露后的心理健康得分都高于被分配到对照组的母亲和儿童。我们现在正处于艾滋病毒流行的第三个十年，除了预防或坚持用药外，对感染艾滋病毒的妇女几乎没有其他干预措施；这项全面试验的纵向设计和扩大样本量将使我们能够探索可能缓和或调解披露影响的孕产妇和儿童特征(例如，年龄、性别、族裔、母亲艾滋病毒/艾滋病污名和疾病严重程度)，以及更详细地调查已被披露的儿童与未被披露的儿童的轨迹。

DESCRIPTION (provided by applicant): The purpose of this Collaborative R01, under Program Announcement PAR-09-153, is to conduct a full-scale trial of an intervention to assist mothers living with HIV (MLH) with disclosing their serostatus to their young (age 6 - 14 year old), well children. A pilot study of the intervention has recently been completed (R01 MH077493) and met its major aims. The basis for development of the pilot intervention was work from three R01s (MH057207, currently Yr. 14) designed to longitudinally assess MLH and their children. Within that work, several studies were conducted on maternal disclosure (e.g., Murphy, Marelich, & Hoffman, 2002; Murphy, Roberts, & Hoffman, 2002; Murphy, Roberts, & Hoffman, 2003; Murphy, Roberts, & Hoffman, 2006; Murphy, Steers, & Dello Stritto, 2001), suggesting disclosure is difficult, and outcomes for MLH and children could be improved by intervention. The pilot study, known in the community as Teaching, Raising, And Communicating with Kids (TRACK), was based on integrative disclosure theory (Derlega et al., 2004). Results of the pilot trial indicate that those in the intervention group were six times more likely to disclose their HIV/AIDS status to their child than those in the control group (O.R. 6.33) by the 9-month follow-up 33% of intervention MLH disclosed, compared to only 7.3% of the control group. Perhaps more importantly, the intervention group's emotional functioning and their satisfaction improved significantly following the intervention, compared to the control group Similarly, child mental health indicators among children of intervention MLH were significantly better than control group children at follow-ups. In this study, TRACK II, we propose to conduct a full-scale trial of the intervention in two sites: (1) Los Angeles county (Site 1, where the pilo trial was conducted), which will include a high proportion of Latina families and a smaller proportion of African-American and White families; and (2) Atlanta, Georgia (Site 2, where the primary consultant on the pilot trial conducts research), which will include a high proportion of Southern African-American families, as well as White families. MLH and their children (N = 440 total; 110 mothers and 110 children per site, n = 220 per site) will be assessed at baseline and at 3, 9, and 15-month follow-ups. MLH will be randomly assigned to the intervention or control. Aims are to: 1. facilitate disclosure of the mothers' HIV status to the children, which will includ secondary aims of: a. increasing mothers' self-efficacy to disclose and respond to child questions regarding HIV; b. reducing mothers' fears regarding disclosure and stigma; c. improving maternal knowledge of child development and how to provide appropriate levels of information given the age of the child; 2. improve MLH mental health indicators over time (i.e., depression, anxiety, quality of life); 3. improve child mental health indicators over time (i.e., depression, anxiety, acting out behaviors); and 4. improve family functioning indicators (e.g., cohesion, perceived closeness between mother and child). PUBLIC HEALTH RELEVANCE: The purpose of this Collaborative R01 is to test the efficacy of a full-scale trial of a disclosure intervention for HIV-infected mothers with children age 6 - 14 years of age. The basis for development of this intervention is work from two previous R01s (MH057207, currently Yr. 14) designed to longitudinally assess HIV-positive mothers and their children. From that observational work, a disclosure intervention was developed and a pilot trial of the intervention was conducted. In the pilot study, mothers in the intervention group were more likely to disclose their serostatus to their children, and both mothers and children in the intervention group showed better mental health scores following disclosure than mothers and children assigned to the control condition. We are now in the third decade of the HIV epidemic, and few interventions, other than for prevention or medication adherence, are available for women living with HIV; the longitudinal design and increased sample size of this full scale trial o the intervention will allow us to explore maternal and child characteristics that may moderate or mediate the impact of disclosure (e.g., demographic factors such as age, gender, ethnicity; maternal HIV/AIDS stigma, and illness severity), as well as investigate in more detail the trajectories of children who have been disclosed to versus those who have not.