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

1/2-孕产妇艾滋病毒：多中心试验以协助向儿童披露

• 批准号: 8308197
• 负责人: DEBRA A. MURPHY
• 金额: $ 38.28万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-11 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8308197
• 关键词: 14 year old; AIDS/HIV problem; Acting Out; African American; Age; Anxiety; Area; Behavior; Characteristics; Charge; Child; Child Development; Child Mental Health; Communities; Control Groups; Country; County; Demographic Factors; Development; Disclosure; Educational Intervention; Educational process of instructing; Emotional; Epidemic; Ethnic Origin; Family; Fright; Gender; HIV; HIV Seropositivity; Individual; Intervention; Intervention Studies; Intervention Trial; Interview; Interviewer; Joints; Knowledge; Latina; Life; Los Angeles; Mediating; Mental Depression; Mental Health; Mothers; NIH Program Announcements; Online Systems; Outcome; Parents; Pilot Projects; Prevention; Protocols documentation; Quality of life; Race; Randomized; Research; Role; Sample Size; Sampling; Secondary Prevention; Self Efficacy; Severity of illness; Site; Stigmata; Time; Treatment Efficacy; Woman; Work; base; cohesion; data management; design; efficacy testing; follow-up; group intervention; improved; longitudinal design; medication compliance; meetings; pilot trial; prevent; quality assurance; satisfaction; social stigma; theories; therapy development

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.

描述（由申请人提供）：根据计划公告PAR-09-153，本合作R 01的目的是进行一项全面的干预试验，以帮助感染艾滋病毒（MLH）的母亲向其子女披露她们的血清状况（6 - 14岁），健康的孩子。最近完成了一项干预措施的试点研究（R 01 MH 077493），并实现了其主要目标。开发试点干预措施的基础是三个R 01（MH 057207，目前Yr. 14)旨在纵向评估MLH及其子女。在这项工作中，对产妇披露情况进行了几项研究（例如，Murphy，Marelich，&霍夫曼，2002; Murphy，Roberts，&霍夫曼，2002; Murphy，Roberts，&霍夫曼，2003; Murphy，Roberts，&霍夫曼，2006; Murphy，Steers，& Dello Stritto，2001），表明信息披露是困难的，通过干预可以改善MLH和儿童的结局。该试点研究，在社区中被称为教学，提高，并与孩子沟通（TRACK），是基于综合披露理论（Derlega等人，2004年）。初步试验的结果表明，干预组的患者是对照组的6倍， 与对照组相比，有可能向孩子透露自己的HIV/AIDS状况（O.R. 6.33），在9个月的随访中，33%的干预组的MLH披露，而对照组只有7.3%。也许更重要的是，与对照组相比，干预组的情绪功能和满意度在干预后显着改善。同样，干预MLH儿童的儿童心理健康指标在随访时显着优于对照组儿童。在这项研究TRACK II中，我们建议在两个地点进行全面的干预试验：（1）洛杉矶县（研究中心1，进行了初步试验），将包括高比例的拉丁裔家庭和较小比例的非裔美国人和白色家庭;和（2）格鲁吉亚亚特兰大（研究中心2，试点试验的主要顾问在此进行研究），其中包括高比例的南部非洲裔美国人家庭以及白色家庭。将在基线和3、9和15个月随访时评估MLH及其子女（共N = 440;每个研究中心110名母亲和110名子女，每个研究中心n = 220）。将MLH随机分配至干预组或对照组。目标是：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.提高母亲披露和回答儿童有关艾滋病毒问题的自我效能; B.减少母亲对披露和污名化的恐惧; c.提高母亲对儿童发展的认识，以及如何根据儿童的年龄提供适当程度的信息; 2.随着时间的推移改善MLH心理健康指标（即，抑郁、焦虑、生活质量）; 3.随着时间的推移改善儿童心理健康指标（即，抑郁、焦虑、行为表现）;以及4.改善家庭功能指标（例如，凝聚力，母亲和孩子之间的亲密感）。 公共卫生关系：本协作R 01的目的是测试一项全面试验的披露干预的艾滋病毒感染的母亲与儿童年龄6 - 14岁的有效性。开发该干预措施的基础是前两个R 01（MH 057207，目前为Yr. 14)旨在纵向评估艾滋病毒阳性母亲及其子女。根据观察工作，制定了披露干预措施，并进行了干预措施的试点试验。在试点研究中，干预组的母亲更有可能向孩子透露自己的血清状况，干预组的母亲和孩子在透露后的心理健康评分都比对照组的母亲和孩子好。我们现在正处于艾滋病毒流行的第三个十年，除了预防或药物依从性外，很少有干预措施可用于感染艾滋病毒的妇女;这项全规模试验的纵向设计和增加的样本量将使我们能够探索可能减轻或介导披露影响的孕产妇和儿童特征（例如，人口统计因素，如年龄、性别、种族;孕产妇艾滋病毒/艾滋病耻辱感和疾病严重程度），并更详细地调查已向儿童披露的儿童与未披露的儿童的轨迹。