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临床试验/NCT00429546
NCT00429546已完成1 期

Maternal HIV: Intervention to Assist Disclosure to Children

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
160
试验地点
2
主要终点
Disclosure of HIV serostatus

研究概览

简要总结

This study will develop and evaluate the effectiveness of an intervention designed to assist HIV-infected mothers of young children in determining whether and how to appropriately disclose their HIV serostatus to their children.

详细描述

HIV is a serious, life threatening illness that requires a lifetime of treatment and disease management. Studies have shown that it can be very difficult for infected mothers to decide whether and/or when to disclose their HIV serostatus to their uninfected children. HIV-infected parents struggle with the fear that their children will be forced to grow up too quickly, become worried or depressed, or be angry with their parents once they learn that their parents have HIV. Family-based intervention programs have been successful in helping facilitate the disclosure process. This study will develop and evaluate the effectiveness of an intervention designed to assist HIV-infected mothers of young children in determining whether and how to appropriately disclose their HIV serostatus to their children.

Participants in this study will be randomly assigned to either the intervention or a standard of care condition. The intervention will consist of three 75-minute sessions that will focus on exploring mothers' concerns, determining children's readiness to receive the news, planning for disclosure, and practicing disclosure. Participants will also receive one follow-up phone call from the therapist about 3 weeks after the last session. Sessions will be scheduled at times that are convenient for the participants and therapists. Follow-up visits will include both mothers and their children, and will be held at Months 3, 6, and 9 following the end of the intervention. Assessments will include readiness to disclose HIV serostatus, mental health indicators, and family functioning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmation of mother's HIV/AIDS status
  • Healthy child (i.e., HIV uninfected) who is between 6 and 12 years of age and is unaware of maternal serostatus
  • Mother is primary caregiver and child resides with her
  • English- or Spanish-speaking

排除标准

  • Child does not meet screening criteria (e.g., diagnosed with depression or suicide attempt, IQ score less than 75)
  • Psychosis of parent or child (as advised by recruitment site clinicians)
  • Child refuses to give assent

结局指标

主要结局

Disclosure of HIV serostatus

时间窗: Measured at Months 3, 6, and 9

Readiness to disclose HIV serostatus

时间窗: Measured at Months 3, 6, and 9

次要结局

  • Mothers' mental health indicators(Measured at Months 3, 6, and 9)
  • Children's mental health indicators(Measured at Months 3, 6, and 9)
  • Parent-child relationship and family functioning(Measured at Months 3, 6, and 9)
  • Children's behavioral problems(Measured at Months 3, 6, and 9)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Debra A. Murphy, Ph.D.

Professor in Residence

University of California, Los Angeles

研究点 (2)

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