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Clinical Trials/NCT00429546
NCT00429546
Completed
Phase 1

Maternal HIV: Intervention to Assist Disclosure to Children

University of California, Los Angeles1 site in 1 country160 target enrollmentSeptember 2007
ConditionsHIV

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
HIV
Sponsor
University of California, Los Angeles
Enrollment
160
Locations
1
Primary Endpoint
Disclosure of HIV serostatus
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
January 2010
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Debra A. Murphy, Ph.D.

Professor in Residence

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Disclosure of HIV serostatus

Time Frame: Measured at Months 3, 6, and 9

Readiness to disclose HIV serostatus

Time Frame: Measured at Months 3, 6, and 9

Secondary Outcomes

  • 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)

Study Sites (1)

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