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Assisting HIV-infected Mothers in Disclosing Their Serostatus to Their Children (TRACK)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Debra A. Murphy, Ph.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00429546
First received: January 29, 2007
Last updated: June 24, 2013
Last verified: June 2013

January 29, 2007
June 24, 2013
September 2007
January 2010   (final data collection date for primary outcome measure)
  • Readiness to disclose HIV serostatus [ Time Frame: Measured at Months 3, 6, and 9 ] [ Designated as safety issue: No ]
  • Disclosure of HIV serostatus [ Time Frame: Measured at Months 3, 6, and 9 ] [ Designated as safety issue: No ]
  • Readiness to disclose HIV serostatus
  • Disclosure of HIV serostatus (all measured at Months 3, 6, and 9)
Complete list of historical versions of study NCT00429546 on ClinicalTrials.gov Archive Site
  • Mothers' mental health indicators [ Time Frame: Measured at Months 3, 6, and 9 ] [ Designated as safety issue: No ]
  • Children's mental health indicators [ Time Frame: Measured at Months 3, 6, and 9 ] [ Designated as safety issue: No ]
  • Children's behavioral problems [ Time Frame: Measured at Months 3, 6, and 9 ] [ Designated as safety issue: No ]
  • Parent-child relationship and family functioning [ Time Frame: Measured at Months 3, 6, and 9 ] [ Designated as safety issue: No ]
  • Mothers' mental health indicators
  • Children’s mental health indicators
  • Children’s behavioral problems
  • Parent-child relationship and family functioning (all measured at Months 3, 6, and 9)
Not Provided
Not Provided
 
Assisting HIV-infected Mothers in Disclosing Their Serostatus to Their Children
Maternal HIV: Intervention to Assist Disclosure to Children

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
HIV
  • Behavioral: Teaching, Raising, and Communicating with Kids (TRACK)
    TRACK is cognitive-behavioral treatment designed to improve mother-child communication and parenting skills and prepare caregiver for disclosure of HIV serostatus to child. The treatment consists of three 75-minute sessions that focus on exploring mothers' concerns, determining children's readiness to receive the news, planning for disclosure, and practicing disclosure.
  • Other: Treatment as usual
    Treatment as usual includes standard care for HIV infected mothers.
  • Experimental: Intervention
    Participants will receive a cognitive-behavioral intervention designed to improve mother-child communication and parenting skills and prepare caregiver for disclosure of HIV serostatus to child
    Intervention: Behavioral: Teaching, Raising, and Communicating with Kids (TRACK)
  • Active Comparator: Control
    Participants will receive treatment as usual
    Intervention: Other: Treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
6 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00429546
R01 MH77493, R01MH077493, DAHBR 9A-ASAP
No
Debra A. Murphy, Ph.D., University of California, Los Angeles
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Principal Investigator: Debra A. Murphy, PhD University of California, Los Angeles
University of California, Los Angeles
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP