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
  Purpose

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.


Condition Intervention Phase
HIV
Behavioral: Teaching, Raising, and Communicating with Kids (TRACK)
Other: Treatment as usual
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Maternal HIV: Intervention to Assist Disclosure to Children

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 160
Study Start Date: September 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Active Comparator: Control
Participants will receive treatment as usual
Other: Treatment as usual
Treatment as usual includes standard care for HIV infected mothers.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429546

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90025
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Debra A. Murphy, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Debra A. Murphy, Ph.D., Professor in Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00429546     History of Changes
Other Study ID Numbers: R01 MH77493, R01MH077493, DAHBR 9A-ASAP
Study First Received: January 29, 2007
Last Updated: June 24, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Disclosure
Serostatus

ClinicalTrials.gov processed this record on August 18, 2014