Assisting HIV-infected Mothers in Disclosing Their Serostatus to Their Children (TRACK)
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|ClinicalTrials.gov Identifier: NCT00429546|
Recruitment Status : Completed
First Posted : January 31, 2007
Last Update Posted : June 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Teaching, Raising, and Communicating with Kids (TRACK) Other: Treatment as usual||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Maternal HIV: Intervention to Assist Disclosure to Children|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
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.
- Readiness to disclose HIV serostatus [ Time Frame: Measured at Months 3, 6, and 9 ]
- Disclosure of HIV serostatus [ Time Frame: Measured at Months 3, 6, and 9 ]
- Mothers' mental health indicators [ Time Frame: Measured at Months 3, 6, and 9 ]
- Children's mental health indicators [ Time Frame: Measured at Months 3, 6, and 9 ]
- Children's behavioral problems [ Time Frame: Measured at Months 3, 6, and 9 ]
- Parent-child relationship and family functioning [ Time Frame: Measured at Months 3, 6, and 9 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429546
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90025|
|Principal Investigator:||Debra A. Murphy, PhD||University of California, Los Angeles|