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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Debra A. Murphy, Ph.D., University of California, Los Angeles

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Readiness to disclose HIV serostatus [ Time Frame: Measured at Months 3, 6, and 9 ]
  2. Disclosure of HIV serostatus [ Time Frame: Measured at Months 3, 6, and 9 ]

Secondary Outcome Measures :
  1. Mothers' mental health indicators [ Time Frame: Measured at Months 3, 6, and 9 ]
  2. Children's mental health indicators [ Time Frame: Measured at Months 3, 6, and 9 ]
  3. Children's behavioral problems [ Time Frame: Measured at Months 3, 6, and 9 ]
  4. Parent-child relationship and family functioning [ Time Frame: Measured at Months 3, 6, and 9 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90025
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Debra A. Murphy, PhD University of California, Los Angeles
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: R01MH077493 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASAP
First Posted: January 31, 2007    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013

Keywords provided by Debra A. Murphy, Ph.D., University of California, Los Angeles:
Disclosure
Serostatus