Assisting HIV-Infected Mothers in Disclosing Their Serostatus to Their Children - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00429546

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 I

MedlinePlus related topics: AIDS Mental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Maternal HIV: Intervention to Assist Disclosure to Children

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Readiness to disclose HIV serostatus [ Time Frame: Measured at Month 11 ] [ Designated as safety issue: No ]
Disclosure of HIV serostatus [ Time Frame: Measured at Months 3, 6, 9, and 11 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mothers' mental health indicators [ Time Frame: Measured at Month 11 ] [ Designated as safety issue: Yes ]
Children's mental health indicators [ Time Frame: Measured at Month 11 ] [ Designated as safety issue: No ]
Children's behavioral problems [ Time Frame: Measured at Month 11 ] [ Designated as safety issue: No ]
Parent-child relationship and family functioning [ Time Frame: Measured at Months 3, 6, 9, and 11 ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intervention: Experimental 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.
Control: Active Comparator Participants will receive treatment as usual	Other: Treatment as usual Treatment as usual includes standard care for HIV infected mothers.

Arms

Assigned Interventions

Intervention: Experimental

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.

Control: Active Comparator

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 abandon 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 beginning 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:	Yes

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

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

Contacts

Contact: Diana L Payne, PhD

310-794-8127

dpayne@mednet.ucla.edu

Locations

United States, California
University of California, Los Angeles	Recruiting
Los Angeles, California, United States, 90025
Contact: Diana L. Payne, PhD 310-794-8127 dpayne@mednet.ucla.edu
Contact: Tim Castro, BA 310-794-8127 tcastro@mednet.ucla.edu

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Debra A. Murphy, PhD

University of California, Los Angeles

More Information

Responsible Party:	UCLA ( Dr. Debra A. Murphy, Prinicipal Investigator )
Study ID Numbers:	R01 MH77493, DAHBR 9A-ASAP
Study First Received:	January 29, 2007
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00429546
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Disclosure
Serostatus

Study placed in the following topic categories:

HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on January 16, 2009