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

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Assisting HIV-Infected Mothers in Disclosing Their Serostatus to Their Children

Official Title ^†

Maternal HIV: Intervention to Assist Disclosure to Children

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.

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Other, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Primary Outcome Measure ^†

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 Measure ^†

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 ]

Condition ^†

HIV

Intervention ^†

Behavioral: Teaching, Raising, and Communicating with Kids (TRACK)
Other: Treatment as usual

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

160

Start Date ^†

September 2007

Completion Date

August 2009

Eligibility 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

Gender

Both

Ages

6 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Diana L Payne, PhD

310-794-8127

dpayne@mednet.ucla.edu

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00429546

Organization ID

R01 MH77493

Secondary IDs ^††

DAHBR 9A-ASAP

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

Debra A. Murphy, PhD

University of California, Los Angeles

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

February 2008

First Received Date ^†

January 29, 2007

Last Updated Date

February 28, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.