Clinical trial NCT00429546: Assisting HIV-infected Mothers in Disclosing Their Serostatus to Their Children
Official title: Maternal HIV: Intervention to Assist Disclosure to Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV
Keywords: Disclosure
Serostatus
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-01-31
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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 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 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

Primary outcomes:
measure: Readiness to disclose HIV serostatus
timeFrame: Measured at Months 3, 6, and 9
measure: Disclosure of HIV serostatus
timeFrame: Measured at Months 3, 6, and 9
Secondary outcomes:
measure: Mothers' mental health indicators
timeFrame: Measured at Months 3, 6, and 9
measure: Children's mental health indicators
timeFrame: Measured at Months 3, 6, and 9
measure: Children's behavioral problems
timeFrame: Measured at Months 3, 6, and 9
measure: Parent-child relationship and family functioning
timeFrame: Measured at Months 3, 6, and 9
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Debra A. Murphy, PhD
role: PRINCIPAL_INVESTIGATOR
References: