Skip to content

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

Maternal HIV: Intervention to Assist Disclosure to Children

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00429546
Acronym
TRACK
Enrollment
160
Registered
2007-01-31
Start date
2007-09-30
Completion date
2010-01-31
Last updated
2013-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Disclosure, Serostatus

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.

Interventions

BEHAVIORALTeaching, 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.

OTHERTreatment as usual

Treatment as usual includes standard care for HIV infected mothers.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Readiness to disclose HIV serostatusMeasured at Months 3, 6, and 9
Disclosure of HIV serostatusMeasured at Months 3, 6, and 9

Secondary

MeasureTime frame
Mothers' mental health indicatorsMeasured at Months 3, 6, and 9
Children's mental health indicatorsMeasured at Months 3, 6, and 9
Children's behavioral problemsMeasured at Months 3, 6, and 9
Parent-child relationship and family functioningMeasured at Months 3, 6, and 9

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026