Assisting HIV-infected Mothers in Disclosing Their Serostatus to Their Children (TRACK)

Maternal HIV: Intervention to Assist Disclosure to Children

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Teaching, Raising, and Communicating with Kids (TRACK); Other: Treatment as usual

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90025
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Readiness to disclose HIV serostatus	Measured at Months 3, 6, and 9
Disclosure of HIV serostatus	Measured at Months 3, 6, and 9

Secondary Outcome Measures

Outcome Measure	Time Frame
Mothers' mental health indicators	Measured at Months 3, 6, and 9
Children's mental health indicators	Measured at Months 3, 6, and 9
Children's behavioral problems	Measured at Months 3, 6, and 9
Parent-child relationship and family functioning	Measured at Months 3, 6, and 9

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Debra A. Murphy, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: January 29, 2007
• First Submitted That Met QC Criteria: January 29, 2007
• First Posted (ESTIMATE): January 31, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): June 26, 2013
• Last Update Submitted That Met QC Criteria: June 24, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Disclosure; Serostatus
• Other Study ID Numbers: R01MH077493 (NIH); DAHBR 9A-ASAP