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

NCT ID: NCT00429546

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-01-31

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Teaching, Raising, and Communicating with Kids (TRACK)

Intervention Type: BEHAVIORAL

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

Participants will receive treatment as usual

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

Treatment as usual includes standard care for HIV infected mothers.

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment as usual

Treatment as usual includes standard care for HIV infected mothers.

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Debra A. Murphy, Ph.D.

Professor in Residence

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Debra A. Murphy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

R01MH077493

Identifier Type: NIH

Identifier Source: secondary_id

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DAHBR 9A-ASAP

Identifier Type: -

Identifier Source: secondary_id

R01MH077493

Identifier Type: NIH

Identifier Source: org_study_id

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