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Completed

NCT Number: NCT00429546

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

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Key information

Conditions

HIV

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Los Angeles

Los Angeles, California, 90025, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teaching, Raising, and Communicating with Kids (TRACK)

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.

Treatment as Usual

Other

Treatment as usual includes standard care for HIV infected mothers.

Primary outcomes

  1. Readiness to disclose HIV serostatus

    Time frame: Measured at Months 3, 6, and 9

  2. Disclosure of HIV serostatus

    Time frame: Measured at Months 3, 6, and 9

Secondary outcomes

  1. Mothers' mental health indicators

    Time frame: Measured at Months 3, 6, and 9

  2. Children's mental health indicators

    Time frame: Measured at Months 3, 6, and 9

  3. Children's behavioral problems

    Time frame: Measured at Months 3, 6, and 9

  4. Parent-child relationship and family functioning

    Time frame: Measured at Months 3, 6, and 9

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Maternal HIV: Intervention to Assist Disclosure to Children

Acronym: TRACK

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 31, 2007
Registry last updated
Jun 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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