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

NCT00429546 | Completed Phase 1

• 2 other identifiers: R01MH077493DAHBR 9A-ASAP
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Disclosure; Serostatus

Outcome Measures

Primary Outcomes (2)

• Readiness to disclose HIV serostatus

  Measured at Months 3, 6, and 9

• Disclosure of HIV serostatus

  Measured at Months 3, 6, and 9

Secondary Outcomes (4)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Control

ACTIVE COMPARATOR

Participants will receive treatment as usual

Other: Treatment as usual

Interventions

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.

Intervention

Treatment as usual OTHER

Treatment as usual includes standard care for HIV infected mothers.

Control

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90025, United States

Location

MeSH Terms

Interventions

Educational Status; Therapeutics

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Debra A. Murphy, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Residence

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 31, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 26, 2013

Record last verified: 2013-06

Locations

US (1)