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Completed

NCT Number: NCT01922206

Maternal HIV: Trial to Assist Disclosure to Children

The purpose of this Collaborative R01, under Program Announcement PAR-09-153, is to conduct a full-scale trial of an intervention to assist mothers living with HIV (MLH) with disclosing their serostatus to their young age 6 - 14 year old), well children. A pilot study of the intervention has recently been completed (R01 MH077493) and met its major aims. The basis for development of the pilot intervention was work from three R01s (MH057207, currently Yr. 14) designed to longitudinally assess MLH and their children. Within that work, several studies were conducted on maternal disclosure, suggesting disclosure is difficult, and outcomes for MLH and children could be improved by intervention. The pilot study, known in the community as Teaching, Raising, And Communicating with Kids (TRACK), was based on integrative disclosure theory. Results of the pilot trial indicate that those in the intervention group were six times more likely to disclose their HIV/AIDS status to their child than those in the control group (O.R. 6.33); by the 9-month follow-up 33% of intervention MLH disclosed, compared to only 7.3% of the control group. Perhaps more importantly, the intervention group's emotional functioning and their satisfaction improved significantly following the intervention, compared to the control group. Similarly, child mental health indicators among children of intervention MLH were significantly better than control group children at follow-ups. In this study, TRACK II, we propose to conduct a full-scale trial of the intervention in two sites: (1) Los Angeles county (Site 1, where the pilot trial was conducted), which will include a high proportion of Latina families and a smaller proportion of African-American and White families; and (2) Atlanta, Georgia (Site 2, where the primary consultant on the pilot trial conducts research), which will include a high proportion of Southern African-American families, as well as White families. MLH and their children (N = 440 total; 110 mothers and 110 children per site, n = 220 per site) will be assessed at baseline and at 3, 9, and 15-month follow-ups. MLH will be randomly assigned to the intervention or control. Aims are to:

1. facilitate disclosure of the mothers' HIV status to the children, which will include secondary aims of:

1. increasing mothers' self-efficacy to disclose and respond to child questions regarding HIV; 2. reducing mothers' fears regarding disclosure and stigma; 3. improving maternal knowledge of child development and how to provide appropriate levels of information given the age of the child; 2. improve MLH mental health indicators over time (i.e., depression, anxiety, quality of life); 3. improve child mental health indicators over time (i.e., depression, anxiety, acting out behaviors); and 4. improve family functioning indicators (e.g., cohesion, perceived closeness between mother and child).

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Key information

Conditions

HIV

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia State University

Atlanta, Georgia, 30302, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Mother is HIV+
  • ability of mother and child to speak and understand English or Spanish
  • child is not HIV+
  • Child is 6-14 years old
  • Child is unaware of maternal HIV status
  • child resides with mother

Exclusion criteria

  • Mother does not consent
  • Child does not assent
  • Psychosis of mother or child
  • Child diagnosed with depression
  • child is developmentally delayed
  • Recent or anticipated death in the family

Treatment and study plan

TRACK Intervention

Behavioral

TRACK Intervention

3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child

Primary outcomes

  1. Disclosure of Maternal HIV status to child

    Time frame: Change in disclosure status between time points 3-, 9-, & 15 month follow ups

Secondary outcomes

  1. Child Mental Health Functioning (Composite measure)

    Time frame: 15- month follow up

    Self and Caregiver reported indicators, including the Child Depression Inventory, Piers-Harris Children's Self-Concept Scale, Penn State Worry Questionnaire

Other outcomes

  1. Maternal Functioning (composite measure)

    Time frame: 15 month follow-up

    CES-D, GAD-7, Health-Related Anxiety Questionnaire, Medical Outcomes Study-Health Self-Report, Alcohol and Drug Assessment

  2. Family functioning (composite measure)

    Time frame: 15 month follow-up

    Cohesiveness, routines, parent-child communication, parent-child relationship quality

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

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

Registry information

Official study title

2/2-Maternal HIV: Multisite Trial to Assist Disclosure to Children

Acronym: TRACK II

Important dates

Study start
2013
Primary completion
2017
Study completion
2019
First posted
Aug 14, 2013
Registry last updated
Jan 18, 2020

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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