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Maternal HIV: Trial to Assist Disclosure to Children (TRACK II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Georgia State University
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Lisa Armistead, Georgia State University
ClinicalTrials.gov Identifier:
NCT01922206
First received: August 2, 2013
Last updated: August 13, 2013
Last verified: August 2013

August 2, 2013
August 13, 2013
March 2013
April 2017   (final data collection date for primary outcome measure)
Disclosure of Maternal HIV status to child [ Time Frame: Change in disclosure status between time points 3-, 9-, & 15 month follow ups ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01922206 on ClinicalTrials.gov Archive Site
Child Mental Health Functioning (Composite measure) [ Time Frame: 15- month follow up ] [ Designated as safety issue: No ]
Self and Caregiver reported indicators, including the Child Depression Inventory, Piers-Harris Children's Self-Concept Scale, Penn State Worry Questionnaire
Same as current
  • Maternal Functioning (composite measure) [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]
    CES-D, GAD-7, Health-Related Anxiety Questionnaire, Medical Outcomes Study-Health Self-Report, Alcohol and Drug Assessment
  • Family functioning (composite measure) [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]
    Cohesiveness, routines, parent-child communication, parent-child relationship quality
Same as current
 
Maternal HIV: Trial to Assist Disclosure to Children
2/2-Maternal HIV: Multisite 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).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
HIV
Behavioral: TRACK Intervention

TRACK Intervention

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

  • No Intervention: Wait-list Control
  • Experimental: TRACK Intervention
    3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child
    Intervention: Behavioral: TRACK Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
440
April 2017
April 2017   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Lisa P Armistead, Ph.D. 404 413 6205 lparmistead@gsu.edu
Contact: Debra Murphy, Ph.D. 310 267-5233 dmurphy@mednet.ucla.edu
United States
 
NCT01922206
MH094233
No
Lisa Armistead, Georgia State University
Georgia State University
University of California, Los Angeles
Principal Investigator: Lisa P Armistead, Ph.D. Georgia State University
Principal Investigator: Debra Murphy, Ph.D. University of California, Los Angeles
Georgia State University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP