An interventional study of TRACK Intervention in HIV, sponsored by Georgia State University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Georgia State University · Not applicable, Interventional, and Supportive care
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:
facilitate disclosure of the mothers' HIV status to the children, which will include secondary aims of:
Georgia State University is the lead sponsor of 52 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the wait-list control condition will receive a group-based version of the TRACK intervention after their 15-month follow up appointment.
3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child
Behavioral: TRACK Intervention
TRACK Intervention 3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child
Disclosure of Maternal HIV status to child
Time frame: Change in disclosure status between time points 3-, 9-, & 15 month follow ups
Child Mental Health Functioning (Composite measure)
Self and Caregiver reported indicators, including the Child Depression Inventory, Piers-Harris Children's Self-Concept Scale, Penn State Worry Questionnaire
Time frame: 15- month follow up
Maternal Functioning (composite measure)
CES-D, GAD-7, Health-Related Anxiety Questionnaire, Medical Outcomes Study-Health Self-Report, Alcohol and Drug Assessment
Time frame: 15 month follow-up
Family functioning (composite measure)
Cohesiveness, routines, parent-child communication, parent-child relationship quality
Time frame: 15 month follow-up
Plan to share: Yes — Data sharing protocols for the longitudinal data from 220 young children and 220 mothers will be in accordance with NIH Notice of Amendment to A-110, consistent with IRB-approved consent restrictions, and follow Inter-University Consortium for Political and Social Research guidelines for data preparation. Data will be stripped of identifiers and available under signed agreement for: (1) using data only for research; (2) securing date using appropriate technology; and (3) destroying or returning data after analyses. Notice of available data will be on both centers' websites, with data use restrictions.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Georgia State University