- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01922206
Maternal HIV: Trial to Assist Disclosure to Children (TRACK II)
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:
facilitate disclosure of the mothers' HIV status to the children, which will include secondary aims of:
- increasing mothers' self-efficacy to disclose and respond to child questions regarding HIV;
- reducing mothers' fears regarding disclosure and stigma;
- improving maternal knowledge of child development and how to provide appropriate levels of information given the age of the child;
- improve MLH mental health indicators over time (i.e., depression, anxiety, quality of life);
- improve child mental health indicators over time (i.e., depression, anxiety, acting out behaviors); and
- improve family functioning indicators (e.g., cohesion, perceived closeness between mother and child).
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30302
- Georgia State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Wait-list Control
Participants in the wait-list control condition will receive a group-based version of the TRACK intervention after their 15-month follow up appointment.
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Experimental: TRACK Intervention
3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child
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TRACK Intervention 3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disclosure of Maternal HIV status to child
Time Frame: Change in disclosure status between time points 3-, 9-, & 15 month follow ups
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Change in disclosure status between time points 3-, 9-, & 15 month follow ups
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
15- month follow up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Functioning (composite measure)
Time Frame: 15 month follow-up
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CES-D, GAD-7, Health-Related Anxiety Questionnaire, Medical Outcomes Study-Health Self-Report, Alcohol and Drug Assessment
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15 month follow-up
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Family functioning (composite measure)
Time Frame: 15 month follow-up
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Cohesiveness, routines, parent-child communication, parent-child relationship quality
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15 month follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa P Armistead, Ph.D., Georgia State University
- Principal Investigator: Debra Murphy, Ph.D., University of California, Los Angeles
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MH094233
- 1R01MH094233 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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