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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH094233 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wait-list Control | No Intervention | Participants in the wait-list control condition will receive a group-based version of the TRACK intervention after their 15-month follow up appointment. | |
| TRACK Intervention | Experimental | 3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRACK Intervention | Behavioral | TRACK Intervention 3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child |
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| Measure | Description | Time Frame |
|---|---|---|
| Disclosure of Maternal HIV status to child | Change in disclosure status between time points 3-, 9-, & 15 month follow ups |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 15- month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Functioning (composite measure) | CES-D, GAD-7, Health-Related Anxiety Questionnaire, Medical Outcomes Study-Health Self-Report, Alcohol and Drug Assessment | 15 month follow-up |
| Family functioning (composite measure) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa P Armistead, Ph.D. | Georgia State University | Principal Investigator |
| Debra Murphy, Ph.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Atlanta | Georgia | 30302 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38661649 | Derived | Marelich WD, Ali B, Murphy DA, Schulte MT, Armistead L. Predictors of serostatus nondisclosure in mothers living with human immunodeficiency virus receiving a disclosure intervention: Analysis of a randomized clinical trial intervention arm. Health Psychol. 2024 Sep;43(9):663-672. doi: 10.1037/hea0001390. Epub 2024 Apr 25. | |
| 33705165 | Derived | Schulte MT, Armistead L, Murphy DA, Marelich W. Multisite longitudinal efficacy trial of a disclosure intervention (TRACK) for HIV+ mothers. J Consult Clin Psychol. 2021 Feb;89(2):81-95. doi: 10.1037/ccp0000622. |
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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.
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Cohesiveness, routines, parent-child communication, parent-child relationship quality
| 15 month follow-up |