Clinical trial NCT01922206: Maternal HIV: Trial to Assist Disclosure to Children
Official title: 2/2-Maternal HIV: Multisite Trial to Assist Disclosure to Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Maternal Disclosure
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: National Institute of Mental Health (NIMH)
First posted: 2013-08-14
Enrollment: 362
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Disclosure of Maternal HIV status to child
timeFrame: Change in disclosure status between time points 3-, 9-, & 15 month follow ups
Secondary outcomes:
measure: Child Mental Health Functioning (Composite measure)
timeFrame: 15- month follow up
Other outcomes:
measure: Maternal Functioning (composite measure)
timeFrame: 15 month follow-up
measure: Family functioning (composite measure)
timeFrame: 15 month follow-up
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Lisa P Armistead, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Debra Murphy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.