Quality of Life Clinical Trial
Official title:
Family to Family: Psychoeducation to Improve Children's Outcomes in HIV+ Families
This project aims to support adults in HIV-affected families in order to improve their
well-being. UCLA's Center for Community Health (CCH), in collaboration with the Thai
Ministry of Public Health, Bureau of Epidemiology, will implement the Family-to-Family (F2F)
intervention in order to improve the social, behavioral and mental health outcomes for
families affected by HIV.
In Phase 1, the investigators pilot tested the current intervention contents and activities
by collecting qualitative data from HIV+ families in the four district hospitals in Chiang
Rai and Nakohn Ratchasima provinces selected for the proposed study. The findings from Phase
was used to develop intervention content, as well as the format and style of the
intervention for Phase 2. In addition, the findings from Phase 1 was used to finalize the
assessment measures the investigators will use in Phase 2.
In Phase 2, 410 families with HIV+ parents from 4 district hospitals in Chiang Rai & Nakhon
Ratchasima Provinces will be recruited to an intervention to benefit their school-aged
children aged 6-17 years. At their clinical care site,the investigators randomly assigned
families to either: 1) F2F, a psychoeducational intervention for HIV+ parents and family
caregivers; or 2) a Standard Care condition. The impact of the F2F intervention will be
monitored over 24 months.
HIV has a negative intergenerational impact on families, particularly children with HIV+
parents. In order to improve the social, behavioral and mental health outcomes for families
affected by HIV, we have designed the Family-to-Family (F2F) intervention that includes the
critical, universal, program components identified by the NIMH Intervention Workgroup. All
efficacious intervention programs: frame the problem by providing information and shaping
beliefs; enhance skills; establish supportive relationships; and remove environmental
barriers to behavior change (e.g., HIV testing, ARV). We aim to evaluate a generic
intervention approach including these components that is culturally-tailored to families
affected by HIV in a specific country, Thailand.
Families in Thailand need such an intervention: 1 in 4 elderly adults in Thailand will raise
an AIDS orphan, even with a relatively low national seroprevalence rate (1.2%, I million
adults). Thailand has a rising seroincidence. This research will design and evaluate an
intervention for improving the long-term adjustment of families with HIV. We will intervene
with HIV+ parents and family caregivers to improve the outcomes for families living with
HIV.
The Specific Aims for the proposed study are:
1. To compare the outcomes over time of the school-age children of families in the
intervention and SC conditions in each of the following domains: a) mental health
symptoms; b) behavioral adjustment, and c) relationships with HIV+ parents, caregivers,
and peers.
2. As intermediate outcomes, to compare the outcomes over time of the HIV+ parent in the
intervention and the SC condition in terms of: health status; HIV transmission acts;
parenting behaviors and bonds with children; and mental health symptoms.
3. As intermediate outcomes, to compare the outcomes over time of the partners and
caregivers (about 80% grandparents) in the intervention and the SC condition in terms
of: health status; mental health symptoms; caregiver burden; relationships with their
HIV+ adult children, their school-age grandchildren, and bonds.
4. To compare the intermediate outcomes among those in the intervention and SC condition
on disclosure and stigma-related stress.
5. To compare the influence of background factors on the impact of the intervention over
time: age and gender of the HIV+ parent, the school-age child's age and gender,
physical proximity in the living situation of the HIV+ parents and family caregivers,
mode of initial transmission for acquisition of HIV (IDU, sexual acts), income and
initial quality of relationships.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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