Family to Family: Psychoeducation to Improve Children's Outcomes in HIV+ Families
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 22, 2009 | ||||||||
| Last Updated Date | February 22, 2012 | ||||||||
| Start Date ICMJE | September 2005 | ||||||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Quality of life [ Time Frame: Assessed up to 24 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01037946 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Family relations [ Time Frame: Assessed up to 24 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Family to Family: Psychoeducation to Improve Children's Outcomes in HIV+ Families | ||||||||
| Official Title ICMJE | Family to Family: Psychoeducation to Improve Children's Outcomes in HIV+ Families | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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:
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Cognitive behavioral sessions
Behavioral: Cognitive-behavioral, small group format sessions delivered in Thai to People Living with HIV and their caregivers once a week for 13 weeks (n=13 sessions).
Other Name: Intervention, families living with HIV |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 1033 | ||||||||
| Completion Date | May 2010 | ||||||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01037946 | ||||||||
| Other Study ID Numbers ICMJE | R01NR009922 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Li Li, University of California, Los Angeles | ||||||||
| Study Sponsor ICMJE | University of California, Los Angeles | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, Los Angeles | ||||||||
| Verification Date | June 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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