Quality of LifeNCT01037946
Family to Family: Psychoeducation to Improve Children's Outcomes in HIV+ Families
A study testing Cognitive behavioral sessions in people with Quality of Life and Family Relations, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Family Relations, Mental Health
- What is being tested?
- Cognitive behavioral sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,033 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV+ or family member of HIV+ person
- living with one or more school-age children aged 12-17;
- Informed consent;
- Disclosure of serostatus to at least one family member
Who cannot join
- No school-age children living at home; or
- No disclosure of the serostatus to any family member; or
- Inability to give informed consent or refusal
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- 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.
- 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.
- To compare the intermediate outcomes among those in the intervention and SC condition on disclosure and stigma-related stress.
- 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.
- Conditions
- Quality of Life, Family Relations, Mental Health, Physical Health
- Being tested
- Cognitive behavioral sessions
- Keywords
- HIV, Family interventions, Thailand
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral sessionsBehavioural
Also called Intervention, families living with HIV
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).
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Arm | No intervention | Families living with HIV, offered intervention at the end of study (24 months after recruitment) |
| Intervention | Experimental | 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). Receives: Behavioral: Cognitive behavioral sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: Assessed up to 24 months
Secondary outcomes (1)
Family relations
Measured: Assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startSep 2005
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,033 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Li, University of California, Los Angeles
- Investigators
- Li Li, Ph.D., Principal investigator, University of California, Los AngelesSam Guo, MBA, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037946
- Sponsor's protocol ID
- R01NR009922
- Status last verified
- Jun 2009
- First submitted
- 22 Dec 2009
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family to Family: Psychoeducation to Improve Children's Outcomes in HIV+ Families
- ClinicalTrials.gov ID
- NCT01037946
- Acronym / sponsor ID
- R01NR009922
- Conditions
- Quality of Life, Family Relations, Mental Health, Physical Health
- Keywords
- HIV, Family interventions, Thailand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,033 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 23 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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.
- To compare the intermediate outcomes among those in the intervention and SC condition on disclosure and stigma-related stress.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Arm | No intervention | –Families living with HIV, offered intervention at the end of study (24 months after recruitment) |
| Intervention | Experimental | Behavioral: Cognitive behavioral sessionsBehavioral: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV+ or family member of HIV+ person
- living with one or more school-age children aged 12-17;
- Informed consent;
- Disclosure of serostatus to at least one family member
Key exclusion criteria (3 listed)
- No school-age children living at home; or
- No disclosure of the serostatus to any family member; or
- Inability to give informed consent or refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral sessionsAlso: Intervention, families living with HIVBehavioral: 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). | Behavioural | Intervention |
Primary outcome
Quality of life
Time frame: Assessed up to 24 months
1 secondary outcome
Family relations
Time frame: Assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Li, Ph.D. principal investigator
University of California, Los Angeles
Sam Guo, MBA study director
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral sessions in people with Quality of Life and Family Relations, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: Assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2012.