HIV InfectionsNCT00723476
Family Centered Advanced Care Planning for Adolescents With HIV/AIDS and Their Families
A study testing Family Centered Advanced Care Planning (FCACP) sessions in people with HIV Infections, run by Maureen Lyon at 1 site in United States.
Trial summary
This study will examine the efficacy of Family Centered Advance Care Planning in enhancing quality of life, integrating effective end-of-life care, and preventing depression and anxiety among HIV infected adolescents and their family members. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Family Centered Advanced Care Planning (FCACP) sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Sep 2008
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adolescent Eligibility Criteria:
- Diagnosed with HIV/AIDS
- Between the ages of 14 and 21 years
- Aware of his or her HIV status
- Able to speak English
- Intelligence Quotient (IQ) greater than 69 (all patients have IQ testing results in chart as part of standard of care)
Show all 20Show fewer
- Consent from the legal guardian if between ages of 14 and 17
- Consent from the surrogate if between ages of 18 and 21
- Assent from adolescent aged 14 to 17
- Consent from adolescent aged 18 to 21
- Legal Guardian Eligibility Criteria (for guardians of adolescents aged 14 to 17):
- Adolescent is willing to discuss problems related to HIV with him/her
- Age 21 or older
- Able to speak English
- Legal guardian
- Surrogate Eligibility Criteria:
- Selected by adolescent aged 18 to 21
- Age 21 or older
- Willing to discuss problems related to HIV and EOL
- Able to speak English
Who cannot join
- Depression in the moderate to severe range on Beck Depression Inventory
- Unaware of HIV status of self, or if proxy, of adolescent
- Presence of HIV dementia, determined at screening using the HIV Dementia Scale
- Active homicidality or suicidality, determined at baseline screening by psychologist or researcher
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Family Centered Advanced Care Planning (FCACP)
This study will examine the efficacy of Family Centered Advance Care Planning in enhancing quality of life, integrating effective end-of-life care, and preventing depression and anxiety among HIV infected adolescents and their family members.
Read the detailed description
More than 30,000 adolescents in the United States die annually from the effects of chronic illnesses. The anxiety from facing a terminal illness often hinders adolescents in making decisions about their own end-of-life (EOL) care. Although minors' preferences are not legally binding, legislature, research, and professional guidelines all recommend that adolescent patients become involved in EOL decisions as part of routine intervention while they are stable. Family Centered Advance Care Planning (FCACP) is an intervention that facilitates EOL discussion among adolescents, their families, and their care providers. This pilot study will examine FCACP's effects on adaptive coping, psychological adjustment, quality of life, and plans and actions in HIV infected adolescents. The study will also provide feedback used for improving the FCACP Web site.
This study will include HIV or AIDS infected adolescents ranging in age from 14 to 21 who will jointly enroll with a selected surrogate older than 21. The adolescent/surrogate pairs will be randomly assigned to receive either the FCACP intervention or a health education control intervention. Pairs not immediately ready to participate will form an observational group. Pairs in the FCACP group will meet with a trained facilitator weekly for a 60- to 90-minute session for a total of 3 weeks. During the first session, participants will take the Lyon Advance Care Planning Survey. The second session will consist of the Respecting Choices Interview, where patients will discuss treatment preferences. The Family Problem-Solving session will be last, culminating with the patient's completion of an advance directive. The control groups will follow the same meeting schedule, but will receive health education sessions, not FCACP sessions. Standardized self-report measures will be administered upon entry, after completion of the sessions, and at a 3-month follow up. Usage data will also be analyzed regarding feasibility and acceptability of FCACP as a standard treatment.
- Conditions
- HIV Infections
- Being tested
- Family Centered Advanced Care Planning (FCACP) sessions, Health education control sessions
- Keywords
- Quality of Life, Adolescent, Advance Care Planning, Palliative Care, End-of-Life Care, HIV/AIDS, Psychological Adjustment
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Centered Advanced Care Planning (FCACP) sessionsBehavioural
FCACP will include three 60- to 90-minute weekly sessions. Sessions consisting of structured conversations with HIV infected adolescents, their proxies, and trained facilitators will aim to enhance quality of life by integrating effective end-of-life (EOL) care and minimizing depression and anxiety. The three sessions will consist of a structured EOL survey, an FCACP interview, and a family problem-solving lesson.
Health education control sessionsBehavioural
Health education control sessions will include three 60- to 90-minute sessions and will involve adolescents with HIV/AIDS and their proxies. Topics covered during sessions will include developmental history, planning for the future, and safety tips.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Participants will receive three 60- to 90-minute health education control sessions. Receives: Behavioral: Health education control sessions |
| B | Experimental | Participants will receive three 60- to 90-minute Family Centered Advanced Care Planning sessions. Receives: Behavioral: Family Centered Advanced Care Planning (FCACP) sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved mental health outcomes (e.g., decreased anxiety, depression), improved quality of life, and improved plans and actions (e.g., communication with primary health care provider, an advanced directive in the medical chart)
Measured: Measured at Month 3 of follow-up
Secondary outcomes (1)
Improved congruence about end-of-life care between adolescents and family, using the Statement of Treatment Preferences
Measured: Measured immediately post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startSep 2005
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maureen Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Maureen Lyon, Children's National Research Institute
- Investigators
- Maureen E. Lyon, PhD, Principal investigator, Children's Research Institute and Children's National Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723476
- Sponsor's protocol ID
- R34MH072541
- Other IDs
- R34MH072541
- Status last verified
- May 2015
- First submitted
- 25 Jul 2008
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lyon ME, Garvie PA, Briggs L, He J, McCarter R, D'Angelo LJ. Development, feasibility, and acceptability of the Family/Adolescent-Centered (FACE) Advance Care Planning intervention for adolescents with HIV. J Palliat Med. 2009 Apr;12(4):363-72. doi: 10.1089/jpm.2008.0261.
PubMed 19327074Lyon ME, Garvie PA, Briggs L, He J, Malow R, D'Angelo LJ, McCarter R. Is it safe? Talking to teens with HIV/AIDS about death and dying: a 3-month evaluation of Family Centered Advance Care (FACE) planning - anxiety, depression, quality of life. HIV AIDS (Auckl). 2010;2:27-37. doi: 10.2147/hiv.s7507. Epub 2010 Feb 18.
PubMed 22096382Garvie PA, He J, Wang J, D'Angelo LJ, Lyon ME. An exploratory survey of end-of-life attitudes, beliefs, and experiences of adolescents with HIV/AIDS and their families. J Pain Symptom Manage. 2012 Sep;44(3):373-85.e29. doi: 10.1016/j.jpainsymman.2011.09.022. Epub 2012 Jul 7.
PubMed 22771129Lyon ME, Garvie P, He J, Malow R, McCarter R, D'Angelo LJ. Spiritual well-being among HIV-infected adolescents and their families. J Relig Health. 2014 Jun;53(3):637-53. doi: 10.1007/s10943-012-9657-y.
PubMed 23104266Lyon ME, Garvie PA, McCarter R, Briggs L, He J, D'Angelo LJ. Who will speak for me? Improving end-of-life decision-making for adolescents with HIV and their families. Pediatrics. 2009 Feb;123(2):e199-206. doi: 10.1542/peds.2008-2379.
PubMed 19171571
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Centered Advanced Care Planning (FCACP)
- ClinicalTrials.gov ID
- NCT00723476
- Acronym / sponsor ID
- R34MH072541
- Conditions
- HIV Infections
- Keywords
- Quality of Life, Adolescent, Advance Care Planning, Palliative Care, End-of-Life Care, HIV/AIDS, Psychological Adjustment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Maureen LyonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 28 Jul 2008 (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 study will examine the efficacy of Family Centered Advance Care Planning in enhancing quality of life, integrating effective end-of-life care, and preventing depression and anxiety among HIV infected adolescents and their family members.
Detailed description
More than 30,000 adolescents in the United States die annually from the effects of chronic illnesses. The anxiety from facing a terminal illness often hinders adolescents in making decisions about their own end-of-life (EOL) care. Although minors' preferences are not legally binding, legislature, research, and professional guidelines all recommend that adolescent patients become involved in EOL decisions as part of routine intervention while they are stable. Family Centered Advance Care Planning (FCACP) is an intervention that facilitates EOL discussion among adolescents, their families, and their care providers. This pilot study will examine FCACP's effects on adaptive coping, psychological adjustment, quality of life, and plans and actions in HIV infected adolescents. The study will also provide feedback used for improving the FCACP Web site.
This study will include HIV or AIDS infected adolescents ranging in age from 14 to 21 who will jointly enroll with a selected surrogate older than 21. The adolescent/surrogate pairs will be randomly assigned to receive either the FCACP intervention or a health education control intervention. Pairs not immediately ready to participate will form an observational group. Pairs in the FCACP group will meet with a trained facilitator weekly for a 60- to 90-minute session for a total of 3 weeks. During the first session, participants will take the Lyon Advance Care Planning Survey. The second session will consist of the Respecting Choices Interview, where patients will discuss treatment preferences. The Family Problem-Solving session will be last, culminating with the patient's completion of an advance directive. The control groups will follow the same meeting schedule, but will receive health education sessions, not FCACP sessions. Standardized self-report measures will be administered upon entry, after completion of the sessions, and at a 3-month follow up. Usage data will also be analyzed regarding feasibility and acceptability of FCACP as a standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: Health education control sessionsParticipants will receive three 60- to 90-minute health education control sessions. |
| B | Experimental | Behavioral: Family Centered Advanced Care Planning (FCACP) sessionsParticipants will receive three 60- to 90-minute Family Centered Advanced Care Planning sessions. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Diagnosed with HIV/AIDS
- Between the ages of 14 and 21 years
- Aware of his or her HIV status
- Able to speak English
- Intelligence Quotient (IQ) greater than 69 (all patients have IQ testing results in chart as part of standard of care)
Key exclusion criteria (4 listed)
- Depression in the moderate to severe range on Beck Depression Inventory
- Unaware of HIV status of self, or if proxy, of adolescent
- Presence of HIV dementia, determined at screening using the HIV Dementia Scale
- Active homicidality or suicidality, determined at baseline screening by psychologist or researcher
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 |
|---|---|---|
| Family Centered Advanced Care Planning (FCACP) sessionsFCACP will include three 60- to 90-minute weekly sessions. Sessions consisting of structured conversations with HIV infected adolescents, their proxies, and trained facilitators will aim to enhance quality of life by integrating effective end-of-life (EOL) care and minimizing depression and anxiety. The three sessions will consist of a structured EOL survey, an FCACP interview, and a family problem-solving lesson. | Behavioural | B |
| Health education control sessionsHealth education control sessions will include three 60- to 90-minute sessions and will involve adolescents with HIV/AIDS and their proxies. Topics covered during sessions will include developmental history, planning for the future, and safety tips. | Behavioural | A |
Primary outcome
Improved mental health outcomes (e.g., decreased anxiety, depression), improved quality of life, and improved plans and actions (e.g., communication with primary health care provider, an advanced directive in the medical chart)
Time frame: Measured at Month 3 of follow-up
1 secondary outcome
Improved congruence about end-of-life care between adolescents and family, using the Statement of Treatment Preferences
Time frame: Measured immediately post-treatment
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 21 May 2015.
- Background: PubMed 19327074Lyon ME, Garvie PA, Briggs L, He J, McCarter R, D'Angelo LJ. Development, feasibility, and acceptability of the Family/Adolescent-Centered (FACE) Advance Care Planning intervention for adolescents with HIV. J Palliat Med. 2009 Apr;12(4):363-72. doi: 10.1089/jpm.2008.0261.
- Background: PubMed 22096382Lyon ME, Garvie PA, Briggs L, He J, Malow R, D'Angelo LJ, McCarter R. Is it safe? Talking to teens with HIV/AIDS about death and dying: a 3-month evaluation of Family Centered Advance Care (FACE) planning - anxiety, depression, quality of life. HIV AIDS (Auckl). 2010;2:27-37. doi: 10.2147/hiv.s7507. Epub 2010 Feb 18.
- Background: PubMed 22771129Garvie PA, He J, Wang J, D'Angelo LJ, Lyon ME. An exploratory survey of end-of-life attitudes, beliefs, and experiences of adolescents with HIV/AIDS and their families. J Pain Symptom Manage. 2012 Sep;44(3):373-85.e29. doi: 10.1016/j.jpainsymman.2011.09.022. Epub 2012 Jul 7.
- Background: PubMed 23104266Lyon ME, Garvie P, He J, Malow R, McCarter R, D'Angelo LJ. Spiritual well-being among HIV-infected adolescents and their families. J Relig Health. 2014 Jun;53(3):637-53. doi: 10.1007/s10943-012-9657-y.
- Results publication: PubMed 19171571Lyon ME, Garvie PA, McCarter R, Briggs L, He J, D'Angelo LJ. Who will speak for me? Improving end-of-life decision-making for adolescents with HIV and their families. Pediatrics. 2009 Feb;123(2):e199-206. doi: 10.1542/peds.2008-2379.
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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.
Maureen E. Lyon, PhD principal investigator
Children's Research Institute and Children's National Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Centered Advanced Care Planning (FCACP) sessions in people with HIV Infections, run by Maureen Lyon 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 20 inclusion and 4 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 21 May 2015. 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?
Improved mental health outcomes (e.g., decreased anxiety, depression), improved quality of life, and improved plans and actions (e.g., communication with primary health care provider, an advanced directive in the medical chart) (time frame: Measured at Month 3 of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00723476, which also lists 5 linked publications.
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 21 May 2015.