HIV Infections Clinical Trial
Official title:
Family Centered Advanced Care Planning (FCACP)
Verified date | May 2015 |
Source | Children's Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | September 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
Inclusion Criteria: 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) - 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 Exclusion Criteria For All Participants: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Research Institute | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Maureen Lyon | National Institute of Mental Health (NIMH) |
United States,
Garvie 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. — View Citation
Lyon 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. — View Citation
Lyon 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. Epub 2010 Feb 18. — View Citation
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. — View Citation
Lyon 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 at Month 3 of follow-up | No | |
Secondary | Improved congruence about end-of-life care between adolescents and family, using the Statement of Treatment Preferences | Measured immediately post-treatment | No |
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