Family Centered Advanced Care Planning for Adolescents With HIV/AIDS and Their Families - Full Text View

Purpose

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.

Condition	Intervention
HIV Infections	Behavioral: Family Centered Advanced Care Planning (FCACP) sessions Behavioral: Health education control sessions


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Family Centered Advanced Care Planning (FCACP)

Resource links provided by NLM:

MedlinePlus related topics: Anxiety HIV/AIDS

U.S. FDA Resources

Further study details as provided by Maureen Lyon, Children's Research Institute:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Improved congruence about end-of-life care between adolescents and family, using the Statement of Treatment Preferences [ Time Frame: Measured immediately post-treatment ]


Enrollment:	82
Study Start Date:	September 2005
Study Completion Date:	September 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Participants will receive three 60- to 90-minute health education control sessions.	Behavioral: Health education control sessions 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.
Experimental: B Participants will receive three 60- to 90-minute Family Centered Advanced Care Planning sessions.	Behavioral: Family Centered Advanced Care Planning (FCACP) sessions 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.

Arms

Assigned Interventions

Active Comparator: A

Participants will receive three 60- to 90-minute health education control sessions.

Behavioral: Health education control sessions

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.

Experimental: B

Participants will receive three 60- to 90-minute Family Centered Advanced Care Planning sessions.

Behavioral: Family Centered Advanced Care Planning (FCACP) sessions

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.

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.

Eligibility


Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723476

Locations


United States, District of Columbia
Children's Research Institute
Washington, District of Columbia, United States, 20010

Sponsors and Collaborators

Maureen Lyon

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Maureen E. Lyon, PhD	Children's Research Institute and Children's National Medical Center

More Information

Publications:

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.

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.

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.

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.

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.


Responsible Party:	Maureen Lyon, Clinical Health Psychologist, Children's Research Institute
ClinicalTrials.gov Identifier:	NCT00723476 History of Changes
Other Study ID Numbers:	R34MH072541 ( US NIH Grant/Contract Award Number )
Study First Received:	July 25, 2008
Last Updated:	May 19, 2015

Keywords provided by Maureen Lyon, Children's Research Institute:


Quality of Life Adolescent Advance Care Planning Palliative Care	End-of-Life Care HIV/AIDS Psychological Adjustment

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on May 25, 2017