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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00723476 |
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 |
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HIV Infections |
Behavioral: Family Centered Advanced Care Planning (FCACP) sessions Behavioral: Health education control sessions |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Family Centered Advanced Care Planning (FCACP) |
Estimated Enrollment: | 100 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Participants will receive three 60- to 90-minute health education control sessions.
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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.
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B: Experimental
Participants will receive three 60- to 90-minute Family Centered Advanced Care Planning sessions.
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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.
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Over 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 over age 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.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Adolescent Eligibility Criteria:
Legal Guardian Eligibility Criteria (for guardians of adolescents aged 14 to 17):
Surrogate Eligibility Criteria:
Exclusion Criteria For All Participants:
United States, District of Columbia | |
Children's Research Institute | |
Washington, District of Columbia, United States, 20010 |
Principal Investigator: | Maureen E. Lyon, PhD | Children's Research Institute and Children's National Medical Center |
Responsible Party: | Children's Research Institute and Children's National Medical Center ( Maureen E. Lyon, PhD ) |
Study ID Numbers: | R34 MH072541, DAHBR 9A-ASPA |
Study First Received: | July 25, 2008 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00723476 |
Health Authority: | United States: Federal Government |
Quality of Life Adolescent Advance Care Planning Palliative Care |
End-of-Life Care HIV/AIDS Psychological Adjustment |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Quality of Life Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |