Family Centered Advanced Care Planning for Adolescents With HIV/AIDS and Their Families
|HIV Infections||Behavioral: Family Centered Advanced Care Planning (FCACP) sessions Behavioral: Health education control sessions|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Family Centered Advanced Care Planning (FCACP)|
- 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 ]
- Improved congruence about end-of-life care between adolescents and family, using the Statement of Treatment Preferences [ Time Frame: Measured immediately post-treatment ]
|Study Start Date:||September 2005|
|Study Completion Date:||September 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723476
|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|