COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Family Centered Advanced Care Planning for Adolescents With HIV/AIDS and Their Families

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00723476
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : May 21, 2015
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Maureen Lyon, Children's National Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Family Centered Advanced Care Planning (FCACP) sessions Behavioral: Health education control sessions Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Family Centered Advanced Care Planning (FCACP)
Study Start Date : September 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety HIV/AIDS

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. Improved congruence about end-of-life care between adolescents and family, using the Statement of Treatment Preferences [ Time Frame: Measured immediately post-treatment ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00723476

Layout table for location information
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)
Layout table for investigator information
Principal Investigator: Maureen E. Lyon, PhD Children's Research Institute and Children's National Medical Center
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Maureen Lyon, Clinical Health Psychologist, Children's National Research Institute Identifier: NCT00723476    
Other Study ID Numbers: R34MH072541 ( U.S. NIH Grant/Contract )
R34MH072541 ( U.S. NIH Grant/Contract )
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Keywords provided by Maureen Lyon, Children's National Research Institute:
Quality of Life
Advance Care Planning
Palliative Care
End-of-Life Care
Psychological Adjustment
Additional relevant MeSH terms:
Layout table for 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