We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov 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.
ClinicalTrials.gov Identifier: NCT00723476
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : May 21, 2015
Information provided by (Responsible Party):

July 25, 2008
July 28, 2008
May 21, 2015
September 2005
August 2008   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00723476 on ClinicalTrials.gov Archive Site
Improved congruence about end-of-life care between adolescents and family, using the Statement of Treatment Preferences [ Time Frame: Measured immediately post-treatment ]
Same as current
Not Provided
Not Provided
Family Centered Advanced Care Planning for Adolescents With HIV/AIDS and Their Families
Family Centered Advanced Care Planning (FCACP)
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.

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.

Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
  • 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.
  • 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.
  • Active Comparator: A
    Participants will receive three 60- to 90-minute health education control sessions.
    Intervention: Behavioral: Health education control sessions
  • Experimental: B
    Participants will receive three 60- to 90-minute Family Centered Advanced Care Planning sessions.
    Intervention: Behavioral: Family Centered Advanced Care Planning (FCACP) sessions

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R34MH072541( U.S. NIH Grant/Contract )
R34MH072541 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Maureen Lyon, Children's Research Institute
Maureen Lyon
National Institute of Mental Health (NIMH)
Principal Investigator: Maureen E. Lyon, PhD Children's Research Institute and Children's National Medical Center
Children's Research Institute
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP