NCT00723476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

2.9 years

First QC Date

July 25, 2008

Last Update Submit

May 19, 2015

Conditions

HIV Infections

Keywords

Quality of LifeAdolescentAdvance Care PlanningPalliative CareEnd-of-Life CareHIV/AIDSPsychological Adjustment

Outcome Measures

Primary Outcomes (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)

    Measured at Month 3 of follow-up

Secondary Outcomes (1)

  • Improved congruence about end-of-life care between adolescents and family, using the Statement of Treatment Preferences

    Measured immediately post-treatment

Study Arms (2)

A

ACTIVE COMPARATOR

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

Behavioral: Health education control sessions

B

EXPERIMENTAL

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

Behavioral: Family Centered Advanced Care Planning (FCACP) sessions

Interventions

Family Centered Advanced Care Planning (FCACP) sessionsBEHAVIORAL

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.

B
Health education control sessionsBEHAVIORAL

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.

A

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (5)

  • 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.

    PMID: 19327074BACKGROUND

  • 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. doi: 10.2147/hiv.s7507. Epub 2010 Feb 18.

    PMID: 22096382BACKGROUND

  • 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.

    PMID: 22771129BACKGROUND

  • 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.

    PMID: 23104266BACKGROUND

  • 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.

    PMID: 19171571RESULT

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Maureen E. Lyon, PhD

    Children's Research Institute and Children's National Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Health Psychologist

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 28, 2008

Study Start

September 1, 2005

Primary Completion

August 1, 2008

Study Completion

September 1, 2008

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

US(1)