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

May 19, 2015 updated by: Maureen Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measured at Month 3 of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Improved congruence about end-of-life care between adolescents and family, using the Statement of Treatment Preferences
Time Frame: Measured immediately post-treatment
Measured immediately post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maureen Lyon

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Maureen E. Lyon, PhD, Children's Research Institute and Children's National Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (Estimate)

July 28, 2008

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH072541 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Health education control sessions

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe