Parental Permission and Adolescent Assent and Decision-Making in Clinical Research

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00571311
First received: December 11, 2007
Last updated: March 14, 2014
Last verified: January 2014
  Purpose

This study will evaluate how adolescents enrolled in clinical research and their parents:

  • Understood the study information presented before they agreed to participate
  • Made decisions about enrolling in the study
  • Experienced the process of assent and consent
  • Perceive the experience of participating in research

The study will determine how adolescents and their parents evaluate risk and benefit, what information they use in making their research enrollment decisions, and how these decisions are made.

In recent years the medical community and the federal government have increasingly recognized the need to conduct pediatric research. Several initiatives have resulted in an expanding number of studies that include children. With more pediatric research comes the need to ensure that protections for the rights and safety of children enrolled in research are performing well.

Adolescent patients between 13 and 18 years of age who are enrolled in a research study at the NIH involving cancer, diabetes mellitus, vaccines, obesity, bipolar disorder, and HIV, as well as healthy adolescent controls, may be eligible. One parent of each adolescent also participates.

Participants are interviewed at the NIH Clinical Center. Each interview will last about 30 minutes and consists of questions in the following areas:

  • Demographics (age, sex, ethnicity, education, socioeconomic status, etc.)
  • Brief medical history of the adolescent
  • Experience and satisfaction with the parental permission/assent process
  • Motivations for participating in clinical research
  • Decision-making process
  • Willingness to accept certain types and levels of hypothetical risks in a study, including those of side effects and invasive procedures
  • Willingness to enroll with different chances of possible benefit
  • Comparison with other activities
  • General understanding of research...

Condition
Adolescents

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Parental Permission and Adolescent Assent and Decision Making in Clinical Research

Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 294
Study Start Date: December 2007
Detailed Description:

This study aims to better understand how adolescents enrolled in clinical research and their parents understood the study information presented, made decisions about enrolling, experienced the process of assent and consent, and perceive the experience of participating in research. Interviews will be conducted with adolescents participating in clinical research and with one of their parents. Adolescents with a number of disorders, including cancer, chronic diseases, bipolar disorder, obesity, and HIV, as well as healthy controls who are enrolled in NIH intramural protocols, will be interviewed.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Inclusion Criteria- Adolescent:

  1. Age 13 to 18.
  2. Currently enrolled in clinical research.
  3. Physically and cognitively able and willing to participate in a 30-minute interview.
  4. Able to understand and speak English or Spanish.

Inclusion Criteria- Parents:

  1. Parent of an eligible adolescent.
  2. Physically and cognitively able and willing to participate in a 30-minute interview.
  3. Able to understand and speak English or Spanish.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571311

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Christine Grady, M.D. National Institutes of Health Clinical Center (CC)
  More Information