AdolescentsNCT00571311
Parental Permission and Adolescent Assent and Decision-Making in Clinical Research
An observational study of Adolescents, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Adolescents
- How many people
- 356 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2007to 12 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13 to 18.
- Currently enrolled in clinical research.
- Gave assent to participate in the primary study within the previous 6 months.
- Physically and cognitively able and willing to participate in a 30-minute interview.
- Able to understand and speak English or Spanish.
- Parent of an eligible adolescent
Show all 9Show fewer
- Physically and cognitively able and willing to participate in a 30 minute interview.
- Gave permission for their child to participate in the primary study within the previous 6 months
- Able to understand and speak English or Spanish
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Parental Permission and Adolescent Assent and Decision Making in Clinical Research
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
Read more
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
Read the 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.
- Conditions
- Adolescents
- Keywords
- Assent, Adolescent, Informed Consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study start10 Dec 2007
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christine Grady, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571311
- Sponsor's protocol ID
- 080032
- Other IDs
- 08-CC-0032
- Status last verified
- 12 Mar 2018
- First submitted
- 11 Dec 2007
- Last updated
- 9 Oct 2019
- Results posted
- No
Publications
Burke TM, Abramovitch R, Zlotkin S. Children's understanding of the risks and benefits associated with research. J Med Ethics. 2005 Dec;31(12):715-20. doi: 10.1136/jme.2003.003228.
PubMed 16319237Brody JL, Scherer DG, Annett RD, Pearson-Bish M. Voluntary assent in biomedical research with adolescents: a comparison of parent and adolescent views. Ethics Behav. 2003;13(1):79-95. doi: 10.1207/S15327019EB1301_10.
PubMed 14552306Brody JL, Annett RD, Scherer DG, Perryman ML, Cofrin KM. Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols. J Adolesc Health. 2005 Sep;37(3):229-35. doi: 10.1016/j.jadohealth.2004.09.026.
PubMed 16109343
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Permission and Adolescent Assent and Decision Making in Clinical Research
- ClinicalTrials.gov ID
- NCT00571311
- Acronym / sponsor ID
- 080032
- Conditions
- Adolescents
- Keywords
- Assent, Adolescent, Informed Consent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 10 Dec 2007
- Study completion
- 12 Mar 2018
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age 13 to 18.
- Currently enrolled in clinical research.
- Gave assent to participate in the primary study within the previous 6 months.
- Physically and cognitively able and willing to participate in a 30-minute interview.
- Able to understand and speak English or Spanish.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Background: PubMed 16319237Burke TM, Abramovitch R, Zlotkin S. Children's understanding of the risks and benefits associated with research. J Med Ethics. 2005 Dec;31(12):715-20. doi: 10.1136/jme.2003.003228.
- Background: PubMed 14552306Brody JL, Scherer DG, Annett RD, Pearson-Bish M. Voluntary assent in biomedical research with adolescents: a comparison of parent and adolescent views. Ethics Behav. 2003;13(1):79-95. doi: 10.1207/S15327019EB1301_10.
- Background: PubMed 16109343Brody JL, Annett RD, Scherer DG, Perryman ML, Cofrin KM. Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols. J Adolesc Health. 2005 Sep;37(3):229-35. doi: 10.1016/j.jadohealth.2004.09.026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Grady, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescents, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571311, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.