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NSDUH Main Study Pretest_PDF 2_Attachments D E.pdf

National Survey on Drug Use and Health: Methodological Field Tests

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OMB: 0930-0290

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NSDUH Main Study Pretest
Attachment D – Parental Permission Forms

Parental Permission and Informed Consent
The National Survey on Drug Use and Health (NSDUH) is a large survey given to about 70,000
people across the country every year. RTI International conducts the NSDUH. It collects
information on many health-related issues. Right now, we’re testing some new questions about
experiences with and attitudes towards e-cigarettes, alcohol, drugs as well as experiences with,
sleep and mental health to learn how well people understand these questions and how they might
go about answering them. We are under contract with the Substance Abuse and Mental Health
Services Administration to carry out this survey. You or your child responded to an
advertisement that we placed for research subjects. At present, we are seeking the help of young
people like your child to see how our new questions work.
Your child is one of approximately 75 adolescent respondents in Research Triangle Park, NC;
Baltimore, MD; Chicago, IL; Washington, DC; Lincoln, NE; Portland, OR; Houston, TX;
Miami, FL; and Southern California who are participating in this study. Taking part in the
interview is strictly voluntary. Your child can skip any portion of the interview he/she does not
wish to be involved with. There is no penalty if he/she chooses to skip any part of the interview.
The interview will be conducted in private to ensure nobody else overhears his/her answers. All
answers will be kept private and confidential. We will not share the information given to us with
any person outside of necessary project staff, and your child's name will never be connected to
the answers he/she provides. Federal law requires us to keep your child’s answers confidential
and to use his/her answers only for statistical purposes (the Confidential Information Protection
and Statistical Efficiency Act of 2002). The only exception to this promise of confidentiality is if
your child tells me that (he/she) intends to seriously harm him/herself or someone else or if
(he/she) tells me (he/she) has been abused, or if your child identifies a person who has given
(him/her) drugs. In this situation I may need to notify a mental health professional or other
authorities.
The interview will take about one hour. During the interview, your child will be asked survey
questions about experiences with and attitudes towards tobacco, e-cigarettes, alcohol, and drugs.
Survey questions may also be asked about your child’s experiences with alcohol, drug or mental
health treatment; experiences with the criminal justice system; their health, including sleep; and
their mental health, including suicide. In addition to these questions, we will ask follow-up items
about the survey questions to determine how your child decided on an answer for these questions
and if they were clear and easy for your child to understand. For example, we may ask your child
to repeat the question in his or her own words.
(He/She) will receive $40 in cash in appreciation for the interview.
We would like to audio and screen record the interactions between your child, the interviewer,
and the computer. This means we will record your child’s spoken answers to the questions and
what was on the computer screen. The recording will not include any images of your child. The
recording will be seen only by members of the research team to help us make sure we have all
the information from your child about how these questions work. To protect (his/her) privacy,
the recording will be protected by a password. The recording will be destroyed soon after the
study ends. However, having the interactions recorded is voluntary and you can decline for your
child.

[Read only if observer is present: Members of the RTI research team or representatives of
SAMHSA are here with us today and would like to observe this interview. If you do not want
anyone else to observe your interview, we will simply ask these people to leave and then do the
interview.]
[Read only if planning for remote-observation: We would like to be able to use screen & audio
sharing to allow members of the RTI research team or representatives of SAMHSA to observe
the interview remotely. The observers will only be able to listen to the interview and see what is
displayed on the computer screen. However, remote observation is voluntary and you can decline
for your child.]
If you have any questions about this study, you can contact Emily Geisen at RTI at 1-800-3348571 X. 26566). If you have any questions about your rights as a parent or legal guardian or your
child's rights as a study participant, you can call RTI's Office of Research Protection at 1-866214-2043 (a toll-free number).
Do we have your permission for [CHILD’S NAME] to participate?
As Parent/Guardian, I give my permission for my child to participate in this interview.
____Yes

____No

As Parent/Guardian, I give my permission for my child’s interview to be recorded:
____Yes

____No

Read only if remote or in-person observer is present: As Parent/Guardian, I give my permission
for members of the RTI research team or representative of SAMHSA to observe the interview:
____Yes

____No

I will sign my name here to indicate that I have explained this information to you and that you
have agreed for your child to be interviewed.
Signature of Interviewer: ______________________________

Date: __________________
NOTICE: Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to SAMHSA
Reports Clearance Officer, Paperwork Reduction Project (0930-0290), Center for Behavioral Health Statistics and Quality; Room 15E57B; 5600 Fishers
Lane, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The OMB control number for this project is 0930-0290, expiration date 5/31/20.

Parental Permission and Informed Consent (Vaping/Sleep)
The National Survey on Drug Use and Health (NSDUH) is a large survey given to about 70,000
people across the country every year. RTI International conducts the NSDUH. It collects
information on many health-related issues. Right now, we’re testing some new questions about
experiences with and attitudes towards e-cigarettes, alcohol, drugs as well as experiences with,
sleep and mental health to learn how well people understand these questions and how they might
go about answering them. We are under contract with the Substance Abuse and Mental Health
Services Administration to carry out this survey. You or your child responded to an
advertisement that we placed for research subjects. At present, we are seeking the help of young
people like your child to see how our new questions work.
Your child is one of approximately 75 adolescent respondents in Research Triangle Park, NC;
Baltimore, MD; Chicago, IL; Washington, DC; Lincoln, NE; Portland, OR; Houston, TX;
Miami, FL; and Southern California who are participating in this study. Taking part in the
interview is strictly voluntary. Your child can skip any portion of the interview he/she does not
wish to be involved with. There is no penalty if he/she chooses to skip any part of the interview.
The interview will be conducted in private to ensure nobody else overhears his/her answers. All
answers will be kept private and confidential. We will not share the information given to us with
any person outside of necessary project staff, and your child's name will never be connected to
the answers he/she provides. Federal law requires us to keep your child’s answers confidential
and to use his/her answers only for statistical purposes (the Confidential Information Protection
and Statistical Efficiency Act of 2002). The only exception to this promise of confidentiality is if
your child tells me that (he/she) intends to seriously harm him/herself or someone else or if
(he/she) tells me (he/she) has been abused, or if your child identifies a person who has given
(him/her) drugs. In this situation I may need to notify a mental health professional or other
authorities.
The interview will take about one hour. During the interview, your child will be asked survey
questions about experiences with and attitudes towards tobacco and e-cigarettes. It may also ask
about your child’s experiences with sleep. In addition to these questions, we will ask follow-up
items about the survey questions to determine how your child decided on an answer for these
questions and if they were clear and easy for your child to understand. For example, we may ask
your child to repeat the question in his or her own words.
(He/She) will receive $40 in cash in appreciation for the interview.
We would like to audio and screen record the interactions between your child, the interviewer,
and the computer. This means we will record your child’s spoken answers to the questions and
what was on the computer screen. The recording will not include any images of your child. The
recording will be seen only by members of the research team to help us make sure we have all
the information from your child about how these questions work. To protect (his/her) privacy,
the recording will be protected by a password. The recording will be destroyed soon after the
study ends. However, having the interactions recorded is voluntary and you can decline for your
child.
[Read only if observer is present: Members of the RTI research team or representatives of
SAMHSA are here with us today and would like to observe this interview. If you do not want

anyone else to observe your interview, we will simply ask these people to leave and then do the
interview.]
[Read only if planning for remote-observation: We would like to be able to use screen & audio
sharing to allow members of the RTI research team or representatives of SAMHSA to observe
the interview remotely. The observers will only be able to listen to the interview and see what is
displayed on the computer screen. However, remote observation is voluntary and you can decline
for your child.]
If you have any questions about this study, you can contact Emily Geisen at RTI at 1-800-3348571 X. 26566). If you have any questions about your rights as a parent or legal guardian or your
child's rights as a study participant, you can call RTI's Office of Research Protection at 1-866214-2043 (a toll-free number).
Do we have your permission for [CHILD’S NAME] to participate?
As Parent/Guardian, I give my permission for my child to participate in this interview.
____Yes

____No

As Parent/Guardian, I give my permission for my child’s interview to be recorded:
____Yes

____No

Read only if remote or in-person observer is present: As Parent/Guardian, I give my permission
for members of the RTI research team or representative of SAMHSA to observe the interview:
____Yes

____No

I will sign my name here to indicate that I have explained this information to you and that you
have agreed for your child to be interviewed.
Signature of Interviewer: ______________________________

Date: __________________
NOTICE: Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to SAMHSA
Reports Clearance Officer, Paperwork Reduction Project (0930-0290), Center for Behavioral Health Statistics and Quality; Room 15E57B; 5600 Fishers
Lane, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The OMB control number for this project is 0930-0290, expiration date 5/31/20.

NSDUH Main Study Pretest
Attachment E – Participant Informed
Consent/Assent Forms

NSDUH Main Study Pretest
Adult Cognitive Interview Participant Informed Consent Form
National Survey on Drug Use and Health (NSDUH)
Introduction
I am going to explain this study to you. You can stop me at any time if you have questions about anything I tell
you.
The purpose of this study is to test some questions that will be used in the National Survey on Drug Use and
Health, or NSDUH. The NSDUH is a large survey given to about 70,000 people across the country each year. It
collects information on many health-related issues. Right now, we're interested in evaluating some questions
about your experience with past drug and alcohol use. We want to see how well people understand these
questions and how they might go about answering them. RTI is carrying out this research study for the
Substance Abuse and Mental Health Services Administration, or SAMHSA, which is part of the US
Department of Health and Human Services. You are one of approximately 150 participants at least 12 years old
who will review the survey questions for this study.
Description of the Interview
Your participation in this interview will involve answering questions about your experiences with and attitudes
towards e-cigarettes, alcohol, drugs. It will ask about your experiences with your health including experiences
with chronic pain, your sleep and your mental health. In addition to answering these questions, I will ask you
follow-up questions to determine how you decided on an answer for these survey questions and if they were
clear and easy for you to understand. For some questions, I may ask you to put the questions in your own words.
The interview will last approximately 60 minutes. Your participation in this study will end after you finish the
interview.
We also would like to audio and screen record what you say and see during the interview. A screen recording
records what is on the computer screen while you answer questions. It does not record your face. Only the
people who work on this study will view the recording. It will help us make sure we have understood your
answers. If you don't want us to audio or screen record you, that's okay.
Confidentiality/Your Rights
Taking part in the interview is completely voluntary. You can skip any interview questions you do not wish to
answer. Your personal information will not be connected to your answers in any way. Federal law requires us to
keep your answers confidential and to use these answers only for statistical purposes (the Confidential
Information Protection and Statistical Efficiency Act of 2002).
[Read only if observer is present: Members of the RTI research team or representatives of SAMHSA are here
with us today and would like to observe this interview. If you do not want anyone else to observe your
interview, we will simply ask these people to leave and then we’ll do the interview after they’ve left.]
[Read only if planning for remote-observation: We would like to be able to use screen & audio sharing to
allow members of the RTI research team or representatives of SAMHSA to observe the interview remotely.
However, remote observation is voluntary and you can decline.]

1

Possible Risks and Benefits
You can ask me to stop the interview at any time. If you want to take a break at any time during the interview,
please tell me. It is possible some of the survey questions may make you feel uncomfortable or upset. If this
happens, I can tell you how to contact a counselor.
There are no direct benefits to you from participating in this interview. However, the answers you give will help
us to improve the quality of questions for the NSDUH.
Payment for Participation
You will be given $40 in cash for completing the interview.
Your Questions
If you have any other questions about the study, you can call Ms. Emily Geisen at 1-800-334-8571 ext. 26566.
If you have any questions about your rights as a study participant, you can call RTI's Office of Research
Protection at 1-866-214-2043 (a toll-free number).

Do we have your permission to participate in this interview?
____Yes

____No

I give my permission for the interview to be recorded:
____Yes

____No

Read only if remote or in-person observer is present: I give my permission for members of the RTI research
team or representative of SAMHSA to observe the interview:
____Yes

____No

I will sign my name here to indicate that I have explained this information to you and that you have agreed to be
interviewed.

___________________________
Signature of Interviewer

_________________________
Date

NOTICE: Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or
any other aspect of this collection of information, including suggestions for reducing this burden, to SAMHSA Reports Clearance Officer, Paperwork Reduction Project (09300290), Center for Behavioral Health Statistics and Quality; Room 15E57B; 5600 Fishers Lane, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0290, expiration
date 5/31/20.

2

Participant Informed Assent (ADOLESCENT)
Introduction
I am going to explain this study to you. You can stop me at any time if you have questions about anything I tell
you.
The purpose of this study is to test some questions that will be used in the National Survey on Drug Use and
Health, or NSDUH. The NSDUH is a large survey given to about 70,000 people across the country each year. It
collects information on many health-related issues. We're interested in evaluating some questions about your
experience with past drug and alcohol use. We want to see how well people understand these questions. We also
want to know how people go about answering the questions. RTI is doing this study for the Substance Abuse
and Mental Health Services Administration, or SAMHSA. You are one of 75 participants between the ages of
12 to 17 who will help us test these questions.
Description of the Interview
Your participation in this interview will involve answering questions about your experiences with and attitudes
towards tobacco, e-cigarettes, alcohol, and drugs. You may also be asked about your experiences with alcohol,
drug or mental health treatment; experiences with the criminal justice system; your health, including sleep; and
your mental health, including suicide and self-harm.. In addition to answering these questions, I will ask you
follow up questions to determine how you decided on an answer for these survey questions and if they were
clear and easy for you to understand. For some questions, I may ask you to put the questions in your own words.
The interview will last approximately 60 minutes. Your participation in this study will end after you finish the
interview.
We also would like to audio and screen record what you say and see during the interview. A screen recording
records what is on the computer screen while you answer questions. It does not record your face. Only the
people who work on this study will view the recording. It will help us make sure we have understood your
answers. If you don't want us to audio or screen record you, that's okay.
Confidentiality/Your Rights
You don't have to answer a question if you don't want to. If you want to take a break at any time, just tell me.
Your name will be kept private. No one else will see your answers to these questions. Your parents will not
find out about your answers to questions. The only exceptions to this promise of confidentiality are if you tell
me that you intend to seriously harm yourself or someone else or if you have been abused or if you identify an
adult who has given you drugs; in these situations I may need to notify a mental health professional or other
authorities.
[Read only if observer is present: Members of the RTI research team or representatives of SAMHSA are here
with us today and would like to observe this interview. If you do not want anyone else to observe your
interview, we will simply ask these people to leave and then we’ll do the interview after they’ve left.]
[Read only if planning for remote-observation: We would like to be able to use screen & audio sharing to
allow members of the RTI research team or representatives of SAMHSA to observe the interview remotely.
However, remote observation is voluntary and you can decline.]

Possible Risks and Benefits
Some of the questions we ask may make you feel uncomfortable or upset. If this happens, let me know right
away, and we can either take a break or I can give you information about talking with a counselor.

3

We are required by law to keep your answers private. The law also requires the study to use your answers only
to learn how the questions work. The name of this law is the Confidential Information Protection and Statistical
Efficiency Act of 2002.
There are no direct benefits to you from doing this interview. Your involvement in this study will help us
improve the questions for the NSDUH.
When we finish, I will give you $40 in cash to thank you for taking time to talk to me. Even if you decide to
leave the interview early or do not answer all of the questions, you will receive the $40.
If you or your parent/guardian have any other questions about the study, you can call Ms. Emily Geisen at 1800-334-8571 ext. 26566. If you or your parent/guardian have any questions about your rights as a participant
in this study, you can call RTI's Office of Research Protection at 1-866-214-2043.

Do we have your permission to participate in this interview?
____Yes

____No

I give my permission for the interview to be recorded:
____Yes

____No

Read only if remote or in-person observer is present: I give my permission for members of the RTI research
team or representative of SAMHSA to observe the interview:
____Yes

____No

I will sign my name here to indicate that I have explained this information to you and that you have agreed to be
interviewed.

___________________________
Signature of Interviewer

_________________________
Date

NOTICE: Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or
any other aspect of this collection of information, including suggestions for reducing this burden, to SAMHSA Reports Clearance Officer, Paperwork Reduction Project (09300290), Center for Behavioral Health Statistics and Quality; Room 15E57B; 5600 Fishers Lane, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0290, expiration
date 5/31/20.

4

Participant Informed Assent (ADOLESCENT – VAPING ONLY)
Introduction
I am going to explain this study to you. You can stop me at any time if you have questions about anything I tell
you.
The purpose of this study is to test some questions that will be used in the National Survey on Drug Use and
Health, or NSDUH. The NSDUH is a large survey given to about 70,000 people across the country each year. It
collects information on many health-related issues. We're interested in evaluating some questions about your
experience with past drug and alcohol use. We want to see how well people understand these questions. We also
want to know how people go about answering the questions. RTI is doing this study for the Substance Abuse
and Mental Health Services Administration, or SAMHSA. You are one of 75 participants between the ages of
12 to 17 who will help us test these questions.
Description of the Interview
Your participation in this interview will involve answering questions about your experiences with and attitudes
towards tobacco and e-cigarettes. It may also ask about experiences with your sleep. In addition to answering
these questions, I will ask you follow up questions to determine how you decided on an answer for these survey
questions and if they were clear and easy for you to understand. For some questions, I may ask you to put the
questions in your own words. The interview will last approximately 60 minutes. Your participation in this study
will end after you finish the interview.
We also would like to audio and screen record what you say and see during the interview. A screen recording
records what is on the computer screen while you answer questions. It does not record your face. Only the
people who work on this study will view the recording. It will help us make sure we have understood your
answers. If you don't want us to audio or screen record you, that's okay.
Confidentiality/Your Rights
You don't have to answer a question if you don't want to. If you want to take a break at any time, just tell me.
Your name will be kept private. No one else will see your answers to these questions. Your parents will not
find out about your answers to questions. The only exceptions to this promise of confidentiality are if you tell
me that you intend to seriously harm yourself or someone else or if you have been abused or if you identify an
adult who has given you drugs; in these situations I may need to notify a mental health professional or other
authorities.
[Read only if observer is present: Members of the RTI research team or representatives of SAMHSA are here
with us today and would like to observe this interview. If you do not want anyone else to observe your
interview, we will simply ask these people to leave and then we’ll do the interview after they’ve left.]
[Read only if planning for remote-observation: We would like to be able to use screen & audio sharing to
allow members of the RTI research team or representatives of SAMHSA to observe the interview remotely.
However, remote observation is voluntary and you can decline.]

Possible Risks and Benefits
Some of the questions we ask may make you feel uncomfortable or upset. If this happens, let me know right
away, and we can either take a break or I can give you information about talking with a counselor.
We are required by law to keep your answers private. The law also requires the study to use your answers only
to learn how the questions work. The name of this law is the Confidential Information Protection and Statistical
Efficiency Act of 2002.
5

There are no direct benefits to you from doing this interview. Your involvement in this study will help us
improve the questions for the NSDUH.
When we finish, I will give you $40 in cash to thank you for taking time to talk to me. Even if you decide to
leave the interview early or do not answer all of the questions, you will receive the $40.
If you or your parent/guardian have any other questions about the study, you can call Ms. Emily Geisen at 1800-334-8571 ext. 26566. If you or your parent/guardian have any questions about your rights as a participant
in this study, you can call RTI's Office of Research Protection at 1-866-214-2043.

Do we have your permission to participate in this interview?
____Yes

____No

I give my permission for the interview to be recorded:
____Yes

____No

Read only if remote or in-person observer is present: I give my permission for members of the RTI research
team or representative of SAMHSA to observe the interview:
____Yes

____No

I will sign my name here to indicate that I have explained this information to you and that you have agreed to be
interviewed.

___________________________
Signature of Interviewer

_________________________
Date

NOTICE: Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or
any other aspect of this collection of information, including suggestions for reducing this burden, to SAMHSA Reports Clearance Officer, Paperwork Reduction Project (09300290), Center for Behavioral Health Statistics and Quality; Room 15E57B; 5600 Fishers Lane, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0290, expiration
date 5/31/20.

6


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