MIHOPE Participant Consent for CPHS REVISED 03May13

MIHOPE Participant Consent for CPHS REVISED 03May13.docx

Mother and Infant Home Visiting Program Evaluation (MIHOPE)

MIHOPE Participant Consent for CPHS REVISED 03May13

OMB: 0970-0402

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0970-0402 can be found here:

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OMB Control No: 0970 -0402

Expiration Date: 7/31/2015

A
Mother and Infant Home Visiting Program Evaluation
greement to Take Part in the

We would like you to take part in an important research project about the effects of home visiting services. The project is funded by the US Department of Health and Human Services. A nonprofit organization called MDRC is running the study. MDRC studies social programs to try to improve the lives of low-income families. The study is being done with Mathematica Policy Research and other researchers. The study might provide information to help improve services for parents with young children.

What does it mean to be in the study?

About 5,100 families will be in the study around the country. Half the families in the study will be offered home visiting services. The other half will receive information about other services in the community. You will have the same chance to get home visiting services as everyone else. Picking the families who will be offered home visiting services will be done randomly, like tossing a coin.

If you agree to take part in the study, we will ask you to do the following:

Agree to be interviewed by telephone for about an hour today or at a convenient time.

We will ask about your health, use of social services, relationships, and background. We will ask about what you do as a parent and your child’s development. We will ask you about alcohol and drug use, experiences with domestic violence, and prior arrests. You will receive a $25 Target gift card for completing the interview. You may refuse to answer any of the questions.

We will ask how we can reach you in the future. We will ask for the names, addresses, and phone numbers of people who know how to reach you.

Allow someone from the study team to observe your home environment. They will take notes about home safety and parenting.
Agree to be interviewed in the future when your baby is about 15 months old.

We will ask about you and your child. You will receive a $25 Target gift card for completing the interview. You may refuse to answer any of the questions.
At that time we would like to visit your home to collect some more information on you and your child. We would like to videorecord you and your child interacting. We would like to learn about your child’s language skills. We would like to measure your weight and your child’s height and weight. We would like to take more notes about your home. You will receive a $20 Target gift card for these activities. You may refuse to do any of these activities.

We will send you a postcard so you can tell us how to reach you. You will receive a $5 gift card for returning it.
Overall, you can receive $75 by the time your baby is 15 months old.

Allow us to obtain information from home visiting programs.

If you are chosen to receive home visiting services, we will ask the program about the services you receive. This will include how often you see the home visitor and what you discuss with the home visitor. We will also ask other home visiting programs in your community about your use of their services.

Allow us to obtain information from government agencies about your family and the services you receive. This information will be used only for research purposes, to understand the effects of home visiting programs. This will be combined with information we collect directly from you. The study team will collect this information until the end of the study. The study team might collect the following information:

Birth outcomes and information about your pregnancy from your children’s birth certificates. This would also include information on infant death.
You and your children’s involvement with the Child Protective Service system.
Health care use through Medicaid and CHIP. This would include information on doctor visits, hospital stays, emergency room use, and prescription medications.
Information on cash assistance and food stamps.
How much you earn through work.
Information from your child’s school after your child starts going to school
Information from you and your child’s health care providers.
We will need your Social Security number to get this information. We may also use your Social Security number to help locate you when we want to talk to you in the future.

Being part of the study is your choice

Taking part in the study is your choice. If you decide not to be in the study, there is no penalty. Your decision will not affect whether you are given a spot in the home visiting program. Only half of families will be able to receive home visiting services. If you are not selected for the home visiting program, you can use other services in your community.

You may opt out of the study at any time by calling MDRC at 1-877-311-6372 or by sending email to [email protected]. We will help you revoke your authorization for collecting health records. You may refuse to answer any questions we ask, both today and in the future. You do not have to give us your Social Security number if you do not want to. You will not lose any benefits or services to which you would be otherwise entitled.

Risks

There are some risks to being in the study. Some of the questions involve sensitive topics and may be stressful to answer. There is a small risk that your information will be seen outside the study team. However, the study team follows strict rules to protect your privacy. No reports will include your name or other identifying information. We will keep your information private unless there is concern that you or someone else may be harmed. For example, we would tell someone if we see evidence of child abuse or neglect.

Benefits

Taking part in the study might help improve services for parents with young children.

Study participant’s bill of rights

Along with this consent form, you are being given a copy of a bill of rights. This bill of rights explains your rights as someone who is part of a research study.

Information will be private

The research team follows strict rules to keep your information private. All study staff are trained to protect privacy. All study staff sign a confidentiality pledge. Right now, we plan to collect information until your baby is 15 months old. The study might be extended, however. If that happens, we might share your information with other researchers. They might continue to collect information about you and your family. They would also keep your information private.

The study has a Certificate of Confidentiality from the U.S. government. This certificate states that we do not have to identify you, even under a court order or subpoena. However, if keeping your answers private would put you or someone else in serious danger, we will have to tell the appropriate agencies to protect you or the other person. In addition, the government may see your information if it audits the study, but it would keep your information confidential.

All information about you will be marked with a code number, not your name. No reports will describe you in a way that would allow you to be identified. We have to deliver the study data to the federal government at the end of the study, but the data file will not contain information that could be used to identify you.

If you have questions at any time, please call MDRC toll-free at 1-877-311-6372.

Participant’s Statement:

“The research procedures, risks and benefits have been explained to me. I recognize that I am free to ask any questions. I understand that taking part in this study is my choice. I understand that being in the study will not affect any benefits that I or members of my family receive, now or in the future. I understand that you will collect information about my children. I understand that I am free to stop taking part in the study at any time. I understand that I can refuse to answer any questions in the interviews. I understand that any information that can be used to identify me will be kept private, unless there is concern that I or someone else may be harmed.

I agree to provide contact information so that I can be interviewed in the future. I agree that the research team may obtain information from government agencies, from home visiting programs, and from my family’s health care providers.”

Agreement to participate in the study:

____________________________

Print Name

____________________________ _____________

Signature Date

Witness:

____________________________

Signature

Mother and Infant Home Visiting Program Evaluation
Assent for Unemancipated Minors to Take Part in the

What does it mean to be in the study?

If you agree to take part in the study, we will ask you to do the following:

Agree to be interviewed by telephone for about an hour today or at a convenient time.

We will ask about your health, use of social services, relationships, and background. We will ask about what you do as a parent and your child’s development. We will ask you about alcohol and drug use, experiences with domestic violence, and prior arrests. You will receive a $25 Target gift card for completing the interview. You may refuse to answer any of the questions.

We will ask how we can reach you in the future. We will ask for the names, addresses, and phone numbers of people who know how to reach you.

Allow someone from the study team to observe your home environment. They will take notes about home safety and parenting.
Agree to be interviewed in the future when your baby is about 15 months old.

We will ask about you and your child. You will receive a $25 Target gift card for completing the interview. You may refuse to answer any of the questions.
At that time we would like to visit your home to collect some more information on you and your child. We would like to videorecord you and your child interacting. We would like to learn about your child’s language skills. We would like to measure your weight and your child’s height and weight. We would like to take more notes about your home. You will receive a $20 Target gift card for these activities. You may refuse to do any of these activities.

We will send you a postcard so you can tell us how to reach you. You will receive a $5 gift card for returning it.
Overall, you can receive $75 by the time your baby is 15 months old.

Allow us to obtain information from home visiting programs.

If you are chosen to receive home visiting services, we will ask the program about the services you receive. This will include how often you see the home visitor and what you discuss with the home visitor. We will also ask other home visiting programs in your community about your use of their services.

Allow us to obtain information from government agencies about your family and the services you receive. This information will be used only for research purposes, to understand the effects of home visiting programs. This will be combined with information we collect directly from you. The study team will collect this information until the end of the study. The study team might collect the following information:

Birth outcomes and information about your pregnancy from your children’s birth certificates. This would also include information on infant death.
You and your children’s involvement with the Child Protective Service system.
Health care use through Medicaid and CHIP. This would include information on doctor visits, hospital stays, emergency room use, and prescription medications.
Information on cash assistance and food stamps.
How much you earn through work.
Information from your child’s school after your child starts going to school
Information from you and your child’s health care providers.
We will need your Social Security number to get this information. We may also use your Social Security number to help locate you when we want to talk to you in the future.

Allow us to ask a parent or guardian to provide consent for you to be in the study.

Because you are a minor, we must get permission from a parent or guardian for you to be in the study. We will not share any information about you with your parent or guardian.

Being part of the study is your choice

Risks

Benefits

Taking part in the study might help improve services for parents with young children.

Study participant’s bill of rights

Along with this consent form, you are being given a copy of a bill of rights. This bill of rights explains your rights as someone who is part of a research study.

Information will be private

If you have questions at any time, please call MDRC toll-free at 1-877-311-6372.

Participant’s Statement:

Agreement to participate in the study:

____________________________

Print Name

____________________________ _____________

Signature Date

Witness:

____________________________

Signature

Agreement to be Video-Recorded during Home Visits for the

Mother and Infant Home Visiting Program Evaluation

Thank you for agreeing to take part in the Mother and Infant Home Visiting Program Evaluation (MIHOPE). As you were told, this is a research project about the effects of home visiting services. The project is being funded by the US Department of Health and Human Services. MDRC is conducting the study with Mathematica Policy Research and other researchers. The study will help improve services for parents with young children.

We are thankful for your time and help in MIHOPE. We would like you to help us in one more way. We might like to video record your interaction with the home visitor at two times in the future. The video recordings will give us information on what happens during the visits. The video recordings are also valuable teaching tools. We would like your permission to use the video records for research and research training purposes. We will not videotape all of the families who give us permission to be videotaped.

What does it mean to be video-recorded?

The study team might like to record a typical visit at two times in the future. About one-third of families in the study who receive home visiting will be chosen to be video-recorded.

The first visit would be about six to eight weeks from now. The second video will be when your child is six to nine months old.

You do not need to change anything you do in meeting with the home visitor. The study team member doing the recording will try to remain out of your way. If you agree to be recorded, the study team may call you to schedule the recording.

You will receive a $20 Target gift card each time you are video recorded. We will also give you a small gift for your child.

Being Video-Recorded is your choice

Being video-recorded is your choice. If you decide not to be recorded, there is no penalty. You may change your mind and decide not to be videotaped in the future.

Risks

There is a small risk that your video will be seen outside the research team. However, the study team follows strict rules to protect the privacy of your information. We will keep your information private unless there is concern that you or someone else may be harmed. No reports will include your name or other identifying information. The information you give us will not be provided to government agencies in a way that could identify you.

Benefits

The recordings might help improve services for parents with young children.

Information will be private

The research team follows strict rules to keep your information private. All study staff are trained to protect confidentiality. All study staff sign a confidentiality pledge. The study has a Confidentiality Certificate from the U.S. government. This states that we do not have to identify you, even under a court order or subpoena. If the video-recording indicates that you or someone else in serious danger, then we will have to tell the appropriate agencies to protect you or the other person. In addition, the government may see your information if it audits the study, but it would keep your information confidential.

No reports will describe you in a way that would allow you to be identified.

If you have questions at any time, please call at MDRC toll-free at 1-877-311-6372.

Participant’s Statement:

“I agree to have my image and voice recorded for the MIHOPE project. This video will show what happens when my children and I meet with the home visitor. This video will not be sold. It will not be used for commercial purposes.

I understand that only the image and voice of my children and me as they appear during the interaction with the home visitor will be revealed. I understand that I do not have to participate in the video. I understand that I can have the recording stopped at any time.”

____________________________

Print Name

____________________________ _____________

Signature Date

Witness:

____________________________

Print Name

____________________________ _____________

Signature Date

Participant's Bill of Rights

You have been asked to be in a research study. Any participant in a research study has the right to:

Be told the nature and purpose of the study.
Be told what will happen during the study and of what you will be expected to do.
Be told of any risks or discomforts you may experience by being in the study.
Be told of any benefits you may expect from being in the study.
Be told of other appropriate choices that may be better or worse than being in the study, and be told of the risks and benefits of those other choices.
Have a chance to ask questions about the study or about your participation in it. You can do this before agreeing to be in the study and during the study.
Be told that you may withdraw your consent and participation in the study at any time. Be told that your withdrawal will not affect your services.
Be told that you may refuse to answer any question.
Be given a copy of the signed and dated consent form.
Be free of pressure when considering whether to consent to, and participate in, the study.
Be informed, upon request, about the results of the study.

F requently Asked Questions about

Mother and Infant Home Visiting Program Evaluation

Q: WHAT KIND OF QUESTIONS WILL BE ASKED DURING THE INTERVIEW?

We will ask about your health, use of social services, relationships, and background. We will ask about what you do as a parent and your child’s development. We will ask about alcohol and drug use, experiences with domestic violence, and prior arrests. You will receive a $25 Target gift card for completing the interview. You may refuse to answer any of the questions.

Q: WHAT KIND OF INFORMATION WILL BE GATHERED FROM GOVERNMENT AGENCIES?

This could include information on birth outcomes and information about pregnancy from birth certificates. This would also include information on infant death. It would include information on your involvement with the Child Protective Service system. It would include information on health care use through Medicaid and CHIP. This would include information on doctor visits, hospital stays, emergency room use, and prescription medications. It might include information on your receipt of cash assistance and food stamps. It will include information on your earnings through work. It might include information from your child’s school after your child starts going to school. It might include information from your health care providers. All information will be used only for research purposes.

Q: WHAT ARE THE RISKS AND BENEFITS OF PARTICIPATION?

We might ask about sensitive topics. They may be stressful to answer. You may refuse to answer any questions, now and in the future. There may be a small risk because you are sharing confidential information with us. However, the study team follows strict rules to protect your privacy. No reports will include your name or other identifying information. We will keep your information private unless there is concern that someone may be harmed. For example, we would tell someone if we see evidence of child abuse or neglect.

Q: DOES MY DAUGHTER HAVE TO TAKE PART IN THE STUDY?

Taking part in the study is your choice. If you decide not to be in the study, there is no penalty. Your decision will not affect any government benefits or services you might receive. Your decision will not affect your ability to participate in the home visiting program. Only half of families will be able to receive home visiting services. If you are not selected for the home visiting program, you can use other services in your community.

Your daughter may stop being in the study at any time. You may refuse to answer any questions we ask. There will be no penalties and you will not lose any benefits to which she would be otherwise entitled.

Q: WILL THE INFORMATION BE KEPT CONFIDENTIAL?

The research team follows strict rules to protect privacy. All study staff are trained to protect privacy and sign a confidentiality pledge. The study has a Confidentiality Certificate from the U.S. government. This certificate states that we do not have to identify you, even under a court order or subpoena. The government may see your information if it audits the study, but it would keep that information private. However, we will have to tell someone if there is concern that someone may be harmed.

All information about you will be marked with a code number, not with a name. No reports will describe you in a way that would allow you to be identified. We have to deliver the study data to the federal government at the end of the study, but the data file will not contain information that could be used to identify you.

If you have questions at any time during the study, you may call MDRC toll-free at 1-877-311-6372.

MIHOPE Protocol for Consenting Minors

A small number of study participants will likely be minors. What constitutes a minor and the rules of emancipation for minors differ by state. We will develop a list of the rules governing minors and emancipation of minors for each state included in our study once states have been recruited. The list of rules will be included in the field staff training materials and discussed during training.

If a state requires parental consent, then Mathematica field staff will contact the minor to obtain written assent using the same procedures for obtaining consent from other study participants. If the minor provides assent, Mathematica staff would contact the minor’s parent or guardian by telephone to obtain oral consent for their child’s participation in the study. This oral consent will be documented. If the parent or guardian does not grant consent, we will document the refusal. The case will be recorded as a final refusal by parent.

If the state does not require parental consent, Mathematica will contact the minor and attempt to recruit him or her into the study, as would be done for other potential study participants.

Home visitors will gather information on eligible minors when determining study eligibility, such as the participant’s date of birth, and the parents or guardians’ names and contact information.

A script and set of frequently asked questions to be used with parents of minors begins on the next page.

MIHOPE SCRIPT FOR PARENTAL CONSENT OF MINORS

ELLO. My name is _____________ from Mathematica Policy Research. May I speak with [PARENT NAME]?

SPEAKING TO [PARENT NAME] 1 GO TO parent name

[PARENT NAME] COMES TO THE PHONE 2 GO TO parent name

PARENT NAME.

Good (morning/afternoon/evening). My name is __________________, and I’m calling from Mathematica Policy Research. We are conducting a study for the U.S. Department of Health and Human Services to learn about home visiting programs and the different kinds of services these programs provide to children and families. Your daughter, (NAME), is eligible to participate in this study and we are contacting you to request your consent as her parent or guardian since she is a minor.

The purpose of the study is to learn more about families who enroll in home visiting programs and how those programs provide different kinds of services to children and families. About 5,100 families in total will be in the study around the country.

Her participation involves 4 main things:

being interviewed by telephone for about an hour at a convenient time during the next couple of weeks;
being interviewed again in the future, when her child is 15 months old;
giving permission to obtain information from state and federal government agencies about your daughter and her child; and
giving permission to video-tape up to two home visits with your daughter’s home visitor to learn about the kinds of things home visitors talk about and do with clients.

Your daughter can refuse to answer any question on the interviews. She can also refuse to be videotaped with the home visitor.

Your daughter’s participation is voluntary. If she does not participate in the study, there is no penalty.

Do you have any questions about the study or (NAME)’s participation in it?

YES 1 GOT TO FAQ

NO 0

DON’T KNOW d

REFUSED r

Do you consent to allow (NAME) to participate in the study?

YES 1

NO 0

DON’T KNOW d

REFUSED r

Thanks very much. Have a nice day. END CALL.

Mother and Infant Home Visiting Program Evaluation

requently Asked Questions for Parents of Unemancipated Minors

Q: WHAT KIND OF QUESTIONS WILL BE ASKED DURING THE INTERVIEW?

We will ask about your child’s health, use of social services, relationships, and background. We will ask about her what she does as a parent and her child’s development. We will ask her about alcohol and drug use, experiences with domestic violence, and prior arrests. She will receive a $25 Target gift card for completing the interview. She may refuse to answer any of the questions.

Q: WHAT KIND OF INFORMATION WILL BE GATHERED FROM GOVERNMENT AGENCIES?

This could include information on birth outcomes and information about pregnancy from birth certificates. This would also include information on infant death. It would include information on your daughter’s involvement with the Child Protective Service system. It would include information on health care use through Medicaid and CHIP. This would include information on doctor visits, hospital stays, emergency room use, and prescription medications. It might include information on her receipt of cash assistance and food stamps. It will include information on her earnings through work. It might include information from her child’s school after the child starts going to school. It might include information from her health care providers. All information will be used only for research purposes.

Q: WHAT ARE THE RISKS AND BENEFITS OF PARTICIPATION?

We might ask about sensitive topics. They may be stressful to answer. She may refuse to answer any questions, now and in the future. There may be a small risk because she is sharing confidential information with us. However, the study team follows strict rules to protect her privacy. No reports will include her name or other identifying information. We will keep your information private unless there is concern that someone may be harmed. For example, we would tell someone if we see evidence of child abuse or neglect.

Q: DOES MY DAUGHTER HAVE TO TAKE PART IN THE STUDY?

Taking part in the study is your and her choice. If you or she decide she should not to be in the study, there is no penalty. Your decision will not affect any government benefits or services she might receive. Your decision will not affect her ability to participate in the home visiting program. Only half of families will be able to receive home visiting services. If she is not selected for the home visiting program, she can use other services in your community.

Your daughter may stop being in the study at any time. She may refuse to answer any questions we ask. There will be no penalties and she will not lose any benefits to which she would be otherwise entitled.

Q: WILL THE INFORMATION BE KEPT CONFIDENTIAL?

The research team follows strict rules to protect privacy. All study staff are trained to protect privacy and sign a confidentiality pledge. The study has a Confidentiality Certificate from the U.S. government. This certificate states that we do not have to identify your daughter, even under a court order or subpoena. The government may see your daughter’s information if it audits the study, but it would keep that information private. However, we will have to tell someone if there is concern that someone may be harmed.

All information about your daughter will be marked with a code number, not with a name. No reports will describe an individual in a way that would allow her to be identified. We have to deliver the study data to the federal government at the end of the study, but the data file will not contain information that could be used to identify her.

If you have questions at any time during the study, you may call MDRC toll-free at 1-877-311-6372.

A
Mother and Infant Home Visiting Program Evaluation
greement for Home Visitor Supervisor to Take Part in the

We would like you to take part in an important research project to learn more about the effects of home visiting services. The project is being funded by the US Department of Health and Human Services. MDRC is conducting the study with James Bell Associates, Johns Hopkins University, and Mathematica Policy Research. The study might give States and the federal government information to help them improve their services for parents with young children.

What does it mean to be in the study?

About 100 home visiting supervisors will be in the study around the country. Home visiting staff members in 12 states are being asked to provide information to help improve home visiting programs.

If you agree to take part in the study, we will ask you to do the following:

Complete a web-based survey today.

This survey will take about 75 minutes to complete.
We will want to learn about you and your home visiting supervision experience and training. We will ask you to answer questions online about employment and supervision, roles and responsibilities, program outcomes, and professional consultation. We will also ask you some demographic questions and questions about your psychological well-being. We will ask you about alcohol and drug use, experiences with domestic violence, and prior arrests.
You will receive a $30 gift card for completing the survey.

Complete a web-based survey in the future.

In one year, you will be asked to complete a similar online survey. The survey will take about 75 minutes to complete.
You will receive a $30 gift card for completing any future survey.

Being part of the study is your choice

Taking part in the study is your choice. If you decide not to be in the study, there is no penalty. Your decision will not affect your employment with the home visiting program.

You may stop being in the study at any time. You may refuse to be interviewed or to answer any questions we ask, both today and in the future.

Risks

Some of the questions we ask involve sensitive topics. They may be stressful to answer. You may refuse to answer any questions, both today and in the future. There is a small risk that the information you sharing will be disclosed outside the study team. However, the study team follows strict rules to protect your privacy and we will keep your information confidential. No reports will include your name or other personally identifiable information. The information you give us will not be provided to your home visiting program in a way that could identify you.

Benefits

Participating in the study might help local, state, and federal agencies improve their home visiting services.

Information will be private

The research team follows strict rules to keep your information private. All study staff are trained to protect privacy and sign a confidentiality pledge. All of your answers in the survey will remain private. If keeping your answers private would put you or someone else in serious danger, then we will have to tell the appropriate agencies to protect you or the other person.

If you have questions at any time during the study, please call MDRC toll-free at 1-877-311-6372.

Subject’s Statement:

“The research procedures, risks and benefits have been explained to me. I recognize that I am free to ask any questions. I understand that taking part in this study is my choice, and that being in it or not being in it will not affect my employment with the home visiting program. I understand that I am free to stop taking part in the study at any time. I understand that I can refuse to answer any question in the survey. I understand that any information that could be used to identify me will be kept private”.

Shape1

Checking this box will serve as your consent to take part in this research study.

A
Mother and Infant Home Visiting Program Evaluation
greement for Home Visitor to Take Part in the

What does it mean to be in the study?

About 510 home visitors will be in the study from 12 states around the country.

If you agree to take part in the study, we will ask you to do the following:

Complete a web-based survey today.

The survey should take about 75 minutes to complete.
We will want to ask about you and your home visiting experience and training. We will ask you to answer questions about employment and supervision, roles and responsibilities, program outcomes, program referrals, and knowledge of child development. We will also ask you some demographic questions and questions about your psychological well-being. We will ask you about alcohol and drug use, experiences with domestic violence, and prior arrests.
You will receive a $30 gift card for completing the survey today.

Complete a web-based survey in the future.

In one year, you will be asked to complete a similar online survey. The survey would take about 75 minutes to complete.
You will receive a $30 gift card for completing the survey.

Agree to be videotaped during some selected home visits with families in your caseload in the future.
- We may ask to video record home visits between you and families in your caseload on some occasions. These videos will be used for research and research training purposes only.

Being part of the study is your choice

Taking part in the study is your choice. If you decide not to be in the study, there is no penalty. Your decision will not affect your employment with the home visiting program.

You may stop being in the study at any time. You may refuse to be interviewed or to answer any questions we ask, both today and in the future. You may refuse to be recorded during home visits.

Risks

Benefits

Participating in the study might help local, state, and federal agencies improve their home visiting services.

Information will be private

If you have questions at any time during the study, please call MDRC toll-free at 1-877-311-6372.

Subject’s Statement:

Shape2

Checking this box will serve as your consent to take part in this research study.

MIHOPE-NS 7/18/2012, IRB Expiration 7/18/2013

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
Author	Ada Tso
File Modified	0000-00-00
File Created	2021-01-30

MIHOPE Participant Consent for CPHS REVISED 03May13