Community Health Through Engagement and Environmental Renewal
Phase: NA
Conditions: Family Relations, Blight
Sponsor: University of Alabama at Birmingham

Community Health Through Engagement and 
Environmental Renewal 
Study Protocol & Statistical Analysis Plan 
NCT04362475 
August 3, 2023
Jeffery T Walker, Professor, Principal 
Investigator University of Alabama at 
Birmingham Birmingham, AL 35294 

1. Background & Rationale
This study is designed to address social and health disparities in vulnerable urban 
neighborhoods through a dual-level intervention model. Prior work demonstrates that 
family dynamics and community environments contribute significantly to youth risk 
behaviors and adult well-being. The CHEER protocol combines a family-based behavioral 
intervention with neighborhood-level environmental renewal to test the effects on family 
communication, adolescent risk behaviors, and community cohesion. 
2. Study Objectives & Hypotheses
Objectives: 
1. To evaluate the impact of the Family Youth Intervention (FYI) on family communication,
boundaries, and adolescent outcomes.
2. To assess the Environmental Social & Physical Intervention (ESPI) effects on
neighborhood cohesion, engagement, and perceived safety.
3. To determine the combined effect of multilevel interventions on long-term public health
outcomes.
Hypotheses: 
- FYI will improve parent–child communication, reduce adolescent risky behavior, and
strengthen family mission development.
- ESPI will increase social cohesion, improve neighborhood environments, and foster
positive resident engagement.
- Together, FYI and ESPI will have synergistic effects on community health.
3. Study Design
Design: Multilevel intervention with a wait-list control. 
Components: 
- Family Youth Intervention (FYI): 8 modules delivered to caregivers and youth aged 11–16.
- Environmental Social & Physical Intervention (ESPI): Neighborhood revitalization through
repurposed lots and community association engagement.
Timeline: For FYI: Baseline, 1-week post-intervention, and 6-month follow-up. For EPSI:
Baseline, 12-month follow-up, and 24-month follow-up.
4. Study Population
FYI Eligibility: Families with children aged 11–16 living in target neighborhoods. 
ESPI Eligibility: Adults residing in designated BUN neighborhoods. 
Recruitment: Via schools, neighborhood associations, and community events. 

5. Interventions 
Family Youth Intervention (FYI): 
- 8-module program, 2-hour sessions held on weekends. 
- Topics: family communication, boundaries, shared values, and problem-solving. 
Environmental Social & Physical Intervention (ESPI): 
- Community-driven vacant lot repurposing. 
- Neighborhood association partnerships. 
- Activities include adopt-a-lot initiatives and shared space design. 
6. Data Collection & Measures 
Surveys: Administered at baseline, post-intervention, 6 months, and 24 months. 
Tools: Qualtrics, encrypted devices for field collection. 
Measures: Demographics, family communication, adolescent risky behaviors, neighborhood 
cohesion, safety perceptions. 
7. Statistical Analysis Plan 
Sample Size: Calculated to detect moderate effect sizes with adequate power. 
Analysis: Repeated measures ANOVA, stratified analysis by intervention group. 
Approach: Separate analyses for FYI and ESPI, plus combined impact testing. 
8. Data Management & Confidentiality 
All data stored in encrypted files on secure servers. 
Password-protected access limited to approved research staff. 
De-identified datasets used for analysis. 
9. Ethical Considerations 
Study approved by Institutional Review Board (IRB). 
Informed consent from caregivers and assent from minors. 
Risks are minimal, primarily associated with survey sensitivity and group discussions. 
Participants informed of benefits, including improved family communication and 
community engagement. 
10. Dissemination Plan 
Results shared with participants, community associations, and stakeholders. 
Findings presented at public health conferences and published in peer-reviewed journals. 
Community feedback sessions will ensure participants benefit from results. 

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The following populaƟons are approved for inclusion in this project:
Children – CRL 1
Documents Included in Review:
IRB PERSONNEL EFORM
To access stamped consent/assent forms (full and expedited protocols only) and/or other
approved documents:
1. Open your protocol in IRAP.
2. On the Submissions page, open the submission corresponding to this approval leƩer. NOTE:
The DeterminaƟon for the submission will be “Approved.”
3. In the list of documents, select and download the desired approved documents. The
stamped consent/assent form(s) will be listed with a category of Consent/Assent Document
(CF, AF, Info Sheet, Phone Script, etc.)

Page 1 of 3
Version Date: 05/12/2020
CONSENT FORM TO BE PART OF A RESEARCH STUDY
Title of Research:
Community Health through Engagement and Environmental Renewal 
(CHEER)
Environment: Social and Physical Intervention (ESPI)
UAB IRB Protocol #:
IRB-300004617
Principal Investigator:
Susan Davies, PhD
Sponsor:
Centers for Disease Control and Prevention
Sponsor Protocol #:
U48DP006404
General Information
You are being asked to take part in a research study. This research study is 
voluntary, meaning you do not have to take part in it. The procedures, risks, and 
benefits are fully described below.
Purpose
The purpose of the study is to improve the run-down appearance in the 
neighborhood by turning vacant lots into places that community members can 
gather and be proud.
Duration & Visits
You will be in this study for three years. 
Overview of Procedures
This study will include completing a baseline survey and two follow-up surveys. 
Risks
The most common risks include psychological stress from neighborhood 
discussions and completing surveys. 
Benefits
You will benefit from participating in this research because the neighborhood will 
look better, you will have places to interact with others in the neighborhood, and 
the neighborhood will be improved overall. 
Alternatives
If you do not want to take part in the study, you do not have to take part in it. 
Purpose of the Research Study
We are asking you to take part in a research study. The purpose of this research study is to encourage social 
interactions to enhance neighborhood unity and confidence. You will help us target negative factors in the 
neighborhood (e.g. vacant and overgrown lots) that impact social connectedness and physical appeal of the 
neighborhood. You are being asked to join because you live in the neighborhood and can tell us how best to 
address the neighborhood’s needs. There will be 500 participants enrolled.
Study Participation & Procedures
If you agree to join the study, you will complete surveys at three interview sessions. 

You will complete a baseline survey that will take about 60 minutes. 

You will complete two 30-minute follow-up surveys about a year apart 

You will also be invited to attend meetings in your neighborhood to discuss which vacant lots to improve 
and how, and what neighborhood activities should planned.

If you are entered and complete the entire study, you will be in the study for three years.
UAB IRB
Approved
18-May-2020

Page 2 of 3
Version Date: 05/12/2020
Risks and Discomforts
You may have some psychological stress that may arise from being a part of neighborhood discussions on 
which vacant lots to address and what to do with that vacant lot; however, this discomfort is common during 
group decision making. 
Benefits
This study may help us better understand how neighborhood upkeep can influence social connectedness and 
interactions among neighbors and reduce negative factors within the neighborhood such as crime. You will 
benefit from participating in this research because the neighborhood will look better, you will have more 
places to interact with others in the neighborhood, and the neighborhood will be improved overall.
Alternatives
The alternative is to not participate in this research study. 
Confidentiality
Information obtained about you for this study will be kept confidential to the extent allowed by law. However, 
research information that identifies you may be shared with people or organizations for quality assurance or 
data analysis, or with those responsible for ensuring compliance with laws and regulations related to research. 
They include:

the UAB Institutional Review Board (IRB). An IRB is a group that reviews the study to protect the rights and 
welfare of research participants.

the Centers for Disease Control and Prevention (CDC)

the Office for Human Research Protections (OHRP)
The information from the research may be published or presented for scientific purposes; however, your 
identity will not be given out in those publications. A description of this clinical trial will be available on 
www.ClinicalTrials.gov, as required by U.S. law. This website will not include information that can identify you. 
At most, the website will include a summary of the results. You can search this website at any time.
Voluntary Participation and Withdrawal
It is your choice whether or not to take part in this research study. There will be no penalty if you decide not to 
take part.. If you decide not to be in the study, you will not lose any benefits you are otherwise owed. You are 
free to withdraw from this study at any time. Contact any member of the study staff if you want to withdraw 
from the study.
Cost of Participation
There will be no cost to you for taking part in this study. 
Payment for Participation
You will be paid $30 for completing the baseline interview and $20 for each of the follow-up interviews in Years 
2 and 4. Payments will be made at the end of each study visit. The maximum total payment you may receive is 
$70. If you do not finish the entire study, you will be paid for your participation up to the time you decide to 
stop taking part in the study. Ask the study staff about the method of payment that will be used for this study 
(e.g., check, cash, gift card, direct deposit).
Questions
If you have any questions, concerns, or complaints about the research, please contact the study doctor. You 
may contact Dr. Susan Davies at 205-975-5448.

Page 3 of 3
Version Date: 05/12/2020
If you have questions about your rights as a research participant, or concerns or complaints about the 
research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. 
Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday.
Legal Rights
You are not waiving any of your legal rights by signing this consent form.
Signatures
Your signature below indicates that you have read (or have had read to you) the information provided above 
and agree to participate in this study. You will receive a signed copy of this consent form.
Signature of Participant
Date
Signature of Person Obtaining Consent
Date

Page 1 of 3
Version Date: 05/12/2020
CONSENT FORM TO BE PART OF A RESEARCH STUDY
(For Intervention)
Title of Research:
Community Health through Engagement and Environmental Renewal 
(CHEER)
Family-Youth Intervention (FYI)- Intervention
UAB IRB Protocol #:
IRB-300004617
Principal Investigator:
Susan L. Davies, PhD
Sponsor:
Centers for Disease Control and Prevention
Sponsor Protocol #:
U48DP006404
General Information
You are being asked to take part in a research study. This research study is 
voluntary, meaning you do not have to take part in it. The procedures, risks, and 
benefits are fully described further in the consent form.
Purpose
The purpose of the study is to improve coping skills that will make family 
interactions better.  
Duration & Visits
You will be in this study for one year and have three interview sessions. 
Overview of Procedures
This study will include three interview sessions and completing an 8-module 
educational series that focuses on family connectedness through teaching 
parental coping skills and childhood resilience. 
Risks
The most common risks include psychological stress while discussing sensitive 
topics with caregiver. 
Benefits
You may benefit by learning new skills that will increase family relationships. 
Alternatives
If you do not want to take part in the study, you do not have to take part in it. 
Purpose of the Research Study
We are asking you to take part in a research study. The purpose of this research study is to test a family 
strengthening intervention with caregivers and one child. The 12 module intervention is designed to improve 
family functioning through increasing coping and communication skill of the parents and to examine resilience 
in the child. There will be 400 parent-child pairs participants enrolled at UAB.
Study Participation & Procedures
The parent-child pairs will be asked to complete assessments during three interview sessions. You will also be 
asked to complete the educational activities designed for the month. If you agree to join the study, you will 
complete surveys at three interview sessions and a 8-module educational series. 

You will complete a baseline survey that will take 90 minutes. 

You will complete two 90-minute follow-up surveys. One follow-up 5 months after the baseline and the 
other one year after your first follow-up. 

You will also complete monthly educational activities that are delivered through text messages and a 
website.

If you are entered and complete the entire study, you will be in the study for one year.
UAB IRB
Approved
18-May-2020

Page 2 of 3
Version Date: 05/12/2020
Risks and Discomforts
You may have some psychology stress that may arise from talking with your child about sensitive topics and 
your child discussing their feelings and conflicts; however, this discomfort is common during parent-child 
conversations about sensitive topics. The 8-module educational series is designed to teach you techniques to 
deal with these conversations. The is a risk of breach of confidentiality; however, we have taken measures to 
ensure that this possibility is minimal.  
Benefits
This study may help us better understand how parents and children communicate and interact to increase 
family connectedness. You will benefit from participating in this research because you will learn skills that will 
help you interact with your child(ren). 
Alternatives
The alternative is not participate in this research study.
Confidentiality
Information obtained about you for this study will be kept confidential to the extent allowed by law. However, 
research information that identifies you may be shared with people or organizations for quality assurance or 
data analysis, or with those responsible for ensuring compliance with laws and regulations related to research. 
They include:

the UAB Institutional Review Board (IRB). An IRB is a group that reviews the study to protect the rights and 
welfare of research participants.

Centers for Disease Control and Prevention (CDC)

the Office for Human Research Protections (OHRP)
The information from the research may be published for scientific purposes; however, your identity will not be 
given out in those publications. A description of this clinical trial will be available on www.ClinicalTrials.gov, as 
required by U.S. Law. This website will not include information that can identify you. At most, the website will 
include a summary of the results. You can search this website at any time.
Voluntary Participation and Withdrawal
Whether or not you take part in this study is your choice. There will be no penalty if you decide not to be in it. 
If you decide not to be in the study, you will not lose any benefits you are otherwise owed. You are free to 
withdraw from this study at any time. Contact any member of the study staff if you want to withdraw from the 
study.
Cost of Participation
There will be no cost to you for taking part in this study.
Payment for Participation
If you participate in the FYI study, you will be paid $ $25 ($25 + $25 + $25 = $75) for each interview and your 
child will be paid $25 for each interview ($25 + $25 + $25 = $75). Payments will be made at the study visit. 
You will also have the opportunity to complete educational modules. You will be paid $50 ($50 x 8 modules = 
$400) for each module that you complete. The total for completing this study is $475 for parents and $75 for 
child.  If you do not finish the entire study, you will be paid at the time you decide to stop taking part in the 
study.  Ask the study staff about the method of payment that will be used for this study (e.g., check, cash, gift 
card, direct deposit).

Page 3 of 3
Version Date: 05/12/2020
Questions
If you have any questions, concerns, or complaints about the research please contact the study doctor. You 
may contact Dr. Susan Davies at 205-975-5448.
If you have questions about your rights as a research participant, or concerns or complaints about the 
research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. 
Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday.
Legal Rights
You are not waiving any of your legal rights by signing this consent form.
Signatures
Your signature below indicates that you have read (or been read) the information provided above and agree to 
participate in this study. You will receive a copy of this signed consent form.
Signature of Participant 14 Years of Age and Older
Date
Signature of Parent or Guardian
Date
Signature of Person Obtaining Consent
Date

Page 1 of 3
Version Date: 05/12/2020
CONSENT FORM TO BE PART OF A RESEARCH STUDY
Title of Research:
Community Health through Engagement and Environmental Renewal 
(CHEER)
Family-Youth Intervention (FYI)
UAB IRB Protocol #:
IRB-300004617
Principal Investigator:
Susan L. Davies, PhD
Sponsor:
Centers for Disease Control and Prevention
Sponsor Protocol #:
U48DP006404
General Information
You are being asked to take part in a research study. This research study is 
voluntary, meaning you do not have to take part in it. The procedures, risks, and 
benefits are fully described below.
Purpose
The purpose of the study is to improve coping and communication skills in order 
to improve family interactions.  
Duration & Visits
You will be in this study for 1 year. 
Overview of Procedures
This study will include 3 interview sessions where you complete surveys about 
family connectedness. 
Risks
There are minimal risks to completing the surveys. 
Benefits
You may not directly benefit from this study. However, this study will help us 
learn more about family connectedness.  
Alternatives
If you do not want to take part in the study, you do not have to. 
Purpose of the Research Study
We are asking you to take part in a research study. The purpose of this research study is to enhance parental 
coping and management of emotions to positively influence parenting practices and parent-child 
communication and to reduce family conflict and adolescent behavior. The parent-child pairs will be asked to 
complete assessments during three interview sessions. There will be 120 parent-child pairs enrolled at UAB.
Study Participation & Procedures
If you agree to join the study, you will complete surveys at three interview sessions 

You and your child will complete a baseline survey that will take about 90 minutes. 

You and your child will complete two 90-minute follow-up surveys; one follow-up survey approximately 5 
months after the baseline and the other follow-up approximately 12 months later. 

If you complete the entire study, you will be in the study for 1 year.
Risks and Discomforts
There is minimal risk associated with competing the surveys. 
Benefits
While you may not personally benefit from this study, the study may help us better understand how parents 
and children communicate and interact, in order to help us develop ways to increase family connectedness. 
UAB IRB
Approved
18-May-2020

Page 2 of 3
Version Date: 05/12/2020
Alternatives
The alternative is to not participate in this research study.
Confidentiality
Information obtained about you for this study will be kept confidential to the extent allowed by law. However, 
research information that identifies you may be shared with people or organizations for quality assurance or 
data analysis, or with those responsible for ensuring compliance with laws and regulations related to research. 
They include:

the UAB Institutional Review Board (IRB). An IRB is a group that reviews the study to protect the rights and 
welfare of research participants.

the Centers for Disease Control and Prevention (CDC)

the Office for Human Research Protections (OHRP)
The information from the research may be presented or published for scientific purposes; however, your 
identity will not be given out in those publications. A description of this clinical trial will be available on 
www.ClinicalTrials.gov, as required by U.S. law. This website will not include information that can identify you. 
At most, the website will include a summary of the results. You can search this website at any time.
Voluntary Participation and Withdrawal
It is your choice whether or not to take part in this study. There will be no penalty if you decide not to 
participate. If you decide not to be in the study, you will not lose any benefits you are otherwise owed. You are 
free to withdraw from this study at any time. Contact any member of the study staff if you want to withdraw 
from the study.
Cost of Participation
There will be no cost to you for taking part in this study.
Payment for Participation
If you participate in the FYI study, you will be paid $25 for each of 3 interviews, for a maximum interview 
payment of $75. Your child will be paid $25 for each of 3 interviews, for a maximum interview payment of $75.  
Payments will be made at the end of the study visit. If you do not finish the entire study, you will be paid for 
your participation up to the time you decide to stop taking part in the study. Ask the study staff about the 
method of payment that will be used for this study (e.g., check, cash, gift card, direct deposit).
Questions
If you have any questions, concerns, or complaints about the research, you may contact Dr. Susan Davies at 
205-975-5448.
If you have questions about your rights as a research participant, or concerns or complaints about the 
research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. 
Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday.
Legal Rights
You are not waiving any of your legal rights by signing this consent form.
Signatures
Your signature below indicates that you have read (or have had read to you) the information provided above 
and agree to participate in this study. You will receive a signed copy of this consent form.

Page 3 of 3
Version Date: 05/12/2020
Signature of Participant 14 Years of Age and Older
Date
Signature of Parent or Guardian
Date
Signature of Person Obtaining Consent
Date

Page 1 of 2
Version Date: 04/27/2020
ASSENT FORM
TITLE OF RESEARCH:
Community Health through Engagement and Environmental 
Renewal (CHEER)
Family-Youth Intervention (FYI)
IRB PROTOCOL:
IRB-300004617
INVESTIGATOR:
Susan Davies, Ph.D.
SPONSOR:
Centers for Disease Control and Prevention
The investigator named above are doing a research study.
These are some things we want you to know about research studies:
We are asking you to be in a research study. Research helps us learn new things. This research 
study will test new ideas about how families communicate.
Whether or not to be in this research is your choice. You can say Yes or No.  Whatever you 
decide is OK. 
Why am I being asked to be in this research study?
You are being asked to be in the study because you live in one of the four CHEER 
neighborhoods in the study (North Titusville, South Titusville, Belview Heights, or Rising-West 
Princeton) and are between the ages 11 and 13.
What is the study about?
This study aides parents and their 11-16 year old children in reducing stress and coping with 
difficult situations. 
What will happen during this study?
If you agree to be in this study, you

Will complete a survey at three different times, which will take about 90 minutes each 
time.  

May have to complete educational activities if selected.  
What are the good things that might happen?
People may have good things happen to them because they are in a research study. These are 
called “benefits.”  One benefit might be that the conversations you have with your parent will 
make it easier for you to talk with them when you need to. This might make you feel more 
connected to your parent or it may not make you feel more connected. The researchers hope to 
learn about the best way to help families feel more connected. 
What if I don’t want to be in this study?
UAB IRB
Approved
18-May-2020

Page 2 of 2
Version Date: 04/27/2020
You do not have to be in the study if you do not want to. 
Who should I ask if I have any questions?
If you have any questions about this study, you or your parents can call Dr. Susan Davies at 
(205) 975-5448.
Do I have to be in the study?
No, you do not have to be in the study. Even if you say yes now, you can change your mind later.  
It is up to you. No one will be mad at you if you don’t want to do this.
Signatures
Before deciding if you want to be in the study, ask any questions you have. You can also ask 
questions during the time you are in the study.
If you sign your name below, it means that you agree to take part in this research study.
Your Name (Printed)
Age
Your Signature
Date
Signature of Person Obtaining Consent
Date
Signature of Witness
Date