Promote Healthy Lifestyle Behaviors for Adolescents With Mental Health Conditions
Phase: NA
Conditions: Behavioral / Psychiatric Disorder, Lifestyle, Healthy
Sponsor: Florida State University

PROTOCOL TITLE: 
Promote Healthy Lifestyle Behaviors for Adolescents with Mental Health Conditions 
PRINCIPAL INVESTIGATOR: 
Rachel Sharp, BSN, RN, CPN 
FSU DNP-FNP Student 
850-865-4443 
rls14c@my.fsu.edu 
VERSION NUMBER/DATE: 
Version 1 – 06/24/22 
Version 2 – 07/08/22 
Version 3 – 08/08/22 
Version 4 – 08/10/22 
Version 5 – 10/31/22 
Version 6- 11/4/22 
Version 7- 11/15/22 (Modification approved by IRB 11/26/22) 
REVISION HISTORY 
 
Revisio
n # 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
7/8/22 
Updated: 
• Section 6.2 – Provide a list of what 
information and data element headers 
will be collected from the medical 
records for study purposes. 
• Clarified that PHI will not be 
obtained from the EHR. The only PHI 
information for this study will be 
provided through the REDCap 
survey.  
• Section 13.1 – Provide information 
about the partially waiver 
• See Appendix G for HIPAA 
Authorization form. 
Yes- HRP 
502 Consent 
Provided. 

• Section 13.2/13.3– List the data 
element headers that will be collected 
form medical records for recruitment 
purposes. 
• Clarified that PHI will not be 
obtained from the EHR. The only PHI 
information for this study will be 
provided through the REDCap 
survey.  
• In the REDCap survey, participants 
will be asked to provide name of 
diagnosis, diagnosis date, name of 
medications, date of birth. 
• Section 18 – Needs to provide Data 
and Safety Monitoring Plan 
• Attached Data and Safety Monitoring 
Plan. 
• Section 17/19 – In accordance with 
45 CFR 164.514(d)(3)(iii)(D) your 
need for disclosure of PHI must 
include a statement to the effect that 
the requested disclosure of PHI is the 
minimum necessary for research 
purposes. Provide a statement to this 
effect in section 17 or 19 of your 
protocol. 
• Updated statement for PHI disclosure. 
• Section 20 – Complete section 20 
• This study will not engage in any 
activities that may lead to potential 
injury for participants.  
• Section 22/23 – Indicate that consent 
will be obtained and documented 
electronically; describe how you will 
explain the study and/or otherwise be 
available (email, telephone, other 
remote interaction) to answer 
prospective subjects' questions given 
that study staff and prospective 
subjects are not interacting in-person; 
describe how prospective subjects 
should electronically affix their 

signatures and date, as well as 
print/sign/scan the consent form and 
return the signed and dated consent to 
the study team; and describe how the 
study team will subsequently counter-
sign, return the counter-signed copy 
to the subject for subjects' records; 
how subjects may maintain a copy of 
their signed consent; and how the 
study team will document and/or 
maintain a record of the executed 
consent form. 
• Updated consent to reflect how PI 
will be available for questions during 
the study. 
2 
8/8/22 
Requested Clarification:  
• Will the participants names be on 
the electronic survey?  
o Participants names will not be 
on the electronic survey.  
• The protocol suggests that you will 
not collect identifiable data on the 
survey. That is, you will not have a 
way to link the participants names 
to the responses on the survey as 
they are taking the survey 
anonymously. Is that accurate? 
There is no mention of any codes 
linking participant names to survey 
responses in the protocol. 
o Participant names will not be 
used to link the participants to 
their survey responses. 
Participants will be linked via 
the email they provide on their 
REDCap survey. 
o This is stated in general, 
adolescent, and children 
consent. 
• During recruitment, are you not 
asking anyone at the Wolfson 
Children’s Hospital for the names 
Yes- Child, 
Adolescent, 
and General 
Consent 

of clients with identified an mental 
health disorder. Is that accurate? 
Are you solely recruiting through 
flyers sent via email by staff and 
posted in the facility? 
o I will not be asking anyone at 
Wolfson Children’s Hospital 
for names of clients with 
identified mental health 
disorders. 
o I will solely be recruiting 
through flyers sent via email 
and staff, posted flyers in the 
facility, and providers and 
staff have agreed to provide 
possible clients meeting the 
project criteria with the 
information for the study.  
3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8/10/22 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Requested Clarification: 
• Please change regarding the 
information below: 
o Parents/legal guardians will be 
sent the survey via email 
before the adolescent is sent 
the survey. During the 
parent/legal guardian survey, 
they will be asked to provide 
assent for their adolescent to 
participate in the study and 
assent for HIPAA 
authorization for their 
adolescent. If parents/legal 
guardians do not provide 
assent for the study, the dyad 
will be removed from the 
study. Once parents/legal 
guardians provide assent and 
finish their survey, the survey 
will then be sent to the email 
address provided for the 
adolescent. 
No- 
Clarification 
on the 
consenting/ 
assenting 
process. No 
change to 
consenting 
documents. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• To explain the process of 
consenting parents and obtaining 
assent from adolescents. For 
example: 
o Parents can consent for their 
children to participate, but you 
still want to obtain child 
assent. So, when the 
parent/legal guardian are sent 
the survey, they will be asked 
to provide consent for their 
child to participate in the 
study. If the parent/legal 
guardian does not provide 
consent, the dyad will be 
removed from the study. Once 
parents/guardians provide 
consent, a survey will be sent 
to the email of the child and 
the child/adolescent will be 
asked to assent. 
• Updating recruitment process to 
include posting approved study flyers 
on social media platforms. Including 
the Bridge program at Wolfson 
Childrens Hospital for study flyer 
placement. 
• Updated estimated project timeline. 
• Update Inclusion/Exclusion criteria. 
Modifications to exclusion/inclusion 
criteria include: "If pt scores <13 on 
WHO-5 criteria, they MUST 
currently be enrolled in therapy 
services to participate."  
• Incentive change: A $30.00 Amazon 
E-Gift Card will be emailed to each 
adolescent-parent dyad after 
completing the post-survey. 
 
 

4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5 
10/31/22 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11/15/22 
• Incentive change: A $30.00 Amazon 
E-Gift Card will be emailed to the 
first 30 adolescent-parent dyads that 
complete the post-intervention survey 
(Change reflected on flyer). 
• Adding statistician to project team. 
• Goal Number of parent-adolescent 
dyads in study. 
• Clarified zoom session meeting dates. 
• Updated final question on the post-
intervention survey to assess the 
impact of the moderator (Rachel 
Sharp) on the receptiveness of the 
educational presentation (Reflected 
on updated questionnaires). 
 
 
 

Study Summary 
 
Study Title 
Promote Healthy Lifestyle Behaviors for Adolescents 
with Mental Health Conditions 
Study Design 
Quasi-experimental study with a one group pretest-
posttest design  
Primary Objective 
To evaluate the impact of an online educational program 
on improving healthy lifestyle knowledge and behaviors 
(nutrition, physical activity, screen time, and sleep) 
among adolescents diagnosed with a mental health 
condition(s) and their parent(s)/ legal guardian(s).   
Secondary 
Objective(s) 
1. Educate adolescents with mental health conditions and 
their family members about ways to improve healthy 
lifestyle behaviors. 
2. Evaluate an increase in knowledge on healthy lifestyle 
behaviors after a 45-minute online education session. 
3. Evaluate an increase in healthy lifestyle behaviors 
after the intervention. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
This project utilizes a one-group pretest-posttest design 
study for 30 (Goal) adolescents (aged 12-17 years) 
diagnosed with a mental health condition(s) and their 
parent(s)/legal guardian(s). This project will implement 
best practices to promote healthy lifestyle knowledge and 
behaviors to adolescents and their parent(s)/legal 
guardian(s). An online educational program will be 
delivered via a 45-minute Zoom meeting. We will 
compare the effects of an educational program on healthy 
lifestyle knowledge and behaviors pre-and post-program 
(after one month) via a REDCap survey for the 
adolescent and their parent/legal guardian. The survey 
will utilize an adapted version of the 2021 National 
Youth Risk Behavior Survey (YRBS) and the 2020 
National Survey of Children's Health (NSCH-T3). The 
analysis of this project will compare changes in healthy 
lifestyle knowledge and using a paired t-test.  
IND/IDE #  
N/A 

Study Population 
- Adolescents, 12-17 years old, with a clinical diagnosis 
of a mental health condition(s) 
- Adolescent’s parent(s)/legal guardian(s) ages 18 or 
older 
Sample Size 
Goal: 30 adolescent-parent dyads 
Study Duration for 
individual 
participants 
One month 
Study Specific 
Abbreviations/ 
Definitions  
PA- Physical Activity 
 

1.0 
Objectives* 
Purpose: 
The purpose of this project is to improve healthy lifestyle knowledge and 
behaviors among adolescents with a mental health condition(s) through preventative and 
detailed nutritional, physical activity, screen time, and sleep education. 
Clinical Question: 
Among adolescents 12-17 years old who are diagnosed with a mental health condition(s), 
does an educational intervention improve healthy lifestyle knowledge and behaviors 
including nutrition, physical activity, screen time, and sleep? 
Aims 
We will accomplish three aims using a one group pretest-posttest design: 
1. Educate adolescents with mental health conditions and their family members about 
ways to improve healthy lifestyle behaviors. 
2. Evaluate an increase in knowledge on healthy lifestyle behaviors after a 45-minute 
online education session. 
3. Evaluate an increase in healthy lifestyle behaviors after the intervention. 
Background* 
Background and Significance 
 
The pediatric population faces a public health crisis involving children and adolescents 
with overweight or obesity. Childhood obesity has become the most disconcerting and 
predominant pediatric nutritional disorder worldwide (Centers for Disease Control and 
Prevention [CDC], 2020a). From 2017 to 2018, 19.3% of the children and adolescents in 
the United States (US) were diagnosed with obesity (CDC, 2020b). Childhood obesity 
has been linked to psychological conditions such as depression and anxiety (CDC, 
2020b). Children that are overweight or obese are more commonly diagnosed with 
depression than children with a healthy weight (Lindberg et al., 2020). In 2019, 13.6% of 
children five to seventeen years old received mental health treatment in twelve months, 
and 8.4% of that population had taken psychotropic medication for their mental health 
condition (CDC, 2020c).  
           Healthy lifestyle behaviors impact short and long-term health and quality of life 
among children with depression. Physical activity (PA), healthy nutritional habits, and 
maintaining a healthy weight can improve children's quality of life with depression and 
overweight or obesity (Rippe, 2018). Parents have the most significant influence on their 
children's health. Thus, family-based intervention studies have been conducted to 

promote children's healthy lifestyle behaviors. Behavioral interventions that combine 
nutritional, physical, and behavioral components and parental involvement have proven 
to be the best and most effective practice for treating and preventing childhood obesity 
among adolescents 12-17 years old (Al‐Khudairy et al., 2017). 
Although there is evidence to support that adolescents benefit from peer and 
family support and group education, there are few in-depth studies documenting lifestyle 
modifications that can improve this population's overall physical and mental health. 
Given this lack of implementation into practice, this project aims to improve healthy 
lifestyle knowledge and behaviors among adolescents with a mental health condition(s) 
through preventative and detailed nutritional, physical activity, screen time, and sleep 
education. 
           This study’s purpose is to identify factors that may aid in answering the clinical 
question: Among adolescents 12-17 years old who are diagnosed with a mental health 
condition(s), does a family-based educational intervention improve healthy lifestyle 
knowledge and behaviors, including nutrition, PA, screen time, and sleep? The specific 
aims are to: Aim 1: To educate adolescents with mental health conditions and their family 
members about ways to improve healthy lifestyle behaviors. Aim 2: To evaluate an 
increase in knowledge on healthy lifestyle behaviors after a 45-minute online education 
session. Aim 3: To evaluate an increase in healthy lifestyle behaviors after the 
intervention. 
Study Endpoints* 
Study Endpoints* 
This study will be completed by May 2023. 
Study Intervention/Investigational Agent 
1.1 Description:  
               This project utilizes a one-group pretest-posttest design study for 30 adolescents 
(aged 12-17 years) diagnosed with a mental health condition(s) and their parent/legal 
guardian. This project will implement best practices to promote healthy lifestyle 
knowledge and behaviors to adolescents and their parent(s)/legal guardian(s). This will be 
a 45-minute educational presentation delivered via Zoom. Participants can select between 
multiple dates/times (over a 3-week period) for the educational session. We will compare 
the effects of an educational program on healthy lifestyle knowledge and behaviors pre-
and post-program (after one month) via a REDCap survey for the adolescent and their 
parent/legal guardian. The survey will utilize an adapted version of the 2021 National 
Youth Risk Behavior Survey (YRBS) and the 2020 National Survey of Children's Health 
(NSCH-T3). The analysis of this project will compare changes in healthy lifestyle 
knowledge and behaviors using a paired t-test. The educational presentation will be 
recorded and emailed to participants within 1 week of intervention to re-watch/review. 

               The educational program will promote a healthy lifestyle knowledge and 
behaviors through education established by the Centers for Disease Control and 
Prevention, the World Health Organization, and the American Academy of Pediatrics. 
Educational sessions will include the importance of healthy lifestyle modifications in the 
adolescent population with a mental health condition(s), lifestyle recommendations 
versus reality, nutrition, physical activity, screen time, and sleep recommendations and 
guidelines. The educational presentation via Zoom will include: 5-10 minutes of 
education regarding recommendations versus reality for nutrition, PA, screen time, and 
sleep, 20-25 minutes of education regarding ways to improve healthy lifestyle knowledge 
and behaviors. Potential obstacles to consider for this project include the recruitment of 
thirty applicants for this study and maintaining participant and family involvement in the 
study from pre-intervention to post-intervention.  
1.2 Drug/Device Handling: N/A 
1.3 N/A 
Procedures Involved* 
1.4 Describe and explain the study design. 

         Interventions will be evaluated through a pre- and post-intervention survey regarding 
parental/adolescent’s healthy lifestyle knowledge and behaviors developed from 
nationally approved health surveys including the National Survey of Children’s Health 
(NSCH), the WHO (Five) Well-Being Index, the Patient Health Questionnaire- 9 (PHQ-
9), and the Youth Risk Behavior Surveillance System (YRBSS) (Bureau, n.d.; Kroenke et 
al., 2001; CDC, 2021; WHO-5 Questionnaires, n.d.). The World Health Organization 
(Five) Well-Being Index questions will appear in the REDCap survey as a screening prior 
to the project survey. This survey is suitable for children nine years and above. If the raw 
score is below 13 or if the patient has answered 0 to 1 to any of the five items, they will 
not be allowed to complete the REDCap survey or participate in the project (The World 
Health Organisation- Five Well-Being Index (WHO-5), n.d.; World Health Organization. 
Regional Office for Europe, 1998).  
        The pre- and post-intervention survey will be the same, except the post-intervention survey 
will not include demographic questions. The adolescent survey will include 61 questions 
total: 6 WHO-5 mental health screening, 7 demographics, 2 weight/self-image, 16 
nutrition, 10 PA, 12 sleep, 5 screen time, 4 home environment, and 1 comment box for 
questions regarding nutrition, PA, screen time, and sleep. The parent/legal guardian(s) 
survey will include 70 questions total: 4 adolescent mental health screening, 11 
demographics, 7 evaluating adolescent overall health, 16 nutrition, 10 PA, 12 sleep, 5 
screen time, 4 home environment, 1 comment box for questions regarding nutrition, PA, 
screen time, and sleep. 1 question will be added to the end of the post-intervention survey 
(for both adolescent and parent/legal guardian surveys) to assess the impact of the Zoom 
moderator on the educational intervention. See Appendix.  
1.5 Provide a description of all research procedures being performed and when they 
are performed, including procedures being performed to monitor subjects for safety 
or minimize risks. 
• This project utilizes a one-group pretest-posttest design study for 30 
adolescents (aged 12-17 years) diagnosed with a mental health 
condition(s) and their parent/legal guardian. 
• This will be an educational program delivered via a 45-minute 
presentation delivered via Zoom. 
• Participants can select between multiple dates/times (over a 3-week 
period) for educational session. 
• The educational presentation will be recorded and emailed to participants 
within 1 week of intervention to re-watch/review. 
• The educational program will promote a healthy lifestyle knowledge and 
behaviors through education evidenced by the CDC, WHO, and the 
American Academy of Pediatrics. Educational sessions will include the 
importance of healthy lifestyle modifications in the adolescent population 
with a mental health condition(s), lifestyle recommendations versus 
reality, nutrition, physical activity, screen time, and sleep 
recommendations and guidelines. The educational presentation will 

include: 5-10 minutes of education regarding recommendations versus 
reality for nutrition, PA, screen time, and sleep, 20-25 minutes of 
education regarding ways to improve healthy lifestyle knowledge and 
behaviors, 10 minutes for questions and discussion.  
• We will compare the effects of an educational program on healthy lifestyle 
knowledge and behaviors pre-and post-program (after one month) via a 
REDCap survey for the adolescent and their parent/legal guardian. 
o The survey will utilize an adapted version of the 2021 National 
Youth Risk Behavior Survey (YRBS) and the 2020 National 
Survey of Children's Health (NSCH-T3). The analysis of this 
project will compare changes in healthy lifestyle knowledge and 
behaviors and knowledge using a paired t-test.  
• Information required for this study will be provided through the pre-and 
post-intervention survey.  
• PHI will not be obtained from the EHR. The only PHI information for this 
study will be provided voluntarily through the REDCap survey.  
a. The PHI information provided through REDCap includes: 
i. Name of current mental health diagnoses 
ii. Mental health diagnosis date 
iii. Name of medications 
iv. Date of birth 
b. Participants names will not be on the electronic survey.  
1.6 The pre- and post-intervention survey will be the same, except the post-intervention 
survey will not include demographic questions. The adolescent survey will include 
61 questions total:6 WHO-5 mental health screening, 7 demographics, 2 
weight/self-image, 16 nutrition, 10 PA, 12 sleep, 5 screen time, 4 home 
environment, and 1 comment box for questions regarding nutrition, PA, screen 
time, and sleep. The parent/legal guardian(s) survey will include 70 questions total: 
4 adolescent mental health screening, 11 demographics, 7 evaluating adolescent 
overall health, 16 nutrition, 10 PA, 12 sleep, 5 screen time, 4 home environment, 
and 1 comment box for questions regarding nutrition, PA, screen time, and sleep. 1 
question will be added to the end of the post-intervention survey (for both 
adolescent and parent/legal guardian surveys) to assess the impact of the Zoom 
moderator on the educational intervention. 
1.7 Describe: 
• 
Procedures performed to lessen the probability or magnitude of risks. 
o Parental Consent and Adolescent Assent 
o Parental Involvement in educational intervention 
o Adolescent mental health screening- The World Health 
Organization (Five) Well-Being Index questions 
a. If the raw score is below 13 or if the adolescent has 
answered 0 to 1 to any of the five items, they will not be 
allowed to complete the REDCap survey or participate in 

the project, unless they are currently enrolled in outpatient 
mental health services (Ex: counseling, therapy, partial 
hospitalization).   
• 
All drugs and devices used in the research and the purpose of their use, and 
their regulatory approval status. N/A 
• 
The source records that will be used to collect data about subjects. (Attach all 
surveys, scripts, and data collection forms.) 
o See Appendix A and B 
1.8 What data will be collected during the study and how that data will be obtained. 
• The data collected will compare the effects of an educational program on 
healthy lifestyle knowledge and behaviors pre-and post-program (after one 
month) via a REDCap survey for the adolescent and their parent/legal 
guardian. 
• The data will be obtained through a REDCap survey. 
1.9 
N/A 
Data and Specimen Banking* N/A 
Sharing of Results with Subjects* N/A 
Study Timelines* 
1.10 Describe: 
• Project recruitment will be begin in early October 2022. 
• Project recruitment will end November 2022. 
• Project pre-survey survey will be sent out the middle to end of November 
2022. 
• Participants will have 2 weeks to complete pre-survey prior to Zoom 
educational session. A reminder email will be sent to complete pre-survey. 
• An online educational session will be held middle to end of November 
2022. Participants can select between multiple dates/times (over a 3-week 
period) for educational session. 
• Participants will be emailed the recorded educational presentation within 1 
week of intervention. 
• Participants will then receive a post-survey 1 month after educational 
session.  
• Study will be completed by middle/end of December 2022-Early January 
2023. 
• 
The duration of an individual subject’s participation in the study. 
o 1 month duration 
• 
The duration anticipated to enroll all study subjects. 
o 1 month 

• 
The estimated date for the investigators to complete this study (complete 
primary analyses) 
o Study will be completed by Middle/End of December 2022- Early 
January 2023   
Inclusion and Exclusion Criteria* 
1.11 Describe how individuals will be screened for eligibility. 
• Adolescents, 12-17 years old, with a clinical diagnosis of a mental health 
condition(s) and their parent/legal guardian. 
• Examples of eligible diagnosed mental health conditions include major 
depressive disorder (MDD), generalized anxiety disorder (GAD), attention-
deficit disorder (ADD)/ attention deficit hyperactivity disorder (ADHD), bipolar 
disorder (BPD). 
• Adolescents that score below 13 on the World Health Organization (Five) Well-
Being Index survey or if the adolescent has answered 0 to 1 to any of the five 
items, they will not be allowed to complete the REDCap survey or participate in 
the project unless they are currently enrolled in outpatient mental health services 
(Ex: counseling, therapy, partial hospitalization). 
Parent(s)/legal guardian(s), 18 years old or order, live with adolescents diagnosed with mental 
health condition(s) 
1.12 Describe the criteria that define who will be included or excluded in your final 
study sample. 
• Inclusion Criteria:  
o Individuals who are not yet adults (Adolescents 12-17 years old ) 
o With diagnosed mental health condition (ex: Depression, Anxiety, 
ADD/ADHD) more than one year ago. 
o Adolescent eligibility determined with WHO-5 screening prior to 
pre-intervention survey.   
o Parent(s)/legal guardian(s), 18 years old or order, live with 
adolescents diagnosed with mental health condition(s) 
o Be able to read/write in English. 
• Exclusion Criteria:  
o Children <12 years old or >18 years old  
o Children 12-17 that are wards of the state or any other agency, 
institution, or entity 
o Adolescent scoring <13 and not currently enrolled in mental health 
services, or if the adolescent has answered 0 to 1 to any of the five 
items, on the WHO-5, and not currently enrolled in mental health 
services. 
o Female participants that report they are pregnant before or after the 
start of the study will be excluded from the study. 

o Parent(s)/legal guardian(s) < 18 years old 
o Non-legal guardians 
1.13 Indicate specifically whether you will include or exclude each of the following 
special populations: (You may not include members of the above populations as 
subjects in your research unless you indicate this in your inclusion criteria.) 
• 
Adults unable to consent N/A 
2.0 
Individuals who are not yet adults (infants, children, teenagers): Adolescents, 12-17 years 
old, with a clinical diagnosis of a mental health condition(s). 
• 
Pregnant women N/A 
• 
Prisoners N/A 
Vulnerable Populations* 
2.2 If the research involves individuals who are vulnerable to coercion or undue 
influence, describe additional safeguards included to protect their rights and 
welfare. 
• 
If the research involves persons who have not attained the legal age for 
consent to treatments or procedures involved in the research (“children”), 
review the “CHECKLIST: Children (HRP-416)” to ensure that you have 
provided sufficient information.: See attached checklist. 
Local Number of Subjects N/A 
Recruitment Methods 
2.3 Describe when, where, and how potential subjects will be recruited. If recruitment 
will involve a non-FSU site, describe whether site approval for recruitment is 
required, and attach documentation of site approval.  
• When: Project recruitment will be begin in early October 2022. 
• Where:  
o The setting will be the Intensive Outpatient Behavioral Health 
Program (IOP) and the Partial Hospitalization Program (PHP) and 
Bridge Program at Wolfson Children's Hospital in Jacksonville, 
Florida. 
o Study flyers will also be posted on social media platforms (ex: 
Facebook and Instagram). 
• Baptist Health IRB approval will be obtained.  
• Attached is Wolfson Children’s Hospital’s Nursing Scientific Review 
Committee’s approval letter.  
• How:  
o Contact nurse and program manager in IOP/PHP/Bridge clinic and 
obtain permission to reach eligible participants. 

o Request that IOP/PHP/Bridge manager emails study flyers with 
monthly clinic email. Request placement of flyers in 
IOP/PHP/Bridge clinic. See Appendix C for project flyer.  
o I will not be asking anyone at Wolfson Children’s Hospital for 
names of clients with identified mental health disorders. 
• I will be recruiting through flyers sent via email and staff, posted 
flyers in the facility, and through flyers posted on social media 
platforms.  
• Providers and staff within IOP, PHP, Bridge have agreed to 
provide possible clients meeting the project criteria with the 
information for the study. 
• See Appendix G for HIPAA Authorization form. Refer to section 
17.4 for information regarding how PHI will be protected during 
this project. 
 
2.4 Describe the source of subjects. 
• Intensive Outpatient Behavioral Health Program (IOP), the Partial 
Hospitalization Program (PHP), and Bridge Program at Wolfson 
Children's Hospital 
• As previously mentioned, PHI will not be obtained from the EHR.  
• Study flyers will be posted on various social media platforms. 
2.5 Describe the methods that will be used to identify potential subjects. 
• Request that IOP/PHP/ Bridge manager emails study flyers with monthly 
clinic email.  
• Request placement of flyers in IOP/PHP/Bridge clinic. See Appendix C 
for project flyer.  
• Study flyers will be posted on various social media platforms. 
• This is the eligibility criteria used in the research flyer to recruit the 
potential participants in this study. Parents/Legal guardians will be asked 
and screened for eligibility. They are to complete the screening and 
provide permission for the adolescent prior to the adolescent’s completion 
of the screening.  

Adolescents, 12-17 years old, with a clinical diagnosis of a mental health condition(s) and their 
parent/legal guardian. 
Examples of eligible diagnosed mental health conditions include major depressive disorder 
(MDD), generalized anxiety disorder (GAD), attention-deficit disorder (ADD)/ attention deficit 
hyperactivity disorder (ADHD), bipolar disorder (BPD). 
Adolescents that score below 13 on the World Health Organization (Five) Well-Being Index 
questionnaire or if the adolescent has answered 0 to 1 to any of the five items, they will not be 
allowed to complete the REDCap survey or participate in the project 
Parent(s)/legal guardian(s), 18 years old or order, live with adolescents diagnosed with mental 
health condition(s) 
•  PHI will not be obtained from the EHR. The only PHI information for 
this study will be provided voluntarily through the REDCap survey.  
a. The PHI information provided through REDCap includes: 
i. Name of current mental health diagnoses 
ii. Mental health diagnosis date 
iii. Name of medications 
iv. Date of birth 
o The use or disclosure of protected health information involves no 
more than a minimal risk to the privacy of individuals. 
o Participant names will not be used to link the participants to their 
survey responses. Participants will be linked via the email they 
provide on their REDCap survey. 
2.6 Describe materials that will be used to recruit subjects. (Attach copies of these 
documents with the application. For advertisements, attach the final copy of printed 
advertisements. When advertisements are taped for broadcast, attach the final 
audio/video tape. You may submit the wording of the advertisement prior to taping 
to preclude re-taping because of inappropriate wording, provided the IRB reviews 
the final audio/video tape.) 
• See Appendix C 
2.7 Describe as applicable whether and how subjects will be paid, earn course or other 
credits, reimbursed or provided with any financial or other incentive, token or gift 
for taking part in the research. Include a description and schedule of the total 
amount or value as well as the timing of any payments, credits, reimbursement or 
other incentive, token or gift. Indicate how if at all any amount is pro-rated for 
research visit or activity completion, and whether and how subjects’ refusal to 
answer any question or subjects’ withdrawal from or discontinuing taking part in 
the study or any study activity will reduce or preclude subjects from earning part or 
all of such any payment, credit, reimbursement or other incentive, token or gift. 
Also describe the proposed method (how, by whom, form etc.) of 
payment/disbursement. While payment should not be contingent upon 

completion of the entire study, a proportion or progressive partial payment 
as an incentive for completion of the study is acceptable. 
Refer to this FSU link regarding use of gift cards: 
https://procurement.fsu.edu/vendors/NationalGiftCard. 
Refer to this FSU Controller link regarding use of cash payments for human 
subject incentive payments:  
https://controller.vpfa.fsu.edu/services/accounts-payable/unencumbered-
payments/employee-cash-advance-requests. 
• A $30.00 Amazon E-Gift Card will be emailed to the first 30 adolescent-
parent dyads that complete the post-intervention survey. 
• This will be offered as an incentive to adolescents and their parent(s)/legal 
guardian(s) to complete the education intervention and pre-and post-
survey. 
• Amazon E-Gift Card will be purchased through the SpearMart catalog 
under the supplier National Gift Cards (NGC) 
13.6 N/A 
Withdrawal of Subjects* 
2.8 Describe anticipated circumstances under which subjects will be withdrawn from 
the research without their consent. 
o Children <12 years old or >18 years old  
o Children 12-17 that are wards of the state or any other agency, 
institution, or entity 
o Adolescent scoring <13 and not currently enrolled in mental health 
services, or if the adolescent has answered 0 to 1 to any of the five 
items, on the WHO-5, and not currently enrolled in mental health 
services. 
o Parent(s)/legal guardian(s) < 18 years old 
o Non-legal guardians 
2.9 
N/A 
2.10 Describe procedures that will be followed when subjects withdraw from the 
research, including partial withdrawal from procedures with continued data 
collection. 
• Subject may withdraw from the study at any time. If subjects withdraw 
from the research, any of their data will be destroyed and their collected 
data will not be included in the final data analysis.  
Risks to Subjects* 
2.11 Participants in this project will be at Minimal risk- means that the probability and 
magnitude of harm or discomfort anticipated in the research are not greater in and 

of themselves than those ordinarily encountered in daily life or during the 
performance of routine physical or psychological examinations or tests. 
• Participants may feel embarrassed with some of the questions that I will 
ask 
• Taking the survey and joining the educational presentation may make 
participants tired. 
2.12 
N/A 
2.13 
N/A 
2.14 
N/A 
Potential Benefits to Subjects* 
2.15 Improved nutrition, physical activity, screen time, and sleep education influenced 
by healthy lifestyle knowledge and behaviors. This project intends to improve 
healthy lifestyle knowledge and behaviors among adolescents with a mental health 
condition(s) through preventative and detailed nutritional, physical activity, screen 
time, and sleep education. 
2.16 N/A 
Data Management* and Confidentiality 
2.17 Data will then be analyzed using SPSS version 27.0. Descriptive statistics for 
adolescent and their parent/legal guardian’s demographic characteristics will be 
computed. The analysis of this project will compare changes in healthy lifestyle 
knowledge and behaviors and knowledge using a paired t-test.  
2.18 Describe the steps that will be taken to secure the data (e.g., training, authorization 
of access, password protection, encryption, physical controls, certificates of 
confidentiality, and separation of identifiers and data) during storage, use, and 
transmission. 
• Data will be collected through REDCap survey 
• REDCap allows users to export any and all data from their REDCap 
projects, supposing they have been given full data export privileges.  
• The Data Export Tool also has advanced export features that allow one to 
implement data deidentification methods, such as being able to 
automatically remove free-form text fields, remove dates, perform date 
shifting, and remove fields tagged as identifiers (e.g. PHI) from the data 
file being exported by the user. 
2.19 Describe any procedures that will be used for quality control of collected data. 
• REDCap stores its data and all system and project information in various 
relational database tables (i.e. utilizing foreign keys and indexes) within a 
single MySQL database, which is an open source RDBMS (relational 
database management system). 
• To help protect and secure the data stored in REDCap’s back end 
database, the software application employs various methods to protect 

against malicious users who may attempt to identify and exploit any 
security vulnerabilities in the system. 
• In REDCap, all incoming data gets intentionally filtered, sanitized, and 
escaped. This includes all data submitted in an HTTP Post request and all 
query string data found in every URL while accessing REDCap, among 
other modes through which user-defined data gets submitted in the 
application. Server environment variables that are vulnerable to forgery by 
users are also checked and sanitized. All user-submitted data is properly 
filtered for any possibly harmful markup tags (e.g. <script>) and is then 
escaped before ever being displayed on a web page within the application.  
2.20 Describe how data or specimens will be handled study-wide: 
• 
What information will be included in that data or associated with the 
specimens? 
o REDCap will store pre- and post-intervention survey responses. 
• 
Where and how data or specimens will be stored? 
o REDCap stores its data and all system and project information in 
various relational database tables (i.e. utilizing foreign keys and 
indexes) within a single MySQL database. 
• 
How long the data or specimens will be stored? 
o The data will be destroyed approximately five years after the study 
ends. 
• 
Who will have access to the data or specimens? 
o Rachel Sharp, Dr. Geneva Scott-King, Insu Paek, Ph.D 
• 
Who is responsible for receipt or transmission of the data or specimens? 
o Data will be automatically uploaded into REDCap. 
• 
How data or specimens will be transported? 
o All project data is stored and hosted there at the local institution, 
and no project data is ever transmitted at any time by REDCap 
from that institution to another institution or organization. 
• 
The requested disclosure of PHI is the minimum necessary for research 
purposes. PHI will not be reused or disclosed to any other person or entity, 
or for other research for which the use or disclosure of protected health 
information for which an authorization or opportunity to agree or object is 
not required by 45 CFR 164.512. 
Provisions to Monitor the Data to Ensure the Safety of Subjects* 
18.1 Study data will be sent to the Research Electronic Data Capture (REDCap) program, 
a secure, web-based application stored on a secure server at the Florida State University 
College of Medicine. Only de-identified information will be maintained on the PI’s 
password-protected computer. The data will be accessed only by the PI using a password 
known only to her. The data will be destroyed approximately five years after the study 
ends. 
 

2.21 Describe: 
• This study is considered a clinical trial because it involves human 
participant that are assigned an intervention (there is no control). This 
study is designed to evaluate the effect of the intervention on behavioral 
outcomes. 
• The PI will periodically evaluate the data collected regarding both harms 
and benefits to determine whether subjects remain safe.   
• This study will not engage in any activities that may lead to potential 
injury for participants. 
o The data will be reviewed through REDCap questionnaire. 
o The project intervention includes a 45-minute educational 
presentation via Zoom will include: 5-10 minutes of education 
regarding recommendations versus reality for nutrition, PA, screen 
time, and sleep, 20-25 minutes of education regarding ways to 
improve healthy lifestyle knowledge and behaviors. 
• Data from this study will be collected through REDCap survey. 
• Data collection will only occur during September – November 2022. 
There will be a pre- and post-intervention survey. 
• The PI and Major Professor will review the data. 
• Since there is no risk for harm during this study, there will not be 
statistical tests for analyzing the safety data to determine whether harm is 
occurring. 
• No conditions that trigger an immediate suspension of the research. 
 
 
 
Provisions to Protect the Privacy Interests of Subjects 
2.22 Describe the steps that will be taken to protect subjects’ privacy interests. “Privacy 
interest” refers to a person’s desire to place limits on whom they interact or whom 
they provide personal information. 
• Participants can refuse to answer any question on the survey. 
• Adolescent refusal to answer screening questions regarding mental health 
screening will lead to withdrawal from the study. 
• The requested disclosure of PHI is the minimum necessary for research 
purposes.  
2.23 Describe what steps you will take to make the subjects feel at ease with the research 
situation in terms of the questions being asked and the procedures being performed. 
“At ease” does not refer to physical discomfort, but the sense of intrusiveness a 
subject might experience in response to questions, examinations, and procedures. 

• Participants will be told that this survey is about health and lifestyle 
behaviors. It has been developed so you can tell us what you do that may 
affect your health. The information you give will be used to develop better 
health education for adolescents and their parent(s)/legal guardian(s). 
• DO NOT include your name on this survey. The answers you give will be 
kept private. No one will know your responses. Answer the questions 
based on what you really do.  
• Completing the survey is voluntary. If you are not comfortable answering 
a question, just leave it blank.  
• The questions that ask about your background will be used only to 
describe the types of students completing this survey. The information will 
not be used to find out your name. No names will ever be reported. 
2.24 Indicate how the research team is permitted to access any sources of information 
about the subjects. 
• The research team is only allowed access to the information provided by 
the participants in the REDCap pre-and post-intervention survey. 
Compensation for Research-Related Injury 
• This study will not engage in any activities that may lead to potential 
injury for participants.  
Economic Burden to Subjects N/A 
Consent Process 
2.25 Indicate whether you will you be obtaining consent, and if so describe: 
• 
Where will the consent process take place? 
o Parent(s)/Legal Guardian(s) and adolescent consent will take place 
online through REDCap survey 
o Consent for parent(s)/legal guardian(s) 
a. Appendix D 
• 
Any waiting period available between informing the prospective subject and 
obtaining the consent. 
o No 
• 
Any process to ensure ongoing consent. 
o Continued participation in the project. If participants do not 
continue to provide consent, they simply can refuse to complete 
the project. 
• 
Whether you will be following “SOP: Informed Consent Process for Research 
(HRP-090).”  
• Yes, parent(s)/legal guardian(s) will be provided with Informed Consent. 
Non-English Speaking Subjects N/A 

Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) N/A 
Subjects who are not yet adults (infants, children, teenagers) 
• 
Describe the criteria that will be used to determine whether a prospective 
subject has not attained the legal age for consent to treatments or procedures 
involved in the research under the applicable law of the jurisdiction in which 
the research will be conducted. (E.g., individuals under the age of 18 years.) 
o 
Adolescent participants will be asked to provide month, day, and year 
they were born. 
o 
Parent(s)/legal guardian(s) will be asked to confirm their child’s age in 
their survey. 
o 
If ages provided by Adolescent and Parent/Legal Guardian(s) do not 
match, the adolescent-parent/legal guardian dyad will be withdrawn 
from the study. 
• 
Describe whether parental permission will be obtained from: 
o 
One parent even if the other parent is alive, known, competent, 
reasonably available, and shares legal responsibility for the care and 
custody of the child. 
o 
Parents/legal guardians will be sent the survey via email before the 
adolescent is sent the survey. When parent/legal guardians are sent the 
survey, they will be asked to provide consent for their child to 
participate in the study. If the parent/legal guardian does not provide 
consent, the dyad will be removed from the study. Once 
parents/guardians provide consent, a survey will be sent to the email of 
the child and the child/adolescent will be asked to assent. 
• 
Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission. Describe the 
process used to determine these individuals’ authority to consent to each 
child’s general medical care. 
o Permission can be obtained from an adolescent’s legal guardian. 
o The process to determine the authority to consent to the project 
will be determined by the first question on the parent/legal 
guardian survey 
a. “Are you the parent of legal guardian of the adolescent 
participating in this project?” 
o The survey will then determine the relationship of the parent/legal 
guardian again in the demographic questions. 
a. EX: How are you related to this child? 

Biological Parent 
Stepparent 
Grandparent  
Legal Guardian 
Other: Relative  
Other: Non-Relative 
• 
Indicate whether assent will be obtained from all, some, or none of the 
children. If assent will be obtained from some children, indicate which 
children will be required to assent. 
o Assent will be obtained from all adolescents participating in the 
study. 
o Assent for adolescents 12-13 
a. Appendix E 
o Assent for adolescents 14-17 
a. Appendix F 
• 
When assent of children is obtained describe whether and how it will be 
documented. 
o Assent will be obtained and documented as the first section of the 
REDCap survey. 
• PI will be available via email to answer any questions/concerns 
participants may have regarding the study. 
Prospective subjects should electronically affix their agreement to consent by checking “yes” to, 
“Do you agree to participate in this study,” and providing the date on their consent through the 
REDCap survey. 
The REDCap survey will ask: 
a. Do you agree to participate in this study? If they answer 
yes, it will populate the following prompts: 
i. Today’s date 
1. All the following questions will be marked 
in REDCap as “identifiers” which will limit 
access to PHI when exporting your data. 
2. To maintain privacy, I will not require 
participants to enter their name for informed 
consent. If they check “yes” to, “Do you 
agree to participate in this study,” that will 
be used in lieu of formal name/signature. 

 
Subjects may maintain a copy of their signed, IRB Stamped, consent by downloading a copy of 
the signed consent from REDCap. 
REDCap survey will state, “Copy of informed consent document for download. Please click on 
PDF document below to download and save to your computer. 
Participants will be able to download their survey responses prior to completing the survey. 
b. Consent will be affirmed through REDCap 
i. The REDCap survey will include a signature of 
person obtaining authorization (PI) and today’s 
date. 
c. Investigator accesses the informed consent form (ICF) to 
affirm informed consent, and e-signs their portion. 
d. Participant and investigator each keep a copy of ICF for 
their research. 
o For those who decline the study, REDCap will provide a message 
for those who decline. 
a. The message as follows: Thank you for your interest. If you 
agree to participate in the future, please let us know. You 
can close this window or click on submit below.” 
b. They will still have the opportunity to download copy of 
informed consent. 
c. A PDF copy of the e-Consent will be automatically saved 
in the project’s file suppository (not in the record), which 
can be accessed and downloaded by authorized users as 
needed. 
d. E-Consent Framework will be enabled which: 
i. Includes a certification page at the end of the survey 
ii. Requires respondents to review and confirm 
information an inline PDF copy of the survey to be 
marked as complete. 
iii. Allows versioning of a form. 
 
Cognitively Impaired Adults N/A 
Adults Unable to Consent N/A 
Adults Unable to Consent N/A 
Process to Document Consent in Writing  
Please check attached consents. 

 
Setting 
2.26 Describe the sites or locations where your research team will conduct the research. 
• 
Identify where your research team will identify and recruit potential subjects. 
• The setting will be the Intensive Outpatient Behavioral Health Program 
(IOP) the Partial Hospitalization Program (PHP) and Bridge Program at 
Wolfson Children's Hospital in Jacksonville, Florida. 
• Study flyers will be posted on various social media platforms.   
• 
Identify where research procedures will be performed. 
o Online via REDCap Survey and Zoom-based educational 
intervention. 
• 
Describe the composition and involvement of any community advisory board. 
o N/A 
• 
For research conducted outside of the organization and its affiliates describe: 
o 
Site-specific regulations or customs affecting the research for research 
outside the organization. N/A 
o 
Local scientific and ethical review structure outside the organization. 
N/A 
• 
Describe non-FSU site approval to conduct research at any non-FSU site or 
location and attach approval documentation. If no such approval was 
required, so state and be prepared to provide documentation. Studies 
involving non-FSU sites, institutions, or agencies, such as TMH, CRMC, 
FAMU, state agencies and other organizations, may require those sites' IRB, 
research review or other approvals. Before submitting your studies for FSU 
IRB review, you must contact such sites to ascertain their review requirements 
and comply accordingly. The FSU IRB may require documentation of such 
site contact. Collaborations involving TMH are subject to specific 
requirements; click here for more information.  
o Please see Appendix G: Baptist Health NSRC support letter.  
Resources Available 
2.27 Describe the resources available to conduct the research: For example, as 
appropriate: 
• 
Justify the feasibility of recruiting the required number of suitable subjects 
within the agreed recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit?  
o Nurse and program manager in IOP/PHP/ Bridge clinic will help to 
recruit eligible participants. 
o Goal: 30 adolescent- parent/legal guardian dyads total 

• 
Describe the time that you will devote to conducting and completing the 
research. 
o Early October 2022- Late December 2022/January 2023 
• 
Describe your facilities. 
• Intensive Outpatient Behavioral Health Program (IOP) ,the Partial 
Hospitalization Program (PHP), and Bridge Program at Wolfson 
Children's Hospital in Jacksonville, Florida. 
• Social media platforms such as Facebook and Instagram. 
• 
Describe the availability of medical or psychological resources that subjects 
might need as a result of an anticipated consequences of the human research. 
o Site liaisons at the Intensive Outpatient Behavioral Health Program 
(IOP), the Partial Hospitalization Program (PHP), and Bridge 
Program at Wolfson Children's Hospital will be available for 
psychological resources during the project. 
• 
Describe your process to ensure that all persons assisting with the research 
are adequately informed about the protocol, the research procedures, and 
their duties and functions. 
o Site liaisons will be informed of their role in helping to recruit 
participants for the project. Any other roles and responsibilities 
will be discussed prior to the recruitment process for the project 
via email. Protocol standards will be established via Baptist Health 
NSRC/IRB. 
Multi-Site Research* N/A