Pilot RCT to Evaluate the Effects of a Trust-Building Depression Management Intervention on Moderate Depressive Symptoms in Low-Income Adolescents
Phase: NA
Conditions: Depressive Symptoms, Quality of Life
Sponsor: Case Western Reserve University

Title: Pilot RCT to Evaluate the Effects of a Trust-Building Depression Management Intervention 
on Moderate Depressive Symptoms in Low-Income Adolescents 
 
NCT: 03599141 
 
Date IRB approved: 10/13/2022 
 
 

 
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PROTOCOL TITLE:  Study comparing two depression management interventions for teens with 
depression 
 
PRINCIPAL INVESTIGATOR: 
 
Heather K. Hardin, PhD, RN 
 
Frances Payne Bolton School of Nursing 
 
216.368.5129  
 
hkh10@case.edu 
 
UH FACULTY ADVISOR:  N/A 
 
OTHER DEPARTMENTS INVOLVED IN THIS STUDY:  Department of Psychology 
 
VERSION NUMBER:   
1.16 
 
DATE:  09/28/2022  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Study Comparing Two Depression Management Interventions for Teens with Depression 
 
Objectives 
(1) Our purpose is to test the Trust-building depression Self-Management Together (TRUST) 
intervention among adolescents with moderate depressive symptoms. Our premise is that trust 
can be learned, that increasing trust will improve self-regulation, and improved self-regulation 
will influence depression management behaviors, which will decrease depressive symptoms 
and increase quality of life (QOL). The study aims are:  
Aim 1. Compare the effects of the TRUST intervention with a depression management 
intervention on depression management behaviors (sleep, stress management, medication 
adherence, appointment keeping) and health status (depressive symptoms, QOL) in 
adolescents with moderate depressive symptoms.  
Aim 2. Assess whether the effects of the TRUST intervention on depression management 
behaviors (sleep, stress management, medication adherence, appointment keeping) and health 
status (depressive symptoms, QOL) are mediated by (respiratory sinus arrhythmia [RSA], 
behavioral interaction assessment, adolescent/parent trust self-reports, relationship quality, self-
regulation, family cohesion, social support, decision making, self-efficacy, rumination, 
decentering).  
Aim 3. Assess the effects of potential moderators (gender, race, perceived stress, parental 
monitoring, household income, parent level of education, parenting style, parent stress) on the 
relationship between the TRUST intervention and depression management behaviors and 
health status (depressive symptoms, QOL).  
(2) Hypothesis:  We hypothesize that variations in adolescent/ parent trust-building will predict 
response to the TRUST intervention and depression management behaviors as evidenced by 
change in depressive symptoms and QOL.  
 
Background 
(1) Depressive symptoms are a serious concern affecting the social, academic, and health 
outcomes of 36% of Cleveland adolescents.2 Health disparities exist in depression 
management—with low-income and minority adolescents more likely to forego treatment for 
depression.3 Students enrolled in Cleveland Metropolitan School District (CMSD) schools are 
100% low-income and 84% ethnic minority.6 We are collaborating with CMSD to address health 
disparities in depression management among low income and minority adolescents. Our team 
has an 8-year ongoing relationship with CMSD schools to improve the health of Cleveland’s 
children and their families.  
Depression among adolescents is affected by health behaviors such as sleep, stress 
management, medication adherence, and appointment keeping, as well as quality of 
relationship with parents. Family focused interventions are well established for reducing 
emotional and behavioral problems in adolescents, and function in part, by fostering positive 
adolescent-parent relationships.7 Rotenberg describes adolescents’ trust of their parent as 
made up of: (a) honesty, which is telling the truth and engaging in benign and genuine 
behaviors; (b) reliability, which is perceived compatibility between one’s words and actions; and 
(c) emotional connection, which is the dependence on others to be receptive to disclosures and 
maintain confidentiality of disclosures.8 We are applying this theory as a basis for the TRUST 
intervention used in this study that builds trust between adolescents and their parents, alongside 
depression management behaviors.  
(2) Preliminary data. In this pilot RCT, we are evaluating the effects of the novel TRUST 
intervention to improve depression management behaviors in adolescents with depressive 
symptoms. PI Hardin has shown that low interpersonal trust is associated with risky health 
behaviors5 and high depressive symptoms in low income adolescents.4 Recent studies indicate 

 
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that self-regulation is a core aspect of positive relationships,9 trust,10 and healthy behaviors.11 
RSA is an indicator of heart rate variability in response to respiration,12 which is a marker of self-
regulation.11,13 We will assess RSA during a behavioral assessment of the quality of adolescent-
parent interaction using microsocial coding approaches.14,15 Co-I Connell has shown that RSA is 
associated with mutual positive affect16 and emotion regulation15 in adolescent-parent behavioral 
interactions. 
 
Inclusion and Exclusion Criteria 
(1) Screening. Using an existing collaboration with the CMSD school system, participants will 
be recruited via advertisements in parent meetings at CMSD schools and social media. 
Candidates whose parents indicate interest by phone call, email, message, or completing an 
online prescreening tool will be contacted using an IRB approved script to recruit, screen, and 
enroll participants. Adolescents will complete the PHQ-8 measure of depressive symptoms over 
the phone or by REDCap link on a tablet computer. A PHQ8 score >8 and <20 will be 
considered for study inclusion. Screening the adolescent with the PHQ8 confirms that the 
adolescent currently has moderate depressive symptoms and will occur during the screening 
process, prior to consent/assent. We have requested a waiver of consent on page 7 for 
screening purposes.  
 
 
(2) Inclusion (adolescent) 
1. 
A Cleveland Metropolitan School District student 
2. 
Ages 14-17 years old 
3. 
Reports diagnosis of depression 
4.  Reports moderate depressive symptoms (PHQ-8 score >8 and <20) 
5. 
Able to read, speak, and understand the English language 
 
Inclusion (parent/guardian) 
1. 
Female parent/guardian 
2. 
Able to read, speak, and understand the English language 
 
 
(3) Exclusion (adolescent) 
1. 
Current suicide risk 
2. 
Diagnosis with bipolar disorder, schizophrenia, or a personality disorder 
3. 
Sever behavioral problems that preclude group participation (as reported by 
parent) 
4. 
Family plans to move from the region within one year 
 
Exclusion (parent) 
1. 
Family plans to move from the region within one year 
 
Number of Research Participants 
(1) N = 30 adolescent/parent dyads  
(2) Single site study, N/A 
 
Vulnerable Populations 
(1) Vulnerable populations included are:   
 
☐ 
Adults unable to consent 
 
☒ 
Minors (infants, children, teenagers)  
 
 
☐ 
Wards of the state 
 
 
☐ 
Foster Children 
 
☐ 
Pregnant Women  

 
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☐ 
Neonates  
 
☐ 
Employees of CWRU or UHHS 
 
☐ 
Prisoners 
 
☐ 
Illiterate Individuals 
 
☐ 
Non-English Speaking 
 
☐ 
University Students 
 
(2) Minors will be recruited with permission of the parent/guardian during the process of 
informed consent with assent designated for acceptance by the minor. Minors are the 
participant of interest, since this is a pediatric study targeting adolescent participants with 
depression. The consent/assent document was designed with adolescents in mind, including 
simple and clear lay language to promote respect for (minor) persons with shared 
consent/assent decision-making between parent and adolescent. Drs. Hardin and Connell have 
conducted previous research protocols that involve adolescent-parent dyads and have 
experienced research assistants and established protocols for quality assurance, crisis 
intervention and referral, as well as initial and ongoing staff training. The research assistants 
hired for this project will have prior experience working with adolescent-parent dyads.  
Risks associated with study procedures (surveys, behavioral interaction, RSA) are not 
greater than encountered in daily life and will be minimized with careful attention to adolescent 
participant needs. There is the potential for stigmatization due to depression diagnosis; 
however, measurements are taken in private and all results are reported privately in a sensitive 
and culturally appropriate manner. If questionnaires indicate symptoms suggestive of severe 
depression or suicidal ideation, the results will be reviewed with Dr. Arin Connell, Ph.D. (co-
investigator, licensed clinical psychologist, #6732) who will consult with the adolescent and/or 
parent/guardian to determine whether the adolescent or parent/guardian is in need of a referral 
for further evaluation and treatment. The nature of this study includes adolescents with a 
diagnosis of depression. If the adolescent becomes upset during study procedures, a study 
research assistant and the participant’s parent will be available to support and comfort the 
adolescent participant if needed. The adolescent/parent dyad will be given an information sheet 
with the number of United Way First Call (211) to access on call mental health professional 
services in their local area or Cuyahoga County 24-Hour Mental Health Crisis Information and 
Referral Hotline (216-623-6888). If the participant is unable to be comforted by the research 
assistant or the parent and further assistance is required, the Mobile Crisis Team from the 
Cuyahoga County 24-Hour Mental Health Crisis, Information, and Referral Hotline will be 
contacted immediately. In addition, our Data and Safety Monitoring Committee (DSMC) will 
include an individual with expertise and experience conducting research studies with minor 
participants.  
(3) Pregnant women are not targeted for inclusion in this study, but will not be excluded in this 
study. Non-English speaking individuals will be excluded in this study. At this time, our study 
does not have the means to accommodate non-English speaking participants. This is a small 
(N=30), proof of concept, pilot study conducted by an early stage investigator. Once our team 
has evidence that trust-building interventions are effective, we will expand our reach with larger 
studies, which will include non-English speaking families.  
 
Recruitment Methods 
(1) The target population are CMSD school students 14-17 years old diagnosed with depression 
and a parent. CMSD has 41 high schools enrolling approximately 10,000 students 14-17 years 
old. According to a recent screening, approximately 36% of CMSD high school students 
reported depressive symptoms, which is approximately 3,600 students ages 14-17 years old.  

 
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(2) Using an existing collaboration with the CMSD school system, participants will be recruited 
via mailed invitation letters, advertisements in parent meetings at CMSD schools, community 
events/locations, on the public bus system, and social media. Due to COVID-19  safety 
restrictions, in person recruitment will follow all guidance made by local government (wearing 
masks, washing hands, or stay at home when appropriate). Parents of participants in our 
previous studies that have consented to notifications of future research will be mailed or emailed 
study information letters and study flyers.  
(3) Frances Payne Bolton School of Nursing investigators have used this recruitment approach 
in a depression management study in which 52 adolescents were recruited in one year. Our 
study aims to enroll 30 adolescent/parent dyads. Candidates whose parents return a phone call, 
message, or online prescreener indicating interest will be contacted using an IRB approved 
script to recruit, screen, and enroll participants.  
(4) Study flyers will be provided to school nurses, school administrators, and school guidance 
counselors for distribution to parents either electronically or, once restrictions associated with 
the COVID-19 pandemic are lifted, in-person. Similarly, once restrictions associated with the 
COVID-19 pandemic are lifted, we will also use traditional methods of recruiting and flyer drops, 
targeting community venues including branches of the local public library, commercial retail 
outlets, and community parks, recreational facilities, and places of congregation (e.g., churches, 
temples). Public bus advertisements will include paid advertising on the interior of the bus, 
aimed at bus riders. These materials will be used to recruit participants during visits with school 
staff, during visits to community venues, and while riding the public bus system.  
 (5) Advertisements on public buses and Facebook will include a brief description of the study 
eligibility and study contact information, while flyers and brochures will include greater details 
about the study, eligibility, and contact information. The study recruitment materials are attached 
with this application.  
Facebook advertisements will be used to advertise the study and evaluate potential eligibility for 
the study (See Facebook Level Up study advertisement attached). This Facebook 
advertisement will be targeted to parents of adolescents 14-17 years old attending a Cleveland 
Metropolitan School District school. The Facebook advertisement will be linked to a 
prescreening tool in REDCap to evaluate potential eligibility for the study. Facebook 
advertisements will take four forms:  1) study advertisements, 2) fun posts, 3) page shares, and 
4) targeted advertising. Examples of Facebook advertisements and the prescreening form are 
attached with the study application.  
A. Study advertisements. We plan to periodically post the following Level Up study 
advertisements on our study Facebook page to assist in recruitment and keep the page 
active: 
a. “Greetings from the Level Up team at Case Western Reserve University Frances 
Payne Bolton School of Nursing! We are actively recruiting for our program 
helping parents and teens feel better. If you have a 14-17 year-old teen enrolled 
at a Cleveland Metropolitan School District school and would like more 
information about our program, please give us a call. Our office phone is 216-
368-5129, and our email address is levelup@case.edu.  We look forward to 
hearing from you!” 
b. “Are you the parent or guardian of a teen ages 14-17 years attending a 
Cleveland Metropolitan School District school? Would you and your teen like to 
join a program to learn how to live healthier and feel better? Simply click the blue 
“Sign Up Now” button, fill out the form, and one of our study team members will 
be in contact with you soon. Participants will be compensated for their time.” 
c. “We are looking for parents and guardians of teens ages 14-17 years living in the 
Cleveland Metropolitan School District who are interested in joining our healthy 

 
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living program. If you are interested, please feel free to contact us or click on the 
“Sign Up Now” button. Participants will be compensated for their time.” 
B. Fun posts. We will make fun Facebook posts to maintain presence and activity of our 
Facebook page. For example, we may make posts about secular holidays such as, 
“Wishing Cleveland families a Happy New Year!”  
C. We will ask other pages to share our page or recruitment posts with their followers. 
These other pages include Frances Payne Bolton School of Nursing, the Cleveland 
Metropolitan School District, local parent groups, local community groups, local 
churches, and national parenting groups.   
D. We will also use paid, targeted advertising on Facebook. These ads will target parents of 
high school age children in Cleveland.  
With the online prescreener form, parents will be contacted for further screening if the 
following conditions are met:  1) parent indicates interest in the study, 2) parent indicates 
concern about their teen’s stress/mood, and 3) parent provides their contact information. 
 
Setting 
(1) Due to restrictions associated with the COVID-19 pandemic, this study will be delivered in a 
remote format. Enrolled families will complete surveys via an electronic device connected to the 
internet, and intervention sessions will similarly be offered in a virtual (phone or video 
conferencing) format. When restrictions associated with the COVID-10 pandemic are eased, the 
survey, behavioral, RSA, and intervention components of this study will be conducted in 
research laboratories at the Frances Payne Bolton School of Nursing and the Department of 
Psychology at Case Western Reserve University. The intervention session component of this 
study will be conducted at private community locations (e.g., library meeting rooms) that are 
convenient for enrolled study participants once covid-19 restrictions are eased. (2) Using an 
existing collaboration with the Cleveland Metro School District, participants will be recruited from 
parent meetings, the community at large, public bus system, and Facebook advertisements.  
(3) Due to the COVID-19 pandemic, assent/consent will be obtained online using a REDCap 
survey facilitated by a phone call with a research assistant to verify understanding of the study. 
When restrictions associated with the COVID-19 pandemic are eased, assent/consent will be 
obtained in-person using the following process. First, consent/assent will be obtained at either 
PI Hardin’s research space at the School of Nursing or Dr. Arin Connell’s research space at the 
Department of Psychology. Next, participants will complete surveys on tablet computers either 
PI Hardin’s research space at the School of Nursing or Dr. Arin Connell’s research space at the 
Department of Psychology. Parent/teen dyads will then be taken to Co-I Connell’s lab at the 
Department of Psychology where they will be seated in comfortable chairs in separate, quiet 
research rooms. Research assistants will then provide an overview of the physiological 
equipment, including the manner of attaching all recording sensors.  
 
Consent Process 
Indicate whether you will be obtaining consent: 
☒ Yes  
☐ No 
 
We will recruit participants using an IRB-approved protocol. All participants will be required 
to give informed written assent/consent to participate in the project. Assent will be obtained from 
adolescent participants and consent will be obtained from the parents. No waiting period will be 
required between screening and consent. Trained research personnel will read, review, and 
discuss assent/consent forms with all potential participants prior to asking them to sign. It is 
anticipated that it will take approximately 30 minutes to complete the consent/assent process, 
but participants may take as long as they need to make a decision. Participants that seem 

 
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unsure about consent/assent will be encouraged to discuss it at home and contact us once a 
decision is made. If the candidate appears confused or indicates a lack of understanding, the 
interviewer will attempt to identify the misunderstanding and to explain the form again. Any 
candidate who still does not comprehend the form will be excluded from the study. We will ask 
questions to confirm understanding of the material covered in the assent/consent procedure 
(e.g., “Could you tell me what’s going to happen if you take part in the study?”). Trained 
research personnel will witness and date the signed forms. Assent/consent procedures will take 
place in a private room or office. PI Hardin will keep assent/consent forms in a secured file 
cabinet within a locked room. At each study visit, study personnel will ask participants about 
their experience in the study (i.e. “How are things going for you in the study?”) and ask if they 
understand what is happening in the study (i.e. “Do you know why you’re here today?” or Do 
you have any questions about the study?”). 
 
As consent is an ongoing process, subjects in the study may need to be re-consented/re-
assented to inform them of new study information and reaffirm their willingness to continue 
participating in the research. National and local guidance recommends the use of the least 
burdensome approach for re-consenting/re-assenting a subject.42,43 The Office of Human 
Research Protections (OHRP) guidance for re-consent/re-assent will be followed,44 which 
includes re-consenting/re-assenting active participants and verbal communication with 
documentation in the study record for participants who have already completed all study 
activities.  
The following is a list of how data will be handled following attempts to re-consent/re-assent. In 
the event that an active participant does not complete re-consent/re-assent, their participation in 
the study will be ended and their data will not be used for analysis. For subjects who have 
completed all study activities and select not to re-consent/re-assent, their data will not be used 
for any new analyses. With a subject who has completed all study activities and cannot be 
contacted for re-consent/re-assent, only the survey data included in previous IRB approvals 
(depressive symptoms, covid-19 anxiety) will be used for data analyses. Finally, all subjects 
who are re-consented/re-assented and reaffirm their willingness to continue participating in the 
research will have all data included in data analyses.   
 
Waiver or Alteration of Consent Process or Documentation  
☒ I will obtain consent, but request a waiver for pre-screening purposes. 
(1) The online prescreener and screening phone call cannot be practicably conducted without a 
waiver of consent/assent for a number of reasons. The information collected for the prescreen 
does not involve any actual intervention or experimentation. Families will only have a 
prescreening done if they are volunteering to learn more about participating in the study. The 
purpose of the pre-screening is to clarify the dyad’s eligibility for the study prior to arranging a 
baseline visit to the lab space at Case Western Reserve University. This is necessary to avoid 
scheduling dyads for baseline visits only to find that they are not eligible, a situation that, if 
avoidable, would anger and disappoint families. Our community advisory board recommended 
that the process of prescreening be efficient and non-burdensome for families, and the 
proposed approach is designed to be consistent with their recommendations. It also avoids 
inappropriate use of CWRU resources. Further, no data will be collected except those pertaining 
to eligibility. To require full consent/assent would create temporal and perceptual impediments 
for families who would otherwise be interested in participating and would likely reduce 
community engagement in the project substantially. Furthermore, the waiver applies only to the 

 
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prescreening by phone, online, or in person visit. All those eligible and wanting to take part in 
the project will compete a full consent/assent prior to beginning the study.  
 
Additional Considerations for Consent Process with Adults 
Non English Speakers:  Not applicable. With this small (N=30), proof of concept, exploratory 
pilot study, we are including only those who can speak, read, and understand the English 
language. Once effectiveness of the intervention has been established, we will include non-
English speakers. We intend to develop a Spanish version of this intervention for use in future 
replication studies, once effectiveness of the intervention has been established.   
Adults Unable to Consent:  Not applicable. The interventions under evaluation in this study are 
social/behavioral in nature and require the ability to read, speak, and understand language, in 
addition to interacting one-on-one and in a group setting.  
 
Research Participants Who Are Not Yet Adults (teenagers) 
Parental permission be obtained from: 
☒ 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.  
(1) With the non-invasive, low-risk nature of this study with potential for participant benefit, we 
will require parental/guardian permission and involvement of only one parent/guardian. The 
screening form will ask both the parent/guardian and adolescent for confirmation that the parent 
providing consent is a legal parent/guardian of the child. Parental consent will be recorded with 
the either the selection of the “yes” checkbox in the electronic consent process during the 
COVID-19 pandemic or with the parent’s signature on the assent/consent form once restrictions 
associated with the COVID-19 pandemic are eased. 
(2) All minor adolescents (ages 14-17) will require consent of a parent or legal guardian. All 
minor adolescents (ages 14-17) will require assent.  
(3) Assent will be recorded with the either the selection of the “yes” checkbox in the electronic 
consent process during the COVID-19 pandemic or with the adolescent’s signature on the 
assent/consent form once restrictions associated with the COVID-19 pandemic are eased. 
Assent will be recorded with the adolescent’s signature on the consent/assent form. The 
consent/assent form has been designed with simple language appropriate for both adults and 
teens. A single consent/assent form treats participants ages 14-17 as autonomous individuals 
able to make decisions for their participation, while reducing burden on families with multiple 
documents.  
(4) Re-consent/assent addendum.  
 
Sharing of Results with Research Participants 
We will not be providing individual results to participants’, however, general group results will be 
shared with participants at the end of the study, or as needed if the results may influence their 
decision to remain in the study.   
 
Study Design, Procedures, and Timeline 
(1) Study Design. We will use an exploratory 2-group pilot RCT to investigate the hypothesized 
effects of the TRUST intervention on depressive symptoms, QOL, sleep, stress management, 
medication adherence, and appointment keeping at 3 months and 6 months in comparison to 
the effects of a Depression Management Intervention.  
(2 & 3) Research Procedures will include: 
a. Recruitment and Informed Assent/Consent: We will recruit participants using an IRB-
approved protocol. All participants will be required to give informed written 
assent/consent to participate in the project. During the COVID-19 pandemic, we will be 

 
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obtaining assent/consent online via REDCap. Research assistants will read, review, and 
discuss assent/consent forms with all potential participants prior to asking them to sign. 
If the candidate appears confused or indicates a lack of understanding, the interviewer 
will attempt to identify the misunderstanding and to explain the form again. Any 
candidate who still does not comprehend the form will be excluded from the study. We 
will ask questions to confirm understanding of the material covered in the assent/consent 
procedure (e.g., “Could you tell me what’s going to happen if you enroll in the study?”). 
Interviewers will witness and date the signed forms. Assent/consent procedures will take 
place in a private room or office. PI Hardin will keep assent/consent forms in a secured 
file cabinet within a locked room. Participants will be enrolled in blocks of 10 dyads, 
using a block randomization scheme to assign each of the 10 dyads to either study 
group. Once a group of 5 is filled, weekly intervention sessions will begin. 
b. Questionnaires: Survey data will be collected using REDCap on a tablet computer. 
Measures used in the study are listed in the Table below. Due to restrictions associated 
with the COVID-19 pandemic, parents and adolescents will be asked to answer 
questions privately and at approximately the same time point on an electronic device 
connected to the internet in their homes. If, for example, only one electronic device is 
able to connect to the internet, the adolescent can complete the survey and then pass 
the device to the parent for survey completion. We are assessing families for internet 
access and device availability in the screening form. For families that do not have a 
device, we will mail them a tablet that they will mail back to us at the end of the study.  
 
Study Variables, Measures, and Data Collection Points 
ADOLESCENT SURVEY 
 
Variable 
Instrument 
Title on Survey 
B 
3M 
 
6M 
 
Depressive 
symptoms 
Patient Health Questionnaire-819 
Depression Questions 
X 
X 
X 
Quality of life  
Youth Quality of Life-Short Form21 
Quality of Life Questions 
X 
X 
X 
Sleep  
PROMIS sleep disturbance-425 
Children’s Report of Sleep 
Patterns22 
Sleep Questions 
More Sleep Questions 
X 
X 
X 
X 
X 
X 
Stress management  
Adolescent Lifestyle 
Questionnaire—stress 
management subscale23 
How do you handle your 
stress? 
X 
X 
X 
Medication 
adherence  
Extent of Medication Adherence24 
Medication Questions 
X 
X 
X 
Appointment keeping  
Hill-Bone Compliance Scale25 
Appointment Questions 
X 
X 
X 
Biologic Trust  
 
Respiratory sinus arrhythmia13 
Not applicable— 
assessment in lab 
X 
X 
 
Behavioral Trust 
Behavioral interaction 
assessment14 
Not applicable— 
assessment in lab 
X 
X 
 
Cognitive Trust 
Children’s General Trust Scale26  
 
Children’s Trust 
Questions 
X 
X 
X 
Cognitive Trust 
Parent Trust of Child Scale—
Adolescent perceived27 
Parental Trust Questions 
X 
X 
X 
Relationship quality 
Inclusion of Other in Self28 
How close are you with 
your parent? 
X 
X 
X 
Self-regulation  
Positive and Negative Affect 
Schedule29 
Emotion Questions 
X 
X 
X 

 
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Note. B = baseline, 3M = 3 months, 6M = 6 months 
 
We are also providing families with information about free or reduced cost internet 
access and free internet hot spots in the community (attached). Once restrictions 
associated with the COVID-19 pandemic are eased, in-person data collection will 
resume. Parent and adolescent will simultaneously answer questions on separate 
computers in a private room. This is intended to allow both to answer questions privately 
and to prevent parents from interfering with adolescent responses. During social 
distancing due to novel coronavirus-19, we will email a link to the questionnaire to 
participants. All materials will be assigned a unique number that will be used to link data 
over time. A master list linking the ID number to the participant’s name will be kept in a 
password-protected computer file, in a locked office, at the local site. This list will be kept 
entirely separate from the data so that responses cannot be linked to the individual 
participant.  
 
c. The risks associated with gathering information from participants by properly trained and 
supervised research assistants are low. Participants may experience discomfort by 
Family cohesion 
Brief Family Relationship Scale30 
Family Relationship 
Questions 
X 
X 
X 
Rumination  
Children’s Response Style 
Questionnaire32 
How do you handle 
sadness? 
X 
X 
X 
Self-efficacy  
PROMIS Self-efficacy - Youth31 
Getting stuff done 
questions 
X 
X 
X 
Decentering 
Experiences Questionnaire33 
Self-awareness 
Questions 
X 
X 
X 
Demographics 
Demographics questionnaire 
Who are you? 
X 
 
 
Perceived stress  
Perceived Stress Scale-Peds34 
Stress Questions 
X 
X 
X 
COVID anxiety  
COVID anxiety-5 
COVID anxiety 
X 
X 
X 
Anxiety symptoms  
PROMIS-25 Pediatric19 
Health Questions 
X 
X 
X 
Executive function  
Pediatric Cognitive Function Short 
Form35 
Thinking Questions 
X 
X 
X 
Parenting monitoring  
Parental Monitoring Scale36 
How much do your 
parents keep an eye on 
you? 
X 
X 
X 
PARENT SURVEY 
Biologic Trust  
 
Respiratory sinus arrhythmia13 
Not applicable— 
assessment in lab 
X 
X 
 
Behavioral Trust 
Behavioral interaction 
assessment14 
Not applicable— 
assessment in lab 
X 
X 
 
Cognitive Trust 
Parent Trust of Child Scale—
Parent27 
Parent’s Trust of Child 
Questions 
X 
X 
X 
Relationship quality 
Inclusion of Other in Self28 
How close are you with 
your teen? 
X 
X 
X 
Relationship quality      Parent-Child Coercion Scale37 
Parent-Child 
Communication 
Questions 
X 
 
X 
 
X 
 
Demographics 
Demographic questionnaire 
Who are you? 
X 
 
 
Parenting style  
Alabama Parenting Questionnaire-
Shor)38 
Parenting Style 
Questions 
X 
X 
X 
Parent stress  
PROMIS Perceived Stress Scale34 
Stress Questions 
X 
X 
X 
General health  
PROMIS-2519 
General Health 
Questions 
X 
X 
X 

 
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some questions assessing stress and depression. In prior research, we have used these 
measures or similar measures with this adolescent-parent dyad population and found 
that adolescent-parent dyads were comfortable with the interviews. However, all 
participants will be instructed that they can stop the interview at any time or can choose 
to skip any question that they wish. Our investigators and staff are experienced 
interviewers in research involving adolescent-parent dyads, and we have rarely 
encountered participant reactions more adverse than transient awkwardness, 
embarrassment, or mild discomfort. If questionnaires indicate symptoms suggestive of 
severe depression or suicidal ideation, the results will be reviewed with Dr. Arin Connell, 
Ph.D. (co-investigator, licensed clinical psychologist, #6732) who will consult with the 
adolescent and/or parent/guardian to determine whether the adolescent or 
parent/guardian is in need of a referral for further evaluation and treatment. The nature 
of this study includes adolescents with a diagnosis of depression. If the adolescent 
becomes upset during study procedures, a study research assistant and the participant’s 
parent will be available to support and comfort the adolescent participant if needed. The 
adolescent/parent dyad will be given an information sheet with the number of United 
Way First Call (211) to access on call mental health professional services in their local 
area or Cuyahoga County 24-Hour Mental Health Crisis Information and Referral Hotline 
(216-623-6888). If the participant is unable to be comforted by the research assistant or 
the parent and further assistance is required, the Mobile Crisis Team from the Cuyahoga 
County 24-Hour Mental Health Crisis, Information, and Referral Hotline will be contacted 
immediately.  
d. Cheek swab DNA test:  The cheek swab DNA test is canceled due to COVID-19. The 
cheek swab DNA test includes swabbing the parent and adolescents’ cheek with 
separate sterile cotton swabs. Participants can remain in the study, but opt out of the 
DNA test, if they choose. Participants will be assured that we will not use the data for 
paternity testing. The sensation of a cotton swab in the mouth may feel uncomfortable 
for some. We will allow participants to swab their own cheek under guidance of study 
staff, if they prefer.  
e. Saliva sample collection: The saliva sample portion of the study is canceled due to 
COVID-19. Saliva will be collected in a tube to measure salivary oxytocin. Fifteen 
minutes pre/post the dyadic behavioral interaction, measures of salivary oxytocin levels 
of both adolescents and parents will be collected using Salivattes and stored at -80 
degrees centigrade until processed and analyzed. Study staff will provide guidance to 
participants on how to provide the saliva sample. Spitting into a tube may be 
uncomfortable for some participants. Participants can remain in the study, but opt out of 
the salivary sample collection, if they choose. 
f. 
Behavioral interaction assessment:  The behavioral interaction is currently on pause 
and will only occur following the easing of restrictions associated with the COVID-19 
pandemic. During the behavioral interaction assessment lab visit, adolescents and 
parents are seated facing each other and will first complete a five-minute paced 
breathing task, which serves as a baseline period for physiological indices, and four 5 
minute discussions tasks on family-related matters. The tasks include discussion of 
family problems, and planning a positive family activity, and have been used in prior 
trials and shown to relate to emotion self-regulation capacity and adaptive coping by 
members of our study team.28,31 Interaction tasks will be digitally recorded using a 
Noldus video capture system. The behavioral interaction assessment may seem 
awkward and uncomfortable to some participants. The paced breathing task and a 
practice discussion question are intended to help participants acclimate to the behavioral 
interaction assessment. Participants may opt out of the use of audio/video capture of the 

 
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interaction. If participants refuse the use of the audio/video recording, study staff will 
make notes of the interaction instead.  
g. Respiratory sinus arrhythmia: The RSA is on pause and will only occur following the 
easing of restrictions associated with the COVID-19 pandemic. Heart rate and 
respiration will be collected simultaneously during the paced breathing and discussion 
tasks, from parent and adolescent, using a Biopac MP150 system and Acqknowledge 
Software.72 To collect heart rate and respiratory rate, we will apply cardiac leads to the 
bare chest of both parent and adolescent. This may be uncomfortable for some 
participants. To reduce discomfort and maintain privacy, the cardiac leads will be placed 
on the participants in a private room and by a same gendered study staff member, if 
requested.  
h. Intervention group protocol: Due to restrictions associated with the COVID-19 
pandemic, we will deliver both types of interventions in remote format wherein parents 
and adolescents will review video recordings of the materials, engage in exercises, and 
complete pre- and post-test to ensure engagement. Following the easing of restrictions 
associated with the COVID-19 pandemic, we will resume offering in-person sessions 
with parent-adolescents in groups of approximately five dyads. Each of eight 90-minute 
weekly sessions of the TRUST intervention will include both a trust-building topic and a 
depression management topic. Trust-building topics include honesty, reliability, and 
emotional connection.8 The honesty portion will include discussion and practice of 
disclosing personal truths and receptivity of others’ disclosures. The reliability portion will 
include discussion and practice of making and keeping promises. The emotional 
connection portion will include discussion of adolescent-parent similarities and bonding 
activities like hugging and eye contact. The depression management portion will focus 
on sleep, stress management, medication adherence, and appointment keeping skills. 
The intervention will build depression management knowledge, set personal and dyad 
goals, and practice self-monitoring. Goal-setting and self-monitoring of progress are also 
forms of making and keeping promises, thus connecting and reinforcing the concepts of 
trust and depression management techniques. The Depression Management group 
will receive 8 sixty-minute weekly sessions that include the only the depression 
management training (sleep, stress management, medication adherence, appointment 
keeping) described above. Both intervention groups will be led by interventionists with 
health behavior change training. 
The interventionist will have a teaching plan with guidelines on time use for TRUST 
topics. Each session will include a trust-building topic and a depression management 
topic, a discussion portion and a practice portion. With the trust building portion, we will 
focus on honesty, reliability, and emotional connection. For example, the Honesty 
portion will teach adolescent and parent to share personal details about themselves 
without judging one another. Parents often get upset when their adolescent shares 
personal details with them and then jump to conclusions, judgment, and reprimands, 
which breaks down trust. The intervention will discuss this, then have adolescent-parent 
dyads practice sharing small truths and being receptive to those disclosures. With the 
Reliability portion, we'll discuss that reliability means following through on your word. 
Dyads will make small promises to one another, then try to follow through on keeping the 
promises in the week between sessions. Emotional Connection is built when each 
person is receptive to disclosures and keeps promises.  
  
With the depression self-management portion, we will focus on stress 
management, sleep, medication adherence, and appointment keeping only. We will 
discuss why these topics are important to health and identify ways to improve them. 
Each adolescent-parent dyad will set goals to improve in each of these areas, then 

 
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identify a way to do that. For example, with stress management it could be taking a walk 
to de-stress, with sleep it might be giving up screen time one hour before bed. Making 
goals and keeping them is also a form of making promises and keeping them--thus 
connecting and reinforcing the concepts of trust and a healthy lifestyle. 
  
We will conduct fidelity monitoring of the intervention groups. Each session of the 
TRUST intervention will be audio-recorded. Half of the sessions will be randomly 
selected for review using an investigator-developed fidelity checklist composed of the 
key elements of the intervention 26. Fidelity will be assessed by checking that each of the 
assigned topics from the teaching plan are discussed during the appropriate meetings.  
 
This is a social/behavioral research study. No drugs or devices will be tested as interventions 
with the research participants. No source records, such as medical or educational records, will 
be used to collect data about participants. 
 
(4) Study Procedures and Time Requirement:   
  
ClinicalTrials.gov Information  
Has this study been registered on ClinicalTrials.gov?  
☒  Yes.  Provide the following: 
i. The ClinicalTrials.gov identifier:  00220503 
ii. Investigator/sponsor responsible for registering: Heather K. Hardin 
☐  No.  Explain if there are plans to register or why registration is not required. 
 
List of Data to be Collected 
1. Indicate what identifiers you will collect 
☒ 
Name 
☒ 
Address 
☒ 
Dates related to an individual (birthdate) 
☒ 
Telephone number 
☐ 
Fax number 
☒ 
Email address  
 
Estimated time requirement 
Study Procedures 
Group 1 
Group 2 
Prescreening 
5 minutes 
5 minutes 
Screening 
30 minutes 
30 minutes 
Study Visit 1 (Baseline) 
30 minutes 
30 minutes 
Intervention week 1 
45 minutes 
1 hours 
Intervention week 2 
45 minutes 
1 hours 
Intervention week 3 
45 minutes 
1 hours 
Intervention week 4 
45 minutes 
1 hours 
Intervention week 5 
45 minutes 
1 hours 
Intervention week 6 
45 minutes 
1 hours 
Intervention week 7 
45 minutes 
1 hours 
Intervention week 8 
45 minutes 
1 hours 
Study Visit 2 (3 months) 
30 minutes 
30 minutes 
Study Visit 3 (6 months) 
30 minutes 
30 minutes 
Total 
8 hours 5 minutes 
10 hours 35 minutes 

 
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☐ 
Social security number 
☐ 
Medical record number 
☐ 
Health plan beneficiary number 
☐ 
Account number 
☐ 
Certificate/license number 
☐ 
Any vehicle or other device serial 
☐ 
Device identifiers or serial numbers 
☐ 
Web URL 
☐ 
Internet protocol (IP) address 
☒ 
Finger or voice prints 
☒ 
Photographic (video) images 
☐ 
Other: Any characteristic that would uniquely identify the individual 
 
 
 
 
Data Analysis Plan 
(1) Statistical Analyses. Each participant will be assigned a unique identifier for tracking 
purposes and all raw data will be uploaded to the secure database in REDCap. We will explore 
all variables using descriptive statistics. To address the Aims 1-2, we will use a linear mixed 
effects model. To address Aim 3, we will apply usual mediation techniques. 
 
Confidentiality of Specimens and Banking 
Salivary specimens and cheek swabs are canceled due to Covid-19. Specimens collected prior 
to Covid-19 were handled as follows. Salivary specimens and cheek swabs will be collected and 
banked until full processing can occur. The specimens will be stored in the Frances Payne 
Bolton School of Nursing biomarker laboratory. Specimen testing is funded with internal monies; 
therefore, specimens will not be transferred to other researchers at this time.  
Saliva specimens will be obtained from each adolescent at baseline and 3-month data 
collections. The saliva samples will be collected by study personnel and labeled with the 
participant’s alpha-numeric study identification code. Fifteen minutes pre/post the dyadic 
behavioral interaction assessment, measures of salivary oxytocin levels of adolescents will be 
collected using SalivaBio passive drool salivary collection kits (Salimetrics LLC, State College, 
PA). Salivary samples will immediately be placed on ice, transported to the laboratory by study 
personnel, and transferred to a locked -80°C freezer until processed and analyzed. Time from 
collection to freezing will be less than 1 hour. Salivary specimens will be processed per 
standard operating protocols to minimize non-biological technical bias. Salivary specimens will 
be stored for approximately 1 year, until enough samples have been collected to fill a single 
assay plate. Only study personnel will have access to the specimens. The remainder of the 
specimens will be destroyed after analysis. The salivary oxytocin testing is funded with internal 
funding and will not be transferred to other researchers.  
Cheek swabs obtained by a Registered Nurse research assistant will be collected only a 
single time during the study and will be used for OXTR genotyping. The Registered Nurse 
research assistant will obtain the cheek swabs, label them with the participant’s alpha-numeric 
study identification code, transport them to the lab at the Case Western Reserve University 
Frances Payne Bolton School of Nursing, and preserve them in lysis buffer until DNA extraction. 
OXTR rs53576 will be genotyped using the TaqMan genotyping platform. The TaqMan 
Genotyping Assay and TaqMan Genotyping Master Mix will be ordered from Thermo Fisher 
Scientific (Thermo Fisher Scientific, Waltham, MA, https://www.fishersci.com). Genotyping will 
be performed in a 20-µl system containing 10 µl of TaqMan Genotyping Master Mix, 1 µl of 

 
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TaqMan Genotyping Assay, and 1 µl genomic DNA using the StepOne Plus real-time PCR 
system (Applied Biosystems, Foster City, CA). Allele determination will be performed using 
StepOne Plus software v2.3 (Applied Biosystems). Cheek swab specimens will be stored for up 
to 10 years and may be used for other genetic analyses. The remainder of the specimens will 
be destroyed after 10 years or when they are no longer viable. Only study personnel will have 
access to the specimens. The OXTR genotyping is funded with internal funding and will not be 
transferred to other researchers. Cheek swabs will be labeled only with study id and date; no 
master list will be made of identities and no attempt will be made to re-identify the specimens.  
 
Are you storing the specimen for future use for other research projects? 
☒ 
Yes 
☐ 
No 
 
 
Confidentiality of Data 
(1) To maintain the confidentiality of the data, I will use a unique study identifier (not derived 
from the participants’ personal identifiers) to code individuals’ data and I will store this ID log 
separate from study data.  
 
(2) How are you storing your electronic data? 
☐ 
UH Redcap 
☒ 
CWRU Redcap  
☐ 
Secure Research Environment (SRE) 
☒ 
CWRU Box 
☐ 
OnCore 
☐ 
UH Secure Network Drive (S:) 
☐ 
CWRU Secure Network Drive 
☐ 
Other:  List storage method and provide justification 
 
 (3) ☒ I acknowledge that paper research data and documents will be stored in a double- 
            locked secure environment in the following location:  
            Location: Locked file cabinet in PI Hardin’s locked research office located in the School  
of Nursing 
 
(4) Data Sharing:  N/A 
 
HIPAA Authorization  
If you are going to be accessing PHI (Protected Health Information), indicate how HIPAA 
authorization will be obtained (check all that apply): 
☐ 
HIPAA authorization is in the consent form 
☐ 
Requesting a full or partial waiver of HIPAA for prescreening 
☐ 
Requesting a full or partial waiver of HIPAA 
 
(1) We are not collecting data from a covered entity; therefore, HIPAA authorization is not 
necessary.  
(2) Research records will be kept in a locked file and access will be limited to the researchers. In 
addition, research guidelines require that we provide access to regulatory bodies such as the 

 
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University IRB, regulatory agencies, and the Center for Reducing on Health Disparities at 
MetroHealth to evaluate the safety of this project. 
(3) Personal identifiers will be kept for 6 years after giving study consent, which is approximately 
5 years after the study ends and data analysis begins.  
 
Risks to Research Participants 
 (1) The level of risk from the proposed trial is no more than encountered in daily life and is 
minimal relative to other clinical trials that test drugs, devices, or medical procedures. Of note, 
we will not be completing the behavioral interaction, RSA, salivary samples, or cheek swabs  
portions of the study while restrictions associated with the COVID-19 pandemic are in-place. We 
will resume this part of our study when public health recommendations allow for this in-person 
data collection.  There is a small risk of loss of confidentiality by participating in this study. Our 
team takes participant confidentiality serious and implements several safeguards against loss of 
confidentiality. However, it is possible that being seen on campus with members of our team will 
identify participants’ role in the Level Up Study to passersby.   
The risks associated with gathering information from participants by properly trained and 
supervised research assistants are low. Participants may experience discomfort by some 
questions assessing stress and depression. In prior research, we have used these measures or 
similar measures with this adolescent-parent dyad population and found that adolescent-parent 
dyads were comfortable with the interviews. However, all participants will be instructed that they 
can stop the interview at any time or can choose to skip any question that they wish. Our 
investigators and staff are experienced interviewers in research involving adolescent-parent 
dyads, and we have rarely encountered participant reactions more adverse than transient 
awkwardness, embarrassment, or mild discomfort. We are prepared to deal with such events 
and have a protocol that instructs the data collector how to obtain assistance for psychological 
issues should they arise.  
There is the potential for stigmatization due to depression diagnosis; however, 
measurements are taken in private and all results are reported privately in a sensitive and 
culturally appropriate manner. The nature of this study includes adolescents with a diagnosis of 
depression. If the adolescent becomes upset during study procedures, a study research 
assistant and the participant’s parent will be available to support and comfort the adolescent 
participant if needed. If questionnaires indicate symptoms suggestive of severe depression or 
suicidal ideation, the results will be reviewed with Dr. Arin Connell, Ph.D. (co-investigator, 
licensed clinical psychologist, #6732) who will consult with the participant to determine whether 
the participant is in need of a referral for further evaluation and treatment.  
(2) Although this study is deemed as having minimal risk, we recognize there are some 
unanticipated risks. An example on an unanticipated risk is that participants may be 
disappointed with the intervention group to which they are assigned.  
(3) As a social/behavioral intervention study, no procedure in this study is a risk to an embryo or 
fetus should the research participant may or may become pregnant.  
(4) There are no known risks to others who are not research participants. 
(5) Drs. Hardin and Connell have conducted previous research protocols that involve 
adolescent-parent dyads and have experienced research assistants and established protocols 
for quality assurance, crisis intervention and referral, as well as initial and ongoing staff training. 
The research assistants hired for this project will have prior experience working with adolescent-
parent dyads. If questionnaires indicate symptoms suggestive of severe depression or suicidal 
ideation, the results will be reviewed with Dr. Arin Connell, Ph.D. (co-investigator, licensed 
clinical psychologist, #6732) who will consult with the youth and/or parent/guardian to determine 
whether the youth or parent/guardian is in need of a referral for further evaluation and treatment. 
 

 
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Provisions to Protect the Privacy Interests of Research Participants 
To protect participants’ privacy, several measures will be taken. During COVID-19 data 
collection, adolescents and parents will be encouraged to complete the surveys in private 
spaces. Following the easing of restrictions associated with the COVID-19 pandemic, in-person 
data collection will resume and the following precautions will be taken, All study procedures will 
be carried out in private rooms. As participants are completing questionnaires, study staff will 
remain available for questions, but avoid moving around the room in any way that would allow 
the staff to see the participants’ questionnaire responses. Both parents and adolescents will 
receive separate tablet computers to complete the questionnaires simultaneously, so that 
participants are each engaged with their own questionnaires and promote privacy of the other 
participant. If participants are uncomfortable with the tablet computer, we will make 
arrangements to complete the questionnaires by participant’s choice of interview by study staff 
or by paper and pencil. During the cheek swab, participants will be allowed to swab their own 
mouths with direction from study staff, if the participants’ desire. When placing the heart rate 
monitoring leads on participants’ chests for the respiratory sinus arrhythmia testing, this will be 
done in a private room and by same gendered study staff, if desired by participants. During the 
behavioral interaction assessment, study staff will remain nearby but step out of the room, in 
order to help adolescent and parent participants’ feel comfortable during the discussion.   
Paper and pencil questionnaire completion will be a rare event. In the event of 
participant’s choice or internet connectivity problems, survey data will be collected through 
paper and pencil surveys. Research staff will be responsible for entering survey data directly 
into REDCap once internet connectivity has become a non-issue. Paper and pencil surveys will 
be stored in a locked, filing cabinet in PI Hardin’s locked research office. Only key research staff 
will have access to this office and access to the key to the filing cabinet.  
 
 
Potential Benefit to Research Participants 
Participants participating in this research may learn new skills for better managing their stress 
and sleep quality; medication adherence and appointment keeping skills may improve their 
health; and trust-building exercises may improve the quality of the adolescent-parent 
relationship.  These improvements may be short-term or long-term changes. We anticipate that 
our findings will demonstrate the linkages between a trust-building behavior change strategy 
and health behavior change that will help adolescents and parents improve their health.  
 
Withdrawal of Research Participants 
Research participants will be withdrawn from the intervention without their consent under these 
circumstances: 
1. participants display disruptive behavior during the group intervention sessions, 
2. evidence of abuse between parent and adolescent dyad, or 
3. indication that a participant may be a harm to themselves or others.  
 
In the event that participants are removed from the intervention, PI Hardin will notify participants 
of their removal. Participant dyads will receive a closeout packet, which will contain a list of 
community resources for further depression symptom management treatment. Participants will 
also receive study personnel contact information to follow up on study outcomes. At this time, 
we will also update participants’ contact information and ask if they are willing to be contacted 
for further study visits, if appropriate.  
 
Alternatives to Participation 

 
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(1) No one will be required to participate in our study. Other available clinical treats are 
individual, family, or group therapy. Community self-management treatments available include 
stress management classes, such as yoga.  
(2) Standard of care therapy, including depression medication and counseling, should be 
continued regardless of participation. Self-management treatments are considered adjuvant to 
clinical treatment. We anticipate and encourage our participants to continue standard of care 
therapy.  
(3) Since self-management training is adjuvant to standard of care treatment, another option is 
to not participate.  
 
Costs to Research Participants 
(1) There are no costs to participation in this study. Our study compensates participants for their 
time and travel costs.  
(2) Participants’ health insurance will not be charged for any services provided in this study.  
(3) This study will pay for the costs of transportation to study visits; cost of group intervention 
sessions including healthy snacks and small gifts; time to complete study visits; costs of 
surveys; and costs of respiratory sinus arrhythmia/behavioral interaction testing.  
 
Research Participant Compensation 
Participation in the study requires time and effort. Because of this, compensation for time spent 
completing the study surveys, respiratory sinus arrhythmia (RSA), and behavioral interaction 
assessment will be provided. Each adolescent and parent participant will receive a $25 gift card 
for completing each structured interview and each behavioral interaction assessment with RSA. 
Thus, adolescent-parent dyad participants who complete all interviews ($150 total) and undergo 
two behavioral interactions with RSA ($100 total) may receive a total up to $250. This amount is 
consistent with our previous work and is not perceived to be coercive by members of the 
community advisory board.  
 
During the intervention groups, participants may receive small gifts (each valued at less 
than $15) intended to assist them in meeting intervention goals. Participants may receive small 
gifts such as an eye mask to promote sleep, a 7-day medication box to promote medication 
adherence, a book about parent/teen communication, and a yoga mat. Healthy snacks will be 
made available to participants during the group sessions. A schedule of compensation is listed 
below.  
 

 
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Compensation for Research Related Injury 
Describe who will pay for the costs of medical treatment and/or compensation in the event of a 
research related injury: 
☐ 
Funding agency is providing some/all payment for injury 
☒ 
Funding agency is providing no payment for injury 
☐ 
Not applicable 
Provisions to Monitor the Data to Ensure the Safety of Research Participants 
(1) The data and safety monitoring plan for this study includes an official committee. The 
committee members who are outside the study team will review data on the study as provided 
by Drs. Hardin and Connell and conduct random auditing of the research records to assess 
study safety and regulatory compliance. Twice annually throughout the project, this committee 
will review data on this study regarding 1) study safety, including auditing selected cases for 
compliance with IRB requirements, conformance with informed consent requirements, 
verification of source documents, and investigator compliance; 2) minimizing research-
associated risk; and 3) protecting the confidentiality of participant data. In addition, it will review 
all causes of mortality and issues with participation. The rate of recruitment refusal (percent and 
reasons) and participant attrition (percent and reasons) will be tracked and reported at these 
reviews. Differential attrition from the intervention arms also will be monitored. If concerns or 
problems are identified by the Data and Safety Monitoring Committee (DSMC), they will be 
reported to the IRB and the sponsor via email by Dr. Hardin and Dr. Douglas, respectively, 
within 3 business days after they are identified. If there are recommendations made by the 
DSMC, the action plan for response or notice of any actions taken by the IRB regarding the 
research and any responses to those actions will be provided to sponsor officials within 2 
weeks. 
 
At the onset and across the duration of the study, all staff and Investigators will have 
instructional review of the nature and types of unanticipated and adverse events as described 
 
Compensation 
Study Procedures 
Adolescent 
Parent 
Study Visit 1 (Baseline) 
  Questionnaires 
  RSA/behavioral interaction 
Transportation (paused)  
$25 gift card 
$25 gift card (paused) 
Transportation (paused)  
$25 gift card 
$25 gift card (paused) 
Intervention week 1 
Small gifts 
Small gifts 
Intervention week 2 
Small gifts 
Small gifts 
Intervention week 3 
Small gifts 
Small gifts 
Intervention week 4 
Small gifts 
Small gifts 
Intervention week 5 
Small gifts 
Small gifts 
Intervention week 6 
Small gifts 
Small gifts 
Intervention week 7 
Small gifts 
Small gifts 
Intervention week 8 
Small gifts 
Small gifts 
Study Visit 2 (3 months) 
  Questionnaires 
  RSA/behavioral interaction 
Transportation (paused) 
$25 gift card 
$25 gift card (paused) 
Transportation (paused) 
$25 gift card 
$25 gift card (paused) 
Study Visit 3 (6 months) 
  Questionnaires 
Transportation (paused) 
$25 gift card 
Transportation (paused) 
$25 gift card 
Total 
$75 gift cards + small gifts; 
transportation + snacks 
(paused) 
$75 gift cards + small gifts; 
transportation + snacks 
(paused) 

 
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by the sponsor and the CWRU IRB. As they occur, all unanticipated events and adverse events 
will immediately be reported to the PI who will report them to the IRB according to the IRB 
protocol reporting procedures for both serious and non-serious adverse event and unanticipated 
problem reporting. These will be summarized in the twice annual reports to the DSMC. Annual 
progress reports to the IRB and the sponsor will include a summary of the DSMC’s activities 
and findings as well as any adverse events regarding human participants. Program Officials of 
the sponsor will be informed in a timely manner (3 business days) of unanticipated problems 
(e.g., a data breach) or unexpected serious adverse events that may be related to the study 
protocol or IRB-approved revisions to the study protocol that indicate a change in risk for 
participants. 
 
(2) A Data and Safety Monitoring Committee (DSMC) will be established for this study. This 
DSMC will independent of the study sponsor and will meet every 6 months of the study. Dr. Daly 
will chair the committee and be responsible to submit reports to the study sponsor and IRB 
within 2 weeks of the meeting.  DSMC members include:   
Dr. Sara Douglas, an experienced family researcher (sld4@case.edu) 
Dr. Val Toly, an NIH-funded researcher with parent/child dyads (vab@case.edu) 
Dr. Chris Burant, a statistician not involved with the project (cxb43@case.edu) 
Dr. Michael Decker, neuroscience of health behavior researcher (mjd6@case.edu) 
Dr. Heather Hardin, PI (hkh10@case.edu) 
Dr. Arin Connell, Co-I (arin.connell@case.edu) 
 
Community-Based Participatory Research:  N/A 
Non-Local Recruitment Methods for Multi-Site Studies:  N/A 
Multi-Site Research Communication Plan:  N/A 
Drugs or Devices: N/A 
 
1. 
Mojtabai R, Olfson M, Han B. National Trends in the Prevalence and Treatment 
of Depression in Adolescents and Young Adults. Pediatrics. 2016. 
2. 
Kann L, McManus T, Harris WA, et al. Youth Risk Behavior Surveillance - United 
States, 2015. MMWR Surveill Summ. 2016;65(6):1-174. 
3. 
Avenevoli S, Swendsen J, He J, Burstein M, Merikangas K. Major depression in 
the National Comorbidity Survey-Adolescent Supplement: Prevalence, 
Correlates, and Treatment. Journal of the American Academy of Child & 
Adolescent Psychiatry.54(1):37-44.e32. 
4. 
Hardin HK, Lee D, Moore SM. Trust of healthcare provider varies by level of 
depressive symptoms in adolescents. Society of Adolescent Health & Medicine; 
March 14, 2018, 2018; Seatle, WA. 
5. 
Hardin HK, McCarthy VL, Speck BJ, Crawford TN. Diminished trust of healthcare 
providers, risky lifestyle behaviors, and low use of health services: A descriptive 
study of rural adolescents. The Journal of school nursing : the official publication 
of the National Association of School Nurses. 2017:1059840517725787. 
6. 
Cleveland Metropolitan School District. Cleveland Metropolitan School District 
Facts. 2017; http://www.clevelandmetroschools.org/domain/24. 
7. 
Sandler I, Ingram A, Wolchik S, Tein J, Winslow E. Long-term effects of 
parenting-focused preventive interventions to promote resilience of children and 
adolescents. Child Development Perspectives. 2015;9(3):164-171. 

 
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8. 
Rotenberg K. Interpersonal Trust During Childhood and Adolescence. 
Cambridge; New York: Cambridge University Press; 2010. 
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