Communication and Coping: Addressing Mothers' Needs to Improve Outcomes in Adolescents With T1D
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Sponsor: Vanderbilt University Medical Center

NIDDK 
 
Protocol Version #: 12 
 
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Protocol Date: 4/11/2023 
 
 
 
 
 
 
 
 
Communication and Coping Randomized 
Clinical Trial 
 
 
Sarah Jaser, PhD, Department of Pediatric Endocrinology, VUMC 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sarah S. Jaser, PhD, Associate Professor 
Department of Pediatrics 
Vanderbilt University 
 
 
 
 
 
 
 
 
 
 
 
 

NIDDK 
 
Protocol Version #: 12 
 
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Protocol Date: 4/11/2023 
 
Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Animal Studies and Previous Human Studies 
4.0 
Inclusion/Exclusion Criteria 
5.0 
Enrollment/Randomization 
6.0 
Study Procedures 
7.0 
Risks of Investigational Agents/Devices (side effects) 
8.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
9.0 
Study Withdrawal/Discontinuation 
10.0 Statistical Considerations 
11.0 Privacy/Confidentiality Issues 
12.0 Follow-up and Record Retention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NIDDK 
 
Protocol Version #: 12 
 
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Protocol Date: 4/11/2023 
Description of Amendments 
Date 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
3-1-19 
Study 
Procedures 
Addition of the Satisfaction 
Survey at the 3-Month Study 
visit. 
 
Removal of the Dad’s Active 
Support Scale (DADS) 
Added to evaluate acceptability of the 
intervention.  
 
Removed to reduce the burden for 
participants. Measure was only valid 
for heterosexual couples. Additional 
questions added to Demographic 
questionnaire to capture secondary 
caregiver information.  
4-16-19 
Change to wording in recruitment 
script to obtain verbal consent for 
screening survey 
Added the wording: "You are free to 
skip questions you do not wish to 
answer; however, this may affect 
your eligibility for the study." to let 
the participant know that skipping 
questions would affect eligibility. 
6-17-19 
Inclusion/ 
Exclusion 
Criteria 
Addition of Parent Diabetes 
Distress Scale (Parent-DDS) as a 
measure of eligibility.  Participant 
can either score 2 or higher on the 
Parent-DDS or have a score of 5-
19 on the Patient Health 
Questionnaire 9 (PHQ-9) to be 
eligible.  
In response to lower than expected 
enrollment, we expanded eligibility to 
include mothers who report clinically 
significant diabetes distress and who 
may benefit from intervention. We 
also expanded eligibility to include 
mothers who use Facebook 2-4 days a 
week rather than at least 5-6 days a 
week.   
6-17-19 
Enrollment/ 
Randomization 
Mother will be friended on 
Facebook during enrollment 
rather than sent an email.  
Ensures that mother gets into 
Facebook group on the day of 
enrollment.  
8-19-19 
Risks 
Addition of the Youth Self Report 
procedure to protocol. If 
individuals mark item 18 or 91 on 
the YSR (items pertaining to 
suicide or self-harm), KSP will 
follow a protocol to ensure the 
safety and access to resource for 
the individual.  
Formalized protocol to further assess 
and provide resources to teens that 
may be at risk for self- harm or 
suicide. 
 
4-23-20 
Study 
Procedures 
Consent 
Expansion the satisfaction survey 
at the 3-month follow-up visit. 
Addition of the option for 
mothers assigned to the education 
group to receive the intervention 
materials after final data 
collection. Addition to the 
consent that investigators from 
1) Addition of questions to the 
satisfaction survey to capture more 
information about the Facebook 
component of the program. 2) Several 
participants have expressed interest in 
learning coping strategies included in 
the intervention materials.  

NIDDK 
 
Protocol Version #: 12 
 
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Protocol Date: 4/11/2023 
Date 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
the University of Connecticut 
would have access to some 
participant data.  
5-26-20 
Study 
Procedures  
COVID-19 related changes to 
protocol, including remote 
enrollment and data collection 
and additional survey questions to 
assess the impact of COVID-19 
on adolescents with type 1 
diabetes and their mothers. 
Given the COVID-19 pandemic and 
social distancing requirements, we 
have made changes to our protocol to 
allow for remote enrollment and data 
collection. We are also adding 
measures to assess the impact of 
COVID-19 on our study participants. 
9-25-20 
Study 
Procedures 
The parent-child video interaction 
recordings for the baseline and 6-
month time points will be done 
over ZOOM rather than in person 
because of the Covid-19 
restrictions and social distancing. 
| This is a temporary change 
because of Covid-19, therefore 
we will report this to the IRB as a 
continuing review and retract this 
amendment. 
Covid-19 restrictions and social 
distancing require us to do the video 
interactions over ZOOM so families 
who feel uncomfortable with in 
person data collection can still 
participate in all parts of the study. 
10-5-20 
Compensation Study personnel will confirm 
each gift card serial number with 
the order invoice to ensure the 
gift card record reflects the 
accurate monetary value. 
Protocol deviation occurred due to 
incorrect record keeping of Amazon 
gift card serial numbers. Gift cards 
worth $20 were incorrectly recorded 
by study personnel as worth $30. 
Therefore, $20 compensation was 
given to 4 dyads instead of the 
sufficient amount of $30. This was 
identified by comparing the gift card 
serial numbers with the numbers 
listed on the order invoice. 
10-28-20 Study 
Procedures + 
Consent 
Optional qualitative interviews 
for study participants to assess the 
impact of COVID-19 on diabetes 
management, stress and coping. 
 
We received supplemental funding 
from NIDDK to study the impact of 
COVID-19 on diabetes management, 
stress and coping. Qualitative 
interviews will be conducted with 
current participants (adolescents with 
type 1 diabetes and their mothers) to 
address the following aims: 1. To 
understand how the experience of 
COVID-19 affects the routines and 
health behaviors of youth with T1D 
and their caregivers as various levels 

NIDDK 
 
Protocol Version #: 12 
 
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Protocol Date: 4/11/2023 
Date 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
of social distancing requirements are 
reduced. 2. To determine how the 
experience of COVID-19 affects 
mothers already experiencing 
diabetes distress and/or depressive 
symptoms and how mothers' 
experiences relate to their coping, 
social support and distress, with an 
emphasis on understanding what is 
similar to and different from their 
experiences with T1D prior to 
COVID-19. 
11-3-20 
The non-compliance submitted 
for this study on October 5th was 
submitted in error and should be 
removed. 
 
12-8-20 
Consent 
Discussed with the study team to 
prevent future occurrences. 
The moderator posted to the 
Facebook study page, rather than to 
the private study groups. As such, 
mothers who were assigned to the 
intervention condition and control 
condition all received the post. 
6-8-21 
Recruitment 
We have drafted language for 
distributing information about our 
study on Research Match and the 
Vanderbilt Research Notifications 
Distribution list to expand our 
recruitment efforts. 
We are planning on recruiting 
through Research Match and the 
Vanderbilt Research Notifications 
Distribution list to reach more 
potential participants. 
7-7-21 
Recruitment 
We are requesting approval to 
recruit using the Research 
Notification Distribution List and 
we are uploading language 
specifically for the Research 
Notification Distribution List 
with the contact information for 
our study. 
We are requesting approval to recruit 
using the Research Notification 
Distribution List and we are 
uploading language specifically for 
the Research Notification 
Distribution List with the contact 
information for our study. 
8-24-21 
Consent 
We will conduct training with the 
study team to clarify which 
protocols require a verbal consent 
and which protocols require a 
Four participant dyads verbally 
consented to participate in the Covid 
Interview supplemental study but did 
not sign the consent and assent 
documents prior to completing the 

NIDDK 
 
Protocol Version #: 12 
 
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Protocol Date: 4/11/2023 
Date 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
written consent/assent. 
supplemental interviews. We are now 
in the process of contacting these 
participants to sign the consent 
documents. 
8-25-21 
Study 
Procedures 
We are adding questions to the 
parental COVID-19 supplemental 
measure. 
In order to remain up-to date on how 
COVID-19 is impacting our current 
participants, we need to add 
additional questions to our COVID-
19 survey measure. These additions 
are related to COVID-19 vaccination 
status and the use of telehealth clinic 
visits. Many COVID-19 restrictions 
currently in place (locally and 
domestically) are dependent on 
vaccination status. We will be asking 
participants if any adults (18+) and 
children (12-17) have been 
vaccinated in their household. Also, 
we are asking if their child has seen 
their diabetes provider via telehealth 
visit since this could impact their 
quality of care and one of our specific 
study aims (glycemic control). These 
will only be applied to the parent 
surveys. 
3-9-22 
Consent + 
Compensation 
We want to offer $20 gift cards 
for completion of 6-month parent-
child interaction videos to 
incentivize collection of this data 
point. These gift cards will be 
funded by the VUMC Division of 
Pediatric Psychology. 
We were not able to collect parent-
child interaction videos at baseline or 
the 6-month time point during the 
transition to a remote protocol, and 
we are not able to use 6-month videos 
that would not have a corresponding 
baseline video. Because of this, we 
have collected less 6-month videos 
than expected. Also, because of the 
switch to a remote protocol, we have 
several participants that will complete 
all other components of their 6 month 
follow up visit but will not schedule a 
time to collect the video with our 
team. We want to offer $20 gift cards 
for completion of 6-month videos to 
incentivize collection of this data 
point. 
9-1-22 
Study 
Change in study coordinator from 
 

NIDDK 
 
Protocol Version #: 12 
 
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Protocol Date: 4/11/2023 
Date 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
Coordinator 
Troy Morrow to Fayo Abadula 
(currently KSP). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NIDDK 
 
Protocol Version #: 12 
 
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Protocol Date: 4/11/2023 
1.0 
Background 
 
Mothers of adolescents with type 1 diabetes (T1D) experience high levels of depressive 
symptoms, which impair their ability to monitor and manage diabetes treatment 
effectively. The regimen recommended for type 1 diabetes is complex and demanding, 
and caregivers - especially mothers - experience stress related to the burden of 
treatment management. This stress is associated with increased risk for psychosocial 
problems in caregivers, with rates of clinically significant symptoms of depression 
evident in up to 61% of parents. Further, maternal depressive symptoms are one of the 
strongest predictors of negative outcomes in adolescents, including deteriorating 
glycemic control, problems with adherence, poorer quality of life, and greater risk for 
depression. Given that adolescents are a high-risk population for suboptimal glycemic 
control - with only 17% meeting treatment goals - there is a critical need for novel 
interventions to improve outcomes in adolescents with T1D. Yet, previous behavioral 
interventions for youth with diabetes have had only modest effects on glycemic control, 
many were time- and resource-intensive, and none have directly targeted maternal 
depressive symptoms.  
 
2.0 
Rationale and Specific Aims 
 
Based on the Transactional Stress and Coping Model, which views chronic illness as a 
stressor to which children and mothers attempt to adapt, the ways in which mothers 
cope with the stress of diabetes play an important role in both maternal and adolescent 
adjustment to the disease. The proposed study is based on the premise that, by 
reducing mothers' depressive symptoms and improving the quality of parental 
involvement, we will improve outcomes in adolescents with T1D. Building on effective 
interventions to treat depression in adults, and our own pilot work in this population, the 
proposed study will use a rigorous approach to evaluate the efficacy of a cognitive-
behavioral intervention for mothers of adolescents with type 1 diabetes to promote the 
use of adaptive coping strategies and positive parenting practices.  
 
The specific aims of this project are: 
1. Evaluate the efficacy of the Communication & Coping intervention as 
compared to an attention control condition on adolescents’ diabetes outcomes 
(i.e., glycemic control, adherence) over 12 months. We will examine whether 
these effects were driven by the targeted mediators (maternal depressive 
symptoms, parental involvement). 
Hypothesis: The adolescents of mothers who receive the intervention will 
demonstrate better glycemic control and better adherence to treatment 
than those in the attention control condition. 
 
2. Evaluate the efficacy of the Communication & Coping intervention as 
compared to an attention control condition on adolescents’ psychosocial 
outcomes (i.e., adolescent depressive symptoms and quality of life) over 12 
months. 
Hypothesis:  The adolescents of mothers who receive the intervention will 
report better quality of life and fewer depressive symptoms than those in 
the attention control condition. 

NIDDK 
 
Protocol Version #: 12 
 
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Protocol Date: 4/11/2023 
 
Exploratory Aim: Examine the differential impact of intervention effects across 
demographic factors (i.e., marital status, income, adolescent age, and sex). 
 
3.0 
Animal Studies and Previous Human Studies 
 
Dr. Jaser and colleagues conducted a pilot study of the communication & coping 
intervention with 30 mothers of adolescents with type 1 diabetes, which supported the 
feasibility and initial efficacy of the intervention (http://psycnet.apa.org/record/2018-
09864-003). Results from our pilot study indicated significant intervention effects on 
adolescents' quality of life and depressive symptoms. In addition, adolescents whose 
mothers received the intervention demonstrated promising improvements in glycemic 
control, and we found support for the effect of the intervention on mediating variables, 
with large effects on maternal depressive symptoms and family conflict. 
 
4.0 
Inclusion/Exclusion Criteria 
 
List the criteria:  
• 
mother or female caregiver to an adolescent (age 11-17)  
• 
mother lives with adolescent at least 50% of the time 
• 
adolescent child has been diagnosed with type 1 diabetes for at least 12 months 
• 
mother uses Facebook regularly  
• 
mother reports mild to moderate symptoms of depression (Patient Health 
Questionnaire 9 score of 5-19) OR mother reports diabetes distress (Parent/Teen 
Relationship Distress Subscale score of 2 or higher) 
• 
mother and adolescent able to speak and read English 
• 
mother and adolescent do not have a history of severe psychopathology (e.g., 
schizophrenia, bipolar disorder) 
 
5.0 
Enrollment/Randomization 
 
Participants will be enrolled from the Children’s Diabetes Program at Vanderbilt.  
 
Due to the COVID-19 pandemic and social distancing requirements, a remote 
recruitment and enrollment protocol was established. KSP will review the diabetes clinic 
schedule, and participants who meet initial eligibility criteria (age, date of diagnosis) will 
be called the week of their clinic visit. The RA will introduce the study, and if mothers 
are interested, verbal consent for the screening questionnaire will be obtained. Mothers 
who consent will be emailed a link to the screening survey in REDCap. The RA will then 
email the mother to let her know if she is eligible or not. Eligible mothers will be asked 
to schedule a time for enrollment. At the preferred time, the mother and adolescent will 
be called, and the RA will provide each with a full description of the risks and benefits of 
the study. If they agree to participate, they will be emailed the link to sign the eConsent 
form in REDCap. The RA will stay on the phone while these are signed to answer any 
questions. Once consent/assent forms are signed, the parent and adolescent will be 
emailed links to complete the study surveys in REDCap. The mother will be asked to text 
the RA when these are completed or if they have any questions. The final enrollment 
will take place over the phone (demo text message and Facebook friending).  

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After completing all baseline data, mothers will be given instructions to "friend" the 
study Facebook account. Once the mother has established a connection to the study 
Facebook account, the mother-adolescent dyad will be randomly assigned to the 
intervention condition or attention control (equal numbers in each group). 
Randomization will be stratified by the adolescents' treatment type (insulin pump vs. 
injections) and use of continuous glucose monitoring (CGM or no CGM) to remove the 
possibility of confounding by differences related to insulin regimen. Randomization will 
be determined by a computerized program created by the biostatistician on the project 
(Chris Slaughter). 
 
Participating mothers will be mailed a study binder and an A1C mail-in kit within 2-3 
days of enrollment. 
 
Adolescents’ glycemic control will be assessed with HbA1c, which is obtained as part of 
regular clinical care. For adolescents who do not have an HbA1c value associated with a 
clinic visit (due to social distancing requirements), we will request that they use a mail-in 
kit. The kit includes clear instructions to provide a dried blood spot that is mailed to the 
lab (Coremedica). When the lab value is available, KSP will notify study participants. 
 
6.0 
Study Procedures 
 
At baseline, 3 months, 6 months, and 12 months, mothers and adolescents will 
complete surveys consisting of measures are widely validated and have been used 
successfully by our research team in previous studies. Follow-up data will be collected at 
regularly-scheduled diabetes clinic visits, so that questionnaire data corresponds with 
clinical data. The measures take about 40 minutes to complete. Mothers will also 
complete a measure of depression (PHQ-9) via a link emailed to them by the study team 
biweekly during the active phase of the intervention (first 3 months). All measures will 
be collected using REDCap. 
 
Demographics - completed by mother 
 
Responses to Stress Questionnaire (RSQ) measures 3 coping factors: primary control 
coping, secondary control coping, and disengagement coping - completed by mother 
 
Multidimensional Scale of Perceived Social Support (MSPSS) - completed by mother 
 
Patient Health Questionnaire - 9 items (PHQ-9)-completed by mother 
 
Generalized Anxiety Disorder Scale - 7 items (GAD-7) completed by mother 
 
Diabetes Family Conflict Scale (DFCS) - completed by mother and adolescent  
 
Self-Care Inventory (SCI) - completed by mother and adolescent  
 
Pediatric Quality of Life Inventory (Peds-QL) diabetes-specific module - completed by 
adolescent  

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Protocol Version #: 12 
 
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Child Behavior Checklist (CBCL) - completed by mother 
 
Youth Self Report (YSR) - completed by adolescent  
 
Problem Area in Diabetes - Teen (PAID-T) - completed by adolescent 
 
Parent Diabetes Distress Scale (PDDS) - completed by mother 
 
Collaborative Parent Involvement Scale - completed by adolescent 
 
Revised Brief Diabetes Knowledge Test - completed by mother 
 
COVID-19 Questions – completed by mother and adolescent 
 
Satisfaction Survey – completed by mother at 3 month follow-up 
 
At baseline and 6 months data collection, adolescent-mother dyads will participate in a 
15-minute videotaped conversation about diabetes-related stress. To choose the topic 
for the video interaction, we will use the mother’s highest-rated stressor on the 
Response to Stress Questionnaire (Connor-Smith, Compas, Wadsworth, Thomsen, & 
Saltzman, 2000), completed as part of the survey data collection, which lists diabetes-
specific stressors. Mothers will rate the frequency of each stressor (e.g., worrying about 
"bad" numbers, remembering diabetes supplies) on a 4-point Likert scale ranging from 0 
(never) to 3 (almost every day). Each dyad will be given a cue card with questions 
regarding the highest-rated stressor (e.g., What happened the last time we [had to you 
remember diabetes supplies], what kind of emotions do we have when we [have to 
remember diabetes supplies]? How can we reduce this stress?) to guide their discussion 
during the videotaped interaction. This protocol has been used successfully in other 
studies conducted by Dr. Jaser, and she has trained several cohorts of raters on the 
Iowa Family Interaction Rating Scales to be reliable coders. 
 
The interaction will be recorded using study iPads. Video files will be transferred from 
the passcoded iPad to an encrypted study computer, and then uploaded to Enterprise 
Storage, the secure, shared drive. Video files will only be viewed by KSP.  
 
Mothers in the study will have 7 individual phone calls with a trained member of our 
research staff to discuss the information in the binders. Calls will last approximately 10-
30 minutes. Mothers assigned to the Communication & Coping group will discuss 
content related to coping with diabetes-related stress and positive parenting strategies, 
following the study manual mailed to participants after randomization. The content of 
this manual was reviewed by a coder trained in health literacy at Vanderbilt's Effective 
Health Communication Core. Each session was given a Suitability Assessment of 
Materials (SAM) score to objectively assess the materials for clear communication and 
health information design (content, literacy demand, graphics, layout and typography, 
learning stimulation, and cultural appropriateness). Scores of 70% to 100% are 
considered superior material suitable for low health literacy individuals (Doak, Doak, & 
Root, 1996). On the SAM scale, our sessions were rated 78% to 86%, with a reading 

NIDDK 
 
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level of 6th-7th grade. In addition, the Patient Education Materials Assessment Tool 
(PEMAT) was used to assess the understandability and actionability of our intervention 
materials, with specific suggestions to raise these scores further (e.g., add pictures, 
highlight goals for each session; Shoemaker, Wolf, & Brach, 2013). On the PEMAT, the 
scores for individual sessions ranged from 79% to 92% (higher scores indicate that 
material is more understandable or actionable). All recommendations for changes were 
incorporated into the final versions of the manual. 
 
Mothers assigned to the Diabetes Education group will discuss content related to 
diabetes management, in line with the educational materials mailed to participants after 
randomization. These materials were based on information available on the American 
Diabetes Association website (www.diabetes.org). Mothers in the Diabetes Education 
group will be given the option to receive the manual containing the Communication and 
Coping content at the 12 month visit, after the mother has completed the study. The 
first 5 calls will occur weekly, and the last 2 "booster" calls will occur monthly. The calls 
will be scheduled at a time that is convenient for study participants. These calls will be 
audio recorded and 20% will be randomly assessed for fidelity by an objective rater. 
Audio files of the intervention sessions will be stored on the same secure, shared drive 
and will only be accessed by trained research staff to assess fidelity or for training 
purposes. 
 
Study participants will be required to "friend" the study Facebook account before they 
are added to the secret groups to ensure that the correct person is added. All mothers 
in the study will receive 1 post per day for 3 months. The posts will be on topics related 
to the group assignment (communication and coping or diabetes education). A 
moderator will view and respond to all comments made by Facebook group members. 
Facebook data will be extracted using programming stored on a protected server and 
stored in a de-identified SPSS file. 
 
7.0 
Risks 
 
Data collection requires participants (adolescents and mothers) to spend approximately 
40 minutes at each collection (baseline, 3 months, 6 months and 12 months) completing 
surveys. At baseline and 6 months, they will spend an additional 15 minutes in a 
videotaped interaction. 
 
Mothers will engage in 7 intervention phone calls that will last 30-45 minutes (the first 5 
sessions will occur weekly, and the 2 booster sessions will occur monthly). In addition, 
we expect mothers to spend approximately 5 minutes per day reviewing Facebook 
posts. This is not anticipated to be an undue burden for the participants. 
 
We will download data from the Facebook group including posts, comments, and 
reactions from the participants so that we can study these data to better understand 
how people participate in this component of the program. We will not download any 
data from participants' Facebook profiles or any posts to their feeds - only the posts, 
comments, and the posts/comments that participants react to in the study Facebook 
group. 
 

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The potential benefit of this study is the provision of new knowledge about innovative 
ways to improve diabetes management in adolescents with type 1 diabetes. In sum, the 
low risk of this study appears to be far outweighed by the larger, more compelling 
potential benefits. 
 
Possible risks in the study include release of confidential data, worsening depression 
symptoms in mothers, indication of depression in adolescents, reports of harm to self or 
others, and reports of child abuse or neglect.   
 
If mothers report severe symptoms of depression (PHQ-9 score of 20 or higher) or 
endorse the 9th item on the PHQ-9, indicating thoughts of self-harm, we will follow up 
with a depression protocol. A member of the research team will give the mother the 
resources handout, which includes crisis hotline numbers and mental health services. 
The PI (or the clinic social worker, if available) will follow up with the mother within 48 
hours to discuss and will refer her to the ER or crisis hotline if needed. 
 
If adolescents endorse items on the Youth Self Report (YSR) measure pertaining to 
suicide or self-harm, we will follow the following procedure for self-harm assessment. 
Item 18 asks individuals to rate from 0-2 (how often) "I deliberately try to hurt or kill 
myself." Similarly, item 91 reads "I think about killing myself." Scores of 1 indicate 
"sometime" and 2 indicate "usually."  When the YSR is given during study enrollment, 
researchers will immediately check items 18 and 91. If a 1 or 2 is indicated on either of 
these items, the Pediatric Endocrinology social worker will be paged and will complete a 
risk assessment following clinic protocol. The PI will also be notified. If the clinic social 
worker is not available, research staff will administer the Columbia Suicide Severity 
Rating Scale (C-SSRS). If information gathered from the C-SSRS indicates low risk 
(non-specific ideation, no plan), individuals will be given information on local behavioral 
health resources and informed that the PI will check in with them within the next 48 
hours. If the C-SSRS indicates high risk or risk is ambiguous the clinic social worker will 
be contacted again for further assessment and/or to transfer the patient for psychiatric 
evaluation. If the clinic social worker cannot be reached, the researcher will accompany 
the patient and their caregiver to the Children's Emergency Department for psychiatric 
evaluation. 
 
We will download data from the Facebook group including posts, comments, and 
reactions from the participants so that we can study this data to better understand how 
people participate and how much response our posts garnered from the group. We will 
not download any data from participants' Facebook profiles or any posts to their feeds - 
only the posts, comments, and the posts/comments participants react to in the study 
Facebook group.  
 
All children will receive clinical care throughout the course of the study. All diabetes 
treatment decisions will be made by the diabetes treatment team. All patients have 
access to the treatment team 24 hours/day and 7 days per week. Participants will be 
informed that they may discontinue the study at any time or skip any questions they do 
not feel comfortable answering. There are no potential legal or social risks to 
participants consenting to participate in this investigation. Parents will be told to follow 
the diabetes clinic providers' guidance on any questions related to diabetes 
management. 

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Any comments made during intervention calls or on the Facebook group that suggest 
the abuse of, neglect of, or inappropriate interactions with minors will be reported to the 
State of Tennessee Child Abuse Hotline (or the appropriate authority of the state in 
which the child resides). All research staff at all sites will complete annual training in 
Protection of Minors, and all research staff will be mandated reporters. 
 
The PI will ensure that the trial is conducted according to the approved protocol and will 
be responsible for carrying out the data safety monitoring plan, which includes: 
- Review of study components for data completeness and accuracy as well as protocol 
compliance 
- Evaluate adverse events (AEs, described below) for severity, relationship to the 
research and actions to be taken 
- Promptly report all severe AEs and unanticipated problems to the data and safety 
monitoring board, IRB, and NIH 
 
KSP will complete human subjects training prior to any contact with participants and 
maintain annual training. KSP will also complete Good Clinical Practice training for social 
and behavioral research annually. 
 
 
 
8.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
 
Any adverse events occurring during the course of this trial will be collected, 
documented and reported by the PI (Dr. Sarah Jaser), to the Data and Safety Monitoring 
Board, along with reporting to the NIDDK and institutional review boards as required. 
Although not anticipated, if any event is identified that may have caused any type of 
harm to a participant, study accrual will be immediately halted until the study team and 
DSMB can review the event and determine if any study procedures need to be revised. 
Study accrual will only resume after review of study protocol has been completed and 
any recommended revisions made as suggested by the DSMB. 
 
 
 
9.0 
Study Withdrawal/Discontinuation 
 
Study participants may contact the study team if they wish to withdraw. 
 
10.0 Statistical Considerations 
 
Baseline variables known to be associated with parenting including age, sex, income, 
and marital status will be compared by treatment group using the Kruskal-Wallis test 
(continuous variables) or Pearson's Chi-squared test (categorical variables).  We will 
also examine if diabetes-related variables (e.g., duration of diabetes, baseline A1C) are 
associated with treatment group. A priori, we assume that our block randomization will 
lead to well-balanced groups so that we will not need to control for additional 
confounders. 

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Effects of the Intervention: We will estimate the effect of the intervention on each of the 
continuous outcomes by fitting linear mixed-effects models developed. In modeling, 
outcomes will be considered at their key time-points (baseline, 3 months, 6 months, and 
12 months) with treatment group and the interaction of treatment with time serving as the 
main explanatory variables.  Such a model will allow us to test for any differences 
between treatment and control groups over time while accounting for baseline values. 
While the randomized block design should minimize confounding, we will adjust for age, 
income, and marital status to improve precision. The results from the adjusted and 
unadjusted models will be compared with respect to their estimates of the treatment 
effects. Our interpretation will focus on describing clinically relevant treatment effects 
(e.g., A1C reductions of >0.5%, >1 additional glucose check per day, reduction from 
moderate to mild depressive symptoms) with corresponding confidence intervals, rather 
than just significance testing. We will include a random intercept to account for within-
subject correlation. The error structure of the model is assumed to be compound 
symmetric, and the validity of this assumption will be examined by computing Akaike 
Information Criteria against other common structures.  Subjects will be included in the 
analysis if they have an outcome measured at baseline and at least one outcome 
measured 6 or 12 months later.  
 
Examining mediators will provide evidence for the mechanisms of change, offering 
direction for program implementation and future research. Investigating mediators of the 
intervention also allows us to test the theoretical basis and the effect of intervention on 
separate outcomes,107 such as glycemic control, and psychosocial outcomes. To assess 
direct and indirect effects of potential mediator variables, we will follow the steps outlined 
by MacKinnon and colleagues108,109 to establish mediation.  The bootstrap method will be 
used to obtain a 95% confidence interval for the total, direct, and indirect effects. We will 
test maternal depressive symptoms and parental involvement as mediators of treatment 
effects, maintaining consistent temporal ordering, by considering baseline randomized 
treatment, 3-month depressive symptoms and parental involvement variables as the 
mediators, and 6-month outcomes (treatment effects), as well as 12-month outcomes 
(sustained treatment effects)  Our longitudinal data will also allow us to consider 
additional analyses that account for the bidirectional relationships between family 
functioning and depressive symptoms. 
 
To determine the feasibility of the intervention, we will examine recruitment and retention 
data. In addition, fidelity checks will be conducted by reviewing 20% of the telephone 
sessions, which will be coded for content by an independent rater. We propose a 
feasibility benchmark of >90% fidelity. To evaluate acceptability of the intervention, we 
will examine participation (phone call attendance), adherence (completion of homework), 
and satisfaction ratings. We propose a feasibility benchmark of > 80% attendance. We 
will also conduct exit interviews with mothers, which will be analyzed with a content 
analysis approach to identify themes across participants.  
 
Assessing biases caused by dropouts:  Some subjects may not return for their follow-up 
visit and hence have missing values of their response variables.  Frequently, such 
subjects ("dropouts") are not a random sample of the entire cohort and an analysis of 
only the complete cases will bias the results.  Indirect information about the nonrandom 
dropouts will be obtained by using binary logistic regression to predict dropout status 
on the basis of all baseline predictor variables.  

NIDDK 
 
Protocol Version #: 12 
 
16 
Protocol Date: 4/11/2023 
 
Exploratory Aim: Examine the differential impact of intervention effects across 
demographic factors (i.e., marital status, income, adolescent age, and sex).  
While evaluating the main effects of interventions is critical to improving health 
outcomes, it is equally important to examine moderators of randomized clinical trials – 
even those that are unsuccessful – in order to determine for whom interventions may 
work. Based on findings from the literature and our own earlier work, we will examine 
potential moderators, with a focus on marital status, income, and adolescent age and 
sex. Moderators will be tested by including an interaction term with treatment group in 
the regression models. 
 
Power and sample size: 
We plan to enroll 154 subjects so that, after allowing for a 15% attrition 
rate, 130 subjects will be available for analysis.  Preliminary data from 
our pilot study with 30 adolescents indicates that mean A1C is 9.0% 
with a standard deviation of 1.16% and a correlation between repeated 
measurements over time of 0.60.  Under these assumptions, we will 
have 80% power to detect a 0.5% difference in A1C if 122 subjects are 
measured at all 4 time points or if 138 subjects are measured only 
twice (out of 4 possible time points).  Since we expect to obtain >3 
measurements on most of subjects, enrolling 130 subjects with 2 to 4 
measurements each will provide sufficient power for Aim 1.  For the 
SCI (a measure of adherence), using preliminary data in 30 subjects 
we estimated baseline scores of 23.6±4.2 with a correlation among 
repeated measures over time of 0.82.  With 130 subjects measured at 
least twice, we will have 80% power to detect a 2.0 unit change due to 
treatment, which is an 8.5% difference from baseline.   
 
Power calculations for mediation models were considered assuming 130 subjects will be 
available for analysis. In preliminary data, partial correlations of the mediators, PHQ9 
and DFC, with A1C were 0.20 and 0.51, respectively. Correlations of the mediators with 
treatment were 0.52 and 0.54, respectively. Under these assumptions, we have 63% 
power to detect an indirect effect of treatment on A1C through PHQ9 and >99% power 
to detect an indirect effect of treatment on A1C through DFC. Calculations assume a 
0.05 significance level. 
 
Power for moderation will depend on the effect size of the moderation and if the 
moderator is measured on a continuous or categorical scale.  For continuous 
moderators (adolescent age), we have 80% power to detect a 0.36% change in the 
treatment effect on A1C per 1-sd change in the moderator.  For a binary moderator 
(frequency 50%), we have 80% power to detect a modification of the treatment effect on 
A1C of 0.55%.  All calculations assume α=0.05. 
 
Despite evidence demonstrating the effectiveness of telephone-based CBT to reduce 
depressive symptoms, there is a chance that mothers who receive the intervention will 
not report reduced depressive symptoms. If this happens, we would examine the data to 
determine for whom the intervention works. For example, it may be that a more limited 
range of scores on the screening tool (PHQ-9) predicts a better response to the 
intervention. 
 
 

NIDDK 
 
Protocol Version #: 12 
 
17 
Protocol Date: 4/11/2023 
 
11.0 Privacy/Confidentiality Issues 
 
Confidential participant data will be safeguarded by multiple password protection 
requirements, data encryption, and locked secure storage of paper documents. 
 
Facebook interactions will be conducted in private (called "secret") Facebook groups. 
Secret groups allow permissions access to be managed and monitored by the study 
staff, only allowing approved study participants into the group. Any Facebook users not 
approved by study staff will not see the group content or that the group exists. All 
interactions in the group will be extracted using programming stored on a protected 
server and stored in an SPSS file. 
 
Study participants will be required to "friend" the study Facebook account before they 
are added to the secret groups to ensure that the correct person is added. All mothers 
in the study will receive 1 post per day for 3 months. The posts will be on topics related 
to the group assignment (communication and coping or diabetes education). A 
moderator will view and respond to all comments made by Facebook group members. 
 
Only Key Study Personnel (KSP) will have access to research information, and all KSP 
will complete training in Good Clinical Practice. 
 
Participants will be identified with an ID number; names will not be included on any data 
outside of RedCAP. Only research staff who have completed IRB training and have been 
added as KSP have access to the study RedCAP. All identifying information will be 
destroyed at the earliest possible time following completion of the study. All data will be 
analyzed by groups, with no potential for individual patients to be identified. Any 
publications arising from the study will not contain personal information. 
Digital files will be erased after completion of the study. 
 
12.0 Follow-up and Record Retention 
 
Duration of the study is anticipated to be 5 years. All data will be analyzed by groups, 
with no potential for individual patients to be identified. Any publications arising from 
the study will not contain personal information.  
 Research records will be maintained for at least three (3) years from the date the 
research is closed with the IRB. All Health Insurance Portability and Accountability Act 
(HIPAA) related documentation will be maintained for at least six (6) years from the 
date of the last use or disclosure of the Protected Health Information (PHI).