Targeting Self-regulation to Promote Adherence and Health Behaviors in Children
Phase: NA
Conditions: Self-regulation, Medication Adherence
Sponsor: University of Michigan

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Adolescent Interventions to Manage Self-Regulation of T1D (AIMST1D) Protocol 
Full NIH Study Title: Targeting self-regulation to promote adherence and health behaviors in children 
 
 
Protocol and Statistical Analysis Plan 
 
NCT number:  NCT03688919 
Unique Protocol ID: UH3HD087979 
IRB-MED HUM Number: HUM00148853 
 
Date Approved by University of Michigan IRB (IRB-MED): 2021-01-13 
 
 
 
 
 

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Adolescent Interventions to Manage Self-Regulation of T1D (AIMST1D) Protocol 
Full NIH Study Title: Targeting self-regulation to promote adherence and health behaviors in children 
 
The goal of this study, called the UH3 phase, is to take lessons learned in our previous study, referred to as 
the UH2 (ABC Brain Games; HUM00104622), and test whether self-regulation (SR) assays and interventions 
can be delivered and change SR in a new sample, and test in a small RCT whether SR interventions lead to 
change in medication adherence. We have designed our UH3 phase based on lessons learned in the UH2 
phase, and detail below our Aims and Approach for UH3. Of note, after observing how our UH2 interventions 
performed with younger children and extensive discussion with our research team, particularly Dr. Fredericks 
(Co-I for UH2, MPI for UH3), an expert in medication adherence, and Drs. Hunter (NIH Project Scientist) and 
Dr. Lee (new Co-I for UH3 phase), experts in Type 1 Diabetes (T1D), we propose to focus the UH3 study on 
adolescents with T1D. These youth have clear medication adherence goals, yet are often nonadherent and at 
great health risk during this developmental period.1-3 As responsibility for diabetes management shifts from 
parent to youth during this time,4,5 intervening with adolescents directly is vital for prevention.6-8 The adolescent 
T1D population therefore represents an ideal focus for our UH3 study for several reasons.  
Urgent need to improve medication adherence in adolescents. To achieve and maintain optimal glycemic 
control, adolescents with T1D must adhere to a complex self-care regimen including monitoring blood glucose, 
administering insulin via daily injections or a pump, regulating carbohydrate intake, physical activity, and 
minimizing hyper- or hypoglycemia.9,10 Adherence to recommended treatment regimen is critical in determining 
health outcomes among pediatric T1D patients.11,12 Yet, poor adherence is common during the transition into 
adolescence.2-4 Only 21% of adolescents meet the American Diabetes Association guidelines for hemoglobin 
A1c (HbA1c) target level of 7.5%.1,12 Moreover, treatment adherence and glycemic control decline across 
adolescence.13 Achieving target HbA1c may prevent long-term complications and enhancing adherence should 
improve health outcomes for adolescents with T1D.14 Yet, strict adherence to T1D regimens is challenging. 
While some intervention approaches have empirical support for improving adherence (e.g. family systems 
therapy), they can be costly and time intensive. There remains an urgent need to identify effective treatment 
strategies to improve medication adherence in this population and create lasting behavior change.  
Self-regulation (SR) deficits may drive poor adherence. Poor SR has been identified in youth with T1D15-19 
and is proposed as a central mechanism contributing to nonadherence.10,20-23 Promising interventions suggest 
that in addition to targeting diabetes-specific adherence behaviors, addressing SR skills is vital.6,10,24,25 Yet, SR 
targets have not been tested as mechanisms of behavior change to improve adherence to T1D regimens in 
youth. Specific aspects of SR that are particularly important for youth with T1D include executive functioning 
(e.g., working memory, inhibitory control); emotion regulation (e.g., capacity to manage stress and worries), 
and future orientation and motivation to stay focused on long term goals.10  In our UH2 study, we developed 
interventions that successfully engaged these SR targets. Thus, in the UH3 phase we propose a small RCT to 
deliver our SR interventions and test their impact on three identified SR targets from the UH2 (Executive 
Function [EF], Emotion Regulation [ER], Future Orientation [FO]), medical regimen adherence, and diabetes-
related health outcomes (quality of life; HbA1C) in youth with T1D.  
Specific SR targets identified in the UH2 Phase (EF, ER, FO) are relevant for T1D regimen adherence.  
Executive Function (EF). EF deficits are documented in youth with T1D across numerous studies.15-17 It has 
been proposed that impairments in EF in youth with T1D interfere with treatment adherence17,20,22 and extant 
work finds associations of EF, treatment adherence, and glycemic control in adolescents.17 In youth ages 13-
17 years, parent-rated EF deficits in working memory and attention were associated with poorer adherence;16 
in other work the association between EF and glycemic control was mediated through treatment adherence.20  
Emotion Regulation (ER). Adherence requires ER skills (e.g., taking medications even if stressed, depressed 
or anxious).10,26 Adolescents with diabetes experience high levels of stress,18,19 which is associated with less 
adherent behavior, poorer perceived competence, and poorer metabolic control.27-29 Relatedly, adolescents 
with poorer ER skills have been found to have higher HbA1c levels.30,31 Relaxation interventions may improve 
metabolic control by promoting better regulation of stress hormones, reducing stress and increasing capacity to 
focus on regimen adherence.19,29  In prior work, biofeedback and relaxation exercises similar to our UH2 phase 
intervention were associated with reductions in blood glucose levels in adults with type 2 diabetes.32,33 Recent 

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pilot studies with adolescents with T1D suggest that motivational techniques to encourage positive affect are 
associated with better adherence.24,25 Thus, improving adolescents’ capacity for ER through relaxation and 
self-calming may reduce the likelihood that distress interferes with adherence.  
Future Orientation/Motivation (FO). Adhering to T1D regimens requires planning to understand and achieve 
goals (e.g., blood glucose monitoring), and motivation to remain engaged (e.g., maintaining optimal HbA1c 
levels to avoid long term complications). Future orientation (FO) has received significant attention from multiple 
SOBC projects, including our own, and is associated with health behaviors that promote long-term goals,34,35 
particularly in adolescents.36 FO has been indexed as future time perspective37,38 and as capacity for episodic 
future thinking (EFT), or projecting to “make the future become the present”.34,35 Individuals who can concretely 
describe and visualize their future may be more willing to invest energy in behaviors leading to long-term 
health outcomes, such as medication adherence. Research has shown associations between FO and better 
diabetes management behaviors.39,40 Yet, few studies examine such associations in adolescents. The period of 
adolescence is characterized by increased capacity to envision the future due to neurological, psychological 
and social changes,41,42 and this capacity is viewed as underlying adolescents’ and adults motivation to engage 
in positive health and other behaviors.37,43,44 Indeed, motivational interviewing is in part based on these 
concepts, and motivational interviewing around diabetes-specific goals shows promise in enhancing adherence 
among adolescents with T1D.6,45,46 Improving FO capacity may thus enhance the power of this approach to 
motivate behavior change in adolescents.47,48 In our UH2 study we used an EFT task based on SOBC Network 
Member Epstein’s prior work49,50 as our FO intervention. Using this task with adolescents who have T1D, for 
whom FO is a critically important developmental skill and who have specific goals to achieve with regard to 
adherence may therefore have important implications for later health.51  
Adolescence is a critical period for SR development. Developmental neuroscience suggests that 
adolescents’ SR skills are increasing, yet still emerging.52 Associations between SR capacities and medication 
adherence have been found in prior work with youth.7,53,54 Medical adherence typically shifts from parent to 
adolescent self-management across this period.4,5,8,55 Therefore, supporting adolescents in developing SR 
skills to manage these tasks is essential6,7 and may have implications for successful health care transitions 
across the lifespan.56  In our UH2 study, we found positive impact of our bundled intervention (Nback, 
relaxation, EFT) on the self-regulation targets EF, FO, and ER. The UH3 phase will therefore employ this 
bundled intervention, with developmental adaptations appropriate for adolescents, and content adaptations 
appropriate for youth with T1D and accompanying medical regimen adherence requirements.  
Scientific Premise and Impact. The Scientific Premise of this proposal is that poor SR underlies poor medical 
regimen adherence in youth with T1D. We further posit that improving SR targets relevant for adherence in 
these youth may yield a novel approach to health behavior change that may apply to youth with other chronic 
illnesses who are becoming independent managers of medical regimens. Findings will therefore not only 
inform our understanding of SR as a mechanism of behavior change and develop interventions to engage SR 
targets in youth with T1D, but also have transdiagnostic implications and thus broad impact. As well, the 
bundled interventions to be delivered in the UH3 phase are designed to be light-touch and scalable, thus may 
yield useful tools and resources to use in future studies of behavior change mechanisms in new populations.  
The Specific Aims are as follows: 
Aim 1. Test the hypothesis that interventions developed in the UH2 phase enhance relevant identified self-
regulation targets (EF, ER, FO) in a new population 
(adolescents with T1D).  
Aim 2. Test whether interventions improve medical regimen 
adherence behaviors and T1D health outcomes. 
 
Approach  
 
Conceptual Model. The model to be tested using an RCT 
design in the UH3 phase is presented in Figure 2. We will 
assess the self-regulation targets of EF, ER, and FO and 
the proximal validation target of medical regimen adherence 

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using multiple methods (see Tables 6 and 7). Diabetes related health outcomes include HbA1c level and 
quality of life.  
 
Participants. 94 youth between 13.0 and 17.99 years of age will be invited to participate. Inclusion criteria are: 
1) youth must have been diagnosed with T1D for at least 6 months; 2) reside with a parent; 3) have HbA1c>7.0 
4) regular access to WiFi; and 5) feel comfortable speaking English enough to complete study activities. 
Exclusion criteria include: 1) non-fluency in English in parent or youth; and 2) psychiatric or cognitive 
conditions that would impede ability to participate. 
 
Recruitment. There are two recruitment streams for this project. The first and primary source will be patients 
from UM. The second source of recruitment will be non-Michigan Medicine patients with T1D living in Michigan 
and northeast Ohio (e.g. Toledo). 
 
The UM Diabetes clinic serves 1300 children with diabetes, primarily T1D. Co-I Lee runs these clinics and has 
successfully used the below strategies to recruit youth with T1D for multiple studies. The clinic participates in a 
hospital-wide registry of patients with diabetes and the T1D Exchange. The University of Michigan is one of the 
leading sites in the T1D Exchange Registry; Co-I Lee’s team enrolled 1009 participants this way (nearly 500 
participants were < 18 years old at enrollment). Participants will be recruited from the UM Pediatrics Diabetes 
Clinic Research Registry and the T1D Exchange T1D Registry.  
 
Targeted recruitment outreach of all eligible potential participants will be conducted through phone calls, 
mailings, and emails as well as in-person outreach for UM patients at routine endocrinology appointments and 
in-person recruitment at fairs, camps and/or community events for any eligible youth with T1D. Electronic 
advertisements will also be posted on UMHealthResearch.org and clinic website umpedsdiabetes.com. The 
study team will inform the staff and providers within Pediatric Endocrinology of the study and its requirements 
and request referrals. Paper advertisements will be distributed in Pediatric Endocrinology clinic rooms at C.S. 
Mott Children’s Hospital and e-newsletter. The team has extensive experience utilizing hospital electronic 
medical records to screen participants for eligibility.  
 
In addition, the team will utilize listservs and other points of contact (e.g. Facebook groups) of T1D-focused 
groups in Southeast Michigan. For example, after gaining permission from colleagues at the local chapter of 
the Juvenile Diabetes Research Foundation (JDRF), the approved study email, flyer, text, and/or 
umhealthresearch.org link could be sent to members of their listserv or posted to their Facebook group. Project 
clinicians will also work with outside endocrinologists to have them share the study with their patients. If 
interested, patients will initiate contact with the study team since the investigators will not have access to other 
clinic’s patient names, addresses or phone numbers. Current families enrolled in the study will also be able to 
share the study with their T1D network or community via word-of-mouth or by sharing approved recruitment 
materials; anyone interested would then initiate contact with the study team. 
 
Interested families will complete eligibility screening through an intake call or in person, based on their 
preferred method. During the intake, informed consent/assent, study activities and random assignment will be 
detailed. Participants will be randomly assigned to intervention group at enrollment using a random number 
generator. We will employ a block randomization scheme stratified for youth sex and age (+/- 1 year), to 
ensure equal allocation to control and intervention groups.  
 
Procedures. The adolescent and their parent will be scheduled to visit our research offices at the Center for 
Human Growth and Development (CHGD), which are set up for family-friendly visits. A parking pass will be 
provided. Pre-test and post-test assessments will be completed at CHGD (see Intervention and Attention 
Control Protocols). The pre-test visit will consist of completing SR behavioral assessments (youth) and 
questionnaires (youth and parent), medication adherence questionnaires (youth and parent), and introduction 
of intervention (for the intervention group) or control activities (for the control group; youth and parent). We will 
also show youth and parents the umpedsdiabetes.com website as a source of information on medication 
adherence, stress relief, and managing medications.  

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We will provide all parents with contact information for resources for themselves and their adolescent in the 
community to access mental health care, as well as social services and resources as needed.  During the 
consenting process we will highlight the referral resource list, noting that it includes referrals for a range of 
services that families might find useful, including community-based behavioral health resources for parents and 
children.  If a parent specifically requests assistance with finding an appropriate referral, PI  Fredericks or Co-I 
Albright will contact the parent to identify an appropriate referral based on individual concerns. 
 
We have balanced feasibility with rigorous measurement; the Pre-test visit is anticipated to take up to two and 
a half hours to complete all study activities. The post-test visit will be nearly identical to the pre-test with the 
exception of the intervention or control activities, and is anticipated to take 1.5 hours. Participants can 
complete post-test surveys remotely by receiving links to the surveys stored in the project’s secure electronic 
database (REDCap). Patient diabetes devices (glucometer, insulin pump, and/or continuous glucose monitor 
(CGM)) will be downloaded at pre-test and post-test visits in adjacent clinic space to obtain these clinical data 
as a measure of adherence. For the post-test visit, devices may also be downloaded remotely and securely. 
The family will be escorted to co-located UM-lab sites or instructed to visit any UM-lab site on their own within 
7 days of pre-test to have blood drawn to assess for HbA1c. A review of the electronic medical record will be 
conducted after the family has completed the post-test to assess number and purpose of clinic visits and any 
health events (e.g., DKA). We will inform the families that we may look at the teen’s medical record up to 1 
year after the 2nd study visit in order to review T1D health events. Youth will be offered up to $175 and parents 
up to $100 using a pro-rated incentive structure designed to enhance retention. For completing their home 
practice, youth in the intervention group will offered up to $80 more and will be entered into a lottery to win a 
gift card.  
Measures. We will use multi-method assessment. Post-test assessments will be conducted 8-10 weeks after 
pre-test, based on anticipated changes in self-regulation, medication adherence, and HbA1c across this period 
of time, and the optimal timing of intervention delivery as determined during the UH2 phase. Table 6 outlines 
self-regulation assessments; Table 7 outlines medical regimen adherence and T1D assessments. 
Self-regulation. SR will be assessed using the multi-method assays developed in our UH2 study. Adolescents 
in the UH3 phase will complete SOBC Network-developed measures that are hypothesized to change as a 
result of our intervention but that we were not able to use in the UH2 due to the younger age of our sample 
(e.g., CFC; 5-trial Delay Discounting). All assays were shown to be psychometrically reliable in our own and/or 
other SOBC Network work, or with adolescents in prior research. EF will be assessed using objective tasks 
and parent-reports to evaluate working memory (Backward Digit Span; BRIEF); inhibitory control (Go-no-go 
task; BRIEF); organization/planning (BRIEF). Parents will also complete a digit span and Go-no-go task to 
assess EF. ER will be assessed using youth self-report and parent-report to evaluate affect dysregulation 
(SIDES) and perceived stress (NIH PSS) and youth self-report of anxiety (GAD-7) and positive and negative 
affect (PANAS). FO will be assessed using youth self-report and objective tasks to evaluate self-efficacy (NIH 
Self-Efficacy), consideration of future consequences of actions (CFC); and delay discounting (5-trial task). We 
also seek to identify potential mechanisms of association between parent SR capacity and youth T1D 
outcomes, including diabetes-relevant family processes that have been identified as important in shaping 
health outcomes for youth with T1D (Table 8). 
Table 6 
Specific Construct 
Measure Details 
Who / Data Source 
Intake  
 
 
 
 
Regimen (Parent and Child), Parent 
Depression, Family Chaos, Family 
Composition and Income, Demographics 
29 min  
Parent for all;  
Child self-report on Regimen 
Executive Function  
 
 
 
Forward & Backwards 
Digit span  
Working memory 
7 min (online) 
Parent and child complete task 
Go No Go task 
Inhibitory control 
7 min (online) 
Parent and child each complete task 
Behavior Rating 
Inventory of Executive 
Function – A  
EF broad  
15 min (75 items) 
Parent self-report  
 
Behavior Rating 
Inventory of Executive 
Function (BRIEF-2)57  
EF (inhibit, shift, emotional control, initiate, 
working memory, organize, monitor) 
10 min; 63 items 
(parent), 55 items (child) 
Parent report on child 
Child-self-report 

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Medical Regimen Adherence. We will obtain clinical measures and parent/youth report of T1D adherence 
behaviors (see Table 7). We will analyze adherence on a continuous basis as well as classify youth as 
“adherent” vs. “nonadherent” based on clinical criteria.63 Clinical Adherence is defined with respect to regimen 
and includes blood glucose monitoring (BGM) frequency and insulin administration. BGM frequency will be 
assessed by downloading data from the prior two weeks from the adolescent’s diabetes devices. Youth may be 
adherent to BGM, insulin administration, or both. Adherence to BGM is defined as an average of 4 blood 
glucose measurements/day and/or wearing a CGM 6 out of 7 days vs. not; insulin administration adherence is 
defined as at least 3 short acting insulin boluses/day vs not. We will assess regimen-specific adherence (BGM; 
insulin administration) at pre-test and assess again at post-test as a dichotomous and continuous variable.63 
The division of Pediatric Endocrinology has access to the latest tools for T1D treatment and monitoring 
including an account with Glooko/diasend, a cloud-based, secure platform for uploading data from over 150 
diabetes devices and consolidating data into a single dashboard; Dexcom Clarity, a system for downloading 
and viewing continuous glucose monitoring data; and Tidepool.org (nonprofit, HIPAA-compliant platform for 
downloading diabetes meter, pump, CGM data). BGM and insulin administration frequency for youth on a CGM 
pump can be measured using the software. For youth on injections, the number of short-acting insulin boluses 
will be measured by self-report. The Self-Care Inventory (SCI-R)64 is a 15-item youth- and parent-report 
measure of multiple T1D self-care adherence behaviors. Versions are available for adolescents and parents 
(identical item content) and shown to be reliable in comparable samples.64 Items reflect main aspects of the 
T1D regimen, including: monitoring and recording glucose, administering and adjusting insulin, regulating 
meals and exercise, and keeping appointments. Respondents report on adherence behaviors on a 5-point 
scale (1=“never do it”; 5=“always do this as recommended without fail”; or N/A. 
Emotion Regulation 
 
 
 
NIH Perceived Stress 
Scale (PSS)58  
Youth stress (parent- and youth-perceived) 
4 min; 10 items 
Parent report on child 
NIH Perceived Stress 
Scale (PSS)58  
Youth stress (parent- and youth-perceived) 
4 min; 10 items 
Child self-report 
NIH Perceived Stress 
Scale (PSS)58  
Parent stress 
4 min; 10 items 
Parent self-report 
Difficulties in Emotional 
Regulation Scale 
(DERS)59 
Parent emotion regulation 
9 min; 36 items 
Parent self-report 
Affect Dysregulation 
Scale (SIDES)60 
Stress reactivity and emotion dysregulation 
2 min; 6 items 
Child self-report 
Positive and Negative 
Affect Schedule 
(PANAS) 
Youth affect 
5 min; 20 items 
Child self-report 
GAD-7 (screener) 
Youth anxiety  
7 items; 5 min 
Child self-report 
Future Orientation 
 
 
 
NIH Self-Efficacy58  
Belief in capacity to manage, control life 
events  
4 min; 10 items 
Parent report on child 
NIH Self-Efficacy 58  
Belief in capacity to manage, control life 
events  
4 min; 10 items 
Child self-report 
NIH Self-Efficacy58  
Belief in capacity to manage, control life 
events  
4 min; 10 items 
Parent self-report 
Consideration of 
Future Consequences 
(CFC)61 
Thinks about long term consequences of 
actions 
10 min; 14 items (break 
out) 
Child self-report 
5-trial Adjusting Delay 
Discounting Task62  
Valuing rewards less as time until reward 
increases 
1 min 
Parent and child each complete task 
Table 7 
Specific Construct 
Measure Details 
Who / Data Source 
Medical Regimen 
Adherence 
 
 
 
Adherence to BGM; Insulin 
Administration 
Clinical Adherence (objective) 
N/A (2nd RA should be 
able to do) 
Diabetes devices 
Adherence  BGM; Insulin 
Administration 
Self-reported adherence  
N/A (only if meter fails) 
Self-report 
T1D Adherence Self-care 
Inventory (SCI)-Revised 
Multiple T1D regimen adherence 
behaviors 
15 items (7 min) 
 
Parent report on child  
Child-self-report 
Health Outcome 
 
 
 
HbA1c 
Glycemic control 
N/A 
Clinic 
 
 
 
 

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T1D-related health outcomes. Glycemic control will be measured by HbA1c, a measure of glycosylated 
hemoglobin in the blood representing glycemic control over the prior 2-3 months that is often used in 
behavioral interventions with youth.46 HbA1c will be collected at MLabs, methods used by Co-I Lee. Guided by 
Co-I Lee, chart reviews will be conducted to assess number and reason for clinic visits and T1D-related health 
events (DKA; Hospitalizations). 
Pain Interference will be measured using the Patient-Reported Outcomes Measurement Information System 
(PROMIS) Pediatric Short Form v2.0 - Pain Interference survey, which is an 8-item measure of the impact pain 
has on engagement with social, physical, cognitive, and emotional activities. Both child-self-report and parent-
report of child’s pain interference will provide information about how the child’s experience of pain impairs 
overall functioning and quality of life. 
Diabetes-Relevant Family Processes. We will measure Diabetes-relevant Family Processes via parent 
completion of several questionnaires (Table 8) and teen completion of one questionnaire. Specifically, 
Diabetes-relevant Family Functioning will be measured by the Revised Diabetes Family Conflict Scale 
caregiver form65 The Revised Diabetes Family Conflict Scale is a 19-item measure of diabetes-specific family 
conflict around diabetes management tasks that are direct (e.g., checking blood glucose) and indirect (e.g., 
identifying what to eat when away from home).  
 
Perceived Family Burden will be measured with the short forms of the Identifying Problem Areas in Diabetes 
Survey – Parent Of Teen Version (P-PAID-T) and Teen Version (PAID-T).66 The P-PAID-T is an 15-item 
measure while the PAID-T has 14 items. Both are valid, reliable, and clinically useful instruments for identifying 
diabetes-related distress among teenagers with T1D and their parents.  
 
Parent Involvement in Diabetes Management will be measured using the Diabetes Family Responsibility 
Questionnaire, a 17-item scale that describes diabetes-specific and general health situations or tasks that 
youth with diabetes commonly engage in.67 Parents report who, if anyone, in their family takes responsibility for 
these situations and tasks, including whether the parent and youth share responsibility.  
 
Covariates. As in the UH2 phase, demographics and covariates will be assessed in order to include in 
analyses as needed. These include family income, composition, and medical history; parent depression 
symptoms (Center for Epidemiologic Studies Depression Scale68), youth anxiety, and household stress 
(CHAOS Scale69).  
Intervention and Attention Control Protocols 
All youth in the intervention condition will receive the bundled intervention, which focuses on EF, ER, and FO. 
The intervention will occur mostly through home practice and be supplemented by engaging youth remotely 
using approaches that PI Fredericks has used in her work with teens managing chronic illness and in other 
studies with this population (e.g., text based reminders and mobile apps to practice techniques70). Intervention 
activities will be introduced after evaluation activities are completed for the pre-test and we will monitor home 
practice to assess dosage as in the UH2 phase (e.g., number of NBack sessions; relaxation practice; EFT 
cues played).   
T1D Events 
Health events (e.g., DKA) 
N/A 
Chart Review 
PROMIS (Short Form v2.0 
Pain Interference 8a) 
Pain Interference 
8 items (3 min) 
Parent report on child 
Child-self-report 
Table 8 
Specific Construct 
Measure Details 
Who / Data Source 
Diabetes-Relevant Family Processes 
 
 
 
Revised Diabetes Family Conflict Scale 
Diabetes-relevant family functioning 
19 items (5 min) 
 
 
All Parent Report, except 
PAID-T 
Identifying Problem Areas in Diabetes – 
Parents of Teen (P-PAID-T)  
and Teen version (PAID-T) 
Perceived family burden 
15 items (5 min) 
14 items (5 min) 
 
Diabetes Family Responsibility 
Questionnaire 
Parent involvement in diabetes 
management 
17 items (5 min) 

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1. EF Intervention. We will use the NBack intervention71-73 as in the UH2 phase.74 Youth will be shown 
how to play a game wherein they recall which image they saw in prior sequences. As in the UH2, 
participants will be given a tablet with the game loaded on it to play at home.  
2. ER Intervention. In the UH2 phase, participants learned how to engage in relaxation and biofeedback 
activities during in person visits by completing activities (e.g., modulating breathing to keep heart rate 
and skin conductance within a certain range) on a computer while wearing sensors.75 They were told to 
complete the relaxation activities on their own at home, but were not given access to a computer-based 
version to practice. In the UH3, we will conduct similar in-person relaxation and biofeedback training but 
also show participants how to practice these activities at home using commercially available apps that 
PI Fredericks uses clinically (e.g., Heartmath and Insight Timer). These will be loaded onto the tablets 
with the Nback task and/or onto the participant’s smartphone.  
3. FO Intervention. In the UH2 phase, we developed an EFT intervention based on SOBC Network 
Member Epstein’s work.49,50 The EFT intervention, in which participants generate positive upcoming 
events and describe these events using prompts to elicit concrete, episodic language, is hypothesized 
to promote future-oriented thinking because the participant is encouraged to mentally project and pre-
experience the future event in the present.76 Our EFT intervention showed positive impact on the 
number of episodic, descriptive words our UH2 child participants used when describing future events. 
For the UH3 phase, as we are working with adolescents who have greater cognitive capacity to engage 
in such activity, and who are at an age when developing FO is critical,51,77-79 As in our UH2 phase, 
participants will be asked to envision and describe future events they are looking forward to, using 
concrete, vivid descriptive language. The interventionist will transcribe the participant’s descriptions, or 
cues, and concise prompts will be texted to participants at home. The participant will be prompted to 
look at the cues at home at specified times of day (e.g., 7am and 3:30PM).  
Attention Control Protocol. Youth in the control condition will receive care that is already in place. After post-
test data collection is complete participants will be asked if they would like to receive a summary of study 
findings at the completion of the study and if results are favorable, will have the option of learning intervention 
techniques.  
Intervention and Attention Control Fidelity Measures. As in our UH2 phase, we will assess fidelity of delivery for 
both the intervention as well as the attention control condition by videotaping and coding a subset of sessions. 
 
COVID-19 follow up study. In light of events with the COVID-19 pandemic, we are inviting participants who 
have finished the post-test visit to complete an online survey to help us understand how families are coping. All 
data collection will occur remotely. The follow up consists of 12 questionnaires that parents answered before 
(10 for teens) plus 1 new survey [11 items] about life changes during the COVID-19 pandemic. In addition, we 
will include the COVID-19 survey in our battery for all pre-test visits going forward. 
 
In the COVID-19 follow-up, parents will be asked to answer the following 12 questionnaires again: Family 
Chaos, CESD, Difficulties in Emotion Regulation Scale, Perceived Stress (parent report on child), Self-Efficacy 
(parent report on child), SCI-R, T1D Regimen Survey, Perceived Stress (self-report), Revised Diabetes Family 
Conflict Scale, Problem Areas in Diabetes Parents of Teens (P-PAID-T), Diabetes Family Responsibility 
Questionnaire, PROMIS. In addition, parents will be asked the 11-item COVID Family Stress scale. The 
COVID-19 Family Stress scale measures increased stress for families in light of the pandemic. It consists of 11 
items in areas such as child care, job loss, and physical health. 
Teens will be asked to answer the following 10 questionnaires again: Perceived Stress (self-report), Affect 
Dysregulation scale, Self-Efficacy (Self-report), Consideration of Future Consequences, PANAS, GAD7, SCI-
R, T1D Regimen Survey, Problem Areas in Diabetes – Teen (PAID-T), PROMIS. As well, teens will be asked 
to answer an 11-item version of the COVID Family Stress Scale modified for their age group.  
Parent and teen participants who choose to participate in the COVID-19 follow up will receive an additional $25 
for completing the follow-up. 
 
Statistical Analysis Plan 

Miller, A. 
 
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We will transform skewed outcome variables as needed, run descriptive statistics, apply transformations to 
assure normality, and assess potential covariates to include. While maximum effort will be made to retain all 
subjects and minimize the amount of missing data, we anticipate there will be some data lost-to-follow-up and 
incomplete measures. Thus as is our practice we will address missing data by applying advanced statistical 
techniques, such as multiple imputation using PROC MI in SAS and IVEWARE SAS macro. Co-I Kaciroti has 
extensive experience managing datasets with missing data using both Likelihood and Bayesian methods. Both 
methods are valid when the missing data mechanism is missing at random, which is less restrictive than data 
missing completely at random. In addition, as needed we will implement sensitivity analysis to assess the 
robustness of the results under different missing-data mechanisms including missing data that are potentially 
missing not at random. Co-I Kaciroti has developed and used Bayesian models for sensitivity analysis for 
different outcomes using these methods.80-84 We outline the analytic plan below.  
Youth will be randomly assigned to receive intervention or control using a random number assignment protocol 
we used in the UH2 phase. To test whether the interventions were effective in changing self-regulation targets 
(Aim 1), medical regimen adherence and T1D health outcomes (Aim 2), and diabetes relevant family 
processes (on an exploratory basis), we will use an intent-to-treat analysis (all analyses will use an alpha value 
of p<.05). Baseline comparability of the groups will be assessed for multiple variables using t-tests for 
continuous variables (e.g., home chaos) and χ2 tests for categorical variables (e.g., regimen type). We will use 
generalized linear (for continuous adherence and health outcomes) and logistic regression (for dichotomous 
adherent/nonadherent outcomes) to compare changes in SR, adherence and health outcomes across the two 
groups (treatment vs. control; α= 0.05). We anticipate that some children will have only partial adherence to the 
intervention (i.e. attend a subset of sessions), thus we will conduct a dose-response analysis where dose 
corresponds to number of sessions, controlling for covariates that relate to number of sessions attended and 
outcome of interest. Sex will be examined as a biological variable as some differences have been identified in 
SR-adherence associations.16,31  Power. In UH3 we will test the feasibility of assaying SR in a new sample and 
detecting change in SR targets and medication adherence. We anticipate medium effect sizes of 0.6 with the 
bundled interventions, so our proposed sample size of 94 (47 per group) should result in sufficient statistical 
Power of 82% to detect such effects using a two-sided Type I error alpha of 0.05. In addition, controlling for 
baseline variables that relate to outcome would reduce the residual variance and further increase the statistical 
Power.  
UH3 Study Timeline. Table 9 outlines the timeline for UH3 activities. We include 3 months of “start-up” to 
refine assays and interventions (which are largely the same as in the UH2 phase), obtain IRB approval, and 
train staff. We will enroll 2 new participants per week to reach our recruitment goals (n=94), which is feasible. 
The rhythm of data collection in 
prior studies is similar to that 
proposed here, and we are 
thus confident in the feasibility 
of the project. Co-I Lee’s 
successful recruitment in the 
UM Diabetes clinics she runs 
and the large population of youth with T1D (638 youth per year who met study criteria) from which to recruit will 
help to ensure success. We had no delays in meeting UH2 milestones, even though we had a limited 
participant pool as we only included children from an existing cohort. In the UH3, we will recruit new 
participants so we do not anticipate difficulties. As well, the Clinical and Translational Science Award at UM 
supports Behavioral Clinical Trial Support Units (CTSUs) that provide pre- and post-award support to 
investigators running behavioral clinical trials (e.g., grants administration specialists; science coordinator). We 
will coordinate with our Children’s and Behavior, Function and Pain CTSU to ensure that we meet IRB, NIH 
clinical trial, Clinicaltrials.gov, and other regulatory requirements and deadlines for all UH3 study activities.  
 
References Cited   
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Wood JR, Miller KM, Maahs DM, et al. Most Youth With Type 1 Diabetes in the T1D Exchange Clinic 
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Adolescent Diabetes Clinical Guidelines. Diabetes Care. 2013;36(7):2035-2037. 
Table 9. Study Timeline 
Sep-
Nov 
Dec-
Feb 
Mar-
May 
Jun-
Aug 
Sep-
Nov 
Dec-
Feb 
Mar-
May 
Jun-
Aug 
Finalize Study Protocols, Train, IRB 
 
 
 
 
 
 
 
 
Participant Recruitment, Randomization 
 
 
 
 
 
 
 
 
8 week Intervention Period 
 
 
 
 
 
 
 
 
Follow-up Assessments  
 
 
 
 
 
 
 
 
Data Analysis and Dissemination 
 
 
 
 
 
 
 
 
SOBC and Study Team Meetings 
 
 
 
 
 
 
 
 

Miller, A. 
 
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