Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1
Phase: NA
Conditions: type1diabetes
Sponsor: Children's National Research Institute

 
 
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Official Title: Feasibility Trial of a Mindfulness Based Intervention to Reduce Maladaptive 
Eating Behaviors in Youth with Type 1 Diabetes 
 
NCT number: NCT05268393 
 
 
Document Date: 11/16/2022 
 

 
 
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CHILDREN’S NATIONAL HOSPITAL 
 
111 Michigan Avenue, NW 
 
Washington, DC 20010 
 
(202) 476-2850 
 
 
RESEARCH PROTOCOL 
 
 
TITLE:  
Feasibility Trial of a Mindfulness Based Intervention to Reduce Maladaptive Eating 
Behaviors in Youth with Type 1 Diabetes 
 
PRINCIPAL INVESTIGATOR:  
Eleanor Mackey, Ph.D., Center for Translational Research, Division of Psychology &  
Behavioral Heath 
 
Co-Investigators:  
Randi Streisand, Ph.D., Center for Translational Research, Division of Psychology & 
Behavioral Health 
 
Fran R Cogen, MD CDE, Interim Co- Chief, Division of Endocrinology and Diabetes, 
Director, Diabetes Services, Director, Washington Nationals Diabetes Care Complex, 
Professor of Pediatrics 
 
Katherine Kelly, Ph.D., Center for Translational Research 
 
RESEARCH PLAN 
 
A. 
Specific Aims 
 
Aim 1. Develop adapted manuals and participant materials for BREATHE-T1D 
intervention and HealthEd-T1D comparison condition. We will conduct/analyze a 
series of structured, open-ended interviews with interdisciplinary T1D experts and 
adolescents with T1D to make adaptations to content/delivery (telehealth) of a 
BREATHE mindfulness group and HealthEd comparison group for adolescents with 
T1D. Our expected outcomes will be a mindfulness-based group program addressing 
negative affectivity and a didactic HealthEd control group, with teen workbooks and 
intervention manuals adapted specifically for youth with T1D.  
Aim 2. Evaluate feasibility/acceptability of BREATHE-T1D and HealthEd-T1D. Our 
hypothesis is that we will be able to recruit participants, as measured by CONSORT 
tracking of recruitment, enrollment, and dropouts, to a 2-way pilot RCT involving 
randomization to BREATHE-T1D telehealth, or HealthEd-T1D. We will assess post-
intervention follow-up rates by condition. We anticipate that both conditions will be 
acceptable, with surveys indicating high satisfaction and qualitative structured 
interviews informing final refinements. We hypothesize BREATHE-T1D telehealth will 
evidence the highest participation (>80%), with both conditions achieving >65% 

 
 
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attendance.  
 
B. 
Background and Significance 
  
Type 1 Diabetes in Adolescents.  T1D is one of the most common childhood chronic 
illnesses, affecting 1 in every 400 youth under age 20 1. Rigorous daily medical 
regimens must be followed including multiple blood glucose checks, insulin injections, 
monitoring food choices and physical activity, maintaining snack availability for 
hypoglycemia, restocking medical supplies, and management of acute complications 
(ADA, 2011).  National studies demonstrate that only 32% of youth aged 13-18 years 
and 18% of youth age 19 and older meet American Diabetes Association (ADA) targets 
for glycemic control, as compared to 56% of adults 2,3. Additionally, up to 1/3 of young 
adults experience diabetes-related acute and chronic complications.4 Thus, glycemic 
control significantly deteriorates across adolescence and continues into young 
adulthood.5. Adherence to diabetes prescribed regimen is critical in achieving glycemic 
control and reducing the risk of acute and long-term complications of diabetes 6. 
Psychological Well-being and T1D in Adolescents 
Although there are multiple reasons for the observed decline in T1D treatment adherence 
and glycemic control during adolescence, one significant and potentially modifiable risk 
factor is negative affectivity. As shown in Figure 1, the conceptual model guiding the 
work is that the high-stress dietary regimen and disruption of physiological signals of 
hunger-satiety signals that are necessary burdens of T1D promote negative affectivity, 
including depression and anxiety symptoms.7 Negative affectivity, in turn, is known to 
promote stress-related behavior, including maladaptive eating behavior, which commonly 
occurs in an effort to cope with unpleasant emotions.7 Consequently, stress-related 
behavior 
leads 
to 
diminished 
treatment 
adherence 
and thereby, worsening 
of glycemic control.7 In 
support of this model, 
there 
is 
a 
well-
established association 
between 
T1D 
and 
increased 
risk 
for 
elevated 
depression 
and anxiety symptoms, 
with 
meta-analyses 
indicating that 40% of 
teens with T1D have 
elevated symptoms of depression or anxiety, as compared to 20% in community 
samples of adolescents without T1D.8,9 Depression and anxiety symptoms have been 
associated with greater risk of developing poor self-care and treatment non-adherence, 
and consequently, poor glycemic control.8,10  
Figure 1. Conceptual etiological model guiding the work  

 
 
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Negative affectivity may impact treatment adherence and glycemic control through a 
variety of stress-related behavioral mechanisms; yet, maladaptive eating behavior 
appears to be particularly salient for youth with T1D, given the hyper-focus on 
food/calories and disruption of hunger-satiety signals that are central features of this 
chronic illness.7 Maladaptive eating behavior refers to a spectrum of unhealthy eating 
and weight-control behaviors that include excessive dietary restriction, loss-of-control or 
binge eating, and specific to individuals with T1D, withholding post-prandial insulin.11 
Intentional insulin omission leads to acute weight loss, whereas regular insulin 
administration promotes weight gain. Overweight (BMI 85th %ile for age/sex) and obesity 
(BMI 95th %ile for age/sex) are increasingly common in youth with T1D, with 25% having 
overweight and 7% obesity.12 Maladaptive eating behavior typically emerges during 
adolescence among youth with T1D, as well as those without T1D, and it is more common 
among adolescents with overweight/obesity.13 Further, adolescents with T1D have very 
high rates of maladaptive eating relative to adolescents without T1D.13 Specifically, 20% 
of adolescents with T1D report clinically significant maladaptive eating behavior, referring 
to symptoms that meet diagnostic criteria for an eating disorder, and an additional ~25% 
report subthreshold maladaptive eating, which is problematic but occurs less frequently 
and/or for a shorter duration than the diagnostic threshold.13,14 Maladaptive eating 
behavior in adolescents with T1D is complicated, because one of the primary aspects of 
daily T1D treatment adherence requires a hyper-focus on food.7 Youth with T1D must 
carefully monitor carbohydrate composition of meals and override hunger-satiety 
physiological signals in order to achieve adequate glycemic control. Of further concern, 
although maladaptive eating behavior is risky for all adolescents, risks to adolescents with 
T1D are high stakes. Maladaptive eating behavior interferes with treatment adherence15 
and increases risk of physical health complications.13,14,16  Thus, interventions in 
adolescents with T1D are needed to provide youth with alternative ways of coping 
with negative affectivity associated with their chronic illness. 
Further, although there are substantial data from longitudinal and experimental studies 
highlighting negative affectivity as a main contributor to stress-related behavior and health 
outcomes, contemporary models are increasingly recognizing the role of negative 
urgency as a key moderating influence in this chain.17 Negative urgency is the propensity 
to act rashly when experiencing negative affectivity. Negative urgency is a core dimension 
of poor executive functioning and impulsivity, and this particular dimension seems to be 
especially important for adolescents.18 Thus, our guiding etiological framework assumes 
that it is the combination of a propensity for negative urgency and the experience of 
negative affectivity that is mostly likely to lead to stress-related behaviors, including 
maladaptive eating, as an unhealthy form of coping in adolescents with T1D. From a 
developmental perspective, the timing of this phenomenon emerging in adolescence 
likely occurs because puberty is accompanied by significant increases in perceived 
stress, including stress related to the burden of T1D, and significant increases in negative 
affectivity.19 For adolescents who are managing the added, major burden of T1D, 
adolescence is often a period when parental figures transfer more autonomy to youth for 
the management of their chronic disease.20 What is more, the increase in negative 
affectivity is simultaneously occurring at a time in the lifespan when executive function 
has not reached maturation.21 Indeed, adolescents, on average, behave significantly 

 
 
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more impulsively than adults, particularly in the face of strong emotions.22 In light of these 
considerations, there is strong evidence to suggest that effective interventions to 
improve treatment adherence and glycemic control in adolescents with T1D will 
necessitate a developmentally-sensitive approach. The dynamic changes in 
responsibility for disease management, increases in negative affectivity, and heightened 
maladaptive eating behavior render adolescence an ideal window of opportunity for 
interventions to optimize treatment adherence and prevent worsening of glycemic control 
in adolescents with T1D. 
Interventions 
Interventions to address treatment non-adherence and poor glycemic control in 
adolescents with T1D must go well beyond standard-of-care T1D education. Drawing 
on a combination of clinical experience, our guiding theoretical model, and extant 
scientific data, we anticipate that interventions should include: (i) explicit 
acknowledgement and acceptance of the burden of T1D, (ii) psychoeducation about 
negative affectivity during adolescence, (iii) provision of tools for self-monitoring and 
identification of unpleasant emotions, cognitions, and body sensations that commonly 
arise in adolescents with T1D, (iv) acceptance and tolerance of such unpleasant 
emotions, cognitions, and body sensations without acting rashly, and (v) coping skills for 
managing T1D stress and its concomitant, negative affectivity, which provide adolescents 
with healthier alternatives to maladaptive eating and that are tailored for adolescents with 
T1D who are required to carefully manage food intake. As such, mindfulness-based 
intervention may be uniquely suited for the needs of adolescents with T1D. 
There has been rising scientific and clinical interest in mindfulness-based interventions to 
decrease negative affectivity23,24 and improve physical health outcomes, including 
stronger treatment adherence and better chronic disease management.25-27 A principal 
goal of mindfulness-based interventions is increasing dispositional mindfulness, referring 
to the propensity to pay attention on purpose to one’s present-moment experiences with 
an attitude of non-judgment and equanimity.28 From the framework of Monitor and 
Acceptance Theory,29,30 mindfulness-based interventions are postulated to decrease 
negative affectivity and thereby, stress-related behavior through (i) increased attention to 
monitoring of present-moment experiences in combination with (ii) increased acceptance 
of experiences regardless of their valence. These mechanisms have been supported in 
recent dismantling studies.29,31-33 We theorize that a mindfulness-based intervention will 
be particularly fitting for decreasing negative affectivity and decreasing stress-related 
behavior in adolescents with T1D. Enhanced monitoring and acceptance of thoughts, 
emotions, and body sensations as they unfold moment-to-moment is theorized to 
decrease negative affectivity through the therapeutic mechanisms of: (i) increased 
monitoring of thoughts, emotions, and body sensations, (ii) increased acceptance and 
equanimity with respect to thoughts, emotions, and body sensation, (iii) increased 
executive function, and (iv) decreased negative urgency (Figure 2).30  

 
 
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Emerging studies of mindfulness-based interventions support 
the possibility that this therapeutic approach may distinctively 
help adolescents to flexibly deploy attention away from 
emotional and physical cues that prompt responding on “auto-
pilot,” including the use of maladaptive eating behavior to 
cope, and to respond alternatively with healthier coping 
strategies.34,35  
A relatively small body of RCTs have evaluated mindfulness-
based interventions in adults or emerging adults with 
diabetes, typically combining populations of adults with T1D 
and type 2 diabetes (T2D). These studies have shown 
moderate effects of mindfulness interventions for decreasing 
depression and anxiety symptoms, relative to waitlist, 
diabetes education, and treatment-as-usual controls, from 
post-treatment to 1-year follow-up.36-43 Some of these RCTs 
also show significant effects of mindfulness interventions on 
improved glycemic control and overall health.36,39,42,43 Yet, not 
all studies have found physical health benefits, particularly 
trials that included patients who already had adequate 
glycemic control.36-38,40,41 To our knowledge, no RCT study 
has evaluated a mindfulness-based intervention in 
adolescents with T1D. Yet, mindfulness interventions may 
be especially valuable in adolescence, given marked 
developments in executive function and openness to new experience, which render this 
transitional period in the lifespan malleable.22,44-47 Pilot and feasibility studies in diverse 
populations, including work conducted by our investigative team, support acceptability 
and credibility of mindfulness interventions in this age group.23,48 Also, RCT studies 
support the efficacy of mindfulness interventions for lowering depression/anxiety in 
diverse samples of adolescents without T1D, with moderate effects compared to attention 
controls.23 Preliminary RCTs also have found that mindfulness interventions decrease 
maladaptive eating in teens (without T1D) who are at risk for weight-related disorders and 
adverse metabolic health, as well as among adults with overweight/obesity.38,40,49-51  
Development of a mindfulness-based intervention tailored for adolescents with 
T1D is a critical first step. Prior to efficacy testing, intervention development to adapt a 
mindfulness-based intervention for this unique chronic illness population is critical. There 
are five main distinct considerations in adolescents with T1D for adapting 
mindfulness-based training to address negative affectivity and stress-related behavior 
particularly maladaptive eating, in this population: (i) adolescents with T1D face 
potentially unpleasant physical and emotional sensations unique to T1D (e.g., 
hypoglycemia); (ii) T1D treatment adherence necessitates a heightened focus on eating 
and nutrition; (iii) T1D treatment adherence requires an overriding of physiological cues 
for hunger-satiety; (iv) T1D treatment adherence often results in higher body weight with 
appropriate insulin administration; and (v) many families have lengthy travel to receive 
specialty healthcare, suggesting novel delivery formats such as telehealth should be 
considered for feasibility, acceptability, and sustainability. 
Figure 2. Mindfulness-based 
intervention conceptual 
model guiding the work  

 
 
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It is also essential to adapt and test feasibility/acceptability of a comparison, health 
education (HealthEd) didactic group program. Our investigative team has experience 
delivering HealthEd content, in an individualized delivery format, within T1D adolescent 
clinicals trials.52 Separately, in adolescents without T1D, we have effectively used a 
general HealthEd group curriculum, matched to BREATHE for intensity, group format, 
and duration, to serve as a didactic control condition.53,54 A comparison, HealthEd-T1D 
didactic group program is needed, which integrates the content relevant to T1D in a group 
delivery format. Vetting the viability of this approach with T1D experts and adolescents 
with T1D is critical, because establishing feasibility and acceptability of the control 
condition is required to enhance feasibility of recruitment, ensure acceptability of 
randomization to the control condition, and to minimize condition effects on attendance 
or confirm no cross-contamination or representation of mindfulness-based content 
between conditions, which could confound treatment effects in a subsequent efficacy 
trial.55 
Current Study 
The proposed study will develop the intervention with stakeholder input and conduct a 
preliminary feasibility and acceptability pilot. This study is essential for developing and 
evaluating both a mindfulness-based group curriculum (BREATHE-T1D) and a health 
knowledge control group (HealthEd-T1D) adapted for youth with T1D, in order to directly 
prepare for a future efficacy trial that can test the efficacy of a mindfulness-based group-
based intervention on negative affectivity, stress-related behavior, treatment adherence, 
and glycemic control. 
 
C. 
Preliminary Studies 
 
Negative affect/maladpative eating in adolescents with T1D at Children’s National. 
Drs. Mackey (PI) and Streisand (Co-I) enrolled N=100 youth with T1D, 11-17y (Mean 
age=14y), in an observational, longitudinal study. The recruitment rate was 59% of eligible 
teens approached in clinic. Thus, our investigative team is well-positioned to access 
the target population. In preliminary analyses of this cohort, we were able to 
characterize rates of negative affectivity (Figure 
3), 
maladaptive 
eating, 
and 
suboptimal 
glycemic control. Consistent with estimates 
from other cohorts of adolescents with T1D, a 
majority (61%) of adolescents receiving 
T1D care at Children’s National Hospital 
(Washington, 
DC) 
reported 
elevated 
symptoms of depression, anxiety, or both, 
and a considerable number (25%) report 
engaging in maladaptive eating behavior. 
Also consistent with national statistics, the 
vast majority (81%) of adolescents with 
T1D had poor glycemic control (A1c 
≥7.5%). 
Figure 3. Rates of elevated depression, anxiety, 
and both types of negative affectivity 
among adolescents  
Depression
Depression
Anxiety
Depression
0
10
20
30
40
50
60
70
% T1D Adolescents with
Elevated Negative Affectivity
or Anxiety
+ Anxiety

 
 
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Further, preliminary analyses provide support for our conceptual model. Using path 
analysis, we found that negative affectivity, as reported by adolescents with T1D and their 
parents, predicted poorer self-care and higher A1c (worse glycemic control) 3 months 
later (Figure 4). In clinically meaningful terms, T1D teens with elevated depression and/or 
anxiety had a nearly 1% higher A1c at 3-month follow-up, controlling for baseline A1c, 
than those with no or low negative affectivity  (Mean A1c 9.7% vs. 8.9%, p=.07). The 
effect of negative affectivity was partially explained by greater maladaptive eating 
behavior. 
Moreover, 
the 
connections 
of 
negative 
affectivity with maladaptive 
eating and self-care were 
moderated 
by 
negative 
urgency. Adolescents with 
T1D were most likely to 
report 
engaging 
in 
maladaptive 
eating 
behavior and poorer self-
care in response to negative 
affectivity when they also 
were higher in negative 
urgency. 
These 
data 
contribute 
to 
the 
overarching 
hypothesis 
for the current work: mindfulness-based intervention may be highly suitable for 
adolescents with T1D because its therapeutic targets include provision of coping 
skills for monitoring emotional states with an attitude of acceptance, increasing 
executive function, and decreasing negative urgency.38,40,48-51,56  
Intervention development in T1D. Drs. Mackey (PI) and Streisand (Co-I) recently 
completed an NIH-funded intervention development grant (DP3DK103998) to promote 
healthy eating and physical activity, in order to improve glycemic control in young children 
with T1D. This project employed the ORBIT model to [create a brand-new intervention 
from the ground up].57 Interviews were initially conducted with 4 parents in the target 
population (parents of children ages 2-5y with T1D). Interviews used a semi-structured 
format with questions about adjustment to diagnosis, regimen, and areas of difficulty and 
strengths, with specific probes for eating behavior and physical activity. A stakeholder 
advisory board, including parents, professional experts in T1D care, and research 
consultants, was created. Once the initial program content was created, the research 
team contracted with a graphic designer to create a logo and visually appealing materials. 
The stakeholder advisory board was consulted for ongoing refinement and was sent 
drafts of the materials for review and feedback. Next, we carried out a small pilot study 
(N=10) to examine feasibility and acceptability of the intervention, approach, and 
assessment protocol. Minor adjustments were made and then a small pilot RCT (N=36) 
was conducted to evaluate feasibility and acceptability of the intervention as compared to 
usual care. Results indicated feasibility of recruitment in that 68% of contacted eligible 
candidates agreed to participate, feasibility of retention with 97% retained through 6-
Figure 4. Path analysis of observational data shows negative affectivity, 
combined with negative urgency, relates to poorer T1D self-care and 
higher A1c at 3-month follow-up, partially through greater maladaptive 
eating; model/all paths p<.05, controlling for age, sex, race/ethnicity, and 
socioeconomic status 

 
 
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month follow-up, and high acceptability/satisfaction, as 100% perceived the program had 
a positive impact on their child’s T1D management and 84% would recommend the 
program to other parents and were glad that they participated. These data indicate the 
unique expertise of the study team to systematically develop T1D behavioral 
interventions that are feasible and acceptable using a similar framework proposed 
in the current study. 
 
D. 
Research Design and Methods  
 
Overview. The proposed approach is consistent with the ORBIT model of progressive behavioral 
intervention development.57 Specifically, we propose to first adapt content/delivery format of an 
existing adolescent mindfulness-based group intervention, Learning to BREATHE, for 
adolescents with T1D using a rigorous qualitative data collection/analysis approach to 
intervention adaptation.58 Then, we will test the feasibility/acceptability of this adapted 
BREATHE-T1D group program delivered via telehealth, with the goal of identifying feasibility of 
delivery for a future efficacy trial. We also will adapt a health knowledge group-based program for 
teens with T1D (HealthEd-T1D) to serve as a didactic, non-overlapping comparison condition that 
will be designed to have viable feasibility/acceptability. The figure below displays the flow and 
estimated time frame of the approach.  For Phase 1 “Adapt BREATHE and HealthEd,” we will  
 
 
Phase 
1
Adapt
BREATHE 
and 
HealthEd
• Year 1: Quarters 1-4
• review existing BREATHE/HealthEd manuals [with specific goals for adaptation: identify skills/behaviors/context relevant for 
T1D and incorporate provider/patient voices in programs]
• [Develop interview guides to elicit nuanced understanding: iteratively/reflexively revise guides]
• conduct/analyze [open-ended, strcutured, in depth] interviews with T1D providers nd make initial adaptations to the 
programs
• Conduct [open-ended, structured, in depth] interviews with adolscnets with T1D and make iterative adaptations based on 
qualitative data [coded/analyzes on a rolling basis using an interpretive design framwork]
• [Finish coding/analysis of adolescent interviews; wrap up] team-based discussion/revision to manuals
• Work with graphic desgin service to draft BREATHE-T1D/HealthEd-T1D adolescent workbooks
• Review adapted curricula with experts and T1D teens [for detailed likes/areas to improve content/formatting/design] and 
incorporate
Phase 
2 
Set up
Pilot and Feasibility 
RCT 
• Year 1: Quarters 3-4 
• Consults with telemedicine expert on behavioral interventions for pediatric populations 
• Fine tune recruitment plan and materials
• Develop standardized operation procedures for all assessment protocols 
• Test all assessment protocols
Phase 
3 
Carry Out
Pilot and Feasibility 
RCT
• Year 2: Quarters 1-3
• Initiate recruitment
• Track all aspects of study flow
• Carry out baseline assessments
• N=40 [3 cohorts; cohorts 1 and 2 n=10-12, cohort 3 n=16-20] randomized to either BREATHE-T1D telehealth or HealthEd-
T1DDeliver BREATHE-T1D telehealth and HealthEd-T1D/track attendence [fidelity & group cohesion ratings]
• Carry out post-intervention assessments, conduct [open-ended, structured] follow-up interviews [with iterative intervention 
refinements for each successive cohort]
Phase 
4
Plan 
Next Steps
• Year 2: Quarter 4 
• Make [final] revisions to curricula based on feasibility, acceptability, and qualitative [coding/analysis using interpretive 
description framework]
• Produce final BREATHE-T1D intervention facilitator manual and participant workbook
• Produce final HealthEd-T1D intervention facilitator manual and participant workbook
• Prepare presentation and manuscripts 
• Prepare grant applications, e.g. UG3/UH3 OR U01 for efficacy trial

 
 
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utilize a rigorous, multistep, iterative process58 to systematically assess, code, and integrate in-
depth, qualitative feedback from T1D experts and teens with T1D on the curricula. In Phase 2 
“Set up Pilot and Feasibility RCT,” we will finalize the BREATHE-T1D and HealthEd-T1D 
manuals/ workbooks, consult with a telemedicine expert to establish standard operating 
procedures for telehealth delivery of BREATHE-T1D, finalize recruitment materials, and establish 
assessment standard operating procedures. In Phase 3 “Carry out Pilot and Feasibility RCT,” 
we will carry out a 2-way pilot RCT in N=40 adolescents, 12-17y, with >1-year duration of T1D, 
randomized to BREATHE-T1D delivered via telehealth, or HealthEd-T1D. We will track all 
elements of study flow and carry out a mixed-methods evaluation of feasibility and acceptability. 
In Phase 4 “Plan Next Steps,” we will make final refinements to BREATHE-T1D and HealthEd-
T1D and study protocols based upon Phase 3 results, disseminate results, and prepare a grant 
application that directly builds upon the R34 findings. Specific elements of each phase are 
described below: 
1. Phase 1: Adapt BREATHE and HealthEd: Phase 1 will focus on [initial] tailoring of 
BREATHE for adolescents with T1D. This phase will include a rigorous qualitative data 
collection and coding/analysis approach to intervention adaptation58 using the inputs of 
interdisciplinary T1D healthcare/provider experts and adolescent patients with T1D to adapt 
and refine BREATHE-T1D. Also, we will use experts’ and patients’ inputs to adapt a credible 
and feasible HealthEd comparison group adapted for adolescents with T1D. The foundation 
for these adaptations will be our existing, manualized BREATHE and HealthEd group 
programs: 
a) Learning to BREATHE: Learning to BREATHE is a mindfulness-based group program 
derived from mindfulness-based stress reduction28 and adapted for adolescents by 
incorporating experiential activities and guided discussions to teach standard mindfulness 
skills.59 Each letter in BREATHE acronym corresponds to a theme: B: Body, R: Reflections, 
E: Emotions, A: Attention, T: Tenderness, H: Habits (of Healthy Living), for overall goal of E: 
Empowerment. Example activities include breath awareness, body scanning, mindful eating, 
sitting meditation, loving-kindness practice, and gentle yoga. The original, published 
curriculum was designed to offer high flexibility in delivery timing and selection of exercises.59 
We previously developed a manualized version of BREATHE for consistency in timing and 
content,48,53 but minimally modified content from its original format. Brief homework (~10 
minutes/day), including formal (e.g., meditation audio-recordings) and informal practices (e.g., 
personalizing mindfulness in daily living), is assigned weekly. Teens are given digital 
meditation audio-recordings, a yoga mat, meditation cushion, homework log, and worksheets. 
Although BREATHE has not been delivered to adolescents with T1D, previous studies show 
it is well-liked by racially/ethnically diverse teens, including in our pilot studies delivering 
BREATHE to teens at-risk for weight-related disorders.48,53 Speaking to its potential 
application for adolescents with T1D, data from our group and others show that BREATHE 
decreases depression symptoms and ameliorates insulin resistance up to 1-year later in pilot 
RCTs.48,53,60-63 
b) HealthEd: The HealthEd curriculum will be derived primarily from a didactic manual that Dr. 
Streisand (Co-I) and colleagues developed as an educational control condition for delivery to 
adolescents with T1D (1R01DK121316-01; PI Jaser). This manualized program provides 
basic education on T1D that would be included as part of standard-of-care, including didactics 
on insulin administration, managing and prevention hypo/hyperglycemia, managing T1D at 
school, considerations for travel, and driving with T1D. The program requires adaptation for 
group delivery, and in doing so, we will draw on the delivery format of a HealthEd didactic 
group program, HeyDurham,64 designed for providing health knowledge to middle and high 
school-age youth, which we have been using as a non-specific, control condition in behavioral 

 
 
Page 10 of 30 
trials.53,54 Also, because the original HealthEd-T1D manual was developed for parents, it is 
necessary to ensure content is relevant, credible, and acceptable to teens with T1D. 
Establishment of feasibility and acceptability of a control condition is necessary to facilitate 
recruitment and retention for a future, larger RCT. 
c) Qualitative design/analytic plan for intervention adaptation: Trained interviewers will 
conduct structured, open-ended interviews with N=10 stakeholders, including n=3 
interdisciplinary T1D healthcare experts, n=3 first wave adolescents with T1D, and n=4 
second wave adolescents with T1D in order to gather in-depth, comprehensive information 
on how best to adapt BREATHE and HealthEd for specific delivery to adolescents with T1D. 
We will use a rigorous, multistep, iterative process, delineated by Rosen et al.,58 for adapting 
BREATHE for the new target population and an interpretive description methodological 
framework will be used for analyses of qualitative data.65 Participants will be purposefully 
sampled to ensure that diverse demographics are included in both stakeholder interviewees 
(e.g., discipline/area of T1D expertise) and adolescents (e.g., age, sex, race/ethnicity, insulin 
regimen). The first step will include interviews with healthcare experts to guide the initial 
adaptations to the manuals. Interview guides with healthcare experts will be designed to elicit 
a comprehensive understanding of providers’ subjective experiences of adolescent T1D 
patient challenges with negative emotions, barriers and facilitators of T1D self-management, 
problematic eating behaviors observed in clinical care, and barriers and facilitators to using 
telehealth as a delivery method of clinical care in this population. We will then ask clinicians 
to review the BREATHE and HealthEd base programs and provide specific feedback and 
commentary regarding patient needs and face evaluation of the potential usefulness of the 
new programs.  
In parallel, we will create and adapt interview guides with teens with T1D. These will be 
designed to elicit a comprehensive understanding of teens’ subjective experiences of negative 
emotions related to T1D and other key life domains, current coping strategies, unhealthy 
eating patterns/weight-control attempts, barriers and enablers to T1D treatment adherence 
and self-care, and desired support. As with clinicians, teens will be asked to comment on the 
base programs of BREATHE content/format/delivery mode and content/format of HealthEd. 
Three teens with T1D will complete interviews and review the base programs. Based on the 
feedback from healthcare experts and initial group of 3 teens, we will make specific 
adaptations to the BREATHE and HealthEd programs and any changes to the interview guide 
for teenagers. Next, we will conduct interviews and ask for comments on the first draft of the 
BREATHE-T1D and HealthED-T1D programs with the final 4 teens. Following these 
interviews, we will make any additional changes to BREATHE-T1D and HealthEd-T1D. We 
will then take this draft back to the stakeholders for any last review or comment. Based on our 
previous experience, we anticipate that specific changes will be needed regarding intervention 
content, examples, and specific discussion, which are an essential aspect of expert 
BREATHE intervention delivery (i.e., the discussion that is facilitated after experiential 
activities). For example, it may be critical to directly address awareness of physical sensations 
that adolescents with T1D may encounter when experiencing hypo/hyperglycemia or adapt 
the mindful eating exercise to reflect that hunger may not be the reason a teen with T1D is 
required to eat. As with our previous studies,66 we have found that acceptability is increased 
when intervention materials are presented in an appealing and professional manner. 
Participant workbooks will be designed by a graphic design service to enhance appeal.  
2. Phase 2: Set up Pilot and Feasibility RCT: The protocol will be submitted to the IRB for 
approval prior to data collection. Data collection procedures will be finalized with input from 
the expert panel and adolescents with T1D to ensure that measures capture essential factors 
and are feasible to administer and complete. 

 
 
Page 11 of 30 
a) BREATHE delivery mode: We will create 1 adaptation of BREATHE-T1D. The format will be 
BREATHE-T1D telehealth. This approach will use a telehealth delivery platform, Zoom, 
currently in use by the telehealth division and CNH providers for a variety of 
behavioral/medical treatments. Zoom allows for groups to occur via video so that each 
member can see the others, mimicking the experience of an in-person group. We anticipate 
that BREATHE-T1D manual/teen workbook will require minimal-to-no modifications in order 
to deliver the program via Zoom.  
b) Finalize standard operating procedures: Written standard operating procedures, with 
accompanying checklists, will be finalized for all aspects of the pilot RCT. An amendment will 
be submitted to the IRB, as needed, based upon protocol revisions and adaptations for 
BREATHE-T1D telehealth and HealthEd-T1D. All research staff will be trained in protocols, 
complete/update CITI trainings in responsible conduct of research, and prepare/test REDCap 
databases for surveys and data management.  
c) Train interventionists: Interventionists will be master’s or doctoral level clinicians who have 
experience working with teens with T1D. Interventionists will participate in a comprehensive 
3-day training to learn BREATHE-T1D and HealthEd-T1D. Training will be led by Drs. Mackey 
(PI), Streisand (Co-I), and Shomaker (Co-I). Drs. Mackey and Streisand have expertise in 
behavioral T1D interventions. Dr. Shomaker has expertise in BREATHE delivery and 
training/supervision. Training will be conducted virtually, and it will include presentations of 
theoretical/empirical background, review of BREATHE-T1D and HealthEd-T1D intervention 
manuals/teen workbooks, modeling of session elements, and role-play using mock-groups. 
Telehealth protocols and delivery methods will be practiced.  
3. Phase 3: Carry out Pilot and Feasibility RCT:  
a) Participants: We will recruit a total N=40 participants for n=20 in each arm of the intervention 
from the ~700 adolescents seen through the CNH T1D clinic annually]. Participants will be 
included on the basis of the following criteria: (i) age 12-17y, (ii) T1D, with at least 1-year 
duration of illness, (iii) negative affectivity, defined as clinically elevated scores (T-score 55 
indicating at least mild depression/anxiety symptoms on either the PROMIS short form-
depression and/or anxiety scales), similar to criteria used in our previous studies in this patient 
population,67 and recommended for use in clinic screening procedures in youth with T1D,68] 
(iv) English-speaking, (v) no cognitive or developmental delays which would interfere with their 
ability to participate in the study, and (vi) have no other serious medical conditions (e.g., cystic 
fibrosis, cancer). Participants with Spanish-speaking parent will not be excluded; consent and 
parent surveys will be translated into Spanish and an interpreter will be utilized for delivery of 
consent. Participants will not be excluded based upon insulin regimen or method of measuring 
blood glucose. Participants will not be excluded based on receiving outside psychological 
support, but treatment outside of the study will be carefully tracked and controlled for in 
analyses. 
b) Recruitment: Participants will be recruited using a variety of approaches that have been 
highly successful in previous studies conducted by Drs. Mackey (PI) and Streisand (Co-I) in 
youth with T1D. Success of these approaches for the particular pilot RCT will be tracked to 
inform a future efficacy trial. Strategies will include: (i) direct mailings, emails, and phone calls 
to participants who, based upon an electronic medical record review, appear to be eligible, 
based upon age, health status/diagnoses, and (ii) in-person approach of teens and parents at 
T1D clinic appointments who are in the target age range. Potentially interested participants 
will be screened for depression and anxiety and will be invited to enroll if they meet the 
criterion for elevated (T-score 55) depression and/or anxiety. Although recruitment feasibility 
must be tested for the current 2-way intervention protocol, our team has a strong history of 

 
 
Page 12 of 30 
recruitment/retention for clinical trials in youth with T1D, with a recruitment rate of 71% in a 
prior trial targeting an adolescent T1D population.69  
c) Baseline assessment: Following the pre-screen, participants who are interested and eligible 
will be met at the clinic most convenient for them. The endocrinology division at CNH sees 
patients across 6 different outpatient clinics across Maryland, Virginia, and DC. Baseline 
assessments will be done via telehealth for maximum flexibility for participants or can be done 
in person to coincide with a quarterly endocrinology healthcare visit. At this telehealth visit, 
they will complete a virtual informed consent process, complete baseline questionnaires, and 
participate in an orientation visit, which we have found in previous studies results in strong 
retention and participation rates. They will receive a $50 ClinCard for completion of this 
assessment and study-specific retention items (e.g., study logo water bottle). 
d) Group participation: A computerized randomization sequence will be created by the data 
manager in randomly permuted blocks. After completion of baseline assessments, allocation 
will be performed by the study coordinator using REDCap, which conceals the sequence. 
Teens will be randomized to BREATHE-T1D telehealth or HealthEd-T1D. As shown in Table 
1, we will aim for n=5 youth/group and interventions will be run in parallel. If scheduling is 
difficult, we will recruit up to 12 for each of the first two cohorts and allow for two groups of 3 
per intervention condition in order not to delay interested candidates and have enough per 
group. We will still maintain an overall n of 40, adjusting the numbers in the final cohort based 
on what we have in cohorts 1 and 2. Based upon our base BREATHE and HealthEd manuals, 
we anticipate that group duration will be ~6 consecutive weeks, 1-hour/week during non-
school hours, with potential for duration/frequency modifications based on the adaptation 
phase.  
Table 1. Estimated timeline for pilot and feasibility RCT of N=40 adolescents with T1D 
Quarter 1 
Quarter 2 
Quarter 3 
Quarter 4 
Recruitment Cohort 1 
n=10-12 
Recruitment Cohort 2 
n=10-12 
Recruitment Cohort 3 
n=16-20 
 
Baseline assessment 
Cohort 1 
Baseline assessment 
Cohort 2 
Baseline assessment 
Cohort 3 
 
Cohort 1 
BREATHE-T1D telehealth 
n=5-6 
HealthEd n=5-6 
Cohort 2 
BREATHE-T1D telehealth 
n=5-6 
HealthEd n=5-6 
Cohort 3 
BREATHE-T1D telehealth 
n=8-10 
HealthEd n=8-10 
 
 
Follow-up assessment  
[& program revisions] 
Cohort 1 
Follow-up assessment  
[& program revisions]  
Cohort 2 
Follow-up 
assessment 
[& final refinements]  
Cohort 3 
All sessions will be audio-recorded and reviewed by Dr. Shomaker (Co-I) on a weekly basis 
for intervention fidelity and interventionist competence using structured rating scales. 
Feedback will be provided in weekly live supervision meetings led by Drs. Streisand and 
Shomaker with facilitators. These protocols previously have been successful as evidenced by 
strong ratings of adherence, competence, and absence of cross-contamination.54,70-72 
Attendance and home practice will be tracked at each session. Adolescents will report 
homework completion to facilitators, and also will record completion of home practices on 
journal logs for BREATHE-T1D (telehealth), and complete satisfaction/acceptability measures 
following each session. Group cohesion will be evaluated by two independent raters’ review 
of audio-recorded sessions using the Therapy Process Observational Coding System-
Group Cohesion scale, which shows good psychometric properties.73 To assess credibility, 
adolescents will report at session 1 their perceived likelihood that stress, mood, and T1D 
health can be improved.74  Descriptions of cohesion/credibility by arm will inform optimization 

 
 
Page 13 of 30 
of facilitator training and intervention delivery. Adolescents will also report on program 
acceptability at the end of each session.  
e) Post-intervention follow-up assessment: Within 4 weeks after intervention completion, 
adolescents will complete surveys online. At post-intervention, all adolescents will complete 
an open-ended, structured interview to query about their subjective experiences of group 
cohesion, facilitator alliance, and perceived relevance and utility of the program. After coding 
n=3 BREATHE-T1D telehealth interviews, and n=3 HealthEd-T1D interviews, Co-I and 
qualitative expert, Dr. Kelly will develop a coding manual for two trained raters to code the 
remainder of the following qualitative post-intervention adolescent interviews. Dr. Kelly will 
oversee coding through regular audits. To assure rich and meaningful information, we will 
make iterative adjustments to interview guides as needed and maintain regular 
communication and systematic discussion among interviewers, data analysts, and 
investigators.  
Based on the feedback received in cohorts 1 and 2, additional modifications will be made to 
BREATHE-T1D and HealthEd-T1D as indicated for cohort 3. Changes can be made in real 
time between each cohort as needed. To carry out these iterative adaptations to the 
interventions, after each set of n=5 interviews per arm, qualitative findings will be reviewed 
by the team to determine if there are needed, minor adjustments or tweaks to the BREATHE 
and/or HealthEd modules for the subsequent cohort(s). Teens will receive a $75 ClinCard to 
complete the first set of post-intervention follow-up assessments, including surveys and the 
interview. Participants will be paid an additional $50 for completing the second set of post-
intervention follow-up assessment at 3 months post-intervention, which consists of the same 
set of online questionnaires completed at baseline. Trained research assistants will complete 
medical record reviews to extract HbA1c as an indicator of glycemic control from the 
immediate endocrine visit that follows the final intervention session. 
f) Measures: To assess feasibility and acceptability of all intervention conditions and the 
assessment protocol, we will carefully track recruitment, retention, participation, fidelity, 
acceptability, and key constructs of interest to be measured in a future efficacy trial. Table 2 
provides an overview of measures and assessment.    
Table 2. Summary of key constructs and measures of Phase 3: Pilot and Feasibility RCT 
Construct 
Measure 
Interval 
Recruitment  
Feasibility/ 
Acceptability 
#  screened per month 
#  enrolled per month 
#  weeks to form cohort 3 
group 
% eligible who enroll 
Study initiation through  
completion of 
recruitment by 
CONSORT guidelines 
Intervention 
Feasibility 
% sessions attended by 
condition recorded by 
intervention facilitator 
 
Weekly/intervention 
phase 
Intervention 
Acceptability 
Teen survey satisfaction 
ratings 
Teen qualitative interview 
Weekly/intervention 
phase 
Post-intervention 
follow-up 
Intervention 
Fidelity 
PI/Co-I structured ratings of 
BREATHE-T1D and 
HealthEd-T1D adherence & 
competence 
Weekly/intervention 
phase 
Retention 
Feasibility/ 
Acceptability 
% complete post-treatment  
follow-up 
Post-intervention 
follow-up 

 
 
Page 14 of 30 
 
 
 
 
 
 
 
 
Data Analysis 
Statistical Design and 
Power 
Overview:  
The first aim of the study 
is to carry out a series of 
iterative 
structured, 
open-ended 
interviews 
with key stakeholders in 
order 
to 
adapt 
an 
evidence-based, mindfulness group intervention, Learning to BREATHE, to be tailored to 
the distinctive needs of adolescents with type 1 diabetes (BREATHE-T1D). We also will 
adapt a didactic T1D health education program for delivery as a group-based control 
program matched for time and attention (HealthEd-T1D). The second aim is to assess 
the feasibility and acceptability of 2 adolescent group-based conditions: 1) BREATHE-
T1D, delivered via telehealth, and 2) HealthEd-T1D, delivered via telehealth. We will 
determine the feasibility and acceptability of recruitment, assessment, retention, and each 
group condition. Together, these data will be essential for informing the final interventions, 
protocols, and design of a future efficacy trial of BREATHE-T1D for adolescents with T1D. 
The qualitative portions add patient voice to intervention adaptation and optimization, 
ensuring that the interventions to be tested and the outcomes to be measured as part of 
a larger efficacy trial will be meaningful, valuable, and helpful for adolescents.75 
Consistent with NCCIH’s policy for the conduct of pilot studies, no preliminary analyses 
of efficacy are planned; yet, the study does include piloting of the measures of predictors, 
outcomes, and hypothesized mechanisms of the mindfulness-based intervention, 
BREATHE-T1D, in order to determine if measure administration is feasible and 
acceptable to adolescents with T1D for use in a future efficacy trial.  
Aim 1: 
Qualitative design/analytic plan for intervention adaptation. Structured, open-ended 
interviews will be conducted with a total of N=10 stakeholders, including n=3 
interdisciplinary T1D healthcare experts and n=7 adolescents with T1D in order to adapt 
BREATHE and HealthEd for specific delivery to adolescents with T1D. Using interpretive 
description methods,65 participants will be purposefully sampled to ensure that diverse 
demographics are included in both stakeholder interviewees (e.g., discipline/area of 
expertise) and adolescent participants (e.g., age, sex, race/ethnicity, insulin regimen, 
glycemic control). Trained research staff will conduct interviews using an interview guide. 
Interview guides will be developed by the investigative team, which now includes an 
Assessment 
Feasibility  
 
% assessments with missing 
vs. complete data 
Baseline; post-
intervention follow-up 
Dispositional  
Mindfulness 
Teen report on Mindful 
Attention Awareness Scale; 
Five-Factor Mindfulness 
Questionnaire 
Baseline; post-
intervention follow-up 
Negative  
Affectivity 
PROMIS short forms 
Depression/  
Anxiety subscales 
Baseline; post-
intervention follow-up 
Maladaptive  
Eating 
Behavior 
Diabetes Eating Problems 
Survey – Revised  
Baseline; post-
intervention follow-up 
Negative 
Urgency 
Teen report on UPPS-P –  
Negative Urgency Subscale 
Baseline; post-
intervention follow-up 
Treatment  
Adherence 
Self-Care Inventory 
Baseline; post-
intervention follow-up 
Glycemic 
Control 
Hemoglobin A1c derived 
from the patient electronic 
medical record 
Baseline; post-
intervention follow-up   
Diabetes 
Distress 
Teen report on Problem 
Areas in Diabetes-Teen 
 
Baseline; post-
intervention follow-up   

 
 
Page 15 of 30 
expert in qualitative research methods and interpretive description, Dr. Katherine Kelly 
(Co-I), who has successfully collaborated with Co-I Dr. Randi Streisand on previous 
mixed-methods studies in pediatric T1D.76  
The first step in this process will include interviews with healthcare experts to guide the 
initial adaptations to the manuals. Interview guides with healthcare experts will be 
designed to elicit a comprehensive understanding of providers’ subjective experiences of 
adolescent T1D patient challenges with negative emotions, barriers and enablers to T1D 
treatment adherence and self-care, problematic eating behaviors observed in clinical care 
experience, and barriers and enablers to using in person healthcare and telehealth as a 
delivery method of clinical care in this population. We will then ask clinicians to review the 
BREATHE and HealthEd base programs and provide specific feedback and commentary 
regarding patient needs and face evaluation of the potential usefulness of the new 
programs based on their clinical experience with adolescents with T1D. We will query 
T1D healthcare experts about intervention formatting and design; ask them to highlight 
sections that they particularly liked; ask them to highlight sections that they particularly 
did not like, thought were unclear, or thought could be improved; and query as to whether 
providers perceive that any important content is missing. 
The second step that will happen in parallel with the provider interviews is that we will be 
creating and adapting interview guides with adolescents with T1D. These guides will be 
designed to elicit a comprehensive understanding of adolescents’ subjective experiences 
of negative emotions related to T1D and other key life domains, current coping strategies, 
unhealthy eating patterns/weight-control attempts, barriers and enablers to T1D 
treatment adherence and self-care, and desired support. As with clinicians, teens also will 
be asked to comment on the base programs of BREATHE content/format/delivery mode 
and content/format of HealthEd. We will initially have n=3 teens with T1D complete these 
interviews and review the base programs.  
Third, based on the feedback from the 3 healthcare experts and the initial group of 3 teens 
with T1D, we will make specific adaptations to the BREATHE and HealthEd programs 
and any changes, as indicated, to the interview guide for teenagers to elicit more 
information on emergent themes and/or to fill in more depth/detail about particular topic 
areas. Following revisions to the teen interview guides, we will conduct interviews and 
ask for comments on the first draft of the BREATHE-T1D and HealthED-T1D programs 
with n=4 new teens with T1D. Finally, findings from these 4 teens will result in additional 
changes made to BREATHE-T1D and HealthEd-T1D. We will then take this second draft 
back to the stakeholders for a last review and comment. 
All interviews will be audio-recorded; interviewers also will take extensive field notes. 
Interviews will be transcribed verbatim for qualitative analyses using Atlas.ti. Dr. Kelly 
(Co-I; qualitative expert) will initially code n=3 healthcare expert and n=3 adolescent 
interviews using interpretive description.65 The PI Dr. Eleanor Mackey then will review 
and validate initial coding. Coding results will be reviewed by the entire investigative team 
and adjustments will be made to the interview schedule as indicated to assure that rich, 
descriptive findings are being elicited. Subsequent interviews will be analyzed on a 
continuous basis, as soon as they are transcribed. To assure the greatest efficiency in 
completing qualitative analyses/coding, Dr. Kelly will complete analysis of these initial 

 
 
Page 16 of 30 
interviews. We adopt an interpretive description framework because it employs an 
inductive constant comparative analysis that produces in-depth conceptualizations of 
interviews.65 This qualitative analysis method is purposefully flexible so that relevant new 
findings can inform subsequent interviews creating a robust and efficient analysis. This 
qualitative analytic approach, in combination with regular, planned communication and 
discussion among the investigative team about interviews/analyses, will ensure that we 
derive the richest information from stakeholder interviews in order to adapt BREATHE-
T1D and HealthEd-T1D.58  See figure below for illustration of full process. 
How Aim 1 qualitative data/analysis will inform the adaptation of BREATHE. Qualitative 
data/analysis will provide critical information on the specific mindfulness-based skills and 
contextual factors that will be most important for mindfulness-based training in 
adolescents with T1D. Qualitative data collection/analysis is ideally suited for intervention 
adaptation because it allows for both confirmation of anticipated changes to intervention 
content that will be necessary (e.g., matching themes with existing BREATHE content) 
as well as emergent or unanticipated information to optimize an intervention for the target 
population through additional changes to content or creation of new content. Based on 
our previous experience, we anticipate that specific changes will be needed regarding 
intervention content, examples that are provided in experiential activities (e.g., case study 
in module on stress and attention, or ways we practice kindness or meanness to 
ourselves), and specific discussion of areas of stress/concern for adolescents with T1D, 
which are an essential aspect of expert BREATHE intervention delivery (i.e., the 
discussion that is facilitated after experiential activities). For example, it may be critical to 
directly address awareness of physical sensations that adolescents with T1D may 
encounter when experiencing symptoms of hypo/hyperglycemia, adapt the mindful eating 
exercise to reflect that hunger may not be the reason a teen with T1D is required to eat, 
or other unique experiences teens with T1D note that will be important to modify or use 
to highlight specific aspects of the BREATHE curriculum. 
Sample size justification. Based upon our past experience76 and recommended 
guidelines,77 a total sample size of N=10 total stakeholders is anticipated to achieve 
informational redundancy.  
Aim 2: 
Statistical design/analytic plan. N=40 adolescents with T1D will be recruited for a pilot 
RCT of BREATHE-T1D delivered via telehealth, and HealthEd-T1D delivered via 
telehealth. The following table provides an overview of measures and methods of 
assessment for Aim 2: 
Construct 
Measure 
Interval 
Expected Outcome 
Recruitment  
Feasibility/ 
Acceptabilit
y 
#  screened per 
month 
#  enrolled per 
month 
#  weeks to form 
cohort 3 group 
% eligible who 
enroll 
Study initiation 
through  
completion of 
recruitment by 
CONSORT 
guidelines 
  30 screened per month 
    5 enrolled per month 
  12 weeks to form cohort 3 
groups 
≥80% eligible enroll after 
screen 

 
 
Page 17 of 30 
Intervention 
Feasibility 
% sessions 
attended by 
condition 
recorded by 
intervention 
facilitator 
 
Weekly/interventio
n phase 
≥80% attend ≥80% of 
BREATHE-T1D  
telehealth  
≥80% attend ≥65% of 
HealthEd-T1D  
Intervention 
Acceptabilit
y 
Teen survey 
satisfaction 
ratings 
 
Teen qualitative 
interview 
Weekly/interventio
n phase 
 
Post-intervention 
follow-up 
≥80% 
liking/credibility/relevance/utili
ty ratings ≥4 (1=not at all to 
5=extremely) 
Themes indicative of 
liking/credibility/relevance/utili
ty 
Intervention 
Fidelity 
Mackey/Shomak
er structured  
ratings of 
BREATHE-T1D 
and HealthEd-
T1D adherence 
and  
competence 
Weekly/interventio
n phase 
≥8 scores on adherence and  
competence ratings (1=poor 
to 10=exceptional) for all 3 
intervention    
conditions 
Retention 
Feasibility/ 
Acceptabilit
y 
% complete post-
treatment  
follow-up 
Post-intervention 
follow-up 
≥80% complete post-
treatment  
follow-up 
Assessment 
Feasibility  
 
% assessments 
with missing 
vs. complete data 
Baseline; post-
intervention 
follow-up 
<5% missing data for 
assessments administered to 
participants 
Disposition
al  
Mindfulness 
Teen report on 
Mindful Attention 
Awareness Scale; 
Five-Factor 
Mindfulness 
Questionnaire 
Baseline; post-
intervention 
follow-up 
 
<5% missing data for 
assessments administered to 
participants  
 
<10% will display worsening 
across conditions 
Negative  
Affectivity 
Teen report on 
PROMIS short 
forms 
Depression/  
Anxiety 
subscales 
Baseline; post-
intervention 
follow-up 
Maladaptive  
Eating 
Behavior 
Diabetes Eating 
Problems Survey 
– Revised  
Baseline; post-
intervention 
follow-up 

 
 
Page 18 of 30 
Negative 
Urgency 
Teen report on 
UPPS-P –  
Negative Urgency 
Subscale 
Baseline; post-
intervention 
follow-up 
Treatment  
Adherence 
Self-Care 
Inventory 
Baseline; post-
intervention 
follow-up 
Glycemic 
Control 
Hemoglobin A1c 
derived from the 
patient electronic 
medical record 
Baseline; post-
intervention 
follow-up   
<10% will display increased 
A1c across conditions 
Diabetes 
Distress 
Teen report on 
Problem Areas in 
Diabetes-Teen 
Baseline; post-
intervention 
follow-up   
 
 
g) Feasibility: The primary focus of the feasibility assessment will be to demonstrate 
that a recruitment, participation, and retention can meet pre-defined targets. To 
evaluate feasibility, a CONSORT table and descriptive statistics regarding 
recruitment, retention, data completeness, and fidelity will be generated by 
intervention group. Feasibility will be determined overall by meeting recruitment 
targets and rates of agreement to participate in the study. Retention, participation, 
and fidelity by group will be examined for meeting feasibility criteria (>80% retention, 
>80% sessions attended, >80% of homework completed, 80% fidelity of intervention 
delivery). Feasibility indicators also will be evaluated for differences between group 
conditions in order to determine if one program is more feasible. For participants lost 
to attrition in each cohort, baseline characteristics and research coordinator feedback 
will be evaluated to determine how recruitment rates may be improved. 
h) Acceptability: To evaluate acceptability quantitatively, descriptive data will be 
generated of post-intervention satisfaction surveys overall and by group condition. 
Acceptability will be determined by a high level of satisfaction with participation, 
perceived utility of the intervention content, and perceived benefit from participation 
(>80% reporting that they were satisfied and perceived utility and benefit). 
Acceptability indicators will also be evaluated for differences between group 
conditions in order to determine if one is more acceptable. 
Qualitative acceptability strand. At post-intervention, all adolescents will complete an 
open-ended, structured interview to query about their subjective experiences of the 
intervention content, relationships with facilitators/other group members, home 
practice completion, and enablers and barriers of making changes in coping with 
negation emotions, eating behaviors, and T1D treatment adherence. After coding 
n=3 BREATHE-T1D, telehealth interviews, and n=3 HealthEd-T1D interviews, Dr. 
Kelly will develop a coding manual to be used by 2 trained coders, who have expertise 
in qualitative analysis, to code the remainder of the following qualitative post-
intervention adolescent interviews. Dr. Kelly will oversee coding through regular 
audits. To assure rich and meaningful information, we will make iterative adjustments 
to interview guides as needed and maintain regular communication and systematic 

 
 
Page 19 of 30 
discussion among interviewers, data analysts, the qualitative expert (Kelly), and 
experts in adolescents with T1D and behavioral interventions (Mackey & Streisand), 
eating (Mackey & Shomaker) and BREATHE (Shomaker). 
Based on the feedback received in cohorts 1 and 2, additional modifications will be 
made to BREATHE-T1D and HealthEd-T1D as indicated for cohorts 2 and 3. 
Specifically, to carry out these additional, iterative adaptations to the interventions, 
after each set of n=5 interviews, qualitative findings will be reviewed by the team to 
determine if there are needed, minor adjustments or tweaks to the BREATHE and/or 
HealthEd modules for the subsequent cohort(s). 
Figure depicting qualitative strand of the study to be carried out in Aims 1 and 2: 
  
 
 
 
 
 
 
i) Measurement: Descriptive statistics using the measurements of hypothesized 
outcome and mechanism indicators will be used to look at variability in responses for 
each measure for utility of use in future trials (e.g., is there sufficient variability across 
participants to make it a worthwhile indicator of the proposed construct, do the 
measures correlate with one another in expected directions). Our primary pilot (and 
subsequent full-scale trial) assessments of improvement in measures will be a set of 
planned contrast comparisons using independent samples group t-tests with further 
validation using the non-parametric Wilcoxon rank sum test. These are: 
i) Comparison of the n=20 active treatment participants in BREATHE-T1D telehealth 
delivery to the n=20 HealthEd-T1D control arm participants on measures of 
feasibility (e.g., recruitment, dropout, data missingness, fidelity) and acceptability 
(e.g., satisfaction ratings) to determine if there are differences in feasibility or 
acceptability between BREATHE-T1D versus HeatlhEd-T1D. 
Sample size justification. For studies that can be considered both feasibility and pilot 
studies we approached sample size assessment for both. There are a range of thoughts 
on sample sizes needed to assess feasibility.78 Julious et al.79 recommend n=12 per 
group as a rule of thumb and justify this recommendation based upon rationale about 
feasibility and precision about the mean and variance. A paper provided by the United 
Kingdom National Institute of Health80 recommends a total pilot sample size between 
N=30 and N=50. We also assessed the 80% completion rule (which is used for several 
of our feasibility outcomes). If we assume a chance response of 50% program completion, 
with a sample size of 15 (at alpha = 0.05 and 80% power), we can detect a difference of 
80% completion or more. Therefore, we believe the proposed study will be powered to 
assess feasibility overall and by group condition. 
Incorporate  
interim interview 
findings into 
subsequent drafts  
of BREATHE-T1D & 
HealthEd-T1D 
Incorporate 
interview findings 
into BREATHE-T1D 
& HealthEd-T1D 
Stakeholder 
interviews 
N= 3 T1D 
healthcare 
experts & 
7 adolescents 
Iterative interviews 
and coding along with 
ongoing manual 
adaptation 
Final versions  
BREATHE-T1D & 
HealthEd-T1D 
Modules ready for 
larger trial 
Aim 1 Manual Adaptation Phase from BREATHE to BREATHE-
T1D
Aim 2 Manual Improvement Phase following each cohort 
3 rounds (cohorts 1 & 2 n=10, 
cohort 3 n=20) following each 
cohort with iterative 
interviews and coding  
First cohort of each program 

 
 
Page 20 of 30 
Concerning the sample size assessment for pilot studies, we reference Cocks and 
Torgerson81  who recommend using a total sample size of N=45 or more to detect a 
significant effect size of 0.25 or greater between 2 group conditions planned in the larger 
trial following the pilot study or to use a total sample size of N=30 to detect a significant 
effect size of 0.31 or greater between 2 group arms in the larger trial following the pilot 
study. Based upon our review of similar studies assessing glycemic control82 and 
mindfulness-based intervention measures,34 we believe these effects size are reasonable 
for our 3 planned 2-group comparisons regarding our primary aims of evaluating feasibility 
and acceptability. 
E. 
Study Population: 
 
There will be 90 total participants across both phases of study (3 diabetes team providers, 
7 adolescents with T1D for the intervention development qualitative feedback, and 40 
adolescent and caregiver dyads for the feasibility trial).  Diabetes team providers (n=3) 
will be interviewed to provide feedback regarding the adaptation of BREATHE for use 
with adolescents with T1D. We will recruit a total N=40 participants for n=20 in each arm 
of the intervention. Participants will be included on the basis of the following criteria: (i) 
age 12-17y, (ii) T1D, with at least 1-year duration of illness, (iii) negative affectivity, 
defined as clinically elevated scores (T-score >55 indicating at least mild 
depression/anxiety symptoms on either the PROMIS short form-depression and/or 
anxiety scales) (iv) A1c >7.5%, (v) English-speaking, (vi) no cognitive or developmental 
delays which would interfere with their ability to participate in the study, (vii) are able and 
willing to complete questionnaires and intervention via the internet, (viii) do not have 
severe depression or active or recent (within the past two months) suicidal ideation and 
(viv) have no other serious medical conditions (e.g., cystic fibrosis, cancer). Participants 
with Spanish-speaking parent will not be excluded; consent and parent surveys will be 
translated into Spanish and an interpreter will be utilized for delivery of consent. 
Participants will not be excluded based upon insulin regimen or method of measuring 
blood glucose. Participants will not be excluded based on receiving psychological support 
outside of the context of the study, but treatment outside of the study will be carefully 
tracked and controlled for in analyses. The study will be nonselective in its recruitment 
and enrollment with respect to gender, race, and ethnicity.  
 
 
F. 
Human Subjects 
 
Adolescents and a primary caregiver will be recruited from the Child and Adolescent 
Diabetes Program at CNMC. Adolescents between the ages of 12-17 will be studied to 
capture both early and later development of eating disorder and disordered eating 
symptoms.   
Participants will be recruited using a variety of approaches that have been highly 
successful in previous studies conducted by Drs. Mackey (PI) and Streisand (Co-I) in 
youth with T1D. Success of these approaches for the particular pilot RCT will be tracked 
to inform a future efficacy trial. Strategies will include: (i) direct mailings, emails, and 
phone calls to participants who, based upon an electronic medical record review, appear 

 
 
Page 21 of 30 
to be eligible, based upon age, health status/diagnoses, A1c and (ii) in-person approach 
of teens and parents at T1D clinic appointments who are in the target age range. 
Potentially interested participants will be screened for depression and anxiety using the 
PROMIS scales and will be invited to enroll if they meet the criterion for elevated (T-score 
55) depression and/or anxiety.  
  
G. 
Risks and Side Effects: 
 
There are no known psychological risks to subjects when providing feedback via 
qualitative interview or when filling out standardized psychological questionnaires. 
However, the questionnaires may contain questions that make the subjects feel 
uncomfortable in that they ask about their physical and psychological health. Additionally, 
we will be recruiting participants with elevations on measures of depression and/or 
anxiety. For participants by self-report responding that they are experiencing a clinically 
significant level of anxiety OR depressive symptoms (using the PROMIS short form – T 
> 55 cutoff for depression and for anxiety subscales), we will follow a protocol that has 
been effective in our prior studies. Additionally, adolescents report on disordered eating 
behaviors, including risky behaviors such as insulin withholding. The DEPRS will be 
screened for clinical cutoff and specifically for endorsing either of the two items that ask 
about insulin withholding. Specifically, all forms will be reviewed by the clinical research 
assistant within 24 hours of completion or in real time for screenings taking place in clinic 
or via zoom (and flagged if either the depression or anxiety scores are above the clinical 
cutoff (T-score > 55) or if the DEPRS is above the clinical cutoff AND/OR either of the 
insulin withholding items are endorsed). If the score is above the clinical cutoff or the 
insulin withholding items are endorsed, the study team will notify the family both that they 
are eligible for participation in the study, and also reminded of additional referrals for care, 
including the in-house diabetes psychologist and other community referrals. The PROMIS 
measures do not assess for suicidal ideation, and we will not be assessing this specifically 
given that it is outside of the scope of this trial. However, if suicidal ideation or intent is 
suggested during the course of any study interactions, the PI Dr. Eleanor Mackey, a 
licensed child clinical/pediatric psychologist, will be informed immediately via cell phone, 
and outreach to the parent and teen will be made. All research staff interacting with 
patients (e.g., research coordinator, research assistants) will be trained in our lab’s risk 
assessment procedures. If deemed necessary, the teen will be referred for immediate 
mental health evaluation at the CNH Emergency Department. Our team of T1D 
psychologists maintains written protocols for all cases that necessitate a possible breach 
of confidentiality and for handling concerns that may arise such as suicidal ideation or 
self-harm. As we have done successfully in prior studies, we will monitor ongoing parent 
and teen reporting of the use of mental health support outside of the study either via usual 
care (e.g., seeing the in-clinic psychologist) or outside therapy/consultation or other 
behavioral health services. Paralleling national trends, most teenagers with T1D, even 
when screened and referred, do not seek regular therapy due to a variety of barriers. 
Thus, the interventions being offered, including the control condition, will likely offer more 
support and monitoring than adolescents would otherwise receive, even when they 
screen positively for depression/anxiety in diabetes clinic.  
 

 
 
Page 22 of 30 
The primary potential source of risk in this study is the risk of gathering sensitive social, 
behavioral, and medical information. Data collection via the Internet will be conducted 
through secure applications (REDCap). The respondent burden for completion of 
questionnaires at each assessment point is approximately 20-40 minutes total. 
 
Protection Against Risk. All members of the research team are currently trained in the 
ethical conduct of research, and will be required to uphold certifications throughout the 
project period. The plan for protecting privacy and confidentiality recognizes that the 
protection of privacy in studies involving sensitive data is of utmost importance. We will 
attempt to do this in several ways. We will emphasize the voluntary and confidential 
nature of the research as well as state the limits to confidentiality in the informed consent 
form, and again at the beginning of any qualitative interviews. All responses to interview 
items will be given by subjects in private. Internet data collection will occur through 
programs that have security features. We will minimize all communications that involve 
names or other identifying information. All clinically-relevant and study information will be 
kept in locked files in locked offices. Information about subjects will not be accessible to 
any non-authorized study personnel without the written consent of the subject. In all 
datasets we will use ID numbers only. A separate dataset linking names with ID numbers 
will be accessible only to authorized study personnel under the direction of the PI. 
 
 
H. 
Benefits:   
 
There are no known direct benefits to subjects to participating in this research. Those 
allocated to the BREATHE-T1D telehealth condition may gain skills in managing negative 
affect and ultimately improving diabetes management behaviors. 
 
 
I. 
Outside Consultants/Collaborators  
 
 
Lauren Shomaker, Ph.D., co-investigator, Colorado State University 
Ann Davis, Ph.D., consultant, Children’s Mercy Hospital 
 
 
J. 
Contractual Agreements      
 
 
None  
 
K. 
Costs To Subjects: 
 
None.   
 
L. 
Conflicts Of Interest: 
 
None.  
 
M. 
Confidentiality: 
 

 
 
Page 23 of 30 
All information collected as part of the study is confidential and will not be released to 
anyone to the extent permitted by law.  To protect privacy, identification numbers will be 
used to identify all study information, and only authorized study personnel will have 
access to study records, with the permission of the PI. Each participant's identifying 
data will be separated from the study data and all clinically-relevant and study data will 
be stored in a password-protected database, on a password-protected computer, or in a 
locked filing cabinet in a locked office. Information about subjects will not be accessible 
to any non-authorized study personnel without the written consent of the participant.   
N. 
Subject Compensation:  
Participants in the intervention refinement phase will receive $20 in a Target gift card for 
their participation. Participants in the pilot intervention will receive money on their 
ClinCard at each data collection time point.  Participants will be compensated with 
increasing amounts assessment completion (baseline $50, first follow-up $75, and 
second follow-up $50).  
 
O. 
Facilities and Equipment 
Data collection will take place in the Diabetes Care Complex at the Children's National 
Medical Center Shiek Zayed campus and surrounding regional outpatient clinics or 
online. 
 
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