Body Emotional Map Method for the Reduction of Parental Stress Related to Diabetes: a Randomized Study. BEM-02
Phase: NA
Conditions: Stress (Psychology), Diabete Type 1
Sponsor: Valentino Cherubini

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STUDY PROTOCOL 
 
BODY EMOTIONAL MAP METHOD FOR THE REDUCTION OF PARENTAL STRESS RELATED TO DIABETES:  
A RANDOMIZED STUDY 
BEM-02 
 
Version N° 2.1 
July 26th 2023 
 
Sponsor: 
Dott. Valentino Cherubini,  
Dipartimento di Diabetologia Pediatrica,  
Ospedale G. Salesi,  
Ancona 
 
 
 
 
 
 
 
 
 
 
 
 
 

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DECLARATION OF COMPLIANCE 
 
The study will be conducted in accordance with the guidelines of the International Conference on 
Harmonisation for Good Clinical Practice (ICH E6), applicable Good Clinical Practice standards, and relevant 
national laws. All personnel involved in the conduct of this study have completed training on the protection 
of human subjects. 
 
 

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SIGNATURE PAGE 
 
The signature below constitutes approval of this protocol and its attachments and provides the necessary 
guarantees that this study will be conducted in accordance with all provisions of the protocol, including all 
confidentiality statements, and in compliance with local legal and regulatory requirements and the ICH-GCP 
(R2) guidelines. 
 
 
 
For the Sponsor: 
Signature:  
Date: 
 
 
Name: Dott. Valentino Cherubini 
 
Title: 
Dipartimento di Diabetologia Pediatrica, Ospedale G. Salesi, Ancona 
 
 
Principal Investigator: 
Signature:  
Date: 
 
 
Name:  
 
Title: 
 
 
 
 

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INDEX 
DECLARATION OF COMPLIANCE ................................................................................................................... 2 
SIGNATURE PAGE......................................................................................................................................... 3 
INDEX .......................................................................................................................................................... 4 
LIST OF ABBREVIATIONS .............................................................................................................................. 6 
STUDY SYNOPSIS .......................................................................................................................................... 7 
KEY ROLES AND CONTACTS .........................................................................................................................11 
1. 
INTRODUCTION: SCIENTIFIC RATIONALE ....................................................................................12 
2. 
STUDY OBJECTIVES .........................................................................................................................13 
2.1 
Objectives of the study............................................................................................................13 
2.2 Study Endpoint ..................................................................................................................................13 
2.2.1 Primary ..........................................................................................................................................13 
2.2.2 Secondary ......................................................................................................................................13 
3 
STUDY DESIGN .................................................................................................................................14 
3.1 
Study duration and participating clinical sites ..........................................................................14 
4 
STUDY POPULATION .......................................................................................................................14 
4.1 
Inclusion criteria .....................................................................................................................14 
4.2 
Exclusion criteria .....................................................................................................................15 
4.3 
Procedures for assigning interventions in the study ................................................................15 
4.3.1 
Randomization procedure .......................................................................................................15 
4.3.2 
Masking procedure .................................................................................................................15 
5 
STUDY INTERVENTION ...................................................................................................................15 
5.1 
Description of the BEM method ..............................................................................................15 
5.2 
Description of the control method ..........................................................................................16 
5.3 
Procedures ..............................................................................................................................16 
5.4 
Questionnaires ........................................................................................................................16 
6 
EVALUATION OF EFFICACY .............................................................................................................18 
6.1 
Efficacy parameters.................................................................................................................18 
6.2 
Frequency of endpoint assessment .........................................................................................19 
7 
STATISTICAL CONSIDERATIONS ....................................................................................................19 
7.1 
Sample Size Calculation ...........................................................................................................19 
7.2 
Statistical Analysis ...................................................................................................................19 
8 
QUALITY ASSURANCE ......................................................................................................................20 
9 
STUDY MONITORING .......................................................................................................................20 

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10 ETHICAL ASPECTS............................................................................................................................20 
10.1 
Ethical Standards ....................................................................................................................20 
10.2 
Informed Consent ...................................................................................................................20 
11 DATA COLLECTION ..........................................................................................................................21 
12 Publication Policy ............................................................................................................................21 
13 REFERENCES .....................................................................................................................................22 
 

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LIST OF ABBREVIATIONS 
 
BEM 
Body Emotional Map 
B-PSQI 
Brief Pittsburgh Sleep Quality Index 
CGM 
Continuous Glucose Monitoring 
COPE 
Coping Orientation to Problems Experienced 
COPE-NVI 
COPE, nuova versione italiana 
CRA 
Clinical Research Associate 
CRO 
Contract Research Organization 
eCRF 
Case Report Form elettronica 
GAD-7 
General Anxiety Disorder 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
HbA1c 
Glycated Hemoglobin 
IC 
Informed Consent 
ICH 
International Conference on Harmonisation 
IRB/IEC 
Institutional Review Board/Independent Ethics Committee 
ISF 
Investigator’s Site File 
NPL 
Neuro-Linguistic Programming  
PHQ 
Patient Health Questionnaire 
PSESDM 
Parental Self-Efficacy for the Management of Diabetes Mellitus 
PSI-SF 
Parental Stress Index Short-Form 
T1DM 
Type 1 Diabetes Mellitus 
TAR 
Time above range 
TBR 
Time below range 
TIR 
Time in range 
TMF 
Trial Master File 
 
 
 

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STUDY SYNOPSIS 
 
 
Titolo  
BODY EMOTIONAL MAP METHOD FOR THE REDUCTION OF PARENTAL STRESS 
RELATED TO DIABETES: A RANDOMIZED STUDY 
Version # 
2.1 
Date 
July 26th 2023 
Project start date  
2023 
Project end date 
2024 
Project type 
National multicenter randomized controlled trial. 
Staff involved 
Psychologists: Maria Cristina Alessandrelli (AN), Maria Cusinato (PD), Giada 
Boccolini (AN) 
Counselor: Manuela Pagnini (AN) 
Principal Investigator: Valentino Cherubini (AN) 
Doctors, dieticians and nurses of the participating teams 
Statisticians: Antonio Nicolucci, Giuseppe Lucisano (PE) 
Background  
Type 1 diabetes (T1D) in childhood and adolescence is a chronic condition 
characterized by significant management complexity, requiring essential 
therapeutic and behavioral synergy between parents and the affected child. 
In chronic illnesses where cure is not achievable, the therapeutic goal shifts to 
adaptation that allows for a good quality of life. The onset of diabetes in a child or 
adolescent is a critical, potentially traumatic event, also for parents, since it 
immediately becomes evident that they are embarking on a long journey of living 
with a chronic condition. 
A good adaptation, which in this context can be considered as the "cure" of the 
chronic disease, is the primary goal of therapeutic intervention. The process toward 
adaptation varies in duration; achieving it is not guaranteed and should be viewed 
as an ongoing process. 
During this journey, obstacles are encountered that require activating resources, 
which can be considered "internal" to the individual or "external," related to 
technology, family environment, social context, and healthcare. In the phase of good 
adaptation, parents experience an improved state of psycho-physical well-being, 
fewer worries related to diabetes, positive mental representations, increased 
confidence in their child's future, and a stronger sense of self-efficacy. Optimal use 
of technology is a key factor in this process. 
In a preliminary pre-post, single-arm study, the BEM (Body Emotional Maps) method 
demonstrated the ability to reduce parental stress measured after three months 
using the Parental Stress Index Short-Form (PSI-SF).  
Objectives 
The purpose of this study is to evaluate the impact of the BEM method on stress and 
well-being in parents of children/adolescents with type 1 diabetes, compared to a 
standard group approach focused on therapeutic education (control group). 
Inclusion criteria  
▪ 
Parents of children and adolescents under 18 years old with type 1 diabetes, 
with a duration of diabetes > 12 months. 

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▪ 
Parents of children who have never been diagnosed with psychiatric or 
behavioral disorders. Adequate understanding of the Italian language 
according to the clinician's judgment. 
▪ 
Parents willing to: 
- 
Be actively involved in group experiential activities; 
- 
Complete the required questionnaires. 
▪ 
Signed informed consent from the participating individual. 
▪ 
Signed informed consent for the processing of the minor's data by both 
parents (if applicable). 
Exclusion criteria 
▪ 
Parents: 
- 
With psychiatric conditions; 
- 
Of patients with psychiatric problems or behavioral disorders; 
- 
With any issue that, according to the clinician's judgment, precludes 
active participation in group experiential activities. 
Experimental group: 
BEM 
The BEM Program involves an experiential, group-based approach facilitated by 2–
3 trained facilitators and a maximum of 25 parent participants. 
Structure of a BEM Session: each session takes place over three consecutive days 
and includes both plenary sessions with the entire group and smaller subgroup 
activities. 
Context: it is essential to conduct the program in a setting that is removed from 
participants' everyday life, ideally immersed in nature. This promotes emotional 
distancing from daily stressors, providing a sense of isolation and tranquility 
conducive to deep personal work. 
Setting: a reserved, welcoming, and intimate room is required to support a safe and 
comfortable environment. 
Methodology: relaxation techniques, breathing exercises, and guided visualizations 
NLP (Neuro-Linguistic Programming) techniques: spatial anchoring, Time Line 
therapy, and future pacing. Approaches based on Transactional Analysis (T.A.) and 
Systemic-Relational frameworks, brief interventions focused on problem-solving. 
Techniques for enhancing bodily and emotional awareness. Interactive group 
discussions. 
Control group: 
TRADITIONAL 
The control intervention will take place during a camp specifically dedicated to 
parents, with the same duration as the BEM program. The intervention includes 
educational and informational sessions on key aspects of type 1 diabetes 
management (management of acute complications, importance of glycemic indices, 
carbohydrate counting, current and emerging perspectives in type 1 diabetes care) 
In addition, the program includes opportunities for parents to share personal 
experiences and participate in recreational activities.  
Study endpoint 
▪ 
The primary endpoint is the change in the Parental Stress Index Short Form (PSI-
SF) score at 3 months following participation in the group activities, compared 
to baseline. 
▪ 
Secondary endpoints include: 
- 
Change in PSI-SF score at 6 months after participation, compared to 
baseline; 
- 
Change in the scores of the individual PSI-SF subscales (Parental 
Distress, Parent-Child Dysfunctional Interaction, and Difficult Child) at 3 
and 6 months post-intervention, compared to baseline; 

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- 
Change in the Patient Health Questionnaire-9 (PHQ-9) score for the 
assessment of depressive symptoms at 3 and 6 months post-
intervention, compared to baseline; 
- 
Change in the Generalized Anxiety Disorder-7 (GAD-7) score for the 
assessment of anxiety symptoms at 3 and 6 months post-intervention, 
compared to baseline;  
- 
Change in the Brief Pittsburgh Sleep Quality Index (B-PSQI) score for the 
evaluation of sleep disturbances at 3 and 6 months post-intervention, 
compared to baseline; 
- 
Change in the Parental Self-Efficacy for the Management of Diabetes 
Mellitus (PSESDM) score assessing parents' perceived self-efficacy in 
managing diabetes at 3 and 6 months post-intervention, compared to 
baseline; 
- 
Change in the Coping Orientation to the Problems Experienced – New 
Italian Version (COPE-NVI) score for the evaluation of parental 
adaptation and coping strategies at 3 and 6 months post-intervention, 
compared to baseline; 
- 
Change in children’s/adolescents’ glycemic metrics (including glycemic 
variability, Time in Range [TIR], Time Above Range [TAR], Time Below 
Range [TBR], and HbA1c) at 3 and 6 months after the intervention, 
compared to baseline. 
▪ 
Additionally, a qualitative analysis will be conducted to explore unmet parental 
needs. 
Study procedure 
After verification of eligibility criteria, parents will be randomly web-based 
randomization to either the BEM group intervention or the control group 
intervention. If both parents are eligible, they will be allocated to the same study 
arm. 
Randomization will be stratified by study center. 
Upon obtaining informed consent, parents will receive login credentials for the 
study’s web platform, through which they will complete the required 
questionnaires. At enrollment, socio-demographic data of the parents and clinical 
data related to the child/adolescent will also be collected. 
Parents will then be invited to participate in either the BEM group intervention or 
the standard group intervention. Both group activities will be conducted under the 
supervision of trained healthcare personnel and will have the same duration, 
although their content will differ. 
(Non-specialized healthcare personnel will receive specific training in a two-day 
weekend course (8 hours per day) led by professionals experienced in the BEM 
methodology).  
Specifically, the BEM group will receive basic information on diabetes management 
using external resources (medical support, technology, telemedicine, carbohydrate 
counting techniques) and internal resources (learning effective techniques and 
behaviors to improve metabolic control). This will be followed by the experiential 
BEM-specific program. 
The control group will receive the same diabetes management information, 
combined with opportunities for parent discussion and recreational activities. 
Each group activity will include 25 parent participants. 

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At 3 and 6 months following the group intervention, parents will be asked to 
complete the same questionnaires again via the web platform. Glycemic data for 
the children/adolescents will be retrieved from electronic medical records. 
Statistical aspects 
Sample Size Estimation 
- 
The difference between the two groups in changes in PSI-SF scores (primary 
endpoint) will be expressed in terms of effect size (i.e., the difference in 
mean scores between groups divided by the common standard deviation at 
baseline). An effect size of at least 0.5 is widely accepted in the literature as 
clinically relevant. In a previous study [13], baseline PSI-SF scores were 
75.4 ± 2.5, indicating that an effect size of 0.5 corresponds to a between-
group difference of 1.25. To detect an effect size of at least 0.5 with 80% 
statistical power (α = 0.05), a minimum of 64 parents per group is required. 
Assuming a dropout rate of 15%, a total of 150 parents (75 per group) will 
be enrolled.  
Data Analysis 
- 
Descriptive statistics will be reported as mean and standard deviation or, in 
the case of non-normally distributed continuous variables, as median and 
interquartile range. Categorical variables will be reported as percentages. 
- 
Between-group comparisons for descriptive variables will be conducted 
using the Student’s t-test or the Mann–Whitney U test for continuous 
variables, and the chi-square test for categorical variables. 
- 
Comparisons between study arms will be performed using Mixed Models 
for Repeated Measures (MMRM), including the baseline value of the 
outcome as a linear covariate and study arm as a fixed effect. MMRMs 
account for both within-subject and between-subject correlations using a 
first-order autoregressive (AR(1)) variance-covariance structure. Similarly, 
comparisons between study arms for secondary endpoints, including 
questionnaire scores and glycemic metrics (change from baseline at 3 and 6 
months), will also be conducted using MMRMs. These models will include 
baseline values of the respective outcomes as linear covariates and the 
study arm as a fixed effect. Results will be reported as estimated means with 
corresponding 95% confidence intervals.  
- 
Subgroup analyses will also be conducted based on parental sex and 
child/adolescent age (<10 years vs. ≥10 years.  
Participating Sites  
Participation is planned for six pediatric diabetes centers. Enrollment will be 
competitive. 
Ethics aspects 
The study protocol will be submitted for approval to the Ethics Committees of the 
participating centers. 
 
 
 

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KEY ROLES AND CONTACTS 
 
Sponsor:  
 
Principal Investigator:   
Doct. Valentino Cherubini  
 
Doct. Valentino Cherubini 
Dipartimento di Diabetologia 
Pediatrica, Ospedale G. Salesi, Ancona 
 
 
 
CRO: 
CORESEARCH S.r.l. 
Corso Umberto I, 103 Pescara 
 
 
 
 
 
 

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1. INTRODUCTION: SCIENTIFIC RATIONALE 
 
Type 1 diabetes (T1D) in pediatric and adolescent populations represents a chronic condition characterized 
by significant management complexity, requiring essential therapeutic and behavioral synergy between 
parents and the affected child (1). 
The parent's need to possess awareness and management skills regarding their child's illness is fundamental 
to ensuring that the child achieves optimal glycemic and metabolic control and to preventing or appropriately 
managing potential disease-related complications (2,3). In particular, the daily requirement of insulin therapy 
entails passive acceptance of the inherent risks associated with the treatment, notably the potential 
occurrence of hypoglycemic episodes (4–6). 
From the moment of diagnosis, parents must be adequately trained on the necessity of promptly initiating 
interventions to resolve hypoglycemic crises, should they occur in their severe form, to prevent serious 
complications that could lead to adverse outcomes (7). 
Another serious complication of T1D is diabetic ketoacidosis (DKA) (4,8). In this context, parents must be 
knowledgeable about this complication and its possible manifestations to recognize it promptly and to 
implement the necessary therapeutic procedures (9). 
All these factors contribute to a high level of distress among parents, which can further impair the 
management of their child's disease (10,11). 
Despite the objective consensus that the most traumatic moment for parents is the diagnosis of their child's 
T1D, it is certainly plausible that the adaptation process to the child's condition is highly subjective and can 
vary in duration over time (12). In chronic illness, where cure is not achievable, the primary goal of 
therapeutic intervention becomes adaptation, enabling the attainment and maintenance of a good quality 
of life. However, achieving adaptation is not guaranteed. Throughout the process aimed at reaching it, 
obstacles and resources are encountered that significantly influence the possibility of adaptation. Obstacles 
and resources can, in turn, be considered either "internal" to the individual or "external," related to the 
family, social, and healthcare environment. During the phase of successful adaptation, parents experience a 
greater sense of psychological and physical well-being, fewer concerns related to diabetes, positive mental 
representations, increased confidence in their child's future, and a stronger sense of self-efficacy. In the field 
of diabetology, but not only, educational approaches aimed at learning and reinforcing knowledge related to 
the management of this chronic disease have been implemented and improved over time. Among these, the 
so-called "summer camps" are certainly noteworthy; these are designed for children and adolescents with 
T1D who participate either alone or accompanied by their parents. Obstacles and resources can, in turn, be 
considered either "internal" to the individual or "external," related to the family, social, and healthcare 
environment. During the phase of successful adaptation, parents experience a greater sense of psychological 
and physical well-being, fewer concerns related to diabetes, positive mental representations, increased 
confidence in their child's future, and a stronger sense of self-efficacy. In the field of diabetology, but not 
only, educational approaches aimed at learning and reinforcing knowledge related to the management of 
this chronic disease have been implemented and improved over time. Among these, the so-called "summer 
camps" are certainly noteworthy; these are designed for children and adolescents with T1D who participate 
either alone or accompanied by their parents. 
The areas addressed during these interventions primarily concern clinical aspects related to the management 
of situations in which the child or adolescent is the main actor. The parents' perspective regarding their 
feelings about their child's illness and the potential impact on their quality of life is sometimes considered 
marginal. The experiential group process for parents can more specifically target these areas, helping to 

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improve adaptation to the child's particular condition. The BEM (Body Emotional Maps) program involves an 
experiential, group-based approach with the participation of 2-3 facilitators and the parents of children 
affected by chronic illness. It includes techniques such as relaxation, breathing exercises, guided 
visualizations; NLP (Neuro-Linguistic Programming) techniques like spatial anchoring, timeline work, future 
pacing; brief problem-solving interventions; body and emotional awareness techniques; and interactive 
discussions (13).  
By applying the BEM methodology, it is expected that parents will improve their adaptation to their child's 
illness, process the trauma associated with the diagnosis, and enhance their quality of life by reducing 
distress and fear related to hypoglycemia. 
In a preliminary pre-post, single-arm study, the BEM method demonstrated the ability to reduce parental 
stress, as measured by the Parental Stress Index Short-Form (PSI-SF), after three months (13). 
 
2. STUDY OBJECTIVES  
 
2.1 Objectives of the study 
 
The aim of this study is to evaluate the impact of the BEM method on stress and well-being in parents of 
children/adolescents with type 1 diabetes, in comparison to a standard group approach focused on 
therapeutic education (control group). 
 
2.2 Study Endpoint  
 
2.2.1 Primary 
 
The primary endpoint is represented by the difference in PSI-SF (Parental Stress Index Short-Form) scores 
after 3 months of participation in the group activities compared to baseline.  
 
2.2.2 Secondary 
 
▪ Difference in PSI-SF (Parental Stress Index Short-Form) scores after 6 months of participation in the 
group activities compared to baseline; 
▪ Difference in the scores of the individual components of the PSI-SF questionnaire (Parental Distress, 
Parent-Child Dysfunctional Interaction, Difficult Child) after 3 and 6 months of participation in the 
group activities compared to baseline; 
▪ Difference in the scores of the Patient Health Questionnaire (PHQ-9) for the assessment of depression 
and depressive symptoms after 3 and 6 months of participation in the group activities compared to 
baseline; 
▪  Difference in the scores of the General Anxiety Disorder (GAD-7) questionnaire for the assessment 
of anxiety and anxious symptoms after 3 and 6 months of participation in the group activities 

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compared to baseline; 
▪ Difference in the scores of the Brief Pittsburgh Sleep Quality Index (B-PSQI) for the assessment of sleep 
disturbances after 3 and 6 months of participation in the group activities compared to baseline; 
▪ Difference in the scores of the Parental Self-Efficacy for the Management of Diabetes Mellitus 
(PSESDM) questionnaire for the evaluation of self-efficacy perception in managing their child's 
diabetes after 3 and 6 months of participation in the group activities compared to baseline; 
▪ Difference in the scores of the Coping Orientation to the Problems Experienced - Italian Version (COPE-
NVI) questionnaire for assessing parental adaptation and coping strategies after 3 and 6 months of 
participation in the group activities compared to baseline; 
▪ Difference in glucometric data of children/adolescents (variability, Time In Range [TIR], Time Above 
Range [TAR], Time Below Range [TBR], HbA1c) after 3 and 6 months of participation in the group 
activities compared to baseline; 
▪ Additionally, a qualitative analysis will be conducted to further explore parents' experiences regarding 
their perception of their child (e.g., "How do I see my child's life now?"). 
 
3 STUDY DESIGN 
 
A randomized, controlled, two-arm, open-label trial. Following verification of eligibility criteria, parents will 
be assigned via centralized web-based randomization to participate in either the BEM group activity or the 
control group. In cases where both parents are eligible, they will be allocated to the same study arm. 
 
3.1 Study duration and participating clinical sites 
 
The study includes a 6-month follow-up after participation in the group activity.  
Six pediatric diabetology sites will participate in the study. 
 
4 STUDY POPULATION 
 
4.1 Inclusion criteria  
 
▪ 
Parents of children and adolescents under 18 years of age with type 1 diabetes duration exceeding 
12 months 
▪ 
Parents of children who have never been diagnosed with psychiatric or behavioral disorders 
▪ 
Adequate understanding of the Italian language, as assessed by the clinician 
▪ 
Parents willing to: 
- 
Actively participate in group experiential activities 
- 
Complete the required questionnaires 
- 
Signed informed consent from the participating individual 
- 
Signed informed consent for data processing of the minor by both parents (if applicable) 
 

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4.2 Exclusion criteria 
 
▪ 
Parents: 
- 
with psychiatric conditions 
- 
of patients with psychiatric issues or behavioral disorders 
- 
with any problem that, according to the clinician's judgment, would prevent active 
participation in group experiential activities 
 
4.3 Procedures for assigning interventions in the study 
 
4.3.1 Randomization procedure  
 
After verification of the eligibility criteria, the parents will be assigned via centralized web-based 
randomization to participate in either the BEM group activity or the control group (1:1 randomization). In 
cases where both parents are eligible, they will be allocated to the same study arm. 
The randomization will be stratified by center.  
 
4.3.2 Masking procedure  
 
The study will be conducted in an open-label design. 
 
 
5 STUDY INTERVENTION 
 
Both study groups (BEM method and control) will participate in activities conducted over three consecutive 
days at an off-hospital location, in contact with nature. Both group activities will be carried out under the 
supervision of specially trained healthcare personnel and will have equal duration, although the content will 
differ. 
The non-specialist staff supervising the school camps will undergo appropriate training during a weekend 
course lasting two days (8 hours per day). The course will be conducted by experienced professionals in the 
BEM method. 
5.1 Description of the BEM method 
 
In the BEM group, participants will receive basic information on diabetes management through external 
resources (medical support, technology, telemedicine, carbohydrate counting techniques) and internal 
resources (learning effective techniques and behaviors to improve metabolic control). Subsequently, the 
specific experiential BEM program will be initiated. The BEM method involves an intervention with the 
parents of children with diabetes, conducted in group settings, aimed at facilitating parents' adaptation to 
their child's "diabetes condition" (13). The intervention is organized into three sessions. 
The first session consists of an introduction and group formation.  
The second session involves sharing the onset of diabetes, identifying the most critical daily challenges, and 
the primary change the participants wish to implement.  

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The third session features the BEM pathway, which includes guided visualization and the creation of a map 
with spatial anchors. This final session is conducted partly in a plenary setting and partly in small groups, 
allowing each participant the necessary time to connect with their deeper parts and express themselves. A 
description of the operational phases of the BEM method is included in Appendix 1 of this study protocol.  
 
5.2 Description of the control method 
 
In the control group, basic information on diabetes management will be provided through external resources 
(medical support, technology, telemedicine, carbohydrate counting techniques) and internal resources 
(learning 
effective 
techniques 
and 
behaviors 
to 
improve 
metabolic 
control). 
The control group will receive the same diabetes management information, accompanied by parent 
discussion sessions and recreational activities guided by the diabetes team staff. As with the BEM group, 
activities will take place over three days in an off-hospital location, in contact with nature. Each group activity 
will involve 25 parents. 
 
STUDY PROCEDURES 
5.3 Procedures 
 
All parents of participating children will be offered the opportunity to participate in the study and will be 
asked to sign an informed consent form during a routine visit of their child. After verifying eligibility criteria 
and obtaining informed consent, parents will be randomly assigned via a centralized web-based 
randomization process to either participate in the BEM group activity or to the control group. If both parents 
are eligible, they will be allocated to the same study arm. 
Once consent to participate has been obtained, parents will receive login credentials for the study's web 
platform, through which they will be able to complete the required questionnaires. Socio-demographic 
information of the parents and clinical data related to the child/adolescent will also be collected at 
enrollment. 
Parents will then be invited to participate in either the BEM group activity or the standard activity. At 3 and 
6 months after the group activity, parents will be asked to complete the questionnaires again via access to 
the portal. The glycemic data of the children/adolescents will be derived from continuous glucose monitoring 
(CGM) measurements and extracted from the electronic medical records provided by the participating 
diabetes centers. 
 
5.4 Questionnaires 
 
All participants will be asked to complete the following questionnaires on a web platform, both at enrollment 
and at three and six months after the completion of group activities. 
 
Parenting Stress Index Short form (PSI-SF) 
The Parenting Stress Index is designed for the early identification of characteristics that, at the level of 
parents or the family as a whole, may compromise the normal development and functioning of the child. It 
aims to identify children with emotional and behavioral disorders as well as parents who may experience 
their parental role in a dysfunctional manner. The instrument is based on the premise that the stress 

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experienced by a parent result from a combination of specific characteristics of the child, the parent 
themselves, and a series of situational factors closely related to the parental role. The Italian validation 
pertains only to the short form of the test (PSI-SF), which is directly derived from the extended version. The 
short form is highly practical, easy to administer and interpret, making it particularly useful in clinical settings 
[14]. The PSI-SF investigates three main domains of stress-related factors, which are attributable to the child's 
characteristics, the parent's traits, and situational-demographic events. The short form consists of 36 items 
divided into three subscales: 1) Parental Distress (12 items), which assesses the level of distress a parent is 
experiencing in their parental role, understood as stemming from personal factors directly related to that 
role; 2) Dysfunctional Parent-Child Interaction (12 items), focusing on the parent's perception that the child 
does not meet their expectations and that interactions with the child do not reinforce their parental role; 3) 
Difficult Child (12 items), centered on key characteristics of the child that make them easy or difficult to 
manage, often originating from temperament, including behavioral patterns of defiance, disobedience, and 
demanding behaviors. Additionally, it is possible to calculate a response style score, which evaluates the 
extent to which the respondent answers the questionnaire with a tendency to present a more favorable 
image of themselves, thereby minimizing indications of problems or stress in the parent-child relationship. 
 
Patient Health Questionnaire (PHQ9) 
The PHQ-9 is a 9-item questionnaire developed as a depression screening tool for use in primary care settings 
[15]. Each of the nine items corresponds to one of the symptoms listed in Criterion A of the DSM-IV for Major 
Depressive Disorder [16]. Participants are asked how often they have been bothered by each depressive 
symptom over the past two weeks. Response options include "not at all," "several days," "more than half the 
days," and "nearly every day," with corresponding scores of 0, 1, 2, and 3. The PHQ-9 scores range from 0 to 
27, with cut-off points of ≥5, ≥10, and ≥15 indicating mild, moderate, and severe levels of depression severity, 
respectively [17]. The psychometric properties of the PHQ-9 are well established [18]. An Italian version of 
the questionnaire is available. 
 
General Anxiety Disorder (GAD-7) 
 
The GAD-7 is a self-reported questionnaire assessing generalized anxiety, consisting of seven items. The 
instrument is designed to evaluate the individual’s mental health status over the previous two weeks [19]. 
The items investigate the extent to which the individual has been bothered by feeling nervous, anxious, or 
on edge; being unable to stop or control worrying; worrying too much about different things; having trouble 
relaxing; being so restless that it is hard to sit still; becoming easily annoyed or irritable; and feeling afraid as 
if something awful might happen. Responses are scored 0, 1, 2, or 3 for experiencing these symptoms "not 
at all," "several days," "more than half the days," and "nearly every day," respectively. The scores are then 
summed to yield a total ranging from 0 to 21. Cut-off scores of 5, 10, and 15 represent thresholds for mild, 
moderate, and severe anxiety, respectively. When screening for an anxiety disorder, a recommended 
threshold for referral for further evaluation is a score of 10 or greater. 
The questionnaire has been validated for use both as a screening tool and as a measure of symptom severity 
[19,20], including in primary care settings [21] and the general population [22]. An Italian version of the 
questionnaire is available. 
 
Brief Pittsburgh Sleep Quality Index (B-PSQI) 
The B-PSQI is the brief version (13 items) of the Pittsburgh Sleep Quality Index (PSQI) [23]. This questionnaire 
assesses the presence of sleep-related problems over the past month across five domains: sleep duration 
and efficiency, sleep latency, sleep disturbances, nighttime awakenings, and daytime dysfunction. Each 
domain is scored on a scale from 0 (best outcome) to 3 (worst outcome). A global score is then calculated by 

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summing the scores of the individual domains, resulting in a total score ranging from 0 to 15. A total score 
greater than 4 is indicative of poor sleep quality. An Italian version of the PSQI is available, of which the B-
PSQI includes a subset of the original items. 
 
Parental Self-Efficacy for the Management of Diabetes Mellitus (PSESDM) 
The PSESDM was developed to assess parental self-efficacy in performing diabetes-related tasks for their 
young children [24]. This questionnaire, designed for parents of children with diabetes, consists of eight 
items, each rated on a 5-point Likert scale. Responses range from 1 = "Strongly disagree" to 5 = "Strongly 
agree." Items 1, 2, 6, and 7 are reverse-scored. The total score ranges from 8 to 40, with higher scores 
indicating greater parental confidence in managing their child’s diabetes. 
The Italian version of the instrument will be validated using data from the present study. 
 
Coping Orientation to Problems Experienced (COPE)  
The COPE inventory will be used to assess parental adjustment and the adoption of different coping styles. 
The study will utilize the new Italian version of the instrument (COPE-NVI) [25]. The questionnaire consists of 
60 items covering five domains: social support (12 items), avoidance strategies (16 items), positive attitude 
(12 items), problem-focused coping (12 items), and transcendence orientation (8 items). Participants are 
asked to indicate how frequently they engage in a given coping strategy when faced with difficult or stressful 
situations. Responses are rated on a 4-point scale ranging from 1 (I usually don’t do this at all) to 4 (I do this 
a lot). Scores for individual items are summed separately for each of the five domains. 
 
It should be noted that the instruments used in this study are intended for epidemiological and screening 
purposes and are not to be considered diagnostic tools. Furthermore, the questionnaires are anonymous, as 
they are completed directly through a dedicated online platform accessed via personal login credentials. 
Therefore, the researchers will not have access to individual scores. However, if pathological scores are 
identified, the participant will be informed and, if necessary, referred to specialized services. 
 
 
6 EVALUATION OF EFFICACY 
6.1 Efficacy parameters 
 
The effectiveness of the BEM method compared to a standard educational approach will be assessed by 
comparing the differences in scores from baseline between the two groups, based on self-administered 
questionnaires (PSI-SF, PHQ-9, GAD-7, B-PSQI, PSESDM, COPE). Additionally, differences in glycemic indices 
in children/adolescents (variability, TIR, TAR, TBR) and HbA1c values relative to baseline will be evaluated. 
The definitions of the glycemic indices and the recommended targets are provided in the table below [26]. 
 
Glucose Index 
Blood glucose range 
Recommended target 
(% of readings and daily 
duration) 
Variability 
Coefficient of variation (%) 
≤36% 
Time in Range (TIR) 
70-180 mg/dl 
>70%; >16 hours and 48 
min 
Time below range (TBR) livello 1 
<70 mg/dl 
<4%; <1 hour 

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Time below range (TBR) livello 2 
<54 mg/dl 
<1%; <15 min 
Time above range (TAR) livello 1 
>180 mg/dl 
<25%; <6 hours 
Time below range (TAR) livello 2 
>250 mg/dl 
<5%; <1 hour 
 
6.2 Frequency of endpoint assessment 
 
Study questionnaires will be completed at baseline (randomization) and at 3 and 6 months following 
participation in group activities. The primary endpoint will be the comparison between study arms of the 
difference in PSI-SF questionnaire scores at 3 months post-participation relative to baseline. Clinical 
parameters (glycemic indices) will be recorded with the same frequency (baseline, 3 and 6 months), and the 
values considered will be those from the two weeks preceding baseline and follow-up at 3 and 6 months. 
 
 
7 STATISTICAL CONSIDERATIONS 
 
7.1 Sample Size Calculation 
 
The primary endpoint is the PSI-SF questionnaire score at 3 months after the completion of group activities. 
The primary efficacy assessment will therefore involve comparing the differences in PSI-SF scores at 3 months 
relative to baseline between the study arms. 
The difference between the two groups in changes of PSI-SF scores will be expressed in terms of effect size 
(the difference in scores between the two groups divided by the common standard deviation at baseline). It 
is widely accepted in the literature that an effect size of at least 0.5 can be considered clinically relevant [27]. 
From the previous study [13], baseline PSI-SF values were 75.4 ± 2.5; therefore, an effect size of 0.5 would 
correspond to a difference of 1.25 between groups.  
To detect an effect size of at least 0.5 with a statistical power of 80% (α=0.05), at least 64 parents per group 
need to be evaluated. Assuming a dropout rate of 15%, a total of 150 parents will be enrolled (75 per group) 
 
 
7.2 Statistical Analysis 
 
All subjects enrolled in the study will be included in the analysis. 
Descriptive data will be expressed as means and standard deviations or as medians and interquartile ranges 
for continuous variables, and as percentages for categorical variables. 
Group comparisons for descriptive variables will be performed using Student’s t-test or the Mann-Whitney 
U test for continuous variables, and the chi-square test for categorical variables. 
Regarding the primary endpoint (difference in PSI-SF scores at 3 months compared to baseline), the 
comparison between study arms will be conducted using mixed-effects models for repeated measures 
(MMRM), which will include the baseline outcome value as a linear covariate and the study arm as a fixed 
effect. MMRM accounts for within- and between-subject correlations through a variance-covariance matrix 
with an autoregressive order 1 structure. 
Similarly, comparisons between study arms for secondary endpoints related to questionnaire scores and 
glucometric measures (differences at 3 and 6 months compared to baseline) will be performed using MMRM. 

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These models will include the baseline value of the respective outcomes as a linear covariate and the study 
arm as a fixed effect. Results will be expressed as estimated means with 95% confidence intervals. 
In addition to the analysis of the entire sample, subgroup analyses will be conducted separately based on 
parent sex and children/adolescents’ age (<10 years and ≥10 years). 
 
8 QUALITY ASSURANCE 
 
The study will be conducted in accordance with Good Clinical Practice (GCP) guidelines to ensure the ethics 
and data integrity of the study. The study documents and data will be stored in the Trial Master File (TMF) 
and the Investigator Study File (ISF), to be completed and archived in compliance with current regulations.  
 
9 STUDY MONITORING 
 
The investigator/institution will permit monitoring, audits, IRB/IEC review, and regulatory inspections where 
required, 
providing 
direct 
access 
to 
all 
collected 
data 
and 
original 
documents. 
The monitor (CRA) from the Contract Research Organization (CRO) and any potential auditor will have access 
to all electronic Case Report Forms (eCRFs) and informed consents collected for source data verification. 
Paper or electronic medical records are considered source documents that provide evidence of the patient's 
existence and confirm the integrity of the collected data. Source documents are stored at the investigative 
site. 
A monitoring plan will be developed, and monitoring reports will be prepared during various monitoring visits 
(site initiation visit, remote monitoring, and close-out visit), conducted either remotely or onsite at the 
investigative centers. 
 
10 ETHICAL ASPECTS 
 
10.1 
Ethical Standards 
 
This study will be conducted in accordance with the Declaration of Helsinki concerning medical research 
involving human subjects (Declaration of Helsinki - Ethical Principles for Medical Research Involving Human 
Subjects - 64th WMA General Assembly, Fortaleza, Brazil, October 2013), in compliance with the protocol, 
Good Clinical Practice (GCP), the General Data Protection Regulation (GDPR), and applicable Italian 
regulations. 
The investigator, by signing the protocol, affirms adherence to the instructions and procedures described 
therein and also declares compliance with GCP principles. 
Prior to the initiation of the study, the protocol, the informed consent form, and the information provided to 
children and their parents must be approved by the local Independent Ethics Committee (IEC). Any 
amendments to the protocol, except for administrative changes, must also be approved by the local IEC. 
 
 
10.2 
Informed Consent 
 
Before participating in the study, informed consent (IC) must be obtained, signed by each parent, and 
drafted in accordance with GCP guidelines and national regulatory and legal requirements. The paper IC 

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must be personally signed and dated by both the parent and the investigator. Any documents related to 
the parent will be retained by the investigator as part of the study documentation. Each parent will be 
provided with a signed copy of the informed consent and the clinical trial information sheet. Along with 
the IC, parents will also sign a authorization for the processing of their personal data and their child's data 
with DT1. 
11 DATA COLLECTION 
 
The medical history and data of children with T1D, who are the offspring of study participants, will be 
extracted 
from 
their 
medical 
records 
and 
recorded 
on 
a 
pseudonymized 
eCRF. 
At study entry, the following information regarding the child will be collected: sex, age, level of education, 
ethnicity, body weight, height, duration of diabetes, diabetes treatment, presence of diabetes-related 
complications, last HbA1c value, glucometric data from continuous glucose monitoring (TIR, TAR, TBR), 
presence of other chronic conditions, hospitalizations in the past year due to severe hypoglycemia, diabetic 
ketoacidosis, or other reasons, participation in school camps, and engagement in physical activity. The 
medical records will serve as source documents for these data. 
The data required by the protocol will be entered into an electronic case report form (eCRF). The quality and 
completeness of the data will be verified during and after data collection. 
Regarding the parents, the collected data will include age, education level, employment status, marital status 
(married or cohabiting, separated, divorced, widowed, single/celibate), number of children, household size, 
and presence of other family members with diabetes. These details will be directly recorded by the parents 
through personalized access to the dedicated web platform used for the study, which will also facilitate 
questionnaire completion. 
Throughout and at the end of the study, a database review will be performed to monitor data quality and 
completeness. Any modifications will be tracked using audit trail systems. Once all queries are resolved, the 
database will be frozen. The database will then be archived and subjected to backup and storage policies in 
accordance with GCP guidelines, and made available for subsequent audits if required. Raw data will be 
stored in a database for statistical analysis, which will be conducted after database lock. The impact of missing 
data on the primary endpoint will be assessed, and the need for imputation techniques will be considered. 
An anonymized database will be managed and analyzed at the Center for Outcomes Research and Clinical 
Epidemiology (CORESEARCH s.r.l.) in Pescara. 
 
12 Publication Policy 
 
All analysis results will be produced solely and exclusively in aggregated form and in a manner that is not 
attributable, either directly or indirectly, to any individual patient. 
The researcher and the sponsor commit to making the results of this study publicly available within one year 
of its completion, regardless of the outcome. The authorship, acknowledgments, and review procedures for 
scientific publications will be established prior to the end of the study and before any publication plan is 
developed. 
 

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