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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). The BEM Program involves an experiential, group-based approach facilitated by 2-3 trained facilitators and a maximum of 25 parent participants. Each session takes place over three consecutive days and includes both plenary sessions with the entire group and smaller subgroup activities. Metodology of BEM approach includes: 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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BEM group | Experimental | 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). |
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| Control group | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The BEM (Body Emotional Maps) program | Other | 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". 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". 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. The third session features the BEM pathway, which includes guided visualization and the creation of a map with spatial anchors. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in PSI-SF (Parental Stress Index Short-Form) scores after 3 months | 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. PSI-SF subscale scores range from 12 to 60, and the total score from 36 to 180. High subscale scores and a high PSI-SF total score indicate higher levels of stress. Responses above the 85th percentile are considered clinically significant. | From enrollment to 3 months after the participation in the BEM activities |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in PSI-SF (Parental Stress Index Short-Form) scores after 6 months and in the scores of the individual components of the PSI-SF questionnaire | The secondary endpoint is represented by the difference in PSI-SF (Parental Stress Index Short-Form) scores (total and of each suscale) after 6 months of participation in the group activities compared to baseline. Subscale scores range from 12 to 60, and the total score from 36 to 180. High subscale scores and a high PSI-SF total score indicate higher levels of stress. Responses above the 85th percentile are considered clinically significant. |
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Inclusion Criteria:
Exclusion Criteria:
Parents:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Women's and Children's Health Azienda Ospedaliero Universitaria delle Marche, G. Salesi Hospital | Ancona | 60123 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 26, 2023 | Jul 24, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| Control group | Other | 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. |
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| from enrollment to 6 months from participation in the group activities compared to baseline |
| Patient Health Questionnaire (PHQ-9) | Difference in the scores of the Patient Health Questionnaire (PHQ-9) for the assessment of depression and depressive symptoms after 3 and 6 months from the baseline. Each symptom is rated on a 4-point scale. Scores range from 0 to 27, with different levels of depression severity depending on the score: 10-14 = Mild major depression; 15-19 = Moderate major depression; ≥ 20 = Severe major depression. | From enrollment to 3 and 6 months from participation in the group activities compared to baseline |
| General Anxiety Disorder (GAD-7) | Difference in the scores of the General Anxiety Disorder (GAD-7) questionnaire for the assessment of anxiety and anxious symptoms. Scores of 0, 1, 2, or 3 are assigned for symptoms occurring "not at all," "several days," "more than half the days," and "almost every day," respectively. The scores are then summed and range from 0 to 21. Scores of 5, 10, and 15 represent cutoffs for mild, moderate, and severe anxiety, respectively. | From enrollment to 3 and 6 months from participation in the group activities compared to baseline. |
| Brief Pittsburgh Sleep Quality Index (B-PSQI) | Difference in the scores of the Brief Pittsburgh Sleep Quality Index (B-PSQI) for the assessment of sleep disturbances. For each area, a score from 0 (highest positive) to 3 (lowest negative) is assigned, as follows: "Never during the last month" = 0; "Less than once a week" = 1; "1 or 2 times a week" = 2; "3 or more times a week" = 3. Summary score is then generated, obtained by adding the scores for the individual areas, with a value ranging from 0 to 21. Score between 5 and 7 indicates mild sleep disturbances may occur; score above 7 indicates that it is recommended to consult a doctor for a more in-depth evaluation of sleep disturbances. | From enrollment to 3 and 6 months from participation in the group activities compared to baseline |
| Parental Self-Efficacy for the Management of Diabetes Mellitus (PSESDM) questionnaire. | 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. Responses range from 1 = "Strongly disagree" to 5 = "Strongly agree." Items 1, 2, 6, and 7 are reverse-scored. The total score on the measure ranges from 8 to 40. A higher score on the PSESDM represents greater parental confidence in managing their child's diabetes. | From enrollment to 3 and 6 months from participation in the group activities compared to baseline |
| Coping Orientation to the Problems Experienced - Italian Version (COPE-NVI) | Difference in the scores of the Coping Orientation to the Problems Experienced - Italian Version (COPE-NVI) questionnaire for assessing parental adaptation and coping strategies. Responses to each question are given on a scale from 1 = "I usually don't do it" to 4 = "I almost always do it." Individual question scores are summed separately for each of the 5 areas. | From enrollment to 3 and 6 months from participation in the group activities compared to baseline |
| Glucometric data of children/adolescents | Difference in glucometric data of children/adolescents:
| From enrollment to 3 and 6 months from participation in the group activities compared to baseline. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008722 | Methods |