Here is the design of a clinical trial:

Official Title: Intervention in Emotional Intelligence in Adolescents With Type 1 Diabetes Mellitus

Included conditions:
- Type1 Diabetes Mellitus

Study Armgroups:
- {'label': 'Emotional abilities training program', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intervention program on emotional abilities that will be carried out for 10 hours distributed over 5 weeks, in two and a half hour session. The work methodology will be eminently practical, working in groups including real case analysis and interactive simulation', 'interventionNames': ['Behavioral: Emotional abilities training program']}
- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Control group that will not receive the training program on emotional abilities but usual care.'}

Interventions:
- {'type': 'BEHAVIORAL', 'name': 'Emotional abilities training program', 'description': 'A randomized controlled trial that evaluates the effectiveness of a program of emotional skills on metabolic control to be assessed through the glycosylated hemoglobin (HbA1c), healthy lifestyle habits and wellbeing in adolescents with type 1, Diabetes Mellitus', 'armGroupLabels': ['Emotional abilities training program']}

Primary Outcomes:
- {'measure': 'Change in emotional skills of adolescents with type 1 diabetes related to a greater emotional regulation', 'description': 'Participants will be asked to complete a battery of psychological questionnaires\n\n-Difficulties in Emotion Regulation Scale (DERS) This is a 28-item, self-report questionnaire measuring clinically relevant difficulties in emotion regulation. In the Spanish adaptation, the items are grouped into five subscales: impulse control difficulties, non-acceptance of emotional response, difficulties engaging in goal-directed behavior, lack of emotional awareness and lack of emotional clarity. Subscales are scored on a 5-point scale ranging from 1 (never) to 5 (always). Higher scores indicate greater difficulty with emotion regulation. This scale has been shown to have adequate psychometric properties.', 'timeFrame': 'Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)'}
- {'measure': 'Change in emotional skills of adolescents with type 1 diabetes related to less stress levels', 'description': "Participants will be asked to complete a battery of psychological questionnaires\n\n-The Diabetes Distress Scale (DDS-17). It assesses the emotional distress associated with diabetes and it includes four dimensions: emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal distress. Higher scores indicate greater stress related to disease. This scale has been shown to have adequate internal consistency and validity. Cronbach's alpha ranged from 0.88 to 0.93", 'timeFrame': 'Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)'}
- {'measure': 'Change in emotional skills of adolescents with type 1 diabetes related to a greater positive affect', 'description': "Participants will be asked to complete a battery of psychological questionnaires\n\n-Positive and Negative Affect Schedule (PANAS). It is a self-reported adjective checklist that contains two 20-item subscales designed for the assessment of positive and negative affect. Respondents use a 5-point Likert scale to rate the extent to which they usually feel each of 20 emotion-related words. Reliability and validity reported by Watson and colleagues was moderately good. Cronbach's alpha ranged from 0.87 to 0.90.", 'timeFrame': 'Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)'}
- {'measure': 'Change in emotional skills of adolescents with type 1 diabetes related to an increase in healthy life habits', 'description': 'Participants will be asked to complete a battery of psychological questionnaires\n\n-eVITAL toolkit8. Adaptation of the Macrodomain Diet and Exercise 4.1 Domain diet and nutrition and 4.2. Domain exercise eVITAL toolkit for measuring healthy habits in diabetes.', 'timeFrame': 'Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)'}
- {'measure': 'Change in emotional skills of adolescents with type 1 diabetes related to a greater perception of quality of life', 'description': 'Participants will be asked to complete a battery of psychological questionnaires\n\n-The PedsQL 4.0 Generic Core Scales. The 23-item PedsQL 4.0 Generic Core Scales comprise four multi-item scales that explore dimensions of health-related quality of life: 1) physical functioning (8 items), 2) emotional functioning (5 items), 3) social functioning (5 items), and 4) school functioning (5 items). Respondents use a 5-point Likert scale. Higher scores indicate greater quality of life.', 'timeFrame': 'Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)'}
- {'measure': 'Change in the emotional skills of adolescents with type 1 diabetes that will be related to a glycosylated index between normal values', 'description': 'Metabolic variables will be assessed using a flash glucose monitoring (FGM) device.\n\nGlycemic control. Participants report their HbA1c level from their last blood test. The American Diabetes Association recommends a target HbA1c of 7.5% for children and adolescents. Moreover, mean glucose, standard deviation, percentage of glucose in normoglycemia (time in range, according to individualized target), percent of time in hypoglycemia (below 70) and percent of time in hyperglycemia (according to an individualized target), and number of hypoglycemic episodes will be collected. Variables will be analyzed from the last 15 days prior to evaluation. Metabolic variables will be obtained using a flash glucose monitoring (FMG) device (Free Style Libre) as it has become the standard glucose monitoring system in the Andalusian Public Health System for the pediatric population. For non-FMG users, metabolic variables will be obtained by glucometers through their specific software.', 'timeFrame': 'Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)'}

Please estimate the sample size based on the assumption: 
80% power, 5% significance level, mean (SD) HbA1c of 8.84% (1.39) in adolescents aged 11-16 years diagnosed within the previous 12 months.
Sample size
        Thirty-one participants will be needed per group (n=62) to achieve an 80% probability of detecting a 1% (11 mmol/mol) difference in mean HbA1c between the two groups with a 5% significance in adolescents who initially have HbA1c above a high range of 8%â8.5%.29 In adolescents with reduced HbA1c (less than 8%), the goal will be combined taking into account the reduction of HbA1c and the reduction of the hypoglycaemic rate.
        For the evaluation of hypoglycaemia, the aim is to reduce the number of episodes of hypoglycaemia (<70âmg/dL) by 20% and/or to obtain a number of hypoglycaemia less than four episodes per week, ensuring the evaluation of records of six capillary glycaemia a day. The estimation for the sample size is based on a mean (SD) HbA1c of 8.84% (1.39) (73.1Â±15.3âmmol/mol) in adolescents 11â16 years of age diagnosed within the previous 12 months.