<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04476433</url>
  </required_header>
  <id_info>
    <org_study_id>FACTORADAPT</org_study_id>
    <nct_id>NCT04476433</nct_id>
  </id_info>
  <brief_title>Intervention in Chronic Pediatric Patients and Their Families.</brief_title>
  <acronym>FACTORADAPT</acronym>
  <official_title>Application of a Program in Chronic Pediatric Patients With Different Pathologies and in Their Families.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital General Universitario de Valencia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Clínico Universitario de Valencia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario La Fe</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Valencia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project consists of a psychological intervention in patients and their families with&#xD;
      different chronic diseases in order to carry out a comparative study between medical&#xD;
      pathologies to know which are the protective or risk variables for the adaptation to the&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adolescence is a period characterized by a multitude of changes at the biopsychosocial level,&#xD;
      all of which also implies many challenges. If the diagnosis or the presence of a chronic&#xD;
      disease or condition (CD) is added, the adjustment of the adolescent to this period become&#xD;
      even more difficult.&#xD;
&#xD;
      The World Health Organization (WHO) (2017) defines chronic diseases (CD) as &quot;long-lasting and&#xD;
      usually slow-progressing diseases&quot;. Among the main child-juvenile CDs are the allergic, the&#xD;
      endocrine; in particular, Diabetes Mellitus Type 1 (DM1) and Short stature (SS), and&#xD;
      respiratory, such as bronchial asthma (BA).&#xD;
&#xD;
      Chronic pediatric disease is a medical condition that affects both the patient and the family&#xD;
      caregiver. Chronic disease is characterized by unforeseeable changes in the course of the&#xD;
      disease, a reduction in physical capacity, changes in appearance, a prolonged dependence on&#xD;
      medical specialists, continuous treatments and the need for assistance.&#xD;
&#xD;
      The presence of CD in adolescence is a risk factor for developing a psychological disorder.&#xD;
      The most common psychopathology in childhood-juvenile CD is emotional, particularly anxiety&#xD;
      symptoms, followed by depression symptoms, being possible the development of an anxiety&#xD;
      disorder or of a major depression.&#xD;
&#xD;
      When someone is diagnosed with a chronic disease, the family as a whole is affected by the&#xD;
      stressors associated with the disease and the side effects of treatment, being inevitable the&#xD;
      alteration of the whole family system, especially in cases where the patient is a infant or&#xD;
      adolescent. In addition, it is necessary to underline that studies indicate that most of the&#xD;
      care of adolescent patients generally is undertaken by one specific member of the family,&#xD;
      usually called the main caregiver. The stress due to the care tasks has been associated with&#xD;
      anxiety and depression symptoms, often causing emotional disturbances in the caregivers,&#xD;
      associating the above with greater emotional symptomatology in adolescents and worse control&#xD;
      of their disease.&#xD;
&#xD;
      That's why more studies like the one proposed are needed to study more deeply the protective&#xD;
      factors of psychological and physical health during the course of chronic disease at this&#xD;
      stage of life, both in the adolescent patients as well as in their family.&#xD;
&#xD;
      The main aim of this research is to study the psychosocial factors, adjustment to the disease&#xD;
      and improvement of psychological well-being in the adolescent population with chronic&#xD;
      disease. In order to do this, the investigators are going to analyse the main characteristics&#xD;
      (psychological, family related and adjustment to disease) in the adolescent population with&#xD;
      endocrinological problems (short stature and diabetes mellitus type 1), respiratory (asthma)&#xD;
      and allergenic problems. These characteristics will also be analysed in the family of the&#xD;
      adolescent patients. The personal adaptation profiles and families features that favor the&#xD;
      psychological and physical health in these patients and their family caregivers will be also&#xD;
      identified. In addition, the investigators also propose as an aim the development and&#xD;
      implementation of an assessment and intervention program (in a pilot sample) that provides&#xD;
      socio-emotional education in adolescent patients with chronic disease and their family&#xD;
      caregivers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change Emotional Distress in caregivers (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Assessment with Hospital Anxiety and Depression Scale in caregivers (HADS): Screening instrument for the detection of affective disorders, in non-psychiatric subjects who go to hospitals. The scale is made up of 14 items, with a range of scores from 0 to 42. The interpretation is that the higher the score, the greater the presence of anxiety-depressive symptoms.&#xD;
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.&#xD;
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.&#xD;
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Emotional Distress in patients (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Assessment with Hospital Anxiety and Depression Scale in patients (HADS): Screening instrument for the detection of affective disorders, in non-psychiatric subjects who go to hospitals. The adaptation for this sample, it is made up of 11 items, with a range of scores from 0 to 33. The interpretation is that the higher the score, the greater the presence of anxiety-depressive symptoms.&#xD;
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.&#xD;
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.&#xD;
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Caregiver burden (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Assessment with Parental Inventory: It aims to assess the stress of parents with children who require regular medical attention. It consists of 12 situations related to the hospital environment that are considered potentially stressful for parents with sick children. The range of scores is 12 to 60. And it is interpreted like higher scores, higher levels of stress.&#xD;
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.&#xD;
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.&#xD;
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Emotional competences in patients (Baseline-Pre-post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Emotional Skills and Competence Questionnaire (ESCQ-21): this is a self-report measure developed by Takšić to assess emotional competence. In the present study, the reduced version (ESCQ-21) was used, adapted and validated in a Spanish sample by Schoeps et al. The aim of assessing is emotional competence: perception and comprehension, expressing and labeling and management and regulation)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Self-esteem in patients (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Rosenberg Self-Esteem Questionnaire. It assesses the level of self-esteem. It is made up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Perceived level of disease threat (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Brief Disease Perception Questionnaire (B-IPQ): This is a measure of patients' cognitive</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change Resilience in caregivers (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Connor-Davidson Resilience Scale to assess the ability to cope with stress and adversity. The resilience scale is made up of 10 items, with a range of scores from 0 to 40, with higher scores indicating greater resilience.&#xD;
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.&#xD;
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.&#xD;
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Adaptation to chronic disease (DM1) (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Adaptive response questionnaire to the disease in diabetic patients: with the aim of evaluating the elements involved in the psychological and social response in pediatric diabetic patients. This instrument includes cognitive, emotional and behavioural elements that may be related to the adjustment response to the disease. The lower the score, the more severe the disease, the worse the health behaviour, the various complaints associated with the disease.&#xD;
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.&#xD;
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.&#xD;
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Adaptation to chronic disease (Respiratory chronic diseases) (Baseline-Pre-Post</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>This questionnaire evaluates health-related quality of life in relation to chronic respiratory problems. It is made up of 4 dimensions: sensation of dyspnea, sensation of fatigue, emotional symptomatology and disease control.&#xD;
The total score is obtained by adding up the score in each of the dimensions and dividing by 4. The resulting evaluation ranges from 1 (maximum affectation of up to 7 (no affectation) First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.&#xD;
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.&#xD;
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Adaptation to chronic disease (Rhinoconjunctivitis) (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>It is a specific quality of life assessment instrument for the pediatric population with rhinoconjunctivitis. It aims to obtain a measure of the impact that allergic symptoms have on patients' daily functioning, and not only the severity and frequency. All items are weighted equally and a higher score is indicative of a poorer quality of life.&#xD;
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.&#xD;
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.&#xD;
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Adaptation to chronic disease (Food Allergy)(Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Quality of Life Questionnaire in Food Allergy (FAQLQ- TF) It assessed quality of life relation with food allergy. The range of scores is from 0 to 6. The interpretation of the scores is reversed, i.e. the lower the score, the better the perceived quality of life.&#xD;
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.&#xD;
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.&#xD;
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in family functioning in caregivers (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Family Functioning Questionnaire (CAF) based on Olson's model. It was created with the aim of constructing a measuring instrument to evaluate the variables that make up the dynamics of a family</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parental styles in patients (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Scale for the evaluation of the educational style of parents of adolescents (EP). It allows evaluating the perception that adolescents have of the educational style of their parents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Psychological well-being (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Psychological well-being scale for adolescents (BIEPS-J) to determine the level of psychological well-being in adolescents</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Glycaemic control (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>HbA1c: It will be used to evaluate the glycemic control of the diabetic patient in endocrinology diseases</description>
  </other_outcome>
  <other_outcome>
    <measure>Weight (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Kilograms For assessment of nutritional status</description>
  </other_outcome>
  <other_outcome>
    <measure>Height (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Meters For assessment of nutritional status</description>
  </other_outcome>
  <other_outcome>
    <measure>Body mass index (BMI) (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>BMI in kg/m^2, for assessment of nutritional status</description>
  </other_outcome>
  <other_outcome>
    <measure>Spirometry values (Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>All values obtained are expressed as volume (in ml). The main spirometric parameters recorded are forced vital capacity (FVC), vital capacity (VC), peak expired air volume in the first second (FEV1) and peak expiratory flow (PEF).</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood test ( Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>For monitoring nutritional status (blood concentration of protein, lipids, fat-soluble vitamins, iron and calcium-phosphorus metabolism) and blood concentration of c) glucose metabolism d) acute phase reactants and immune status (immunoglobulins, alpha1 antitrypsin, and e) hepatic and renal functions.) exocrine pancreatic function&#xD;
• glucose metabolism d) acute phase reactants and immune status (immunoglobulins, alpha1 antitrypsine)</description>
  </other_outcome>
  <other_outcome>
    <measure>Exocrine pancreatic test ( Baseline-Pre-Post)</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>For monitoring pancreatic test, faecal elastase and steatorrhoea, and hepatic and renal functions.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Type 1 Diabetes</condition>
  <condition>Allergic Rhinitis</condition>
  <condition>Allergic Asthma</condition>
  <condition>Asthma</condition>
  <condition>Short Stature</condition>
  <condition>Food Allergy</condition>
  <condition>Atopic Dermatitis</condition>
  <condition>Rhinoconjunctivitis</condition>
  <condition>Cystic Fibrosis</condition>
  <condition>Primary Ciliary Dyskinesia</condition>
  <condition>Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients and caregivers who receive the treatment program, will previously constitute their own control group (waiting list control group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients and caregivers who receive the treatment program, will previously constitute their own control group (waiting list control group). Thus, diagnostic measures will be obtained in all of them in an initial evaluation (T1), and after 6 months of this evaluation the treatment program will be started. In the first contact session at 6 months after T1 all subjects (patients and relatives) will be re-evaluated (T2) and after this the treatment program will be started (within an estimated time of 15 days maximum from this second pre-treatment evaluation, the estimated duration of treatment being 5 months). After the completion of the patient and family treatment sessions, a new diagnostic test pass will be performed (T3) (within an estimated maximum period of 15 days from the completion of treatment) in order to evaluate the post-treatment change. Thus, the estimated time between T2 and T3 will be equivalent to that between T1 and T2, being 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ten Vida (10Vida)</intervention_name>
    <description>10Vida is a psychoeducational and emotional programme for chronic illness in adolescents and their families.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis at least 6 months.&#xD;
&#xD;
          -  To have signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No previous psychological diagnosis.&#xD;
&#xD;
          -  Attention Deficit Hyperactivity Disorder(ADHD), epilepsy or brain tumor&#xD;
&#xD;
          -  Infant cerebral palsy&#xD;
&#xD;
          -  Not understanding the Spanish language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marián Pérez-Marín, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Valencia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marián Pérez-Marín, PhD</last_name>
    <phone>0034 9639</phone>
    <phone_ext>83392</phone_ext>
    <email>marian.perez@uv.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Inmaculada Montoya-Castilla, PhD</last_name>
    <phone>0034 9639</phone>
    <phone_ext>83433</phone_ext>
    <email>inmaculada.montoya@uv.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marián Pérez-Marín, PhD</last_name>
      <phone>0034 9639</phone>
      <phone_ext>83392</phone_ext>
      <email>marian.perez@uv.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>M. Antonia Pérez-Marín</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Caregivers</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Depression</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Intervention Study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Ciliary Motility Disorders</mesh_term>
    <mesh_term>Dyskinesias</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Food Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04476433
org study id: FACTORADAPT
nct id: NCT04476433
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project consists of a psychological intervention in patients and their families with
      different chronic diseases in order to carry out a comparative study between medical
      pathologies to know which are the protective or risk variables for the adaptation to the
      disease.
Adolescence is a period characterized by a multitude of changes at the biopsychosocial level,
      all of which also implies many challenges. If the diagnosis or the presence of a chronic
      disease or condition (CD) is added, the adjustment of the adolescent to this period become
      even more difficult.

      The World Health Organization (WHO) (2017) defines chronic diseases (CD) as "long-lasting and
      usually slow-progressing diseases". Among the main child-juvenile CDs are the allergic, the
      endocrine; in particular, Diabetes Mellitus Type 1 (DM1) and Short stature (SS), and
      respiratory, such as bronchial asthma (BA).

      Chronic pediatric disease is a medical condition that affects both the patient and the family
      caregiver. Chronic disease is characterized by unforeseeable changes in the course of the
      disease, a reduction in physical capacity, changes in appearance, a prolonged dependence on
      medical specialists, continuous treatments and the need for assistance.

      The presence of CD in adolescence is a risk factor for developing a psychological disorder.
      The most common psychopathology in childhood-juvenile CD is emotional, particularly anxiety
      symptoms, followed by depression symptoms, being possible the development of an anxiety
      disorder or of a major depression.

      When someone is diagnosed with a chronic disease, the family as a whole is affected by the
      stressors associated with the disease and the side effects of treatment, being inevitable the
      alteration of the whole family system, especially in cases where the patient is a infant or
      adolescent. In addition, it is necessary to underline that studies indicate that most of the
      care of adolescent patients generally is undertaken by one specific member of the family,
      usually called the main caregiver. The stress due to the care tasks has been associated with
      anxiety and depression symptoms, often causing emotional disturbances in the caregivers,
      associating the above with greater emotional symptomatology in adolescents and worse control
      of their disease.

      That's why more studies like the one proposed are needed to study more deeply the protective
      factors of psychological and physical health during the course of chronic disease at this
      stage of life, both in the adolescent patients as well as in their family.

      The main aim of this research is to study the psychosocial factors, adjustment to the disease
      and improvement of psychological well-being in the adolescent population with chronic
      disease. In order to do this, the investigators are going to analyse the main characteristics
      (psychological, family related and adjustment to disease) in the adolescent population with
      endocrinological problems (short stature and diabetes mellitus type 1), respiratory (asthma)
      and allergenic problems. These characteristics will also be analysed in the family of the
      adolescent patients. The personal adaptation profiles and families features that favor the
      psychological and physical health in these patients and their family caregivers will be also
      identified. In addition, the investigators also propose as an aim the development and
      implementation of an assessment and intervention program (in a pilot sample) that provides
      socio-emotional education in adolescent patients with chronic disease and their family
      caregivers.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change Emotional Distress in caregivers (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: Assessment with Hospital Anxiety and Depression Scale in caregivers (HADS): Screening instrument for the detection of affective disorders, in non-psychiatric subjects who go to hospitals. The scale is made up of 14 items, with a range of scores from 0 to 42. The interpretation is that the higher the score, the greater the presence of anxiety-depressive symptoms.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.
measure: Change Emotional Distress in patients (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: Assessment with Hospital Anxiety and Depression Scale in patients (HADS): Screening instrument for the detection of affective disorders, in non-psychiatric subjects who go to hospitals. The adaptation for this sample, it is made up of 11 items, with a range of scores from 0 to 33. The interpretation is that the higher the score, the greater the presence of anxiety-depressive symptoms.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.
measure: Change Caregiver burden (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: Assessment with Parental Inventory: It aims to assess the stress of parents with children who require regular medical attention. It consists of 12 situations related to the hospital environment that are considered potentially stressful for parents with sick children. The range of scores is 12 to 60. And it is interpreted like higher scores, higher levels of stress.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.
measure: Change Emotional competences in patients (Baseline-Pre-post)
time frame: Baseline up to 12 months
description: Emotional Skills and Competence Questionnaire (ESCQ-21): this is a self-report measure developed by Takšić to assess emotional competence. In the present study, the reduced version (ESCQ-21) was used, adapted and validated in a Spanish sample by Schoeps et al. The aim of assessing is emotional competence: perception and comprehension, expressing and labeling and management and regulation)
measure: Change Self-esteem in patients (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: Rosenberg Self-Esteem Questionnaire. It assesses the level of self-esteem. It is made up
measure: Change of Perceived level of disease threat (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: Brief Disease Perception Questionnaire (B-IPQ): This is a measure of patients' cognitive
measure: Change Resilience in caregivers (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: Connor-Davidson Resilience Scale to assess the ability to cope with stress and adversity. The resilience scale is made up of 10 items, with a range of scores from 0 to 40, with higher scores indicating greater resilience.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.
measure: Change of Adaptation to chronic disease (DM1) (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: Adaptive response questionnaire to the disease in diabetic patients: with the aim of evaluating the elements involved in the psychological and social response in pediatric diabetic patients. This instrument includes cognitive, emotional and behavioural elements that may be related to the adjustment response to the disease. The lower the score, the more severe the disease, the worse the health behaviour, the various complaints associated with the disease.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.
measure: Change of Adaptation to chronic disease (Respiratory chronic diseases) (Baseline-Pre-Post
time frame: Baseline up to 12 months
description: This questionnaire evaluates health-related quality of life in relation to chronic respiratory problems. It is made up of 4 dimensions: sensation of dyspnea, sensation of fatigue, emotional symptomatology and disease control.
The total score is obtained by adding up the score in each of the dimensions and dividing by 4. The resulting evaluation ranges from 1 (maximum affectation of up to 7 (no affectation) First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.
measure: Change of Adaptation to chronic disease (Rhinoconjunctivitis) (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: It is a specific quality of life assessment instrument for the pediatric population with rhinoconjunctivitis. It aims to obtain a measure of the impact that allergic symptoms have on patients' daily functioning, and not only the severity and frequency. All items are weighted equally and a higher score is indicative of a poorer quality of life.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.
measure: Change of Adaptation to chronic disease (Food Allergy)(Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: Quality of Life Questionnaire in Food Allergy (FAQLQ- TF) It assessed quality of life relation with food allergy. The range of scores is from 0 to 6. The interpretation of the scores is reversed, i.e. the lower the score, the better the perceived quality of life.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.
Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out.
Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out.
measure: Change in family functioning in caregivers (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: Family Functioning Questionnaire (CAF) based on Olson's model. It was created with the aim of constructing a measuring instrument to evaluate the variables that make up the dynamics of a family
measure: Change in parental styles in patients (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: Scale for the evaluation of the educational style of parents of adolescents (EP). It allows evaluating the perception that adolescents have of the educational style of their parents.
measure: Change Psychological well-being (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: Psychological well-being scale for adolescents (BIEPS-J) to determine the level of psychological well-being in adolescents
measure: Glycaemic control (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: HbA1c: It will be used to evaluate the glycemic control of the diabetic patient in endocrinology diseases
measure: Weight (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: Kilograms For assessment of nutritional status
measure: Height (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: Meters For assessment of nutritional status
measure: Body mass index (BMI) (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: BMI in kg/m^2, for assessment of nutritional status
measure: Spirometry values (Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: All values obtained are expressed as volume (in ml). The main spirometric parameters recorded are forced vital capacity (FVC), vital capacity (VC), peak expired air volume in the first second (FEV1) and peak expiratory flow (PEF).
measure: Blood test ( Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: For monitoring nutritional status (blood concentration of protein, lipids, fat-soluble vitamins, iron and calcium-phosphorus metabolism) and blood concentration of c) glucose metabolism d) acute phase reactants and immune status (immunoglobulins, alpha1 antitrypsin, and e) hepatic and renal functions.) exocrine pancreatic function
• glucose metabolism d) acute phase reactants and immune status (immunoglobulins, alpha1 antitrypsine)
measure: Exocrine pancreatic test ( Baseline-Pre-Post)
time frame: Baseline up to 12 months
description: For monitoring pancreatic test, faecal elastase and steatorrhoea, and hepatic and renal functions.
arm group label: Control Group
arm group type: No Intervention
description: Patients and caregivers who receive the treatment program, will previously constitute their own control group (waiting list control group).
arm group label: Experimental Group
arm group type: Experimental
description: Patients and caregivers who receive the treatment program, will previously constitute their own control group (waiting list control group). Thus, diagnostic measures will be obtained in all of them in an initial evaluation (T1), and after 6 months of this evaluation the treatment program will be started. In the first contact session at 6 months after T1 all subjects (patients and relatives) will be re-evaluated (T2) and after this the treatment program will be started (within an estimated time of 15 days maximum from this second pre-treatment evaluation, the estimated duration of treatment being 5 months). After the completion of the patient and family treatment sessions, a new diagnostic test pass will be performed (T3) (within an estimated maximum period of 15 days from the completion of treatment) in order to evaluate the post-treatment change. Thus, the estimated time between T2 and T3 will be equivalent to that between T1 and T2, being 6 months.
intervention type: Other
intervention name: Ten Vida (10Vida)
description: 10Vida is a psychoeducational and emotional programme for chronic illness in adolescents and their families.
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 12 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marián Pérez-Marín, PhD
role: Principal Investigator
affiliation: University of Valencia
last name: Marián Pérez-Marín, PhD
phone: 0034 9639
phone ext: 83392
email: marian.perez@uv.es
last name: Inmaculada Montoya-Castilla, PhD
phone: 0034 9639
phone ext: 83433
email: inmaculada.montoya@uv.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: M. Antonia Pérez-Marín
investigator title: Associate Professor
mesh term: Cystic Fibrosis
mesh term: Asthma
mesh term: Ciliary Motility Disorders
mesh term: Dyskinesias
mesh term: Dermatitis
mesh term: Food Hypersensitivity
sharing ipd: No