Clinical trial NCT04476433: Intervention in Chronic Pediatric Patients and Their Families.
Official title: Application of a Program in Chronic Pediatric Patients With Different Pathologies and in Their Families.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Allergic Rhinitis
Allergic Asthma
Asthma
Short Stature
Food Allergy
Atopic Dermatitis
Rhinoconjunctivitis
Cystic Fibrosis
Primary Ciliary Dyskinesia
Pulmonary Disease
Keywords: Caregivers
Adolescent
Anxiety
Depression
Quality of life
Intervention Study
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario de Valencia
name: Hospital Clínico Universitario de Valencia
name: Hospital Universitario La Fe
First posted: 2020-07-20
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis at least 6 months.
* To have signed the informed consent.

Exclusion Criteria:

* No previous psychological diagnosis.
* Attention Deficit Hyperactivity Disorder(ADHD), epilepsy or brain tumor
* Infant cerebral palsy
* Not understanding the Spanish language

Primary outcomes:
measure: Change Emotional Distress in caregivers (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Change Emotional Distress in patients (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Change Caregiver burden (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Change Emotional competences in patients (Baseline-Pre-post)
timeFrame: Baseline up to 12 months
measure: Change Self-esteem in patients (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Change of Perceived level of disease threat (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Change Resilience in caregivers (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Change of Adaptation to chronic disease (DM1) (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Change of Adaptation to chronic disease (Respiratory chronic diseases) (Baseline-Pre-Post
timeFrame: Baseline up to 12 months
measure: Change of Adaptation to chronic disease (Rhinoconjunctivitis) (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Change of Adaptation to chronic disease (Food Allergy)(Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Change in family functioning in caregivers (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Change in parental styles in patients (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Change Psychological well-being (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
Other outcomes:
measure: Glycaemic control (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Weight (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Height (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Body mass index (BMI) (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Spirometry values (Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Blood test ( Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
measure: Exocrine pancreatic test ( Baseline-Pre-Post)
timeFrame: Baseline up to 12 months
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: Marián Pérez-Marín, PhD
role: PRINCIPAL_INVESTIGATOR
References: