Intervention in Chronic Pediatric Patients and Their Families.

Application of a Program in Chronic Pediatric Patients With Different Pathologies and in Their Families.

Sponsors

Lead Sponsor: University of Valencia

Collaborator: Hospital General Universitario de Valencia
Hospital Clínico Universitario de Valencia
Hospital Universitario La Fe

Source University of Valencia
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.

Overall Status Recruiting
Start Date February 4, 2019
Completion Date February 4, 2023
Primary Completion Date December 30, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change Emotional Distress in caregivers (Baseline-Pre-Post) Baseline up to 12 months
Change Emotional Distress in patients (Baseline-Pre-Post) Baseline up to 12 months
Change Caregiver burden (Baseline-Pre-Post) Baseline up to 12 months
Secondary Outcome
Measure Time Frame
Change Resilience in caregivers (Baseline-Pre-Post) Baseline up to 12 months
Change Self-esteem in patients (Baseline-Pre-Post) Baseline up to 12 months
Change of Emotional competence (Baseline-Pre-Post) Baseline up to 12 months
Change of Adaptation to chronic disease (DM1) (Baseline-Pre-Post) Baseline up to 12 months
Change of Adaptation to chronic disease (Respiratory chronic diseases) (Baseline-Pre-Post Baseline up to 12 months
Change of Adaptation to chronic disease (Rhinoconjunctivitis) (Baseline-Pre-Post) Baseline up to 12 months
Change of Adaptation to chronic disease (Food Allergy)(Baseline-Pre-Post) Baseline up to 12 months
Change of Perceived level of disease threat (Baseline-Pre-Post) Baseline up to 12 months
Enrollment 200
Condition
Intervention

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

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

Gender: All

Minimum Age: 12 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Marián Pérez-Marín, PhD Principal Investigator University of Valencia
Overall Contact

Last Name: Marián Pérez-Marín, PhD

Phone: 0034 9639

Phone Ext.: 83392

Email: [email protected]

Location
Facility: Status: Contact: University of Valencia Marián Pérez-Marín, PhD 0034 9639 83392 [email protected]
Location Countries

Spain

Verification Date

July 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Valencia

Investigator Full Name: M. Antonia Pérez-Marín

Investigator Title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Control Group

Type: No Intervention

Description: Patients and caregivers who receive the treatment program, will previously constitute their own control group (waiting list control group).

Label: Experimental 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.

Acronym FACTORADAPT
Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov