Intervention in Chronic Pediatric Patients and Their Families. (FACTORADAPT)

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Type 1 Diabetes; Allergic Rhinitis; Cystic Fibrosis; Pulmonary Disease; Atopic Dermatitis; Food Allergy; Allergic Asthma; Rhinoconjunctivitis; Primary Ciliary Dyskinesia; Short Stature
• Intervention / Treatment: Other: Ten Vida (10Vida)

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Patients and caregivers who receive the treatment program, will previously constitute their own control group (waiting list control group).
Experimental: Experimental Group; 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.	Other: Ten Vida (10Vida); 10Vida is a psychoeducational and emotional programme for chronic illness in adolescents and their families.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Emotional Distress in caregivers (Baseline-Pre-Post)	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.	Baseline up to 12 months
Change Emotional Distress in patients (Baseline-Pre-Post)	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.	Baseline up to 12 months
Change Caregiver burden (Baseline-Pre-Post)	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.	Baseline up to 12 months
Change Emotional competences in patients (Baseline-Pre-post)	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)	Baseline up to 12 months
Change Self-esteem in patients (Baseline-Pre-Post)	Rosenberg Self-Esteem Questionnaire. It assesses the level of self-esteem. It is made up	Baseline up to 12 months
Change of Perceived level of disease threat (Baseline-Pre-Post)	Brief Disease Perception Questionnaire (B-IPQ): This is a measure of patients' cognitive	Baseline up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Resilience in caregivers (Baseline-Pre-Post)	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.	Baseline up to 12 months
Change of Adaptation to chronic disease (DM1) (Baseline-Pre-Post)	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.	Baseline up to 12 months
Change of Adaptation to chronic disease (Respiratory chronic diseases) (Baseline-Pre-Post	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.	Baseline up to 12 months
Change of Adaptation to chronic disease (Rhinoconjunctivitis) (Baseline-Pre-Post)	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.	Baseline up to 12 months
Change of Adaptation to chronic disease (Food Allergy)(Baseline-Pre-Post)	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.	Baseline up to 12 months
Change in family functioning in caregivers (Baseline-Pre-Post)	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	Baseline up to 12 months
Change in parental styles in patients (Baseline-Pre-Post)	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.	Baseline up to 12 months
Change Psychological well-being (Baseline-Pre-Post)	Psychological well-being scale for adolescents (BIEPS-J) to determine the level of psychological well-being in adolescents	Baseline up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycaemic control (Baseline-Pre-Post)	HbA1c: It will be used to evaluate the glycemic control of the diabetic patient in endocrinology diseases	Baseline up to 12 months
Weight (Baseline-Pre-Post)	Kilograms For assessment of nutritional status	Baseline up to 12 months
Height (Baseline-Pre-Post)	Meters For assessment of nutritional status	Baseline up to 12 months
Body mass index (BMI) (Baseline-Pre-Post)	BMI in kg/m^2, for assessment of nutritional status	Baseline up to 12 months
Spirometry values (Baseline-Pre-Post)	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).	Baseline up to 12 months
Blood test ( Baseline-Pre-Post)	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)	Baseline up to 12 months
Exocrine pancreatic test ( Baseline-Pre-Post)	For monitoring pancreatic test, faecal elastase and steatorrhoea, and hepatic and renal functions.	Baseline up to 12 months

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Hospital Universitario La Fe; Hospital General Universitario de Valencia; Hospital Clínico Universitario de Valencia
• Investigators: Principal Investigator: Marián Pérez-Marín, PhD, University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Adolescent; Depression; Anxiety; Quality of life; Caregivers; Intervention Study
• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Neurologic Manifestations; Congenital Abnormalities; Infant, Newborn, Diseases; Bronchial Diseases; Genetic Diseases, Inborn; Otorhinolaryngologic Diseases; Movement Disorders; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Pancreatic Diseases; Abnormalities, Multiple; Ciliopathies; Asthma; Dermatitis; Cystic Fibrosis; Dyskinesias; Food Hypersensitivity; Ciliary Motility Disorders
• Other Study ID Numbers: FACTORADAPT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No