Intervention in Chronic Pediatric Patients and Their Families.

NCT04476433 | Completed

• 1 other identifier: FACTORADAPT
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Change Resilience in caregivers (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

Other Outcomes (7)

• Glycaemic control (Baseline-Pre-Post)

  Baseline up to 12 months

• Weight (Baseline-Pre-Post)

  Baseline up to 12 months

• Height (Baseline-Pre-Post)

  Baseline up to 12 months

Study Arms (2)

Control Group

NO INTERVENTION

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

Experimental Group

EXPERIMENTAL

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)

Interventions

Ten Vida (10Vida) OTHER

10Vida is a psychoeducational and emotional programme for chronic illness in adolescents and their families.

Experimental Group

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead
• Hospital General Universitario de Valencia: collaborator
• Hospital Clínico Universitario de Valencia: collaborator
• Hospital Universitario La Fe: collaborator

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Rhinitis, Allergic; Asthma; Dwarfism; Food Hypersensitivity; Dermatitis, Atopic; Cystic Fibrosis; Ciliary Motility Disorders; Lung Diseases; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Bronchial Diseases; Lung Diseases, Obstructive; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Marián Pérez-Marín, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 20, 2020
• Study Start: February 4, 2019
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)