Application of a Program in Chronic Pediatric Patients With Different Pathologies and in Their Families.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change Self-esteem in patients (Baseline-Pre-Post)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis at least 6 months.
- •To have signed the informed consent.
排除标准
- •No previous psychological diagnosis.
- •Attention Deficit Hyperactivity Disorder(ADHD), epilepsy or brain tumor
- •Infant cerebral palsy
- •Not understanding the Spanish language
研究组 & 干预措施
Control Group
Patients and caregivers who receive the treatment program, will previously constitute their own control group (waiting list control group).
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.
干预措施: Ten Vida (10Vida) (Other)
结局指标
主要结局
Change Self-esteem in patients (Baseline-Pre-Post)
时间窗: Baseline up to 12 months
Rosenberg Self-Esteem Questionnaire. It assesses the level of self-esteem. It is made up
Change Caregiver burden (Baseline-Pre-Post)
时间窗: Baseline up to 12 months
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.
Change Emotional competences in patients (Baseline-Pre-post)
时间窗: Baseline up to 12 months
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)
Change Emotional Distress in caregivers (Baseline-Pre-Post)
时间窗: Baseline up to 12 months
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.
Change Emotional Distress in patients (Baseline-Pre-Post)
时间窗: Baseline up to 12 months
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.
Change of Perceived level of disease threat (Baseline-Pre-Post)
时间窗: Baseline up to 12 months
Brief Disease Perception Questionnaire (B-IPQ): This is a measure of patients' cognitive
次要结局
- Change in family functioning in caregivers (Baseline-Pre-Post)(Baseline up to 12 months)
- Change Resilience in caregivers (Baseline-Pre-Post)(Baseline up to 12 months)
- Change in parental styles in patients (Baseline-Pre-Post)(Baseline up to 12 months)
- Change Psychological well-being (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 (Rhinoconjunctivitis) (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 (Food Allergy)(Baseline-Pre-Post)(Baseline up to 12 months)
研究者
M. Antonia Pérez-Marín
Associate Professor
University of Valencia