Psychotherapy Group for Parents of Children With Leber Congenital Amaurosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Self-Reporting Questionnaire
研究概览
简要总结
The objectives of this study are to evaluate the effect of a group psychotherapy intervention for parents of children/adolescents with LCA on indicators of emotional health, parental stress, acceptance, cognitive defusion, and mindfulness. The study design is a repeated measures design with pre-, post-, and 3-month follow-up assessments. Forty parents of children and adolescents with LCA will be included in the sample. Twenty will participate in the psychotherapy groups, divided into 2 groups of 10 people, and 20 will be in the control group. To assess the indicators mentioned in the objective, the following questionnaires will be applied: Self-Reporting Questionnaire, Parental Stress Scale, Acceptance and Action Questionnaire, Cognitive Fusion Questionnaire, and Freiburg Mindfulness Inventory. A subsequent data analysis will be conducted to evaluate and correlate these indicators before, after, and 3 months post-intervention.
详细描述
INTRODUCTION
Parent-Child Relationships and Their Influence on Child Development:
Families with children diagnosed with inherited retinal diseases (IRD) exhibit high levels of depression, anxiety, and social isolation. Additionally, parents of children with IRD experience financial stress, as their productivity is affected by caregiving responsibilities, alongside increased expenditures on general health and rehabilitation. Regarding Leber congenital amaurosis (LCA), there are no studies assessing these indicators. However, since LCA falls under the IRD category, it can be presumed to have similar effects.
The parent-child relationship in the context of autism spectrum disorder (ASD) is frequently associated with high levels of parental stress and psychological distress. Previous studies have identified maladaptive behavior in children with ASD, particularly problematic behaviors, as the primary factor increasing parental stress, negatively affecting their mental health and psychological adjustment. Coping strategies, such as experiential avoidance, often linked to mental health issues, exemplify how parents may be negatively impacted by the complexity of their children's behavior.
Other studies investigating the emotional health of parents of children with various chronic illnesses have reported similar findings, indicating that experiential avoidance is directly related to parental psychological distress. Experiential avoidance refers to passivity towards a behavior or even fleeing from it. The mechanism that should replace experiential avoidance is psychological acceptance. Acceptance is a process that involves consciously embracing difficult situations without attempting to suppress or avoid them. It benefits individuals who need to accept immutable conditions, such as chronic, incurable, or untreatable health conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Forty parents of children and adolescents with LCA will be included in the sample. These parents must have both the clinical and genetic diagnoses of their children.
排除标准
- •Parents with diagnosed mental disorders prior to the birth of their children and unrelated to the acceptance of LCA will be evaluated by the psychologists and excluded from the sample. The exclusion criteria were assigned based on the impact of these variables on the study analysis. Additionally, parents who are undergoing individual psychotherapy and/or using psychiatric medication will also be excluded.
研究组 & 干预措施
Intervention Group
The psychotherapy group will consist of 10 virtual sessions, each lasting 1 hour and 15 minutes. Each session will begin with a mindfulness exercise to bring the participants into the present moment, followed by a pre-determined topic for discussion. At the end of each session, there will be a closing segment to summarize the reflections and teachings of the day, and a homework assignment will be provided. The topics covered will be: Opening, Psychoeducation, Diagnosis Report, Acceptance, Psychological Flexibility, Cognitive Defusion, Self as Context, Values, Committed Action, and Closure.
干预措施: Psychotherapy group for parents (Behavioral)
Control Group
For the parents who will participate in the control group, the steps undertaken will include the administration of the Self-Reporting Questionnaire, Parental Stress Scale, Acceptance and Action Questionnaire, Cognitive Fusion Questionnaire, and Freiburg Mindfulness Inventory, before the intervention, after the intervention, and after 3 months.
干预措施: Control Group (Behavioral)
结局指标
主要结局
Self-Reporting Questionnaire
时间窗: 2 Months
The SRQ-20 questionnaire has been validated for the Brazilian population and contains 20 items that assess the presence or absence of mental disorders. The questions are scored in a dichotomous format, and a score of 7 or more indicates the possible presence of a mental disorder. The SRQ-20 serves as a screening tool but does not identify the specific mental disorder experienced by the patient.
Freiburg Mindfulness Inventory
时间窗: 2 Months
The FMI assesses mindfulness through 14 items and has been validated for the Brazilian population. Each item is rated on a Likert scale from 1 to 4. Higher scores indicate that the individual acts more consistently with mindfulness.
Cognitive Fusion Questionnaire
时间窗: 2 Months
The CFQ is a tool used to assess the degree of cognitive fusion, which refers to the tendency of individuals to identify with their thoughts and treat them as absolute truths. It consists of 7 items, is validated for use with the Brazilian population, and responses are rated on a scale from 1 to 7. Higher scores indicate a higher level of cognitive fusion.
Acceptance and Action Questionnaire
时间窗: 2 Months
The AAQ-II questionnaire has been validated and adapted for Portuguese and contains 7 items that assess inflexible behaviors. The items are rated on a Likert scale from 1 to 7, where 1 means "Never" and 7 means "Always." Lower scores indicate greater psychological flexibility, meaning a higher ability to deal with different events in different ways.
Parental Stress Scale
时间窗: 2 Months
The EEPa has been validated and adapted for Brazil and contains 16 items-eight questions related to parental satisfaction with the parenting experience and eight related to parental stressors. Responses are given on a Likert scale from 0 (strongly disagree) to 4 (strongly agree). The total score is 64 points, and higher scores indicate greater levels of parental stress experienced by participants.
次要结局
未报告次要终点