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临床试验/NCT05778630
NCT05778630招募中不适用

Emotions and Cognitions in Pediatric Chronic Physical Conditions - the Creation and Implementation of a Psychological Intervention

Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
2
主要终点
Interview data outcomes

研究概览

简要总结

Children living with a chronic physical condition (CPC) are more likely than their peers without a disease to develop psychological difficulties or disorders (Hysing et al., 2007). To prevent or treat these difficulties and disorders, many psychotherapeutic approaches have been developed and tested. Most of them follow a categorical approach, based on a global diagnosis (e.g., Moreira et al., 2013). Few interventions are conducted from a processual perspective (Nef et al., 2012) studying underlying mechanisms of psychological functioning. Emotions and cognitions represent such underlying processes and play an important role in many psychopathological disorders. These processes can weaken but also protect a child from developing psychological difficulties, depending on whether they are effective or not (Gipson et al., 2006; Hysing et al., 2007; Lahaye et al., 2011). The present research project aims to identify a psychological intervention that builds on knowledge of emotional and cognitive processes, considered as protective and risk factors, to prevent/treat psychological difficulties. The project will be conducted in two parts:

  1. The first phase aims to better understand the action mechanisms of psychological interventions, focused on emotional and cognitive difficulties of children with CPCs. First, a systematic review will identify recent literature which reports the efficacy of psychological interventions which focused on emotional and cognitive processes. Second, interviews with experts (e.g., pediatricians, psychiatrists, psychologists, nurses, educators) in the field of CPCs and with parents/families of children with CPCs will be conducted. Individual and focus group meetings will be organized, with the aim of identifying the needs of children, based on clinical and practical knowledge and experience. A third phase will consist of the selection of an intervention that will be based on the results of the first two phases.
  2. In the second part (not yet registered), the selected intervention will be set up for a feasibility study (Bowen et al., 2009). For this, a small sample of children will participate in the intervention. Participants will be randomly allocated to an intervention group and a control group. The control group will participate in an alternative intervention (e.g., information on chronic diseases). The exact content of the intervention and its form (number of sessions, duration etc.) will be determined by the focus group. The intervention's efficacy will be evaluated (evaluation of emotional and cognitive processes as well as psychological and physiological health), using a mixed method approach. The results will be analyzed and discussed with the focus group. Limitations and perspectives will be formulated to allow for possible transfer of the intervention for future use or to other areas of psychology (Durlak & DuPre, 2008).

详细描述

The research project will be conducted as a non-medical intervention study, based on a mixed method and action-research principles (Bradbury & Lifvergren, 2016; Ivankova & Wingo, 2018; Malengreaux et al., 2020; Marshall et al., 2006). It will include a systematic literature review, quantitative (standardized questionnaires, self and hetero-reports) and qualitative measures (dialogues and discussions, semi-directed interviews, audio-recordings, observations, written reports). The effectiveness study of PART II of the research project will be carried out as randomized controlled trial but is not described in this registration.

PART 1

Phase I.a:

A systematic literature review is conducted by all investigators (researchers) in order to better understand action mechanisms of psychological interventions for children with chronic diseases (registered in PROSPERO: CRD42021233505).

Phase I.b:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Health care professionals who are not in regular contact with children, 8 to 12 years- old, with a chronic physical condition
  • Parents with a child with CPC who is not 8 to 12 years old
  • Participants who do not speak French

结局指标

主要结局

Interview data outcomes

时间窗: October 2021-December 2024

Interview questions will explore: 1) emotional and cognitive difficulties and resources of children with CPC, 2) emotional and cognitive needs of children with CPC. Audio data from semi-structured group meetings and semi-structured individual interviews will be transcribed and analysed with thematic analysis (Braun \& Clarke, 2006).

次要结局

  • Interview data outcomes and systematic review results(October 2021-December 2024)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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