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临床试验/NCT03901027
NCT03901027已完成不适用

The FAM-SOTC Intervention: Families of Children With Chronic Illnesses

University of Iceland0 个研究点目标入组 31 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
主要终点
The ICE-Perceived Family Support from nurses Questionnaire (14-Items) at baseline

研究概览

简要总结

Purpose: A growing number of families with children are dealing with chronic illnesses or health problems that places increased demand on the family. Nurses are in a core position to support and empower these families. The benefit of therapeutic conversation between nurses and families dealing with health problems have shown positive results and therefore received increasing attention. The aim of this study was to evaluate the benefits of two sessions of the Family Strength Oriented Therapeutic Conversation (FAM-SOTC) intervention, offered by advanced practice nurses (APN), for parents of children and adolescents with Juvenile idiopathic arthritis (JIA), epilepsy, diabetes, and with sleep disturbance with attention deficit hyperactivity disorder (ADHD).

Design: The effectiveness of the intervention was tested within a quasi-experimental study with one group pre- and-posttest design.

Method: The intervention was based on the Calgary family assessment and intervention models and the Illness Beliefs model and was offered in March 2015--December 2016. Parents (N=31) at the Children's Hospital at the National University Hospital of Iceland, got two sessions of the FAM-SOTC intervention focusing on emotional support, evidence based information and recommendations and on the strengths of family members.

详细描述

Sample Data were collected at the Children's Hospital (CH) at the National University Hospital of Iceland (NUHI) in Reykjavik, Iceland. The population of Iceland is about 340,000 people. The incidence of diabetes among children in Iceland is 18 per year, and similar frequency among children and adolescents is reported regarding arthritis, epilepsy and sleeping disorder with ADHD. Participants in this study were 31 primary caregivers who all were the mothers of the children/adolescents with diabetes, arthritis, epilepsy or sleeping disorder with ADHD (see Table 1). A research assistant offered all the primary caregivers (N = 39; n=38 mothers and n=1 father) of children with one of the above-mentioned illnesses/disorders at the time of the data collection, to participate in the study. The 31 primary caregivers, who signed the consent form, participated in the study and represented 80% response rate. Parents completed online the questionaires at the clinic, before they started the first session and then again after the second session. Three APN ,specialists in the child illness diagnosis and who had special graduate educational training in family system nursing or had a doctorate degree in family nursing, offered the families the FAM-SOTC intervention. The parents meet with the APN at the Children´s Hospital without the child in both sessions, but each session lasted for 45 to 90 minutes. The sessions were offered with 4-8 weeks interval.

Description of the FAM-SOTC intervention The description of the development of the FAM-SOTC as well as a figure of the FAM-SOTC intervention, has been published elsewhere.

The first FAM-SOTC session:

When the APN had greeted the parents and made them comfortable, a family assessment was conducted by drawing a family tree and the quality of the family relations indicated, as well as asking them who belonged to their family. Therapeutic questions were used and parents asked questions like where they got support from? The parents were encouraged to talk about their child's illness experience and to reflect on how they perceived the diagnose of the child/adolescent. Further, the main concerns of each of the parent where explored by using therapeutic questions such as: (a) What is your greatest challenge now? and (b) If something could be different, what would that be? Throughout the therapeutic conversaton's the nurse acknowledge the suffering of each family member and normalized their emotional responses. The nurse than drew attention to the family strengths that had been observed. Potential resources were then discussed and the nurse offered advice and education. At the end of the therapeutic conversations the nurse again mentioned the parents strengths and resources and a time was set for the next appointment.

The second FAM-SOTC session:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Being a parents of children/adolescents with diabetes, arthritis, epilepsy or sleeping disorder with ADHD who were in active treatment at a University Hospital.
  • Parents needed to be fluent in the Icelandic language.

排除标准

  • Parents who did not understand Icelandic or English.
  • Parents who could not read or write at the 4th grade level.

研究组 & 干预措施

Parents of children with chronic illnesses

Experimental

psycho-educational intervention for parents

干预措施: Therapeutic Conversation Interventions (Behavioral)

结局指标

主要结局

The ICE-Perceived Family Support from nurses Questionnaire (14-Items) at baseline

时间窗: 1 week

Has two factors: Cognitive (alpha=0.874) and emotional (alpha=0.937) support. Total alpha= 0.952. Has been reported to be both reliable and valid. The range of the scores is between 1-5. The total scale score range from 14-70, with higher score indicating better outcome.

The ICE-Perceived Family Support from nurses Questionnaire (14-Items)

时间窗: 8-10 weeks

Has two factors: Cognitive (alpha=0.874) and emotional (alpha=0.937) support. Total alpha= 0.952. Has been reported to be both reliable and valid. The range of the scores is between 1-5. The total scale scores range from 14-70, with higher score indicating better outcome.

The ICE-Family Illness Beliefs Questionnaire (7-Items) at baseline

时间窗: 1 week

I a one factor instrument regarding families illness beliefs. Alpha=0.789-0.910. The instrument has been reported to be both reliable and valid. The range of the scores is between 1-5. The total scale score range from 7-35, with higher score indicating better outcome.

The ICE-Family Illness Beliefs Questionnaire (7-Items)

时间窗: 8-10 weeks The total scale score range from 7-35, with higher score indicating better outcome.

I a one factor instrument regarding families illness beliefs. Alpha=0.789-0.910. The instrument has been reported to be both reliable and valid. The range of the scores is between 1-5.

次要结局

  • The PedsQL-Healthcare Satisfaction Generic Module (24-items)(8-10 weeks)
  • the PedsQL-Family Impact Module (36-item) at baseline(1 week)
  • the PedsQL-Family Impact Module (36-item)(8-10 weeks)
  • The PedsQL-Healthcare Satisfaction Generic Module (24-items) at baseline(1 week)

研究者

申办方类型
Other
责任方
Sponsor

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