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临床试验/NCT03873142
NCT03873142已完成不适用

The Effectiveness of a Mindful Parenting Intervention for Parents of Children With Psoriasis and Parents of Children With Eczema: A Single Group Case Series

University of Sheffield5 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年10月19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
14
试验地点
5
主要终点
Change in parenting stress (idiosyncratic measure)

研究概览

简要总结

This study investigates the impact of a mindful parenting intervention on parents of children with psoriasis or eczema. More specifically, this study will investigate the impact of the group on both the child and the parents mental health and quality of life.

详细描述

Psoriasis and eczema are chronic inflammatory skin conditions that affect up to 2% and 20% of children respectively (Mahe, 2016; Plötz, Wiesender, Todorva & Ring, 2014). These skin conditions are associated with poorer mental health in the children themselves and in their parents (Megna et al., 2015; Hammer-Helmich et al., 2016). Little research has investigated ways of reducing parental stress in parents of children with chronic health conditions, such as psoriasis and eczema.

"Mindful Parenting" interventions offer one potential way of improving mental health and quality of life in parents and their children. Mindful parenting refers to a parenting style which involves paying close, non-judgemental attention to the child (Duncan et al., 2009). However, no research has investigated the impact of mindful parenting interventions on children with skin conditions and their parents.

The main aim of the current study is to investigate whether a mindful parenting intervention can improve mental health and quality of life in children with psoriasis/eczema and their parents. A single-group case-series design will be adopted, whereby participants will act as their own control; data collected from participants during and after they have received the intervention will be compared to data collected before they have received the intervention. Interviews will also be conducted after the intervention, to explore participants experience of the group.

The investigators predict that the intervention will improve mental health and quality of life in children with psoriasis/eczema and their parents. More specifically, we predict:

  • There will be a reduction in negative parental idiosyncratic measures of stress throughout the intervention phase, in comparison to baseline phase, that will be maintained in the follow-up phase.
  • There will be an improvement in positive parental idiosyncratic measures of stress during the intervention phase in comparison to baseline phase that will be maintained in the follow-up phase.
  • There will be a significant increase in levels of mindful parenting following the intervention phase, in comparison to baseline phase, that will be maintained in the follow-up phase.
  • There will be a significant decrease in levels of parental stress at end of intervention phase compared to baseline phase that will be maintained in the follow-up phase.
  • There will be a significant increase in parental quality of life and paediatric quality of life at the end of intervention phase compared to baseline phase that will be maintained in the follow-up phase .
  • There will be a significant improvement in psoriasis severity and itch at the follow-up phase compared to the baseline phase.

研究设计

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

盲法说明

No party will be masked in this study. There is only one arm and participants will act as their own controls.

入排标准

年龄范围
4 Years 至 16 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Child inclusion criteria:
  • •Received a diagnosis of psoriasis or eczema from a medical professional
  • •Aged 4-16 years
  • •Fluent English speaker
  • •Psoriasis or eczema is the primary health concern
  • •Parent inclusion criteria:
  • •Parent of child (aged four to 16 years old) with psoriasis or eczema
  • •Aged 16 or over
  • •Self-identifies as experiencing stress due to the child's skin condition
  • •Fluent English Speaker
  • •Able and willing to attend 9 group sessions
  • •Willing to commit sufficient time to carrying out the practice (e.g. at home)
  • •Willing to respond to daily brief text messages

排除标准

  • •Parent exclusion criteria:
  • •Active thoughts of suicide
  • •Active thoughts of self-harm
  • •Engaging in, or about to start, psychological therapy during the study period
  • •Previously attended a mindful parenting group
  • •Recent severe life events such as deliberate self-harm, hospital admission, or psychotic episode (last 12 months)
  • •Experiencing physical pain or problems that may be worsened by yoga exercises.

研究组 & 干预措施

Mindful parenting intervention

Experimental

There is only one arm in this study. A range of variables will first be measured (daily and weekly) over a baseline period in a group of participants. Following this baseline period, participants will be take part in a mindful parenting intervention whilst the same variables are measured. Following the intervention, there will be an 8-week follow-up period, and mindful parenting groups will not run during this time.

干预措施: Mindful Parenting (Behavioral)

结局指标

主要结局

Change in parenting stress (idiosyncratic measure)

时间窗: Daily for 20 weeks (baseline-intervention-follow-up)

The primary outcome measures for the proposed study are idiosyncratic measures of stress which will be assessed daily by text message. Participants will be asked to identify one stress-related positive target (something the participant would like to improve) and one negative target (something the participant would like to reduce). Participants will respond to the daily text messages with a score on a 0-100 scale.

次要结局

  • Demographic information(1-time point (baseline period))
  • Mindful parenting(4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later) end of intervention (8 weeks later) follow-up (8 weeks later))
  • Parental Stress(4 time-points. Baseline (beginning of study) beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later))
  • Parental Anxiety(4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later))
  • Parental Depression(4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later))
  • Paediatric quality of life(Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later))
  • Parental quality of life(Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later))
  • General Stress(5 time-points. Screening interview (pre-study), baseline (beginning of study, approx. 2-4 weeks later), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later))
  • Paediatric psoriasis/eczema severity(2 time-points. Baseline (beginning of study), follow-up (18 weeks later))
  • Paediatric psoriasis/eczema itch intensity(2 time-points. Baseline (beginning of study), follow-up (18 weeks later))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Thompson

Principal Investigator

University of Sheffield

研究点 (5)

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