跳至主要内容
临床试验/NCT06691711
NCT06691711已完成不适用

Adult-caregiver Supported Positive Psychology Intervention to Increase Resilience (ASPIRE): Developing and Refining a Caregiver-delivered Positive Psychology Intervention to Increase the Resilience of Children Who Have Experienced Adversities - Work Package 2

Norfolk and Suffolk NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年1月31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
24
试验地点
1
主要终点
Intervention feasibility / fidelity of delivery

研究概览

简要总结

The goal of this feasibility study was to investigate a new intervention designed to help parents/carers of children aged 8-12 who have experienced adversities to build their child's resilience to mental health difficulties using a 'positive psychology' approach. The research questions concerned the acceptability, feasibility and safety of the intervention.

详细描述

Background: Adverse Childhood Experiences (ACEs) are traumatic or stressful events before age 18 that have been linked to poor mental health across the life course. Resilience is the ability of an individual to maintain or return to a thriving state following adversity. As resilience is not a static trait, intervening to increase the resilience of children exposed to ACEs has the potential to decrease the risk of later mental health difficulties. Positive psychology interventions (i.e. interventions that aim to increase factors that have been identified as important to individual and community flourishing) have been shown to be effective in increasing resilience. However, there was not yet a positive psychology intervention designed to meet the needs of young people exposed to ACEs and their caregivers (parents/carers).

Objectives: To investigate the acceptability, feasibility and safety of a co-produced caregiver-delivered positive psychology intervention to enhance the resilience to mental health difficulties of children who have experienced ACEs.

Methods: The project was guided by a Stakeholder Research Team (SRT) comprising both adults and young people with relevant expertise-by-experience. The study was divided into two work packages. In work package 1, the researchers completed a component analysis of existing positive psychology interventions, and a qualitative study to understand the needs and preferences of young people, parents/carers and professionals. They then conducted a series of intervention development workshops to co-produce the intervention with the SRT, informed by the findings of the component analysis and qualitative study. In work package 2, the researchers carried out a waitlist-controlled feasibility study involving 12 families with a child aged 8-12 years who had experienced ACEs. Families were randomised to receive the intervention either immediately or after a 10-week waiting period and mixed methods data collected to enable us to assess the acceptability, feasibility and safety of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
8 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The child's parent or carer identifies that their child has been significantly impacted by one or more Adverse Childhood Experience (ACE).
  • •Child is aged 8 to 12 years.
  • •Child is willing and able to provide informed assent to participate.
  • •The child's parent or carer is willing and able provide parental consent for their child's participation.
  • •At least one adult caregiver (aged 18+) is willing and able to provide informed consent to participate themselves.

排除标准

  • •Child is currently under the care of specialist child and adolescent mental health services (CAMHS).
  • •There are ongoing safeguarding concerns that might have an impact on the family's ability to participate safely (e.g. ongoing abuse or neglect).
  • •The child or their caregiver has a learning disability that would prevent them from accessing the intervention or completing outcome measures (reasonable adjustments will be made to allow families to participate wherever possible).
  • •In addition, professionals involved in supporting caregivers to deliver the intervention (ASPIRE facilitators) will be invited to participate as staff participants.

研究组 & 干预措施

Immediate intervention

Experimental

Those allocated to the immediate arm will be offered the ASIRE support package over a 10 week period immediately post randomisation. The caregiver will be provided with access to all module resources and supported through the programme by a trained practitioner (their ASPIRE facilitator) who offers information, advice and encouragement during the intervention period (providing up to 8 support sessions in total).

干预措施: ASPIRE support package (Behavioral)

Waitlist

No Intervention

Participants randomised to the waitlist arm will not be denied access to any support or treatment available as part of current service provision during the waiting period. Both young people and parents/carers will be encouraged to continue engaging with any support they already receive and can be referred/self-refer to additional services as required. After the 10-week waiting period is complete, participants randomised to this arm will be offered the ASPIRE intervention as described above.

结局指标

主要结局

Intervention feasibility / fidelity of delivery

时间窗: 20 weeks

ASPIRE intervention adherence checklist

Potential risks of the intervention

时间窗: 20 weeks

Modified Edinburgh Adverse Effects of Psychological Therapy Scale

Intervention acceptability

时间窗: 20 weeks

Qualitative acceptability of the intervention from the perspective of children, caregivers and professionals, assessed via interviews and focus groups

Intervention feasibility / fidelity of delivery

时间窗: 10 weeks

ASPIRE intervention adherence checklist

Potential risks of the intervention

时间窗: 10 weeks

Modified Edinburgh Adverse Effects of Psychological Therapy Scale

Intervention acceptability

时间窗: 10 weeks

Qualitative acceptability of the intervention from the perspective of children, caregivers and professionals, assessed via interviews and focus groups

次要结局

  • Me and My Feeling Questionnaire(Post intervention (10 weeks) & 20 week follow-up for immediate arm only)
  • The Student Resilience Survey(Post intervention (10 weeks) & 20 week follow-up for immediate arm only)
  • Students' Life Satisfaction Scale(Post intervention (10 weeks) & 20 week follow-up for immediate arm only)
  • Strengths and Difficulties Questionnaire (parent-report version)(Post intervention (10 weeks) & 20 week follow-up for immediate arm only)
  • Me as a Parent(Post intervention (10 weeks) & 20 week follow-up for immediate arm only)
  • Short Warwick Edinburgh Mental Wellbeing Scale(Post intervention (10 weeks) & 20 week follow-up for immediate arm only)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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