跳至主要内容
临床试验/NCT06656663
NCT06656663进行中(未招募)不适用

INcreasing Adolescent Social and Community SupporT - Pilot

University College, London2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
78
试验地点
2
主要终点
Loneliness

研究概览

简要总结

Background: Social prescribing is a mechanism of connecting patients with non-medical forms of support within the community and has been shown to improve loneliness. Yet uptake from young people has been lower than for adults. This is thought to be due to accessibility issues as young people are less likely to draw on primary care, where social prescribing in based, for wellbeing support. INACT will pilot a social prescribing pathway via schools to support young people who are lonely. It will test the feasibility and acceptability of delivering and evaluating it through a randomised controlled trial.

Methods: 78 pupils reporting loneliness will be recruited across 12 mainstream (6 primary and 6 secondary) schools in England and be randomly allocated to signposting or social prescribing. Pupils in the control group will receive signposting to sources of support from school staff. The co-produced social prescribing intervention includes up to 6 sessions with a Link Worker who will work with individuals to understand 'what matters to them' and connect them with local sources of support. Data will be collected at baseline, 3- and 6-months later. Acceptability and feasibility will be assessed via recruitment and retention, as well as via qualitative interviews. Interviews will also explore barriers, facilitators and mechanisms of change. Potential primary and secondary outcomes for a future trial will be completed to assess response and completeness, including measures of loneliness, mental health and wellbeing.

Discussion: INACT will provide preliminary evidence of the feasibility and acceptability of both the research design and social prescribing intervention. Results will inform a potential future randomised trial.

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
9 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children and young people in a participating school and in Years 4, 5 or 7, 8
  • Parental consent and young person assent is provided
  • A score of 6 or above on the Good Childhood Index loneliness questions

排除标准

  • Private schools
  • Children and young people with severe learning disabilities

结局指标

主要结局

Loneliness

时间窗: 3 Months

Good Childhood Index is assessed using 3 questions on a 3-point Likert scale (scoring between 3-9). Higher scores indicate higher reported loneliness.

Intervention Feasibility (School Staff and Link Workers)

时间窗: 6 months

Feasibility of Intervention Measure (FIM) is assessed using 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher intervention feasibility

Intervention Acceptability (School Staff and Link Workers)

时间窗: 6 months

Acceptability of Intervention Measure (AIM) is assessed using 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher intervention acceptability

Intervention Appropriateness (School Staff and Link Workers)

时间窗: 6 months

Intervention Appropriateness Measure (IAM) is assessed using 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher intervention appropriateness

次要结局

  • Peer loneliness(3 and 6 months)
  • Wellbeing(3 and 6 months)
  • Mental health (emotional difficulties)(3 and 6 months)
  • Service Use(3 and 6 months)
  • Stress(3 and 6 months)
  • Loneliness(6 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

INcreasing Adolescent Social and Community SupporT -... | 临床试验