INcreasing Adolescent Social and Community SupporT - Full Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 215
- 试验地点
- 1
- 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 update 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 is based, for wellbeing support. The INACT pilot sought to test the feasibility and acceptability of a Social Prescribing pathway via schools to support young people who are lonely through a randomised controlled trial. Findings suggested that study procedures, including the measures were appropriate and that Social Prescribing was deemed by young people, social prescribers and school staff as feasible, acceptable and suitable and there was evidence of impact in the social prescribing arm when compared to signposting. Given the positive pilot findings, the aim of the INACT full trial is to build upon the pilot work and conduct a clinical and cost effectiveness trial into the impact of Social Prescribing in schools for loneliness and low community connection, compared to signposting.
Methods: A minimum of 215 pupils reporting loneliness will be recruited across 30 mainstream 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. The clinical and cost effectiveness of Social Prescribing for young people with loneliness will be assessed using measures of loneliness, mental health, wellbeing, quality of life, and service use. Data will be collected at baseline and 3, 6, and 12 months later. Qualitative interviews will also be conducted to explore barriers, facilitators, mechanisms of change and impact.
Discussion: INACT will provide evidence of the clinical and cost effectiveness of Social Prescribing in schools for supporting young people experiencing loneliness. It will also establish what types of community and social activities young people engage in and what factors affect participation.
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 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A primary or secondary school willing to participate in INACT
- •In England
- •Have classes of pupils in eligible year groups to participate (Years 5, 7, 8)
- •Pupils and their parents/guardians:
- •Score 7 or above on the Good Childhood Index (indicating high loneliness)
- •Parents/guardians consent, and pupils assent, to get support
排除标准
- •Private schools or sixth form/colleges
- •Specialist schools
- •Schools only offering alterative provision
- •Outside of England
- •Does not have classes of pupils in eligible year groups to participate (Years 4, 5, 7, 8)
- •Pupils and their parents/guardians:
- •Score below 7 on the Good Childhood Index (indicating low loneliness)
- •Parents/guardians do not consent, or pupils do not assent, to get support
- •Children and young people with severe learning disabilities who are unable to complete questionnaires
研究组 & 干预措施
Social Prescribing
SP is a person-centred approach to wellbeing involving the co-development of a non-clinical prescription, between an individual (i.e. young person) and Link Workers (LWs), based on the perceived difficulties for the referral and the YPs values, needs and preferences. LWs have a good knowledge of their local areas, via community asset mapping and networking, allowing them to connect individuals with different types of available support and activities. Typically, SP ranges from 6-12 sessions (average 8 sessions: unpublished data from sites) with a LW over an 8-week period. Sessions may take place online, via phone call, or in person. As part of this process, LWs draw on psychological skills such as motivational interviewing and behavioural activation as well as employ problem solving and goal setting. Following the identification of issues and preferences, the LW will discuss with the YP what the available local activities and support structures are that best match their preferences.
干预措施: Social Prescribing (Behavioral)
Signposting
Those in the control group will receive signposting to activities and local sources of support in their communities. This will consist of school pastoral staff meeting with YP identified as lonely and providing them with a leaflet detailing the same local sources of support identified by the LW from asset mapping.
干预措施: Signposting (Behavioral)
结局指标
主要结局
Loneliness
时间窗: Baseline, 3, 6 and 12 months
Measured using the Good Childhood Index containing 3 questions on a 3-point Likert scale (scoring between 3-9). Higher scores indicate higher reported loneliness. Baseline, 3, 6 and 12 months
次要结局
- Wellbeing(Baseline, 3, 6 and 12 months)
- Mental health (emotional difficulties)(Baseline, 3, 6 and 12 months)
- Service use(Baseline, 3, 6 and 12 months)
- Quality of Life(Baseline, 3, 6 and 12 months)
- Stress(Baseline, 3, 6 and 12 months)
- Intervention Acceptability(3, 6, and 12 months)
- Intervention Feasibility (School Staff and Link Workers),(Approx 3 months after intervention delivery has begun)
- Intervention Acceptability (School Staff and Link Workers)(Approx 3 months after intervention delivery has begun)
- Intervention Appropriateness (School Staff and Link Workers)(Approx 3 months after intervention delivery has begun)
- Wellbeing(Baseline, 3, 6 and 12 months)
- Mental health (emotional difficulties)(Baseline, 3, 6 and 12 months)
- Service use(Baseline, 3, 6 and 12 months)
- Quality of Life(Baseline, 3, 6 and 12 months)
- Stress(Baseline, 3, 6 and 12 months)
- Emotion Regulation(Baseline, 3, 6 and 12 months)
- Intervention Acceptability(3, 6, and 12 months)
- Intervention Feasibility (School Staff and Link Workers),(Approx 3 months after intervention delivery has begun)
- Intervention Acceptability (School Staff and Link Workers)(Approx 3 months after intervention delivery has begun)
- Intervention Appropriateness (School Staff and Link Workers)(Approx 3 months after intervention delivery has begun)