Tackling Youth Loneliness in Urban Areas: Measuring Feasibility, Acceptability, and Benefits of a Community-based Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
The aim of this study is to evaluate the feasibility and acceptability of a new community-based programme designed to tackle loneliness for young and working-age adults. The programme focuses on encouraging social interactions and connections through offering community initiatives and activities, online spaces for interaction, and free or low-cost social events for young adults. Further aims of this study are to determine the cost-effectiveness of the programme.
详细描述
Loneliness is associated with adverse mental and physical health outcomes. Most interventions are aimed at older adults even though young adults, including those of working-age, have been identified as being at-risk for persistent loneliness. This study aims to formatively evaluate the feasibility and acceptability of a community-based social interaction intervention. Therefore, the main objectives of this study are to:
- Assess the feasibility and acceptability of the community-based intervention.
- To determine the costs and effects related to the community-based intervention using quantitative feasibility study data and qualitative interviews with study participants.
In this mixed-methods two-arm randomised feasibility study with qualitative evaluation, participants will be randomly allocated to the community-based intervention over 12 weeks or to the wait-list control group. The intervention consists of weekly community social activities with the aim of reducing feelings of loneliness. Participants in the wait-list control group can continue any standard care or support they were receiving e.g. use of GP or mental health services. For both groups, online self-report assessments will take place at baseline (time 0, t0), 12-week follow-up (end of the intervention period; time 1, t1) and 6-weeks post intervention (18-weeks after baseline, time 2, t2). For the intervention group, an additional qualitative interview will be taken at the final timepoint (time 3, t3; 6 weeks post-intervention).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-40
- •Reside in London
- •Reports that they are some of the time or often lonely in response to a single questionnaire item ("How often do you feel lonely?)
- •No prior interaction with the community-based intervention we are investigating
- •Able to communicate in English sufficiently well to engage in qualitative interviews and complete the outcome measures and questionnaires.
- •Available and willing to participate in the study for 18 weeks
排除标准
- •Age < 20 or age >
- •Resides outside of London.
- •Does not report frequent levels of loneliness ("hardly ever or never" in response to single questionnaire item).
- •Previously attended any event or is an existing member of the community-based programme that is forming the intervention arm.
- •Unable to communicate even with communication support.
- •Planned unavailability for >3 weeks during intervention and follow up periods.
- •Participating in another research project related to loneliness.
- •Reports current severe unstable health problems (mental or physical) or is deemed overburdened with respect to participating in research.
研究组 & 干预措施
Community-based intervention group
The participants in the community-based intervention group will be invited to attend weekly social activities over a period of 12 weeks. Participants must be committed to attend at least 8 activities during the 12 week period. Following the 12-week intervention period, the intervention group will enter a 6-week post-intervention period where they will no longer be encouraged to attend the activities to help understand the impact of stopping the intervention.
干预措施: Community-based social interaction intervention (Behavioral)
Wait-list control
The participants allocated to the wait-list control will continue to receive any standard care they were receiving (e.g., National Health Services (NHS) services) during the 18-week trial. All participants will be eligible and able to access the community-based intervention as independent members once the trial ends (after 18 weeks).
结局指标
主要结局
Feasibility
时间窗: From enrollment to 6-weeks post-intervention (18 weeks total)
To determine feasibility, we will record: (i) Number of participants that complete the screening stage. (ii) Number of eligible participants following the screening. (iii) Number of participants who consent to take part in the intervention. (iv) Number of participants randomised. (v) Number of participants who drop out and reasons offered for this. (vi) During the intervention: range and average number of sessions completed as a proportion of those offered. Data completeness for each questionnaire will be summarised at each time point.
Acceptability
时间窗: 6-weeks post intervention
Qualitative interviews will be conducted to explore participants' experiences of the intervention, barriers and facilitators, perceived active ingredients, potential benefits, and suggested changes. They will also seek to understand the reach, engagement, and benefits of the intervention by focusing on topics around engagement, tolerability, and safety. The interviews will be conducted with the intervention group and facilitated using topic guides.
次要结局
- Wellbeing(Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).)
- Loneliness(Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).)
- Social connectedness(Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).)
- Health Related Quality of Life(Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).)
- Capability(Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).)
- Client Service Receipt Inventory(Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).)