- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06805136
Establishing Social Connections in Urban Areas: Evaluating a Community-based Programme
Tackling Youth Loneliness in Urban Areas: Measuring Feasibility, Acceptability, and Benefits of a Community-based Intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Lau
- Phone Number: 020 7882 3850
- Email: j.lau@qmul.ac.uk
Study Locations
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-
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London, United Kingdom
- Recruiting
- In the community in London, England
-
Contact:
- David Gradon
- Phone Number: 07590 420947
- Email: david@friendship-project.co.uk
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London, United Kingdom
- Not yet recruiting
- Youth Resilience Unit, Wolfson Institute of Population Health, Queen Mary University of London
-
Contact:
- Jennifer Lau
- Phone Number: 020 7882 3850
- Email: j.lau@qmul.ac.uk
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Principal Investigator:
- Jennifer Lau
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Age < 20 or age >40.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
The intervention focuses on free or low-cost social interaction by offering community initiatives and activities, online spaces for interaction, and social events to young and working-age adults in London.
Activities include but are not limited to social walks, bingo nights, board game afternoons and pub quizzes.
|
|
No Intervention: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility
Time Frame: 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.
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From enrollment to 6-weeks post-intervention (18 weeks total)
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Acceptability
Time Frame: 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.
|
6-weeks post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loneliness
Time Frame: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
|
The University of California Los Angeles (UCLA) loneliness scale.
The UCLA loneliness scale consists of 20 questions related to loneliness, including how often you 'lack companionship', 'feel left out', or 'feel isolated from others'.
Higher scores indicate greater levels of loneliness
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Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
|
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Wellbeing
Time Frame: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
|
The short version of the Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS).
The SWEMWBS measures mental wellbeing using 7 statements with a recall period of 2 weeks.
Higher scores indicate higher positive mental wellbeing.
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Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
|
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Social connectedness
Time Frame: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
|
The Social Connectedness Scale (SCS).
This SCS scale measures connectedness using 20 items measuring belongingness, on a 6-point Likert scale.
|
Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
|
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Health Related Quality of Life
Time Frame: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
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The European Quality of Life 5 Dimensions 5 Level version (EQ-5D-5L) has five dimensions, each dimension has five levels of response.
The dimensions cover mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Scores are used to obtain utility values where one is perfect health, 0 represents death, and negative scores reflect health states worse than death.
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Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
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Capability
Time Frame: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
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ICEpop CAPability measure for Adults (ICECAP-A).
This tool assesses five capabilities covering feeling settled/secure, love/friendship/support, being independent, achievement/progress, and enjoyment/pleasure.
Each capability has four levels of response.
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Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
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Client Service Receipt Inventory
Time Frame: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
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Client Service Receipt Inventory (CSRI) captures health and social care resource utilisation.
These will be recorded over a 6-week period.
Questions will include frequency of resource use in primary, community, and secondary care, medications, and employment status.
Health and social care resource use will be used, combined unit costs, to evaluate the cost of healthcare resources used by each group (intervention and control) Unit costs will be obtained from the Unit Costs of Health and Social Care, supplemented with the National Reference Costs.
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Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Russell D, Peplau LA, Ferguson ML. Developing a measure of loneliness. J Pers Assess. 1978 Jun;42(3):290-4. doi: 10.1207/s15327752jpa4203_11.
- Al-Janabi H, Flynn TN, Coast J. Development of a self-report measure of capability wellbeing for adults: the ICECAP-A. Qual Life Res. 2012 Feb;21(1):167-76. doi: 10.1007/s11136-011-9927-2. Epub 2011 May 20.
- Shah N, Cader M, Andrews B, McCabe R, Stewart-Brown SL. Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS): performance in a clinical sample in relation to PHQ-9 and GAD-7. Health Qual Life Outcomes. 2021 Nov 24;19(1):260. doi: 10.1186/s12955-021-01882-x.
- Eager S, Johnson S, Pitman A, Uribe M, Qualter P, Pearce E. Young people's views on the acceptability and feasibility of loneliness interventions for their age group. BMC Psychiatry. 2024 Apr 23;24(1):308. doi: 10.1186/s12888-024-05751-x.
- Bryan BT, Thompson KN, Goldman-Mellor S, Moffitt TE, Odgers CL, So SLS, Uddin Rahman M, Wertz J, Matthews T, Arseneault L. The socioeconomic consequences of loneliness: Evidence from a nationally representative longitudinal study of young adults. Soc Sci Med. 2024 Feb 22;345:116697. doi: 10.1016/j.socscimed.2024.116697. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- QME24. 0657
- APP19330 (Other Identifier: Economic and Social Research Council (ESRC) - UKRI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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