AzTrials
AzTrials

LonelinessINACTNCT06656663

INcreasing Adolescent Social and Community SupporT - Pilot

A study testing Social Prescribing and Signposting in people with Loneliness, run by University College, London at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 9 to 13 years
Conditions the study is for
Loneliness
What is being tested?
Social Prescribing and Signposting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteUnited Kingdom
Study dates
12 Nov 2024to 31 Aug 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University College London

    Greater London, WC1E 7HB

Other trials in United Kingdom

About this study

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.

Conditions
Loneliness
Being tested
Social Prescribing, Signposting
Keywords
Social Prescribing, Loneliness, School, Pupils, Link Worker

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Social PrescribingBehavioural

    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 LW, based on the perceived difficulties for the referral and the YPs values, needs and preferences. LWs have an excellent 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.

  • SignpostingBehavioural

    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.

Study groups in NCT06656663
Study groupRoleWhat they receive
Social PrescribingExperimentalSP 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.
Receives: Behavioral: Social Prescribing
SignpostingActive comparatorThose 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.
Receives: Behavioral: Signposting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Loneliness

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

    Measured: 3 Months

  2. Intervention Feasibility (School Staff and Link Workers)

    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

    Measured: 6 months

  3. Intervention Acceptability (School Staff and Link Workers)

    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

    Measured: 6 months

  4. Intervention Appropriateness (School Staff and Link Workers)

    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

    Measured: 6 months

Secondary outcomes (6)

  1. Peer loneliness

    LACA - Peer Subscale is assessed using 12 questions each on a four-point Likert scale (scoring between 12-48). Higher scores indicate higher peer loneliness

    Measured: 3 and 6 months

  2. Wellbeing

    Kidscreen-52 is assessed using 6 questions each on a five-point Likert scale (scoring between 6-30). Higher scores indicate greater well-being.

    Measured: 3 and 6 months

  3. Mental health (emotional difficulties)

    Me and My feelings is assessed using 10 questions on a 3-point Likert scale (scoring between 0-20). Higher scores indicate higher emotional difficulties

    Measured: 3 and 6 months

  4. Service Use

    Client Service Receipt of Inventory is assessed using 11 questions on a five-point Likert scale. Scoring can be looked at by individual items (i.e. score between 1-5) or by scoring all items (i.e. scores between 11-55). Higher scores indicate more contact with a service/services.

    Measured: 3 and 6 months

  5. Stress

    Perceived Stress Scale 4 is assessed using 4 questions on a five-point Likert scale (scoring between 0-16). Higher scores indicate higher levels of perceived stress

    Measured: 3 and 6 months

  6. Loneliness

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

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start12 Nov 2024
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion31 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study utilises a two-group (intervention vs. active control) parallel randomised design, with YP as the unit of randomisation.
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06656663
Sponsor's protocol ID
6735/017
Acronym
INACT
Status last verified
Dec 2024
First submitted
18 Oct 2024
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Some IPD data will be shared but we specific data is being currently discussed with the funder. We will update this record when we know more.

Publications

  • Hayes D, Burton A, Bu F, Humphrey N, Qualter P, Han E, Sticpewich L, Wright J, Bone JK, Maguire S, Gonzalez Umpierrez LC, Stapley E, Tibber MS, Fancourt D. INcreasing Adolescent social and Community supporT (INACT): Pilot study protocol. PLoS One. 2025 Mar 26;20(3):e0317823. doi: 10.1371/journal.pone.0317823. eCollection 2025.

    PubMed 40138284

Questions about this trial

What is this clinical trial studying?

A study testing Social Prescribing and Signposting in people with Loneliness, run by University College, London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loneliness (time frame: 3 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06656663, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in