LonelinessINACTNCT07154225
INcreasing Adolescent Social and Community SupporT - Full Trial
A study testing Social Prescribing and Signposting in people with Loneliness, run by University College, London at 1 site in United Kingdom.
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 update from young people has been lower than for adults. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Loneliness
- What is being tested?
- Social Prescribing and Signposting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2025to 30 Jun 2027
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Schools:
- 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
Who cannot join
- Schools:
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
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 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.
- Conditions
- Loneliness
- Being tested
- Social Prescribing, Signposting
- Keywords
- Loneliness, Social Prescribing, Schools, Pupils
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 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.
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 group | Role | What they receive |
|---|---|---|
| Social Prescribing | Experimental | 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. Receives: Behavioral: Social Prescribing |
| Signposting | Active comparator | 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. Receives: Behavioral: Signposting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
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
Measured: Baseline, 3, 6 and 12 months
Secondary outcomes (10)
Wellbeing
Measures using the Wellbeing subscale (Kidscreenn-52) which contains 6 questions each on a five-point Likert scale (scoring between 6-30). Higher scores indicate greater well-being.
Measured: Baseline, 3, 6 and 12 months
Mental health (emotional difficulties)
Measured using the Emotional difficulties subscale (Me and My feelings questionnaire) which contains 10 questions on a 3-point Likert scale (scoring between 0-20). Higher scores indicate higher emotional difficulties.
Measured: Baseline, 3, 6 and 12 months
Service use
Measures using the Client Service Receipt of Inventory which contains 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: Baseline, 3, 6 and 12 months
Quality of Life
Measured using the CHU-9D which contains 9 questions on a five-point Likert scale (scoring between 1-5). Higher scores indicate higher quality of life.
Measured: Baseline, 3, 6 and 12 months
Stress
Measured using the Perceived Stress Scale 4 which assesses stress using 4 questions on a five-point Likert scale (scoring between 0-16). Higher scores indicate higher levels of perceived stress (secondary school pupils only)
Measured: Baseline, 3, 6 and 12 months
Emotion Regulation
Emotion Regulation Index for Children and Adolescents is assessed using 16 items on a five-point Likert scale (scoring between 1-5). Higher scores indicate greater emotion regulation.
Measured: Baseline, 3, 6 and 12 months
Intervention Acceptability
Measured using a single item adapted from the NHS Friends and Family Test on a five-point Likert scale . Higher scores indicate higher acceptability. Social prescribing arm only.
Measured: 3, 6, and 12 months
Intervention Feasibility (School Staff and Link Workers),
Measured using the Feasibility of Intervention Measure (FIM) which contains 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher intervention feasibility.
Measured: Approx 3 months after intervention delivery has begun
Intervention Acceptability (School Staff and Link Workers)
Measured using the Acceptability of Intervention Measure (AIM) which contains 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher intervention acceptability.
Measured: Approx 3 months after intervention delivery has begun
Intervention Appropriateness (School Staff and Link Workers)
Measured using the Intervention Appropriateness Measure (IAM) which contains 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher intervention appropriateness. 3 months
Measured: Approx 3 months after intervention delivery has begun
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start15 Sep 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, National Academy for Social Prescribing, We Do Wellbeing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154225
- Sponsor's protocol ID
- 1207
- Acronym
- INACT
- Status last verified
- May 2026
- First submitted
- 26 Aug 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Some IPD data will be shared but specific data is being currently discussed with the funder. We will update this record when we know more.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INcreasing Adolescent Social and Community SupporT - Full Trial
- ClinicalTrials.gov ID
- NCT07154225
- Acronym / sponsor ID
- INACT / 1207
- Conditions
- Loneliness
- Keywords
- Loneliness, Social Prescribing, Schools, Pupils
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University of Manchester, National Academy for Social Prescribing, We Do Wellbeing
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Prescribing | Experimental | Behavioral: Social PrescribingSP 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. |
| Signposting | Active comparator | Behavioral: SignpostingThose 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. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Schools:
- Pupils and their parents/guardians:
Key exclusion criteria (10 listed)
- Schools:
- Pupils and their parents/guardians:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social PrescribingSP 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. | Behavioural | Social Prescribing |
| SignpostingThose 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. | Behavioural | Signposting |
Primary outcome
Loneliness
Time frame: 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
10 secondary outcomes
Wellbeing
Time frame: Baseline, 3, 6 and 12 months
Mental health (emotional difficulties)
Time frame: Baseline, 3, 6 and 12 months
Service use
Time frame: Baseline, 3, 6 and 12 months
Quality of Life
Time frame: Baseline, 3, 6 and 12 months
Stress
Time frame: Baseline, 3, 6 and 12 months
Emotion Regulation
Time frame: Baseline, 3, 6 and 12 months
Intervention Acceptability
Time frame: 3, 6, and 12 months
Intervention Feasibility (School Staff and Link Workers),
Time frame: Approx 3 months after intervention delivery has begun
Intervention Acceptability (School Staff and Link Workers)
Time frame: Approx 3 months after intervention delivery has begun
Intervention Appropriateness (School Staff and Link Workers)
Time frame: Approx 3 months after intervention delivery has begun
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided. Some IPD data will be shared but specific data is being currently discussed with the funder. We will update this record when we know more.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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 7 inclusion and 10 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 12 May 2026. 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: Baseline, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.