AnxietyNCT06188962
Evaluating Knowledge Insight Tools (KIT) for Reducing Anxiety and Low Mood in UK Secondary School Students
A study testing CBT-informed school-based counselling in people with Anxiety and Depression, run by University College, London at 1 site in United Kingdom.
Trial summary
Background and Study Aims: Secondary school students are reporting unprecedented levels of anxiety and mood difficulties. To ensure that the needs of all young people are met, there is a need to evaluate more accessible forms of support, such as psychological therapies offered in schools. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Anxiety, Depression, Internalizing Problems
- What is being tested?
- CBT-informed school-based counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Oct 2023to 18 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 11-18 years old
- Attends a secondary school in England, Scotland or Wales
- Experiencing problems with low mood and/or anxiety that are affecting day-to-day functioning.
- Experiencing problems that are at least in part within their control as opposed to the system being the problem (systems work/advocacy might be more relevant in these cases).
- Are seeking help and are motivated towards change.
Who cannot join
- Pose a significant risk to themselves and/or others (e.g., where there is significant self-harm [e.g., self-harm that risks accidental death, such as cutting, self-strangulation, under/overusing medications, tablets or substances, and swallowing hazardous materials], suicidal ideation, suicidal intent, sexual/physical violence to/from others, hospitalization due to alcohol/substance misuse/self-harm/psychiatric reasons)
- Are experiencing severe anxiety/mood difficulties, or whose primary difficulties are not related to anxiety/low mood, e.g., uncontrolled eating disorders, substance/alcohol dependence, psychotic disorders, body dysmorphia, antisociality, risk-taking problems, and personality disorders.
- Have significant special educational needs or learning difficulties.
- Are younger than 16 and for whom it would pose significant issues if their parents/carers were informed of their involvement with Place2Be services.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pragmatic Randomized Multiple Baseline Trial Evaluating Knowledge Insight Tools (KIT), a Cognitive Behavioural Therapy-informed School-based Counselling Intervention for Secondary School-aged Children and Young People With Anxiety and Mood Difficulties in the UK
Background and Study Aims:
Secondary school students are reporting unprecedented levels of anxiety and mood difficulties. To ensure that the needs of all young people are met, there is a need to evaluate more accessible forms of support, such as psychological therapies offered in schools. The aim of this trial is to test a new form of school-based psychological therapy called Knowledge Insight Tools (KIT). KIT is based on Cognitive Behavioural Therapy, which is known to be helpful for young people experiencing difficulties with anxiety and low mood. The investigators want to see whether offering KIT to secondary school students can reduce their anxiety and/or low mood, compared to a period of time when they did not receive any support.
Read more
Who can participate?
Children and young people aged 11-18 can participate if they are attending a secondary school in England or Scotland, are experiencing problems with low mood and/or anxiety that are disrupting their everyday lives and are not mainly the result of external factors, and are actively seeking support. Children and young people cannot participate if they pose a significant risk to themselves and/or others, if their primary difficulties are not related to anxiety and/or low mood, if they have significant special educational needs or learning difficulties, and are younger than 16 years and for whom it would pose significant issues if their parents/carers were informed of their involvement with Place2Be services.
What does the study involve?
The study starts with a waiting period, where each young person will not receive any support for 3-8 weeks, except for a weekly check-in with a trained professional. This is meant to provide a stable measurement of young people's mental health before KIT is introduced. The length of the waiting period for each young person is chosen at random by a computer program. This helps mix up the influence of things other than KIT that could impact young people's mental health, such as differences in the natural (and sometimes healing) passage of time. Young people will then be offered 10 sessions of KIT, where they will learn about the ways in which unhelpful thoughts and behaviours can inadvertently make them feel low or anxious. They will also be asked to practice ways of testing their unhelpful thoughts and changing their behaviours outside of sessions, and the investigators will review how this affects their mood and well-being over the course of treatment.
What are the possible benefits and risks of participating?
The main benefit of participating is that young people will be contributing to science, which will help young people struggling with anxiety and mood problems in future be offered forms of school-based psychological therapy that have been rigorously tested. The main risk is that young people might wait longer to start KIT than had they not participated in the study. Young people will still receive KIT if they refuse to participate or withdraw their participation, which they can do at any time.
Where is the study run from?
The study is run from secondary schools in the UK and is being conducted by the Evidence-Based Practice Unit (a research group and collaboration between University College London and the Anna Freud) and researchers and school-based practitioners from Place2Be.
When is the study starting and how long is it expected to run for?
The study started on 01/08/2022 with the recruitment of the first student. The study is expected to run until September 2024. There are plans to extend the study until September 2025 if another wave of recruitment is needed.
Who is funding the study?
The study is funded by Place2Be and Anna Freud, both UK-based charities.
Who is the main contact?
The main contact and principle investigator for the trial is Professor Jessica Deighton (j.deighton@ucl.ac.uk).
- Conditions
- Anxiety, Depression, Internalizing Problems, Low Mood
- Being tested
- CBT-informed school-based counselling
- Keywords
- pragmatic, multiple baseline design, randomized trial, school-based counselling, CBT, secondary school, children and young people, high school, middle school
- Medical subject headings
- Anxiety Disorders, Depression, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-informed school-based counsellingBehavioural
Knowledge Insight Tools (KIT) is a CBT-based model of one-to-one therapy for secondary school pupils who are struggling with low mood and/or anxiety. KIT incorporates the key features of CBT (e.g., agenda setting, formulation around maintenance cycles, inter-session work involving exposure and/or behavioural activation) but is delivered in a semi-structured way that meets the young person's needs and pace of learning. Whilst there is an emphasis on symptom reduction, the primary focus is on the young person's goals for living and co-producing an understanding of how symptoms can interfere with these goals. Practitioners are encouraged to incorporate different therapeutic tools and modalities that complement the young person's strengths and ways of learning, including non-verbal forms of expression like arts and crafts, music, and dance. By being flexible, person-led, goal-focused, and integrative, KIT was designed to suit the needs of secondary school students.
| Study group | Role | What they receive |
|---|---|---|
| 3-8 week baseline wait period followed by CBT-informed school-based counselling | Other | All participants undergo a baseline wait period but are randomized to different baseline lengths (3-8 weeks) Receives: Behavioral: CBT-informed school-based counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE)
Child-reported psychological distress/coping, anxiety, and mood difficulties. Scores range from 0-40, with higher scores reflecting worse psychological distress.
Measured: Assessed at the beginning of each weekly baseline session throughout each participant's 3-8 week baseline wait period, and at the beginning of each weekly intervention session over the 10-week intervention period.
Secondary outcomes (1)
Revised Children's Anxiety and Depression Scale (RCADS)
Child-reported anxiety and depression symptoms. Scores range from 0-141, with higher scores reflecting worse anxiety and depression difficulties. Raw total and subscale scores are usually converted to T-scores, where T-scores greater than 64 reflect the borderline clinical range, and T-scores above 69 reflect the clinical range.
Measured: Assessed on the first intervention session, 4th and 7th review sessions during the intervention, and the final intervention session (usually the 10th intervention session but this may vary by participant)..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start3 Oct 2023
- Primary completion18 May 2025
- Study completion18 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional randomized multiple baseline design: We are using a multiple baseline design, where all participants are offered the same intervention (e.g., Knowledge Insight Tools; KIT), but start the intervention after a randomly varying baseline period where no intervention is offered. Participants will be randomly assigned to a baseline wait period of either three, four, five, six, seven, or eight weeks. Randomization controls for extraneous factors such as maturation and test-retest effects, thereby improving the study's internal validity compared to single-group uncontrolled designs. We are using a non-concurrent design, in which participants start their baseline wait period on different (absolute) start dates.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Anna Freud, Place2Be
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188962
- Sponsor's protocol ID
- 5420/004
- Status last verified
- Jul 2026
- First submitted
- 1 Dec 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Constantinou MP, Stepanous J, Lereya ST, Wilkinson H, Golden S, Deighton J. Study protocol for a pragmatic randomised multiple baseline trial evaluating Knowledge Insight Tools (KIT), a cognitive behavioural therapy-informed school-based counselling intervention for children and young people in UK secondary schools with low mood and anxiety. Trials. 2024 Sep 30;25(1):637. doi: 10.1186/s13063-024-08299-z.
PubMed 39350145
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Multiple Baseline Trial Evaluating Knowledge Insight Tools (KIT), a Cognitive Behavioural Therapy-informed School-based Counselling Intervention for Secondary School-aged Children and Young People With Anxiety and Mood Difficulties in the UK
- ClinicalTrials.gov ID
- NCT06188962
- Acronym / sponsor ID
- 5420/004
- Conditions
- Anxiety, Depression, Internalizing Problems, Low Mood
- Keywords
- pragmatic, multiple baseline design, randomized trial, school-based counselling, CBT, secondary school, children and young people, high school
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Anna Freud, Place2Be
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 18 May 2025 (actual)
- Study completion
- 18 May 2025 (actual)
- First posted
- 3 Jan 2024 (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 and Study Aims:
Secondary school students are reporting unprecedented levels of anxiety and mood difficulties. To ensure that the needs of all young people are met, there is a need to evaluate more accessible forms of support, such as psychological therapies offered in schools. The aim of this trial is to test a new form of school-based psychological therapy called Knowledge Insight Tools (KIT). KIT is based on Cognitive Behavioural Therapy, which is known to be helpful for young people experiencing difficulties with anxiety and low mood. The investigators want to see whether offering KIT to secondary school students can reduce their anxiety and/or low mood, compared to a period of time when they did not receive any support.
Who can participate?
Children and young people aged 11-18 can participate if they are attending a secondary school in England or Scotland, are experiencing problems with low mood and/or anxiety that are disrupting their everyday lives and are not mainly the result of external factors, and are actively seeking support. Children and young people cannot participate if they pose a significant risk to themselves and/or others, if their primary difficulties are not related to anxiety and/or low mood, if they have significant special educational needs or learning difficulties, and are younger than 16 years and for whom it would pose significant issues if their parents/carers were informed of their involvement with Place2Be services.
What does the study involve?
The study starts with a waiting period, where each young person will not receive any support for 3-8 weeks, except for a weekly check-in with a trained professional. This is meant to provide a stable measurement of young people's mental health before KIT is introduced. The length of the waiting period for each young person is chosen at random by a computer program. This helps mix up the influence of things other than KIT that could impact young people's mental health, such as differences in the natural (and sometimes healing) passage of time. Young people will then be offered 10 sessions of KIT, where they will learn about the ways in which unhelpful thoughts and behaviours can inadvertently make them feel low or anxious. They will also be asked to practice ways of testing their unhelpful thoughts and changing their behaviours outside of sessions, and the investigators will review how this affects their mood and well-being over the course of treatment.
What are the possible benefits and risks of participating?
The main benefit of participating is that young people will be contributing to science, which will help young people struggling with anxiety and mood problems in future be offered forms of school-based psychological therapy that have been rigorously tested. The main risk is that young people might wait longer to start KIT than had they not participated in the study. Young people will still receive KIT if they refuse to participate or withdraw their participation, which they can do at any time.
Where is the study run from?
The study is run from secondary schools in the UK and is being conducted by the Evidence-Based Practice Unit (a research group and collaboration between University College London and the Anna Freud) and researchers and school-based practitioners from Place2Be.
When is the study starting and how long is it expected to run for?
The study started on 01/08/2022 with the recruitment of the first student. The study is expected to run until September 2024. There are plans to extend the study until September 2025 if another wave of recruitment is needed.
Who is funding the study?
The study is funded by Place2Be and Anna Freud, both UK-based charities.
Who is the main contact?
The main contact and principle investigator for the trial is Professor Jessica Deighton (j.deighton@ucl.ac.uk).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional randomized multiple baseline design: We are using a multiple baseline design, where all participants are offered the same intervention (e.g., Knowledge Insight Tools; KIT), but start the intervention after a randomly varying baseline period where no intervention is offered. Participants will be randomly assigned to a baseline wait period of either three, four, five, six, seven, or eight weeks. Randomization controls for extraneous factors such as maturation and test-retest effects, thereby improving the study's internal validity compared to single-group uncontrolled designs. We are using a non-concurrent design, in which participants start their baseline wait period on different (absolute) start dates.
| Arm | Type | Receives |
|---|---|---|
| 3-8 week baseline wait period followed by CBT-informed school-based counselling | Other | Behavioral: CBT-informed school-based counsellingAll participants undergo a baseline wait period but are randomized to different baseline lengths (3-8 weeks) |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 11-18 years old
- Attends a secondary school in England, Scotland or Wales
- Experiencing problems with low mood and/or anxiety that are affecting day-to-day functioning.
- Experiencing problems that are at least in part within their control as opposed to the system being the problem (systems work/advocacy might be more relevant in these cases).
- Are seeking help and are motivated towards change.
Key exclusion criteria (4 listed)
- Pose a significant risk to themselves and/or others (e.g., where there is significant self-harm [e.g., self-harm that risks accidental death, such as cutting, self-strangulation, under/overusing medications, tablets or substances, and swallowing hazardous materials], suicidal ideation, suicidal intent, sexual/physical violence to/from others, hospitalization due to alcohol/substance misuse/self-harm/psychiatric reasons)
- Are experiencing severe anxiety/mood difficulties, or whose primary difficulties are not related to anxiety/low mood, e.g., uncontrolled eating disorders, substance/alcohol dependence, psychotic disorders, body dysmorphia, antisociality, risk-taking problems, and personality disorders.
- Have significant special educational needs or learning difficulties.
- Are younger than 16 and for whom it would pose significant issues if their parents/carers were informed of their involvement with Place2Be services.
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 |
|---|---|---|
| CBT-informed school-based counsellingKnowledge Insight Tools (KIT) is a CBT-based model of one-to-one therapy for secondary school pupils who are struggling with low mood and/or anxiety. KIT incorporates the key features of CBT (e.g., agenda setting, formulation around maintenance cycles, inter-session work involving exposure and/or behavioural activation) but is delivered in a semi-structured way that meets the young person's needs and pace of learning. Whilst there is an emphasis on symptom reduction, the primary focus is on the young person's goals for living and co-producing an understanding of how symptoms can interfere with these goals. Practitioners are encouraged to incorporate different therapeutic tools and modalities that complement the young person's strengths and ways of learning, including non-verbal forms of expression like arts and crafts, music, and dance. By being flexible, person-led, goal-focused, and integrative, KIT was designed to suit the needs of secondary school students. | Behavioural | 3-8 week baseline wait period followed by CBT-informed school-based counselling |
Primary outcome
Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE)
Time frame: Assessed at the beginning of each weekly baseline session throughout each participant's 3-8 week baseline wait period, and at the beginning of each weekly intervention session over the 10-week intervention period.
Child-reported psychological distress/coping, anxiety, and mood difficulties. Scores range from 0-40, with higher scores reflecting worse psychological distress.
1 secondary outcome
Revised Children's Anxiety and Depression Scale (RCADS)
Time frame: Assessed on the first intervention session, 4th and 7th review sessions during the intervention, and the final intervention session (usually the 10th intervention session but this may vary by participant)..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Derived from this study: PubMed 39350145Constantinou MP, Stepanous J, Lereya ST, Wilkinson H, Golden S, Deighton J. Study protocol for a pragmatic randomised multiple baseline trial evaluating Knowledge Insight Tools (KIT), a cognitive behavioural therapy-informed school-based counselling intervention for children and young people in UK secondary schools with low mood and anxiety. Trials. 2024 Sep 30;25(1):637. doi: 10.1186/s13063-024-08299-z.
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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 CBT-informed school-based counselling in people with Anxiety and Depression, 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 21 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE) (time frame: Assessed at the beginning of each weekly baseline session throughout each participant's 3-8 week baseline wait period, and at the beginning of each weekly intervention session over the 10-week intervention period.). 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 NCT06188962, 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 21 Jul 2026.