Clinical trial NCT06188962: Evaluating Knowledge Insight Tools (KIT) for Reducing Anxiety and Low Mood in UK Secondary School Students
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
middle school
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Place2Be
name: Anna Freud
First posted: 2024-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

1. 11-18 years old
2. Attends a secondary school in England, Scotland or Wales
3. Experiencing problems with low mood and/or anxiety that are affecting day-to-day functioning.
4. 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).
5. Are seeking help and are motivated towards change.

Exclusion Criteria:

1. 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)
2. 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.
3. Have significant special educational needs or learning difficulties.
4. Are younger than 16 and for whom it would pose significant issues if their parents/carers were informed of their involvement with Place2Be services.

Primary outcomes:
measure: Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE)
timeFrame: 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:
measure: Revised Children's Anxiety and Depression Scale (RCADS)
timeFrame: 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)..
Other outcomes:
measure: Implementation Survey
timeFrame: Completed by practitioners at post-intervention, i.e. after all 10-week interventions are completed
measure: KIT Fidelity Checklist
timeFrame: Assessed at the end of each weekly intervention session over the 10-week intervention period.
Locations:
city: Multiple Cities Across The UK
country: United Kingdom
facility: Place2Be services within UK schools
Study officials:
References: