PYCES2 Randomised Trial of Trauma-Focused CBT for PTSD in Children Aged 3-8 Years
Summary
The PYCES2 study (ISRCTN79860495) is a multi-centre, two-arm randomised controlled efficacy trial comparing CBT-3M (trauma-focused cognitive behavioural therapy) against care-as-usual (CAU) for post-traumatic stress disorder in children aged 3-8 years. The trial will enrol 80 participants across NHS sites in Cambridge, Norwich, and South-East London over approximately three years (June 2025 to March 2028). CBT-3M consists of 12 structured weekly sessions involving both the child and parent/caregiver, including psychoeducation, coping skills, graduated exposure, trauma narrative, and cognitive restructuring. The primary outcome is PTSD diagnostic status at 3-month follow-up. The study received ethics approval on 23/03/2026 from the East of England - Cambridge South Research Ethics Committee.
“The primary objective of this study is to establish whether trauma-focused cognitive behavioural therapy for young children (CBT-3M) is an efficacious intervention for young children with post-traumatic stress disorder (PTSD).”
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What changed
This document registers the PYCES2 clinical trial (ISRCTN79860495), a prospective randomised controlled efficacy trial sponsored by Cambridgeshire and Peterborough NHS Foundation Trust and funded by the National Institute for Health and Care Research (NIHR). The trial will evaluate CBT-3M, a trauma-focused cognitive behavioural therapy tailored for young children with PTSD, against standard NHS care-as-usual. Eligible participants are children aged 3-8 years with a principal PTSD diagnosis following a single-incident trauma such as an accident, medical emergency, or witnessed violence. The trial excludes children at ongoing risk of trauma or abuse, those with serious head injury, learning disabilities, or other primary psychiatric conditions requiring prior treatment.
For clinical investigators and NHS mental health services, this registration indicates a forthcoming evidence base for treating PTSD in pre-school and early primary school-aged children — a population for which no approved UK treatment currently exists. The trial's results may inform future commissioning of trauma-focused therapies within NHS child and adolescent mental health services (CAMHS). Recruitment at NHS sites in Cambridge, Norwich, and South-East London is expected to begin 1 June 2026.
Archived snapshot
Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Trauma-focused cognitive behavioural therapy for young children with posttraumatic stress disorder
| ISRCTN | ISRCTN79860495 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79860495 |
| Integrated Research Application System (IRAS) | 335868 |
| Central Portfolio Management System (CPMS) | 59122 |
| National Institute for Health and Care Research (NIHR) | 207262 |
| Protocol number | PYCES2_2025 |
| Sponsor | Cambridgeshire and Peterborough NHS Foundation Trust |
| Funder | National Institute for Health and Care Research |
Submission date 18/08/2025 Registration date 27/04/2026 Last edited 27/04/2026 Recruitment status Not yet recruiting Overall study status Ongoing Condition category Mental and Behavioural Disorders Prospectively registered Protocol Statistical analysis plan Results Individual participant data Record updated in last year
Plain English summary of protocol
Background and study aims
Many young children who experience traumatic events such as accidents, medical emergencies, or witnessing violence may go on to develop post-traumatic stress disorder (PTSD). PTSD can cause distressing symptoms like nightmares, flashbacks, anger outbursts, and changes in behaviour or play. While there are effective treatments for older children and adults, there is currently no approved treatment in the UK for children as young as 3 years. This study aims to find out whether a new therapy, CBT-3M, can help young children with PTSD recover and improve their daily functioning.
Who can participate?
Children aged 3 to 8 years who have experienced a single traumatic event (such as an accident, a medical emergency, or witnessing violence) and who are diagnosed with PTSD can take part, along with a parent or caregiver.
Children are not able to take part if they:
1. Are currently at risk of ongoing trauma or abuse
2. Have a serious head injury or a history of brain damage
3. Have a learning disability or another mental health condition that needs treatment first
4. Are not able to speak English with their family
What does the study involve?
Children will be randomly assigned to receive either CBT-3M or care-as-usual through the NHS. CBT-3M is a trauma-focused cognitive behavioural therapy delivered over 12 weekly sessions involving both the child and their parent/caregiver. It includes games, storytelling, and other activities to help the child make sense of the trauma and feel safer. Families will be assessed before, during, and after the therapy to see how well it works and what their experiences are.
What are the possible benefits and risks of participating?
Participants in the therapy group may benefit from symptom relief and improved coping. Risks are minimal but may include emotional discomfort when talking about the traumatic event. Support will be available throughout the study.
Where is the study run from?
The study is run from the Medical Research Council Cognition and Brain Sciences Unit at the University of Cambridge, in collaboration with the Cambridgeshire and Peterborough NHS Foundation Trust (CPFT), and NHS sites in Cambridge, Norwich, and South-East London (UK).
When is the study starting and how long is it expected to run for?
June 2025 to March 2028
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Mrs Alicja Podgorski, alicja.podgorski@mrc-cbu.cam.ac.uk
Contact information
Mrs Alicja Podgorski
Public, Scientific University of Cambridge
MRC Cognition and Brain Sciences Unit
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
| 0000-0002-0147-6460 | |
|---|---|
| +44 (0)1223769906 | |
| alicja.podgorski@mrc-cbu.cam.ac.uk |
Prof Tim Dalgleish
Principal investigator University of Cambridge
MRC Cognition and Brain Sciences Unit
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
| 0000-0002-7304-2231 | |
|---|---|
| +44 (0)1223 767654 | |
| tim.dalgleish@mrc-cbu.cam.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre patient-level two-arm randomized controlled efficacy trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Parents and Young Children under Extreme Stress (PYCES2): A randomised controlled efficacy trial of trauma-focused cognitive behaviour therapy for post-traumatic stress disorder (PTSD) in young children aged 3-8 years |
| Study acronym | PYCES2 |
| Study objectives | The primary objective of this study is to establish whether trauma-focused cognitive behavioural therapy for young children (CBT-3M) is an efficacious intervention for young children with post-traumatic stress disorder (PTSD). This question will be investigated by comparing CBT-3M to a care-as-usual (CAU) control group in the UK NHS. Secondary objectives are to gather qualitative data on children and families lived experience of the intervention, and to acquire basic demographic, cognitive and behavioural data in trial participants to assess mediators and moderators of outcome. |
| Ethics approval(s) | Approved 23/03/2026, East of England - Cambridge South Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; +44 020 7104 8241; cambridgesouth.rec@hra.nhs.uk), ref: 26/EE/0048 |
| Health condition(s) or problem(s) studied | Post-traumatic stress disorder (PTSD) in young children aged 3–8 years following a single-incident or short-term trauma such as an accident, medical emergency, or witnessed violence |
| Intervention | Participants will be randomised using a minimisation procedure stratified by age (3–5 vs 6–8 years), sex, and baseline PTSD severity, as assessed by the Diagnostic Infant and Preschool Assessment (DIPA). |
The intervention group will receive CBT-3M, a trauma-focused cognitive behavioural therapy tailored for young children. It consists of 12 structured sessions with the child and parent/caregiver, including psychoeducation, coping skills, graduated exposure, trauma narrative, and cognitive restructuring.
The control group will receive Care As Usual (CAU) through NHS and GP-referred services, which typically does not include trauma-focused psychological therapy for this age group. |
| Intervention type | Behavioural |
| Primary outcome measure(s) | PTSD diagnostic status assessed using the Diagnostic Infant and Preschool Assessment (DIPA) at 3-month follow-up post-treatment |
| Key secondary outcome measure(s) | 1. Co-morbid psychiatric diagnoses, assessed using the Diagnostic Infant and Preschool Assessment (DIPA) at baseline, post-treatment, and 3-month follow-up
2. PTSD symptoms, measured by the Young Child PTSD Checklist (parent-report) at baseline, mid-treatment, post-treatment, and 3-month follow-up
3. General emotional distress, measured by the Paediatric Emotional Distress Scale (PEDS) at baseline, mid-treatment, post-treatment, and 3-month follow-up
4. Parental PTSD symptoms, measured by the PTSD Checklist for DSM-5 (PCL-5) at baseline, mid-treatment, post-treatment, and 3-month follow-up
5. Parental depression symptoms, measured by the Patient Health Questionnaire (PHQ-9) at baseline, mid-treatment, post-treatment, and 3-month follow-up
6. Parental anxiety symptoms, measured by the General Anxiety Disorder-7 (GAD-7) at baseline, mid-treatment, post-treatment, and 3-month follow-up
7. Parental trauma-related beliefs and behaviours, assessed using the Parental Trauma Response Questionnaire (PTRQ) at baseline, mid-treatment, post-treatment, and 3-month follow-up
8. Child post-traumatic cognitions, measured using a 4-item developmentally adapted interview based on the Child Post-Traumatic Cognitions Inventory (CPTCI) at baseline and post-treatment
9. Child cognitive processes (decision-making under uncertainty), assessed using an explore/exploit task adapted from Kim et al. (2025) at baseline and post-treatment
10. Cognitive functions: inhibitory control (assessed using Go/No-Go), working memory (assessed using Mr. Ant), and cognitive flexibility (assessed using Card Sorting) via the Early Years Toolbox
11. Child irritability, assessed using the Affective Reactivity Index (ARI-P) at baseline and post-treatment
12. Child functioning, assessed using the Strengths and Difficulties Questionnaire (SDQ) at baseline and post-treatment
13. Treatment acceptability and experience, explored through qualitative interviews:
13.1. With parents at 3-month follow-up or earlier if they withdraw
13.2. With clinicians following CBT-3M delivery |
| Completion date | 31/03/2028 |
Eligibility
| Participant type(s) | Carer, Patient, Service user |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 8 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Participants will be children aged 3–8 years with a principal diagnosis of PTSD, according to the developmentally sensitive algorithm validated in our background work, following a discrete single-incident or short-lived stressor (e.g., accident, witnessing or experiencing violence, medical emergency or procedure). |
- PTSD will be assessed with the Diagnostic Infant and Preschool Assessment (DIPA; see outcome measures section).
- Children with either acute (1–6 months post-trauma) or chronic (>6 months post-trauma) PTSD will be included, as our feasibility trial data and US data indicate that CBT-3M provides benefit across this boundary. | | Key exclusion criteria | 1. In line with the feasibility trial, victims of chronic sexual/physical abuse will not be invited into the trial given the need to involve specialist services.
- Head trauma (Glasgow Coma Score <8)
- Learning disability
- Another primary psychiatric diagnosis that warrants treatment using a psychological therapy ahead of the traumatic stress response
- Inability to speak English within the family
- Ongoing exposure to trauma or other threats
- History of organic brain damage | | Date of first enrolment | 01/06/2026 | | Date of final enrolment | 01/03/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
MRC-Cognition and Brain Sciences Unit, University of Cambridge 15 Chaucer Rd
Cambridge
CB2 7EF
England Cambridgeshire and Peterborough NHS Foundation Trust Elizabeth House
Fulbourn Hospital
Fulbourn
Cambridge
CB21 5EF
England South London and Maudsley NHS Foundation Trust Bethlem Royal Hospital
Monks Orchard Road
Beckenham
BR3 3BX
England Norfolk and Suffolk NHS Foundation Trust Trust Headquarters
County Hall
Martineau Lane
Norwich NO COUNTRY SPECIFIED, assuming England
NR1 2DH
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | De-identified (anonymised) individual participant data (IPD) may be made available upon reasonable request to qualified researchers. Any requests must be approved by the trial sponsor and relevant ethics committees. Data will only be shared for research purposes that align with the original aims of the study and must comply with UK data protection regulations. Requests should be submitted in writing to the Chief Investigator and will be reviewed on a case-by-case basis. |
Study outputs
Search:
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
| --- | --- | --- | --- | --- | --- |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Showing 1 to 2 of 2 entries
Editorial Notes
18/08/2025: Study's existence confirmed by the NIHR.
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