Trauma-focused cognitive behavioural therapy for young children with posttraumatic stress disorder

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN79860495

Enrollment

Registered

2026-04-27

Start date

2026-07-31

Completion date

Unknown

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 Mental and Behavioural Disorders

Interventions

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 (DIP

Eligibility

Sex/Gender

All

Age

3 Years to 8 Years

Inclusion criteria

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). 2. PTSD will be assessed with the Diagnostic Infant and Preschool Assessment (DIPA; see outcome measures section). 3. 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.

Exclusion criteria

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. 2. Head trauma (Glasgow Coma Score <8) 3. Learning disability 4. Another primary psychiatric diagnosis that warrants treatment using a psychological therapy ahead of the traumatic stress response 5. Inability to speak English within the family 6. Ongoing exposure to trauma or other threats 7. History of organic brain damage

Design outcomes

Primary

Measure	Time frame
PTSD diagnostic status assessed using the Diagnostic Infant and Preschool Assessment (DIPA) at 3-month follow-up post-treatment	—

Secondary

Measure	Time frame
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 the	—

Measure

Time frame

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 the

—

Countries

England, United Kingdom

Contacts

Public ContactAlicja Podgorski

alicja.podgorski@mrc-cbu.cam.ac.uk+44 (0)1223769906

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026