Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Following horrific or life-threatening events around 10-15% of young children develop post-traumatic stress disorder (PTSD). The symptoms of this are distressing – nightmares, flashbacks, anger outbursts and disturbed play. These can cause major disruption to all areas of the child’s functioning and, if left untreated, can persist for many years. As yet there are no established and clinically validated treatments for this disorder in young children. Trauma-focussed cognitive behaviour therapy is a psychological intervention that is effective in treating the disorder in older children and adults. This study evaluates the effectiveness of a developmentally appropriate form of trauma-focussed cognitive behaviour therapy which we have developed for children as young as 3 years.

Who can participate?
This study aims to recruit 60 children (boys and girls) aged 3-8 years who have been involved in or witnessed a traumatic event like a car crash or an assault. It does not matter how long ago the event happened.

What does the study involve?
All children involved in the study will have an initial assessment (a parent will complete some interviews and questionnaires, and the child will do tasks). If the child is diagnosed with PTSD, then they will be invited onto the study. They will be randomly allocated to have the treatment straight away (12 weekly sessions) or to wait for 12 weeks. Children assigned to the wait-list are still able to access any help outside of this study. Both groups will be assessed half way through the 12 weeks (by parents completing some more questionnaires). At the end of the treatment/waiting period all children will have another assessment – parent interviews and questionnaires, and child tasks. If a child still has PTSD at the end of the waiting period, they will then be offered the treatment.

What are the possible benefits and risks of participating?
The main benefit to children who do have PTSD is that they will be offered psychological treatment (trauma-focussed cognitive behavioural therapy). Even participants who are assigned to wait for 12 weeks will receive this treatment (if they still have PTSD) sooner than they may receive help from their local Child and Adolescent Mental Health Service. Children who do not have PTSD will still have a thorough assessment. The children and their parents may appreciate this and the opportunity to discuss the trauma in a non-judgemental, confidential and empathetic setting.
The treatment involves talking about the frightening event, and this can sometimes be upsetting. However, other studies have shown that the treatment works well and treats PTSD in older children and adults. Participants will be given breaks whenever they need them, and will be reminded that they are free to leave the study at any time. Clinical psychologists within the team will be available for follow-up phone calls and meetings with people who need them. We have found previously that any distress experienced during therapy is short-lived and outweighed by the benefit of successfully treating PTSD.

Where is the study run from?
This study is run from the MRC Cognition and Brain Sciences Unit in Cambridge. We recruit participants from all over East Anglia – several Emergency Departments are involved in our screening study and anybody can refer a child to us, for example – schools, nurses, GPs or parents.

When is the study starting and how long is it expected to run for?
July 2013 to October 2017

Who is funding the study?
National Institute of Health Research, UK.

Who is the main contact?
Dr Ben Goodall Trial Coordinator and the main Clinical Psychologist working on the project
Isobel Chadwick is the Assistant Psychologist

Trial website

Contact information



Primary contact

Dr Tim Dalgleish


Contact details

MRC Cognition and Brain Sciences Unit
15 Chaucer Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A pilot randomised clinical trial of trauma-focused cognitive behaviour therapy for posttraumatic stress disorder (PTSD) in young children aged 3-8 years (PYCES)



Study hypothesis

PYCES is a randomised controlled trial assessing the effectiveness of trauma-focused cognitve behavioural therapy (CBT) as an intervention for post-traumatic stress disorder in 3-8 year olds.

More details can be found at:

Ethics approval

NRES Committee East of England – Cambridge South, January 2013, ref: 12/EE/0458

Study design

Interventional randomised controlled trial; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Participant information sheets can be found at


Topic: Mental Health Research Network; Subtopic: Anxiety; Disease: Post-traumatic stress disorder (PTSD)


Random allocation to have the treatment straight away (12 weekly sessions) or to wait for 12 weeks.

Trauma-Focused CBT, Manualised 12-session developmentally appropriate trauma-focused cognitive behavioural therapy.

The treatment is delivered by highly trained Clinical Psychologists who have extensive experience of working with young children. This treatment involves both the child and a parent/caregiver. It is delivered over 12 weekly sessions and involves learning about PTSD, recognising feelings, thinking and talking about the trauma and training in coping skills. The therapist will set homework each week, to consolidate the material covered in session. Three sessions take place with the child and parent together. The remaining sessions are divided into two halves; the first half involves the therapist and child only. The second half involves just the therapist and caregiver and provides an opportunity to discuss any problems and the homework. Booster sessions will be provided to the child or parent/caregiver if necessary.

Follow Up Length: 12 months

Study Entry : Registration only

Intervention type



Not Applicable

Drug names

Primary outcome measure

Determine efficacy of TF-CBT as an intervention for young children with PTSD; Timepoint(s): End of study

Secondary outcome measures

1. Assess feasibility and acceptability of the intervention; timepoint(s): end of study;
2. Assess mediators and moderators of outcome; timepoint(s): end of study
3. Assess the course of PTSD symptoms on young children over the first 3 months post-trauma; timepoint(s): end of prospective study
4. Compare cognitive variables of children with PTSD vs non-PTSD trauma-exposed children; timepoint(s): end of study
5. Investigation of genetic factors in PTSD onset and in treatment response; timepoint(s): end of study
6. Preliminary health economics analysis; timepoint(s): end of study

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Exposure to a road traffic accident, an assault, or another discrete traumatic stressor (i.e. any event that involved the threat of death, severe injury, or threat to bodily integrity, or witnessing such an event);
2. Age 3-8 years
3. Target Gender: Male & Female

Participant type


Age group




Target number of participants

Planned Sample Size: 90; UK Sample Size: 90; Description: 60 PTSD and 30 non-PTSD participants

Total final enrolment


Participant exclusion criteria

1. Intellectual disability
2. Another primary psychiatric diagnosis
3. PTSD following another previous trauma
4. Unconscious for >15 minutes following the traumatic event
5. Not being fluent in English
6. Ongoing exposure to threat
7. History of organic brain damage
8. Risk of self-harm

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

MRC Cognition and Brain Sciences Unit
United Kingdom

Sponsor information


Medical Research Council (MRC) (UK)

Sponsor details

MRC Cognition and Brain Sciences Unit
15 Chaucer Road
United Kingdom

Sponsor type

Research council



Funder type


Funder name

NIHR (UK) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0211-24045

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Planned open-access publication in a peer-reviewed journal.

IPD sharing statement: The datasets and statistical acode generated during the current study will be available from the MRC Cognition and Brain Sciences Unit Data Repository, which can be acccessed at .

Intention to publish date


Participant level data

Stored in repository

Basic results (scientific)

Publication list

2015 protocol in:

Publication citations

Additional files

Editorial Notes

18/11/2019: The total final enrolment number was added. 26/10/2018: The following changes were made: 1. The publication and dissemination plan was added. 2. The intention to publish date was added. 3. The participant level data was added. 22/10/2018: The overall trial end date was updated from 01/10/2017 to 30/11/2018. 05/02/2016: Publication reference added.