Condition category
Mental and Behavioural Disorders
Date applied
05/02/2010
Date assigned
05/05/2010
Last edited
26/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Post-traumatic stress disorder (PTSD) is an anxiety disorder which can affect people following incidents such as road traffic accidents, assaults and natural disasters. This study is looking at a treatment for PTSD in children and young people who have recently experienced trauma. It is already known that the talking therapy Cognitive Behavioural Therapy (CBT) can help children and young people who have had PTSD for some time (chronic) but it is not known if it helps them in the acute (recent) stage. It is felt to be important to help children and young people in the early stages as the condition could become chronic and affect their development. The main aim of this study is to test the effectiveness of CBT as an early intervention for PTSD in children and young people. The researchers will also look at the course and prevalence of PTSD in the first 2 months after the traumatic event. Finally possible biological and psychological factors that may be associated with PTSD will be investigated.

Who can participate?
60 children and young people aged 8-17 who have experienced a road traffic accident, an assault or other single traumatic event and have a diagnosis of PTSD.

What does the study involve?
In the main study, participants are randomly allocated into two groups to either receive a course of up to 10 sessions of CBT or to be put on the waiting list. This allows the researchers to compare the differences between those who receive CBT and those that don’t (those on the waiting list who are still experiencing PTSD after 10 weeks will be offered CBT). Participants are recruited 2-4 weeks after the traumatic event and re-assessed after 2 months. Participants from the CBT group are also assessed after 6 and 12 months to see if any benefits are maintained. For the other parts of the study, two more groups of 60 children of similar age and gender are recruited. One group will have experienced a traumatic event but without developing significant PTSD symptoms and the other group will not have experienced trauma. Participants undergo a series of psychological and physical tests.

What are the possible benefits and risks of participating?
The study will provide important information about the development of PTSD in children and young people, what factors effect recovery and whether CBT is an appropriate early treatment. There were no major risks of participating.

Where is the study run from?
MRC Cognition and Brain Sciences Unit (UK)

When is the study starting and how long is it expected to run for?
May 2010 to August 2013

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
Dr Richard Meiser-Stedman
richard.meiser-stedman@mrc-cbu.cam.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Meiser-Stedman

ORCID ID

http://orcid.org/0000-0002-0262-623X

Contact details

MRC Cognition and Brain Sciences Unit
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
+44 (0)1223 273624
richard.meiser-stedman@mrc-cbu.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Cognitive behavioural therapy (CBT) as an early intervention for post-traumatic stress disorder (PTSD) in youth: preliminary efficacy and mechanisms of action

Acronym

ASPECTS

Study hypothesis

Is cognitive behavioural therapy (CBT) an efficacious early intervention for post-traumatic stress disorder (PTSD) in children and adolescents? This question will be addressed using a randomised controlled trial, where CBT is compared to a wait-list control group.

Ethics approval

Cambridgeshire 1 Research Ethics Committee, 29/04/2010, ref: 10/H0304/11

Study design

Single-centre single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Post-traumatic stress disorder (PTSD)

Intervention

Participants will enter the trial at 2 - 3 months after a traumatic event. They will either be allocated to active treatment or a wait list.

The experimental intervention will be a course of cognitive behavioural therapy (CBT). This will last for up to 10 sessions, and be delivered over a 10 week period. This treatment would be based largely on the treatment package devised for a previous trial of CBT for chronic PTSD in children and adolescents. Each session will last 60 - 90 minutes.

The control intervention will be a 10 week wait list group, with the same pre- and post-intervention assessments as the experimental intervention.

Post-treatment assessments will be conducted by doctoral-level psychologists blind to treatment allocation. Participants who still have PTSD at the end of the wait list period will be offered the CBT treatment.

Total duration of treatment for CBT will be 10 - 15 hours, over 10 weekly sessions; follow ups will take place at 6 months and 12 months post-treatment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. PTSD status, as assessed using the Children's PTSD Inventory (CPTSDI)
2. Child PTSD Symptom Scale (CPSS)

All of the primary and secondary outcome measures will be completed at the pre- and post-treatment assessments; all primary and secondary measures will be completed at the 6- and 12-month follow ups, with the exception of the Clinician's Global Assessment Scale.

Secondary outcome measures

1. Mood and Feelings Questionnaire (MFQ)
2. Spence Children’s Anxiety Scale (SCAS)
3. Children’s Global Assessment Scale (CGAS)

All of the primary and secondary outcome measures will be completed at the pre- and post-treatment assessments; all primary and secondary measures will be completed at the 6- and 12-month follow ups, with the exception of the Clinician's Global Assessment Scale.

Overall trial start date

01/05/2010

Overall trial end date

01/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Exposure to a road traffic accident, an assault, or another discrete traumatic stressor (i.e. any event that involve the threat of death, severe injury, or threat to bodily integrity, or witnessing such an event)
2. Aged 8 - 17 years, either sex
3. Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic criteria for PTSD, or the alternative algorthim for children and young people proposed by Scheeringa and colleagues (Scheeringa, Wright, Hunt, & Zeanah, 2006), assessed by a structured interview
4. The index trauma occurred 2 - 3 months prior to trial entry

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Intellectual disability (i.e. mental retardation)
2. Another primary psychiatric diagnosis
3. PTSD following another previous trauma
4. Unconscious for greater than 15 minutes following the traumatic event
5. Not being fluent in English
6. Ongoing exposure to threat
7. History of organic brain damage
8. Significant risk of self-harm

Recruitment start date

21/02/2011

Recruitment end date

01/08/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Cognition and Brain Sciences Unit
Cambridge
CB2 7EF
United Kingdom

Trial participating centre

30 patient identification centres and research sites
-
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

MRC Cognition and Brain Sciences Unit
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
-
anthea.hills@mrc-cbu.cam.ac.uk

Sponsor type

Research council

Website

http://www.mrc-cbu.cam.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) - Clinician Scientist Fellowship awarded to Dr Richard Meiser-Stedman (ref: G0802821)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Analysis is completed, awaiting publication

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/02/2016: Plain English summary added.