Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
26/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stallard Paul

ORCID ID

Contact details

Department of Child & Family Therapy
RUH
Combe Park
Bath
BA1 3NG
United Kingdom
+44 01225 825075
paul.stallard@awp.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0038183431

Study information

Scientific title

Acronym

Study hypothesis

What is the efficacy of early, brief trauma-focused CBT for the treatment of significant acute posttraumatic reactions in child road traffic accident (RTA) victims?

Ethics approval

Not provided at time of registration

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Mental and Behavioural Disorders: Post-traumatic disorder

Intervention

1. Immediate course of psychotherapeutic sessions
2. Delayed course of psychotherapeutic sessions

Initial assessments for subjective distress, and diagnostic symptoms of PTSD. Children with high scores entered into study. Diary completed daily by child for 3 weeks, followed by assessments for PTSD, anxiety and depression. Those with significant enduring posttraumatic symptoms as determined by the CIES or the CPSS randomised into either the immediate or delayed treatment arms of the study.

Change in the severity of posttraumatic symptoms, determined by MANOVA. Changes in associated anxiety and depression. CIES, CPSS. Treatment effect size for changes in PTST symptoms analysed using Cohen's D statistic.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Child PTSD Symptom Scale (CPSS)
2. Children's Impact of Events Scale (CIES)
3. Children's Revised Manifest Anxiety Scale (MAS)
4. Birleson Depression Inventory (BDI)
5. 10 point cognitive change scale

Secondary outcome measures

Not provided at time of registration

Overall trial start date

27/04/2006

Overall trial end date

31/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged 7 to 18 who attend the A&E departments at the Royal United Hospital Bath, and Frenchay Hospital Bristol, following an RTA.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

1. Experienced life threatening physical injuries (Triage rating 1)
2. Were unconscious for 15 minutes or more
3. Suffer significant learning difficulties
4. Live outside 30 mile radius of RUH in Bath (so cannot attend treatment sessions)

Recruitment start date

27/04/2006

Recruitment end date

31/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Child & Family Therapy
Bath
BA1 3NG
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Avon and Wiltshire Mental Health Partnership NHS Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Summary of outcome of one of the processes employed in the study:
Salter, E. & Stallard, P. (In Press). A pilot study to explore the effect of symptom monitoring in children and adolescents with posttraumatic stress reactions following road traffic accidents. Behavioural and Cognitive Psychotherapy.

Publication citations

Additional files

Editorial Notes