Prevention of post-traumatic stress disorder in children and adolescents

ISRCTN	ISRCTN07286192
DOI	https://doi.org/10.1186/ISRCTN07286192
Protocol serial number	N/A
Sponsor	University Maastricht (UM) (The Netherlands)
Funder	Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Manon J B Vincken
Scientific

University Maastricht
Department of Medical, Clinical and Experimental Psychology
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone	+31 (0)43 388 1047
Email	m.vincken@dmkep.unimaas.nl

Primary study design	Interventional
Study design	Randomised, crossover, single blind multicentre trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Risk of chronic Post-Traumatic Stress Disorder (PTSD) after Acute Stress Disorder (ASD) diminishes with an early intervention (Cognitive Behavioural Therapy [CBT]) that attempts to modify cognitive appraisals.
Ethics approval(s)	Approval received from the Medical Ethics Commission academic hospital of Maastricht/Maastricht University (Medisch Ethische Commissie azM/UM) on the 11th OCtober 2006 (ref: 06-3-045).
Health condition(s) or problem(s) studied	Post-Traumatic Stress Disorder (PTSD)
Intervention	Brief trauma-focused cognitive behavioral therapy intervention or control-condition (wait-list-controls).
Intervention type	Other
Primary outcome measure(s)	1. Presence versus absence of PTSD 2. PTSD-symptom-severity, assessed with: a. structured interview (Anxiety Disorders Interview Schedule for Children [ADIS-C]) b. self-completed questionnaires (Child Post-traumatic Stress Scale [CPSS])
Key secondary outcome measure(s)	Symptoms of anxiety and/or depression according to questionnaires (Revised Children's Anxiety and Depression Scale [RCADS]) and quality of life.
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Upper age limit	17 Years
Sex	Not Specified
Target sample size at registration	80
Key inclusion criteria	1. Children (aged seven to 17) 2. Had contact with Victim Assistance experiencing a traumatic event less than two weeks ago 3. Meet the Diagnostic and Statistical Manual of mental disorders (DSM) criteria for Acute Stress Disorder
Key exclusion criteria	1. Brain injury 2. Psychotic or organic mental disorder 3. Current suicidal ideation 4. Intelligence Quotient (IQ) less than 80 5. Low proficiency in Dutch 6. No parent willing to participate in the study
Date of first enrolment	01/12/2006
Date of final enrolment	01/01/2008

University Maastricht

Maastricht
6200 MD
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan