Prevention of post-traumatic stress disorder in children and adolescents

ISRCTN ISRCTN07286192
DOI https://doi.org/10.1186/ISRCTN07286192
Secondary identifying numbers N/A
Submission date
22/01/2007
Registration date
22/01/2007
Last edited
24/01/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
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

Contact information

Dr Manon J B Vincken
Scientific

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

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

Study information

Study designRandomised, crossover, single blind multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesRisk 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) studiedPost-Traumatic Stress Disorder (PTSD)
InterventionBrief trauma-focused cognitive behavioral therapy intervention or control-condition (wait-list-controls).
Intervention typeOther
Primary outcome measure1. 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])
Secondary outcome measuresSymptoms of anxiety and/or depression according to questionnaires (Revised Children's Anxiety and Depression Scale [RCADS]) and quality of life.
Overall study start date01/12/2006
Completion date01/01/2008

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit7 Years
Upper age limit17 Years
SexNot Specified
Target number of participants80
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2006
Date of final enrolment01/01/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Maastricht
Maastricht
6200 MD
Netherlands

Sponsor information

University Maastricht (UM) (The Netherlands)
University/education

P.O. Box 616
Maastricht
6200 MD
Netherlands

http://www.unimaas.nl/default.asp?taal=en
ROR logo https://ror.org/02jz4aj89

Funders

Funder type

Research organisation

Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Private sector organisation / Other non-profit organizations
Alternative name(s)
Netherlands Organisation for Health Research and Development
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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