| - candidate number | 2358 |
| - NTR Number | NTR831 |
| - ISRCTN | ISRCTN07286192 |
| - Date ISRCTN created | 22-jan-2007 |
| - date ISRCTN requested | 12-jan-2007 |
| - Date Registered NTR | 7-dec-2006 |
| - Secondary IDs | N/A |
| - Public Title | Prevention of Posttraumatic stress disorder in Children and Adolescents. |
| - Scientific Title | Prevention of Posttraumatic stress disorder in Children and Adolescents. |
| - ACRONYM | N/A |
| - hypothesis | Risk of chronic PTSD after ASD diminishes with an early intervention (CBT) that attempts to modify cognitive appraisals. |
| - Healt Condition(s) or Problem(s) studied | Posttraumatic stress disorder (PTSD) |
| - Inclusion criteria | Children (aged 7-17) who have had contact with Victim Assistence experiencing a traumatic event less than 2 weeks ago, children meet the DSM-criteria for Acute Stress Disorder. |
| - Exclusion criteria | Exclusion criteria include: 1. Brain injury; 2. Psychotic of organic mental dirorder; 3. Current suicidal ideation; 4. IQ less than 80; 5. Proficiency in Dutch; 6. No parent willing to participate in the study. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Not applicable |
| - group | Crossover |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 1-dec-2006 |
| - planned closingdate | 1-jan-2008 |
| - Target number of participants | 80 |
| - Interventions | Brief trauma-focused cognitive behavioral intervention or control-condition (wait-list-controls). |
| - Primary outcome | Presence vs. absence of Posttraumatic Stress Disorder, and PTSD-symptom-severity (assessed with structured interview (ADIS-C interview Anxiety disorders interview scedule for children) and self-completed questionnaires (CPSS: child posttraumatic stress scale)). |
| - Secondary outcome | Symptomss of anxiety and/or depression according to questionnaires (a.o. RCADS: revised children's anxiety and depression scale) and quality of life. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Drs. Manon J.B. Vincken |
| - CONTACT for SCIENTIFIC QUERIES | Dr. Iris M. Engelhard |
| - Sponsor/Initiator | University Maastricht (UM) |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N/A |
| - Brief summary | Traumatic events often cause severe and persisting psychological complaints. About one-fourth of children and adolescents develop PTSD. For more than half of them, the disorder becomes chronic (duration > 6 months). Comorbid disorders include depression, physical complaints and behavioural problems, which can result in developmental delay. It is important to prevent this to occur through early intervention. Cognitive-behavioral therapy for individuals with Acute Stress Disorder appears to be effective in preventing chronic PTSD. Therefore, early intervention guidelines, suggest that CBT appears to be the most justified early intervention. However, there has been no controlled outcome research on early intervention with children and adolescents. The objective of this study is to investigate wether early CBT with parental involvement reduces risk of chronic PTSD in children and adolescents with ASD. This study is part of a bigger research-project which aims to predict, explain and prevent PTSD in children and adolescents. Our study population consist of children and adolescents who expierenced a single traumatic event. Children will be assigned to CBT-group or control-condition (wait-list-controls). Also their parents will be involved in our study, regardless of their involvement in the traumatic event. Cognitive-behavoir therapy-protocol includes 5 sessions for the children. The program is individual. |
| - Main changes (audit trail) | |
| - RECORD | 7-dec-2006 - 12-jan-2011 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl