|- candidate number||22543|
|- NTR Number||NTR5352|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-aug-2015|
|- Secondary IDs||W14_281 METC AMC|
|- Public Title||Screening for risk of posttraumatic stress disorder in young children following an accident|
|- Scientific Title||Screening for risk of posttraumatic stress disorder in young children following an accident - PEDS-study|
|- hypothesis||The aim of the study is to develop a screening tool to identify young children at risk of posttraumatic stress disorder following an accident. |
|- Healt Condition(s) or Problem(s) studied||Post traumatic stress disorder, Accidents, Children|
|- Inclusion criteria||- Children 0-7 years.|
- Children involved in an accident and thereafter transported to the hospital by ambulance, and medically treated in a trauma (resuscitation) room at the emergency department.
|- Exclusion criteria||- Children 8 years and older|
- Inadequate proficiency of the Dutch language by parents
- Children who are injured due to child abuse
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||13-okt-2014|
|- planned closingdate||31-dec-2017|
|- Target number of participants||150|
|- Interventions||Not applicable. |
|- Primary outcome||Presence/absence of posttraumatic stress disorder in children and presence/absence of posttraumatic stress symptoms in parents.|
|- Secondary outcome||Comorbid disorders in children: anxiety, behavior, mood and obsessive-compulsive disorders. |
|- Timepoints||- Within two weeks after the accident the PEDS-ES screening tool for the risk of PTSD in children and the STEPP screening tool for the risk of PTSD in parents is administered. |
- Three months after the accident child PTSD and comorbid disorders are assessed with a semi-structured interview (Diagnostic Infant and Preschool Assessment; DIPA) and questionnaires (TSCYC, CBCL, CRIES for parents). Parents are screened for PTSD with self-report questionnaires (SVL, PCL-5).
- Six months after the accident parents fill in questionnaires on child and parental PTSD and on comorbid disorders in their children (TSCYC, CBCL, CRIES for parents, SVL, PCL-5).
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Maj Gigengack|
|- CONTACT for SCIENTIFIC QUERIES|| Maj Gigengack|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Young children are very accident-prone. In comparison to older children, young children have a high risk of getting injured from accidents like near drowning, burns, poisoning, falls, suffocation and choking. Being involved in an accident is a potentially traumatic event, which places children at risk for posttraumatic stress symptoms (PTSS). The majority of children with unintentional injury are resilient or experience natural recovery in PTSS. However, a substantial number of the children do not recover and develop posttraumatic stress disorder (PTSD). PTSD is a debilitating psychiatric disorder. If remained untreated, PTSD can negatively influence the physical recovery, the psychosocial functioning and other domains of the development of children.
Studies on PTSD in young children exposed to accidental trauma show that about 10% of the children develop PTSD. In order to prevent the long-term negative consequences for these children, it is important to identify PTSD in an early stage. However, PTSD is often not recognized. If we could identify the children who are at risk of developing PTSD after the accident, we would be able to monitor these children and offer timely treatment.
For children 8-18 years a screening tool for the risk of PTSD is available in the Netherlands. However, we lack such a screening tool for young children 0-7 years. In Switzerland the Pediatric Emotional Distress Scale - Early Screener (PEDS-ES) appeared to be a valid screening tool for young children who are involved in an accident. The aim of the current study is to validate the PEDS-ES for the Netherlands. Furthermore, additional risk factors for PTSD, derived from literature, will be examined. The aim is to explore if these risk factors improve the psychometric properties of the PEDS-ES. |
|- Main changes (audit trail)|
|- RECORD||6-aug-2015 - 25-aug-2015|