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Youth Experience Study.


- candidate number11271
- NTR NumberNTR3356
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-mrt-2012
- Secondary IDsNL37420.068.11 METC azM/UM
- Public TitleYouth Experience Study.
- Scientific TitleTraumatic life events in childhood and its relation to psychopathology.
- ACRONYMJES
- hypothesis1. Is there an association between trauma and psychopathology in children?
2. Is there a (causal) relationship between trauma and expression of psychosis (liability)?
3. Is there evidence of (epi) genetic moderation of this association?
4. What are the mechanisms underlying the association between childhood trauma and psychosis?
5. Do genetic polymorphisms, that previous research suggests may mediate environmental sensitivity, moderate the association between trauma and psychosis?
- Healt Condition(s) or Problem(s) studiedTrauma , Psychosis, Anxiety, Depression
- Inclusion criteriaChildren under treatment:
Need to be between 12 and 17 years old.

Siblings:
1. Need to be at least 12 years of age (no upper age limit);
2. At least one sibling needs to participate (if available);
3. More than one sibling is allowed to participate (if available).

Parents of cases:
1. Need to be the biological parent;
2. Participation is preferred, however not needed for cases and their siblings to be included into the study;
3. More than one parent is allowed to participate.

Controls:
Need to be between 12 and 17 years old.

Parents of controls:
1. Need to be the biological parent;
2. Participation is preferred, however not needed for controls to be included into the study;
3. More than one parent is allowed to participate.
- Exclusion criteriaAll participants:
When a participant (child and/or parent) does not want to be informed about any possible clinically relevant findings that can be found throughout the study.
Children under treatment:
1. Mental Retardation (IQ score below 70);
2. Insufficient knowledge of the Dutch language;
3. Being diagnosed with an Autistic Spectrum Disorder according to the DSM-IV with the exception of Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). The reason for this is the difficulties autistic children will have in participating with the assessments;
4. Being adopted.

Siblings:
1. Mental Retardation (IQ score below 70);
2. Insufficient knowledge of the Dutch language;
3. Being diagnosed with an Autistic Spectrum Disorder according to the DSM-IV with the exception of Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS);
4. Being adopted.

Parents of cases:
1. Mental Retardation (IQ score below 70);
2. Insufficient knowledge of the Dutch language.

Controls:
1. Mental Retardation (IQ score below 70);
2. Insufficient knowledge of the Dutch language;
3. Being diagnosed with an Autistic Spectrum Disorder according to the DSM-IV with the exception of Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS);
4. Being adopted;
5. In the presence of a lifetime history of treatment at a mental health care institution.

Parents of controls:
1. Mental Retardation (IQ score below 70);
2. Insufficient knowledge of the Dutch language.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 15-mrt-2012
- planned closingdate15-mrt-2016
- Target number of participants650
- InterventionsThis is not an intervention study.
The study is about the effects of youth experiences on the development later in life which will be studied using:
1. Interviews;
2. Questionnaires;
3. Experimental tasks;
4. Saliva sample;
5. Experience sampling method.
- Primary outcome1. Psychosis;
2. Depression;
3. Anxiety.
- Secondary outcomeThe mechanisms by which trauma leads to psychopathology.
- TimepointsBaseline and follow-up 2 years later.

Measurements that will be used:
Interviews: KSDADS-PL, ITEC and CIDI.
Questionnaires: CAPE, BDI-II, YSR, STAI, PBI, JTV, RPV.
Experience sampling method (psymate).
Computer tasks: Picture sequencing Task, Beads task, Facial affect recognition, white noise task.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. J. Os, van
- CONTACT for SCIENTIFIC QUERIESProf. dr. J. Os, van
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Education, Culture and Science
- PublicationsN/A
- Brief summaryThere is a growing body of evidence linking childhood trauma to psychosis. However, the exact mechanisms driving the association remain to be elucidated. The study will specifically focus on how traumatic events in childhood could result in onset of psychotic symptoms. We also strive to gain more detailed insight into the relation between specific characteristics of the traumatic events and subsequent risk of psychosis.
- Main changes (audit trail)
- RECORD4-mrt-2012 - 5-apr-2012


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