|- candidate number||22424|
|- NTR Number||NTR5293|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jul-2015|
|- Secondary IDs||NL48702.068.14 |
|- Public Title||Succesfactors in Antillean immigrants to Rotterdam|
|- Scientific Title||Succesfactors in Antillean immigrants to Rotterdam|
|- ACRONYM||STAIR study|
|- hypothesis||The increased rate of psychosis and crime in Antillean immigrants may be related to social defeat, but this has never been examined prospectively.|
|- Healt Condition(s) or Problem(s) studied||Social problems, Psychosis|
|- Inclusion criteria||- Immigration from one the former Dutch Antilles or Aruba to Rotterdam as registrated by the Municipality during the first year of the study. |
- At least one parent born in one of the former Dutch Antilles or Aruba.
- A self defined Antillean ethnicity.
- Age in the inclusion period between 18 and 24 years old.
|- Exclusion criteria||- Not able to give informed consent.|
- Clinical relevant psychotic symptoms at baseline.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||6-jul-2015|
|- planned closingdate|
|- Target number of participants||280|
|- Primary outcome||The main study parameters of this study are the measurements of social defeat, psychotic symptoms and crime.|
|- Secondary outcome||-|
|- Timepoints||Annual assessments with questionnaires during five years (baseline and 4 follow ups).|
|- Trial web site||na|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. D.J. Vinkers|
|- CONTACT for SCIENTIFIC QUERIES||Dr. D.J. Vinkers|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|- Brief summary||SUMMARY|
Rationale: The increased rate of psychosis and crime in Antillean immigrants may be related to social defeat, but this has never been examined prospectively.
Objective: To assess the prospective relationship between social defeat on one hand and psychosis and crime on the other hand in Antillean immigrants to Rotterdam in comparison with a control group of native Dutch inhabitants of Rotterdam matched by neighbourhood and age category.
Study design and population: Prospective study of approximately 280 Antillean immigrants aged 18 to 24 years to Rotterdam, compared to the same number of Dutch native inhabitants of Rotterdam, matched by neighbourhood and age category.
Main study parameters/endpoints: Psychotic symptoms and crime, scored by participant and interviewer, both in the case and control group.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden associated with participation is the annual assessment by an interviewer. A possible risk is that participants will pay more attention to negative parameters, like social defeat and psychotic symptoms. A possible benefit for participants is that they become more aware of the relation between acculturation and social functioning.
|- Main changes (audit trail)|
|- RECORD||8-jul-2015 - 19-aug-2015|