Study I aims to explore dysregulation of biological stress systems among traumatized youths with and without ID in residential care, and compare them with a healthy control group. Study II aims to conduct a randomized controlled trial (RCT) to test…
ID
Source
Brief title
Condition
- Other condition
- Psychiatric and behavioural symptoms NEC
Synonym
Health condition
autonomic nervous system activity; hypothalamic-pituitary-adrenal system activity
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The focus of this project is on the one hand on the parameters of the HPA axis
(i.e. cortisol) and ANS activity (i.e. RSA and PEP), both under resting and
social stress conditions. On the other hand, we focus on posttraumatic
symptoms, stress, depression, anxiety, and aggression.
Secondary outcome
nvt
Background summary
Many youths in residential institutions have posttraumatic symptoms that
interfere with their development and functioning, but that remain untreated.
Their traumatic experiences may have resulted in alterations of their
biological stress systems (i.e. the hypothalamic-pituitary-adrenal [HPA] axis
and autonomic nervous system [ANS] activity) that are likely to play a role in
the development and maintenance of psychological and behavioural problems.
Study objective
Study I aims to explore dysregulation of biological stress systems among
traumatized youths with and without ID in residential care, and compare them
with a healthy control group. Study II aims to conduct a randomized controlled
trial (RCT) to test the effectiveness of a gamified relaxation intervention on
posttraumatic symptoms, stress, and biological stress systems.
Study design
This project consists of (study I) a cross-sectional study to examine
biological stress systems among traumatized youths with and without ID, and
healthy controls, and (study II) a RCT with treatment as usual (TAU) as a
control group.
Intervention
The intervention consists of twee biweekly 15-minute sessions during which
participants in the experimental condition play Muse. Participants in the
control condition receive TAU; the kind of treatment that is normally being
delivered in their situation.
Study burden and risks
The study comprises several assessments: questionnaires, psychophysiological
tasks, saliva and hair collection. There are no risks associated with
participation.
Montessorilaan 3
Nijmegen 6525 HR
NL
Montessorilaan 3
Nijmegen 6525 HR
NL
Listed location countries
Age
Inclusion criteria
Both clinical and control sample:
- age between 10 and 18 years
- being able to speak the Dutch language, to ensure that participants can understand the task instructions and questionnaires, are able to give informed consent or assent, and can participate in the diagnostic interview;Clinical sample:
- admitted to residential treatment within youth mental health care, the youth welfare system or care for youth with intellectual disability (ID)
- score of 30 or higher on the CRIES-13, a questionnaire to screen for posttraumatic symptoms
Exclusion criteria
Both clinical and control sample:
- current or recent (within the last 3 months) EMDR or CBT treatment specifically targeting post-traumatic symptoms
- simultaneous participation in another clinical intervention study
- psychotic symptoms
- negative clinician advice, for example the clinician fears that participation in the study would have negative effects on the participant or that the participants has not the capacities to take part in the study (we have no exclusion criteria based on IQ, to promote external generalizability);Control sample:
- presence of any Axis I disorder
- current or recent (withing the last 3 months) psychological treatment
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58674.091.16 |