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Traumatized Youths in Residential Care: Exploring the Dysregulation of Biological Stress Systems and Testing a Gameful Relaxation Intervention to Normalize These Stress Systems.

Traumatized Youths in Residential Care: Exploring the Dysregulation of Biological Stress Systems and Testing a Gameful Relaxation Intervention to Normalize These Stress Systems.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28675
Enrollment
80
Registered
2017-12-02
Start date
2017-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adolescents, ANS, biological stress system, cortisol, gameful intervention, HPA-axis, neurofeedback, posttraumatic symptoms, residential care, serious game, stress, trauma.

Interventions

Muse (developed by InteraXon, Toronto, Canada) is a gameful meditation app that is played on an Ipad. Muse provides 17 tutorials teaching relaxation techniques. The relaxation tutorials resemble eleme
Weisz & Kazdin, 2010). Each tutorial is followed by a short meditation session during which players are provided with real-time neurofeedback on their level of calmness. The brain-sensing headband con
the kind of treatment that is normally being delivered in their situation.

Sponsors

Pluryn, Research & Development Radboud University Nijmegen VU Medical Center Amsterdam Erasmus Medical Center Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Age between 10 and 18 years. • Being able to speak the Dutch language, to ensure that participants are able to give informed consent and understand the questionnaire administered in the interview and task instructions. • Admitted to residential treatment within youth mental health care, the youth welfare system, or care for youth with ID. • CRIES-13 score of 30 or higher at T0.

Exclusion criteria

Exclusion criteria: • 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).

Design outcomes

Primary

MeasureTime frame
• Posttraumatic symptoms (self- and mentor-report) • Stress (self-report)

Secondary

MeasureTime frame
• HPA-axis activity: o Cortisol reactivity to a stress-inducing task, measured with salivary cortisol samples o Resting cortisol, measured with HCC • ANS activity: The ANS consist of a dynamic interplay of sympathetic and parasympathetic activity, thus, we will not only measure RSA, but also other ANS parameters, both resting levels and reactivity to a stress-inducing task. o RSA (parasympathetic activity) o Pre-ejection period (PEP; sympathetic activity) o Heart rate (HR; sympathetic and parasympathetic activity) o Hearth rate variability parameters (HRV; sympathetic and parasympathetic activity) o Skin conductance levels (SCL; mainly sympathetic activity) o Skin conductance response (SCR; mainly sympathetic) • Psychopathology: o Depression (self-report) o Anxiety (self-report) o Aggression (self- and mentor-report) o Executive functioning (mentor-report)

Contacts

Public ContactAngela Schuurmans
aschuurmans01@pluryn.nl088-7795799

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)