|- candidate number||13324|
|- NTR Number||NTR3634|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-sep-2012|
|- Secondary IDs||ECG2012-0910-047 |
|- Public Title||Implementation of kernels to promote mental health in first year Bachelor students.|
|- Scientific Title||Implementation of kernels to promote mental health in first year Bachelor students.|
|- hypothesis||It is expected that the experimental, but not the control participants, will show a significant decrease in depressive symptoms and anxiety, and a significant increase in physical activity, pro-social behavior and general mental health.|
|- Healt Condition(s) or Problem(s) studied||Mental health, Anxiety, Depression, Stress|
|- Inclusion criteria||First year student of pedagogic at Radboud University Nijmegen participating in the academic skills course.|
|- Exclusion criteria||Second to fourth year pedagogic students of the Radboud University Nijmegen.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||3-sep-2012|
|- planned closingdate||15-jun-2013|
|- Target number of participants||243|
|- Interventions||Students of the first year BA course ‘Academic Skills’ will be randomly assigned to the experimental or control group. Students in the experimental condition will receive four short interventions called ‘kernels’ (Embry & Biglan, 2008).|
The 4 kernels are:
1. Physical exercise (for more information see Otto & Smits, 2011);
2. Information about the benefits of Omega3 (for more information see Embry, 2007);
3. Expressive writing (for more information see Thomaes et al., 2012);
4. Basic principles of Cognitive-Behavioral Interventions (components of the ‘Op Volle Kracht’ program Tak et al., 2012);
5. These kernels are taught in the regular class hours. Teachers provide instructions and students are asked to complete assignments. In total that takes 15 minutes each time. Prior to the classes teachers are instructed about the kernels by the research team.
The control condition follows the regular curriculum of the academic skills course without any intervention.
|- Primary outcome||1. Fear of failure (Vragenlijst Studieproblemen (VSP) see: Bruinsma, M: Motivation, cognitive processing and achievement in higher education (2004));|
2. Procrastination (Vragenlijst Studieproblemen (VSP) see Bruinsma, M: Motivation, cognitive processing and achievement in higher education (2004);
3. Perceived stress (assessed through a Dutch version of the Perceived Stress Scale see Cohen, et al., 1983)
|- Secondary outcome||1. Depressive symptoms (measured with the BDI, Beck et al., 1961);|
2. Anxiety (measured with the BAI, Beck & Steer, 1993).
|- Timepoints||Students in both conditions will be asked to complete a set of online questionnaires at pre-, mid-, post- and follow-up measurement.|
1. Pre measurement:beginning of September;
2. Mid measurement: end of October,;
3. Post measurement: beginning of February;
4. Follow-up measurement: beginning of June.
The procedure will be completed within the participants' first academic year, which takes approximately 10 month in total.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Johanna Tewes|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Isabela Granic|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Center Nijmegen|
|- Publications||Thomaes, S., Bushman, B. J., Orobio de Castro, B., & Reijntjes, A. (2012). Arousing “gentle passions” in young adolescents: Sustained experimental effects of value-affirmations on prosocial feelings and behaviors. Developmental Psychology.|
|- Brief summary||Content:|
The aims of the current study are to implement and evaluate the effectiveness of a brief prevention program for first-year Bachelor students. The beginning of university is a period of great transitions for most young people – there are increases in pressures to perform well academically, but also changes in friendships and romantic relationships that are triggered by this new phase in students’ lives. These changes bring about great opportunities for success, but they also usher in a period of vulnerability during which students are at increased risk to develop problems with anxiety and depression.
The evidence-based prevention program will be implemented in the context of a randomized control trial and will involve all consenting students in the first year bachelor program in Orthopedagogics.
Making use of various questionnaires that will be given to the 1rst year students we aim to examine some of the most important variables that might predict how depressive and anxious symptoms are prevented through the program. The questionnaires assess the mental health, perceived stress, physical activities, prosocial behavior of each student:
Students will be introduces to the study after their first lecture and will additionally receive information about the procedure of participation via email. After approximately 6 month all participants will be asked to complete the follow-up session which consists of the same questionnaires as in the first session.
Results from analyses and papers that come out of these studies have the potential to contribute significantly to prevention research and change real-world outcomes for young adults in a variety of educational settings.
|- Main changes (audit trail)|
|- RECORD||17-sep-2012 - 16-okt-2012|