NCT06203899 Depression and Suicide Prevention in Adolescents Attending Special Schools
| NCT ID | NCT06203899 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ggz Oost Brabant |
| Condition | Depressive Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 236 participants |
| Start Date | 2023-12-13 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 236 participants in total. It began in 2023-12-13 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Depression is a major public health concern. In Dutch adolescents, the prevalence of major depressive disorder is estimated at 3.8%, and one in five adolescents report depressive symptoms. Depression is a risk factor in adolescent suicide. School-based prevention programs, for example the STORM approach, are effective in decreasing depressive symptoms among adolescents with elevated depressive symptoms at screening. However, not all adolescents attend general education. In the Netherlands, 7% of all adolescents enters special education (voortgezet speciaal onderwijs and prakijkonderwijs). They form a vulnerable subgroup concerning developing depressive symptoms and suicidality. To adapt and implement programs for these students, is complex yet crucial. This study aims to screen adolescents, offer them a prevention program to prevent the onset or continuation of depression and evaluate the effectiveness of this program. It is a randomised controlled trial with two conditions. The main study parameter is depressive symptomatology. Secondary study parameters are suicidality, anxiety and somatic complaints. Eligible students enter the second or third grade of special education, presenting elevated depressive symptoms. All adolescents will be screened for depressive and suicidal symptoms. Those reporting suicidality will be guided to specialised care, together with their parents. Adolescents with elevated depressive symptoms in the experimental condition will be offered the CBT-based preventive group training Op Volle Kracht in their school setting. The control condition consists of monitoring, and is offered the training if the intervention has shown to be effective. Participants will fill in longitudinal measurements. At all times, adolescents will be guided to mental health care if necessary. Furthermore, teachers in all participating schools will attend a training on how to detect and address depressive and suicidal symptoms among adolescents. The potential value of the study is that we can offer adolescents in the special educational sector a prevention program that is proven to be effective. In order to achieve this goal we need to evaluate the effectiveness of this prevention program in this target group. We are of opinion, however, that the risks associated with participation can be considered negligible. It is specifically aimed at depressive symptoms, within a population which receives care for other problems.
Eligibility Criteria
Inclusion Criteria: * Adolescents are in their second or third year of secondary education, ór adolescents will reach the age 14 or 15 in this academic year. * Score above cut-off on depression symptom questionnaire (≥ 14 on the CDI-2; Bodden et al. (2016)). Exclusion Criteria: * Adolescents who score 2 on item 8 of the CDI-2 or ≥ 23 on the VOZZ-screen (Kerkhof et al., 2015). * Clinical depression based on the clinical interview at baseline ADIS-C (Silverman \& Albano, 1996). * Absence of parental permission. * Adolescent already receiving treatment for depressive symptomatology. * Insufficient knowledge of the Dutch language.
Contact & Investigator
Wendy CH Rongen, MSc
PRINCIPAL INVESTIGATOR
Ggz Oost Brabant
Frequently Asked Questions
Who can join the NCT06203899 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Depressive Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06203899 currently recruiting?
Yes, NCT06203899 is actively recruiting participants. Contact the research team at WCH.Rongen@ggzoostbrabant.nl for enrollment information.
Where is the NCT06203899 trial being conducted?
This trial is being conducted at Boekel, Netherlands.
Who is sponsoring the NCT06203899 clinical trial?
NCT06203899 is sponsored by Ggz Oost Brabant. The principal investigator is Wendy CH Rongen, MSc at Ggz Oost Brabant. The trial plans to enroll 236 participants.