- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06203899
Depression and Suicide Prevention in Adolescents Attending Special Schools (STORM)
Strong Teens and Resilient Minds: School-based Depression and Suicide Prevention in Adolescents Attending Special Schools
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wendy CH Rongen, MSc
- Phone Number: +31888461968
- Email: WCH.Rongen@ggzoostbrabant.nl
Study Locations
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Noordoost Brabant
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Boekel, Noordoost Brabant, Netherlands, 5427 ZG
- Recruiting
- GGZ Oost Brabant
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Contact:
- Wendy WC Rongen, MSc
- Phone Number: +31888461968
- Email: wch.rongen@ggzoostbrabant.nl
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention group
Participating adolescents receive the preventive group training Op Volle Kracht. It is an altered program for adolescents in the special educational sector, based on the eponymous program for general education. It consists of eight meetings of 45 minutes each and one short follow-up meeting each week to offer repetition. It will take place at school during school hours. A trained psychologist of the STORM approach will facilitate the training with a trained school psychologist. Participants will undergo a clinical interview at baseline and at 6-month follow-up to detect clinical depression, and will fill in questionnaires at baseline, post-intervention and follow-up at 6 and 12 months after intervention. Assessments will be conducted through a 30-minute self-report questionnaire. All teachers will be educated on how to recognize and address depressive symptoms and suicidality in adolescents (gatekeeperstraining). |
This is a preventive group training based on cognitive behavioural therapy for depression.
This is a training for teachers to detect and address depressive symptoms and suicidality in their students .
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Active Comparator: Control group
Participating adolescents will undergo a clinical interview at baseline to detect clinical depression, and will fill in questionnaires at baseline, 12 weeks/'post-intervention' and follow-up at 6 and 12 months 'post-intervention'. Besides, participants will undergo a second clinical interview on depressive symptoms at 6 months follow-up. All teachers will be educated on how to recognize and address depressive symptoms and suicidality in adolescents (gatekeeperstraining). Concerning Op Volle Kracht: Adolescents are offered the training after data collection of the study has ended and when the intervention has shown to be effective. |
This is a training for teachers to detect and address depressive symptoms and suicidality in their students .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms in children and adolescents
Time Frame: Depressive symptoms will be measured at the screening, at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
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Depressive symptoms in children and adolescents will be measured with the CDI-2 (Bodden et al., 2016; Kovacs, 2011).
The CDI-2 contains 28 items, each consisting of three statements graded in severity from 0 to 2. This instrument has good internal consistency and convergent validity (Bae, 2012).
The use of the CDI-2 for screening purposes is in accordance with the Dutch multidisciplinary guidelines for depression among youth (Richtlijnen jeugdhulp en jeugdbescherming, 2023).
Suicidality will be measured with item 8 of the CDI-2.
In case children score 2 on this present item, they will be seen by a health professional and eventually redirected to mental health care.
Parents will be informed.
|
Depressive symptoms will be measured at the screening, at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The presence of a clinical depression
Time Frame: The presence of a clinical depression will be measured at T0 (baseline) and T2 (6 months)
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he presence of a clinical depression is measured by a clinical interview using the Anxiety Disorder Interview Schedule for Children, ADIS-C (Silverman & Albano, 1996).
The study will only include the section of affective disorders.
The purpose of this interview is to investigate if children meet the criteria of a depression.
If participants meet the criteria of a depression, the severity will be determined using the checklist of the multidisciplinary guidance depression youth.
Adolescents with a moderate - severe depression will be excluded from this study and redirected to mental health care.
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The presence of a clinical depression will be measured at T0 (baseline) and T2 (6 months)
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Suicidality
Time Frame: Suicidality will be measured at the screening, at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
|
Suicidality will be measured with the VOZZ-screen (Kerkhof et al., 2015).
This questionnaire contains 10 questions regarding thoughts and actions about life, self-harm and suicide.
Items are rated on a 5-point scale.
Children with score 23 or above will redirected to a health professional and eventually redirected to mental health care.
Parents will be informed.
This procedure is equal to the procedure when children score 2 on item 8 of the CDI-2
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Suicidality will be measured at the screening, at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
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Parent-reported depressive symptoms
Time Frame: Parent-reported depressive symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
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Parent-reported depressive symptoms are measured with the CDI-2 parent-report questionnaire consisting of 17 items.
Parents indicate the presence of each symptom in the past two weeks on a 4-point-scale (Bodden et al., 2016; Kovacs, 2011).
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Parent-reported depressive symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
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Anxiety symptoms
Time Frame: Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
|
Anxiety symptoms are measured by using the RCADS-25 self-report questionnaire (Chorpita et al., 2000).
Only items concerning anxiety will be used; the anxiety scale of the RCADS-25 show great psychometric properties (Klaufus et al., 2020).
It is used in children 8 to 18 years old.
Items are rated on an 4-point scale concerning prevalence.
|
Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
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Parent-reported anxiety symptoms
Time Frame: Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
|
Anxiety symptoms are measured by using the RCADS-25 parent questionnaire (Chorpita et al., 2000).
Only items concerning anxiety will be used; the anxiety scale of the RCADS-25-P show great psychometric properties (Klaufus et al., 2020).
It is used in children 8 to 18 years old.
Items are rated on an 4-point scale concerning prevalence.
|
Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
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Somatic symptoms
Time Frame: Somatic symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
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Somatic symptoms will be measured via the Somatic Complaint List, which consists of 11 items about physical health such as 'I feel tired'.
Items are rated on a 3-point scale including never, sometimes or often.
It is validated for participants 8 years and older (Jellesma et al., 2007).
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Somatic symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Data of school-related variable: educational history
Time Frame: Data will be collected at T0 (baseline).
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Data of school-related variables are obtained in collaboration with the schools, including educational history, reason for attending special schools, diagnosis (if applicable), full scale IQ.
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Data will be collected at T0 (baseline).
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Data of school-related variable: reason for attending special schools
Time Frame: Data will be collected at T0 (baseline).
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Data of school-related variables are obtained in collaboration with the schools, including educational history, reason for attending special schools, diagnosis (if applicable), full scale IQ.
|
Data will be collected at T0 (baseline).
|
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Data of school-related variable: diagnosis (if appliable)
Time Frame: Data will be collected at T0 (baseline).
|
Data of school-related variables are obtained in collaboration with the schools, including educational history, reason for attending special schools, diagnosis (if applicable), full scale IQ.
|
Data will be collected at T0 (baseline).
|
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Data of school-related variable: full scale IQ
Time Frame: Data will be collected at T0 (baseline).
|
Data of school-related variables are obtained in collaboration with the schools, including educational history, reason for attending special schools, diagnosis (if applicable), full scale IQ.
|
Data will be collected at T0 (baseline).
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Demographic information
Time Frame: Data will be collected at T0 (baseline).
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Data is gathered through questionnaires.
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Data will be collected at T0 (baseline).
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Previous or present receipt of professional help for psychological problems.
Time Frame: Data will be collected at T0 (baseline) and at T3 (12 months).
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Data is gathered through questionnaires.
Course adherence will be measured in terms of session attendance.
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Data will be collected at T0 (baseline) and at T3 (12 months).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wendy CH Rongen, MSc, GGZ Oost Brabant
Publications and helpful links
General Publications
- Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8.
- Bodden, D., Braet, C., & Stikkelbroek, Y. (2016). Children's depression inventory-2. In: hogrefe.
- Bae, Y. (2012). Test review: children's depression inventory 2 (CDI 2). In: Sage Publications: Los Angeles, CA.
- Jellesma FC, Rieffe C, Terwogt MM. The Somatic Complaint List: validation of a self-report questionnaire assessing somatic complaints in children. J Psychosom Res. 2007 Oct;63(4):399-401. doi: 10.1016/j.jpsychores.2007.01.017.
- Kerkhof, A., Huisman, A., Vos, C., & Smits, N. (2015). Handleiding VOZZ & VOZZ screen: Vragenlijst over Zelfdoding. Amsterdam: Vrije Universiteit Amsterdam.
- Klaufus L, Verlinden E, van der Wal M, Kosters M, Cuijpers P, Chinapaw M. Psychometric evaluation of two short versions of the Revised Child Anxiety and Depression Scale. BMC Psychiatry. 2020 Feb 5;20(1):47. doi: 10.1186/s12888-020-2444-5.
- Kovacs, M. (2011). Children's Depression Inventory 2nd edition (CDI 2): Technical manual. Multi-Health Systems.
- Richtlijnen jeugdhulp en jeugdbescherming. (2023). Richtlijn stemmingsproblemen.
- Lyneham HJ, Abbott MJ, Rapee RM. Interrater reliability of the Anxiety Disorders Interview Schedule for DSM-IV: child and parent version. J Am Acad Child Adolesc Psychiatry. 2007 Jun;46(6):731-736. doi: 10.1097/chi.0b013e3180465a09.
- Rongen WCH, Creemers DHM, Spijker J, Vermulst AA, Rasing SPA. Evaluation of a school-based depression prevention approach among adolescents with elevated depressive symptoms attending special education: study protocol of a cluster randomized controlled trial. BMC Psychiatry. 2025 May 22;25(1):517. doi: 10.1186/s12888-025-06955-5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL83816.091.23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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