Depression and Suicide Prevention in Adolescents Attending Special Schools

NCT06203899 | Recruiting

• 1 other identifier: NL83816.091.23
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms

Keywords

Depression; Prevention; Adolescence; Special education

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms in children and adolescents

  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).

Secondary Outcomes (6)

• The presence of a clinical depression

  The presence of a clinical depression will be measured at T0 (baseline) and T2 (6 months)

• Suicidality

  Suicidality will be measured at the screening, at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).

• Parent-reported depressive symptoms

  Parent-reported depressive symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).

• Anxiety symptoms

  Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).

• Parent-reported anxiety symptoms

  Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).

Other Outcomes (6)

• Data of school-related variable: educational history

  Data will be collected at T0 (baseline).

• Data of school-related variable: reason for attending special schools

  Data will be collected at T0 (baseline).

• Data of school-related variable: diagnosis (if appliable)

  Data will be collected at T0 (baseline).

Study Arms (2)

Intervention group

EXPERIMENTAL

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).

Behavioral: Op Volle Kracht; Behavioral: Gatekeeperstraining

Control group

ACTIVE COMPARATOR

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.

Behavioral: Gatekeeperstraining

Interventions

Op Volle Kracht BEHAVIORAL

This is a preventive group training based on cognitive behavioural therapy for depression.

Intervention group

Gatekeeperstraining BEHAVIORAL

This is a training for teachers to detect and address depressive symptoms and suicidality in their students .

Control group; Intervention group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ggz Oost Brabant: lead

Study Sites (1)

GGZ Oost Brabant

Boekel, Noordoost Brabant, 5427 ZG, Netherlands

RECRUITING

Related Publications (10)

• Bodden, D., Braet, C., & Stikkelbroek, Y. (2016). Children's depression inventory-2. In: hogrefe.

  BACKGROUND

• Bae, Y. (2012). Test review: children's depression inventory 2 (CDI 2). In: Sage Publications: Los Angeles, CA.

  BACKGROUND

• 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.

  PMID: 10937431 BACKGROUND

• 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.

  PMID: 17905048 BACKGROUND

• Kerkhof, A., Huisman, A., Vos, C., & Smits, N. (2015). Handleiding VOZZ & VOZZ screen: Vragenlijst over Zelfdoding. Amsterdam: Vrije Universiteit Amsterdam.

  BACKGROUND

• 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.

  PMID: 32024481 BACKGROUND

• Kovacs, M. (2011). Children's Depression Inventory 2nd edition (CDI 2): Technical manual. Multi-Health Systems.

  BACKGROUND

• Richtlijnen jeugdhulp en jeugdbescherming. (2023). Richtlijn stemmingsproblemen.

  BACKGROUND

• 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.

  PMID: 17513985 BACKGROUND

• 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.

  PMID: 40399869 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Wendy CH Rongen, MSc

  Ggz Oost Brabant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy CH Rongen, MSc

CONTACT

+31888461968; WCH.Rongen@ggzoostbrabant.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-blinded cluster-randomized controlled trial with two parallel conditions (experimental and control)

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 12, 2024
• Study Start: December 13, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After the PhD trajectory has ended (january 2028). For the time frame of 15 years after data collection.
• Access Criteria: Data may be used to replicate the study and in meta analyses. Requests will be reviewed by the principal investigator and/or the head of the research department of GGZ Oost Brabant.

Locations

NL (1)