Depression and Suicide Prevention in Adolescents Attending Special Schools

NCT ID: NCT06203899

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-13
• Study Completion Date: 2026-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Op Volle Kracht

Intervention Type: BEHAVIORAL

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

Gatekeeperstraining

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Gatekeeperstraining

Intervention Type: BEHAVIORAL

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

Interventions

Op Volle Kracht

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

Intervention Type: BEHAVIORAL

Gatekeeperstraining

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ggz Oost Brabant

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy CH Rongen, MSc

Role: PRINCIPAL_INVESTIGATOR

Ggz Oost Brabant

Locations

GGZ Oost Brabant

Boekel, Noordoost Brabant, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Wendy CH Rongen, MSc

Role: CONTACT

WCH.Rongen@ggzoostbrabant.nl

+31888461968

Facility Contacts

Wendy WC Rongen, MSc

Role: primary

wch.rongen@ggzoostbrabant.nl

+31888461968

References

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

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 10937431 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17905048 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 32024481 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 17513985 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40399869 (View on PubMed)

Other Identifiers

NL83816.091.23

Identifier Type: -

Identifier Source: org_study_id