Depression and Suicide Prevention in Adolescents Attending Special Schools

Depressive Symptoms Clinical Trial

— STORM  

Official title:

Strong Teens and Resilient Minds: School-based Depression and Suicide Prevention in Adolescents Attending Special Schools

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203899
• Other study ID #: NL83816.091.23
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: October 2023
• Source: Ggz Oost Brabant
• Contact: Wendy CH Rongen, MSc
• Phone: +31888461968
• Email: WCH.Rongen[@]ggzoostbrabant.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Suicide
• Suicide Prevention

Intervention

Behavioral:
• Op Volle Kracht
This is a preventive group training based on cognitive behavioural therapy for depression.
• Gatekeeperstraining
This is a training for teachers to detect and address depressive symptoms and suicidality in their students .

Locations

Country	Name	City	State
Netherlands	GGZ Oost Brabant	Boekel	Noordoost Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Ggz Oost Brabant

Country where clinical trial is conducted

Netherlands, 

References & Publications (9)

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Data of school-related variable: educational history	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).
Other	Data of school-related variable: reason for attending special schools	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).
Other	Data of school-related variable: diagnosis (if appliable)	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).
Other	Data of school-related variable: full scale IQ	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).
Other	Demographic information	Data is gathered through questionnaires.	Data will be collected at T0 (baseline).
Other	Previous or present receipt of professional help for psychological problems.	Data is gathered through questionnaires. Course adherence will be measured in terms of session attendance.	Data will be collected at T0 (baseline) and at T3 (12 months).
Primary	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	The presence of a clinical depression	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.	The presence of a clinical depression will be measured at T0 (baseline) and T2 (6 months)
Secondary	Suicidality	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	Suicidality will be measured at the screening, at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
Secondary	Parent-reported depressive symptoms	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).	Parent-reported depressive symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
Secondary	Anxiety symptoms	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).
Secondary	Parent-reported anxiety symptoms	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).
Secondary	Somatic symptoms	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).	Somatic symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).