Clinical trial NCT06203899: Depression and Suicide Prevention in Adolescents Attending Special Schools
Official title: Strong Teens and Resilient Minds: School-based Depression and Suicide Prevention in Adolescents Attending Special Schools
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Keywords: Depression
Prevention
Adolescence
Special education
Lead sponsor: Ggz Oost Brabant
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 236
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-blinded cluster-randomized controlled trial with two parallel conditions (experimental and control)
Primary purpose: PREVENTION

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.

Primary outcomes:
measure: Depressive symptoms in children and adolescents
timeFrame: Depressive symptoms will be measured at the screening, at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
Secondary outcomes:
measure: The presence of a clinical depression
timeFrame: The presence of a clinical depression will be measured at T0 (baseline) and T2 (6 months)
measure: Suicidality
timeFrame: Suicidality will be measured at the screening, at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
measure: Parent-reported depressive symptoms
timeFrame: Parent-reported depressive symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
measure: Anxiety symptoms
timeFrame: Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
measure: Parent-reported anxiety symptoms
timeFrame: Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
measure: Somatic symptoms
timeFrame: Somatic symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
Other outcomes:
measure: Data of school-related variable: educational history
timeFrame: Data will be collected at T0 (baseline).
measure: Data of school-related variable: reason for attending special schools
timeFrame: Data will be collected at T0 (baseline).
measure: Data of school-related variable: diagnosis (if appliable)
timeFrame: Data will be collected at T0 (baseline).
measure: Data of school-related variable: full scale IQ
timeFrame: Data will be collected at T0 (baseline).
measure: Demographic information
timeFrame: Data will be collected at T0 (baseline).
measure: Previous or present receipt of professional help for psychological problems.
timeFrame: Data will be collected at T0 (baseline) and at T3 (12 months).
Locations:
city: Boekel
country: Netherlands
facility: GGZ Oost Brabant
state: Noordoost Brabant
Study officials:
affiliation: Ggz Oost Brabant
name: Wendy CH Rongen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bodden, D., Braet, C., & Stikkelbroek, Y. (2016). Children's depression inventory-2. In: hogrefe.
citation: Bae, Y. (2012). Test review: children's depression inventory 2 (CDI 2). In: Sage Publications: Los Angeles, CA.
citation: 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.
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.
citation: Kerkhof, A., Huisman, A., Vos, C., & Smits, N. (2015). Handleiding VOZZ & VOZZ screen: Vragenlijst over Zelfdoding. Amsterdam: Vrije Universiteit Amsterdam.
citation: 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.
citation: Kovacs, M. (2011). Children's Depression Inventory 2nd edition (CDI 2): Technical manual. Multi-Health Systems.
citation: Richtlijnen jeugdhulp en jeugdbescherming. (2023). Richtlijn stemmingsproblemen.
citation: 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.