Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06203899
Other study ID # NL83816.091.23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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).
See also
  Status Clinical Trial Phase
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05702086 - Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Recruiting NCT06100146 - Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls N/A
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Completed NCT05376397 - Testing THRIVE 365 for Black Sexual Minority Men (On The Daily) N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT04403126 - To Increase Psychological Well-being by the Implementation of Forgiveness Education N/A
Recruiting NCT05078424 - Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong N/A
Recruiting NCT06053775 - Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP) N/A
Active, not recruiting NCT04084795 - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia N/A
Recruiting NCT04082052 - Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike N/A
Completed NCT04011540 - Digital Data in Mental Health Therapy N/A
Not yet recruiting NCT06413849 - Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers N/A
Not yet recruiting NCT03659591 - Triple Aim Psychotherapy: Aimed at Improving Patient Experience, Population Health, and Cost N/A
Not yet recruiting NCT02133170 - "Mindfulness vs Psychoeducation in Bipolar Disorder" N/A
Completed NCT02314390 - Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial N/A
Completed NCT01628016 - The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms N/A