Depressive SymptomsSTORMNCT06203899
Depression and Suicide Prevention in Adolescents Attending Special Schools
A study testing Op Volle Kracht and Gatekeeperstraining in people with Depressive Symptoms, run by Ggz Oost Brabant at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Op Volle Kracht and Gatekeeperstraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Dec 2023to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
GGZ Oost Brabant
Boekel, Noordoost Brabant, 5427 ZG
Wendy WC Rongen, MSc, +31888461968, wch.rongen@ggzoostbrabant.nl
About this study
Official title: Strong Teens and Resilient Minds: School-based Depression and Suicide Prevention in Adolescents Attending Special Schools
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
- Being tested
- Op Volle Kracht, Gatekeeperstraining
- Keywords
- Depression, Prevention, Adolescence, Special education
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Op Volle KrachtBehavioural
This is a preventive group training based on cognitive behavioural therapy for depression.
GatekeeperstrainingBehavioural
This is a training for teachers to detect and address depressive symptoms and suicidality in their students .
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Gatekeeperstraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: The presence of a clinical depression will be measured at T0 (baseline) and T2 (6 months)
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
Measured: 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 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).
Measured: Parent-reported depressive symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
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.
Measured: Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
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.
Measured: Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
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).
Measured: Somatic symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start13 Dec 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-blinded cluster-randomized controlled trial with two parallel conditions (experimental and control)
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ggz Oost Brabant
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy CH Rongen, MSc, Principal investigator, Ggz Oost Brabant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203899
- Sponsor's protocol ID
- NL83816.091.23
- Acronym
- STORM
- Status last verified
- May 2026
- First submitted
- 14 Dec 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Bodden, D., Braet, C., & Stikkelbroek, Y. (2016). Children's depression inventory-2. In: hogrefe.
Bae, Y. (2012). Test review: children's depression inventory 2 (CDI 2). In: Sage Publications: Los Angeles, CA.
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.
PubMed 10937431Jellesma 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.
PubMed 17905048Kerkhof, 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.
PubMed 32024481Kovacs, M. (2011). Children's Depression Inventory 2nd edition (CDI 2): Technical manual. Multi-Health Systems.
Richtlijnen jeugdhulp en jeugdbescherming. (2023). Richtlijn stemmingsproblemen.
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.
PubMed 17513985Rongen 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.
PubMed 40399869
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strong Teens and Resilient Minds: School-based Depression and Suicide Prevention in Adolescents Attending Special Schools
- ClinicalTrials.gov ID
- NCT06203899
- Acronym / sponsor ID
- STORM / NL83816.091.23
- Conditions
- Depressive Symptoms
- Keywords
- Depression, Prevention, Adolescence, Special education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Ggz Oost BrabantUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-blinded cluster-randomized controlled trial with two parallel conditions (experimental and control)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Op Volle Kracht, Behavioral: GatekeeperstrainingParticipating 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). |
| Control group | Active comparator | Behavioral: GatekeeperstrainingParticipating 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Op Volle KrachtThis is a preventive group training based on cognitive behavioural therapy for depression. | Behavioural | Intervention group |
| GatekeeperstrainingThis is a training for teachers to detect and address depressive symptoms and suicidality in their students . | Behavioural | Control group, Intervention group |
Primary outcome
Depressive symptoms in children and adolescents
Time frame: Depressive symptoms will be measured at the screening, at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
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.
6 secondary outcomes
The presence of a clinical depression
Time frame: The presence of a clinical depression will be measured at T0 (baseline) and T2 (6 months)
Suicidality
Time frame: Suicidality will be measured at the screening, at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
Parent-reported depressive symptoms
Time frame: Parent-reported depressive symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
Anxiety symptoms
Time frame: Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
Parent-reported anxiety symptoms
Time frame: Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
Somatic symptoms
Time frame: Somatic symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- BackgroundBodden, D., Braet, C., & Stikkelbroek, Y. (2016). Children's depression inventory-2. In: hogrefe.
- BackgroundBae, Y. (2012). Test review: children's depression inventory 2 (CDI 2). In: Sage Publications: Los Angeles, CA.
- Background: PubMed 10937431Chorpita 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.
- Background: PubMed 17905048Jellesma 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.
- BackgroundKerkhof, A., Huisman, A., Vos, C., & Smits, N. (2015). Handleiding VOZZ & VOZZ screen: Vragenlijst over Zelfdoding. Amsterdam: Vrije Universiteit Amsterdam.
- Background: PubMed 32024481Klaufus 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.
- BackgroundKovacs, M. (2011). Children's Depression Inventory 2nd edition (CDI 2): Technical manual. Multi-Health Systems.
- BackgroundRichtlijnen jeugdhulp en jeugdbescherming. (2023). Richtlijn stemmingsproblemen.
- Background: PubMed 17513985Lyneham 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.
- Derived from this study: PubMed 40399869Rongen 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wendy CH Rongen, MSc principal investigator
Ggz Oost Brabant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Op Volle Kracht and Gatekeeperstraining in people with Depressive Symptoms, run by Ggz Oost Brabant at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy CH Rongen, MSc (+31888461968, WCH.Rongen@ggzoostbrabant.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms in children and adolescents (time frame: Depressive symptoms will be measured at the screening, at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06203899, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.