Anxiety DisordersFOPPT4NCT05766072
Early Intervention Coping Kids (TIM) Follow up Study
A study testing EMOTION Kids coping with anxiety and depression (Mestrende barn in Norwegian) in people with Anxiety Disorders and Depression, run by University of Oslo at 1 site in Norway.
Trial summary
The project objectives are to investigate if a preventive intervention targeting anxious and sad children aged 8 to 12 years has haf the anticipated long-term effects, 5 years after receiving the intervention. Read more about this study
- Who is it for?
- Ages 13 to 22 years
- Conditions the study is for
- Anxiety Disorders, Depression
- What is being tested?
- EMOTION Kids coping with anxiety and depression (Mestrende barn in Norwegian)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteNorway
- Study dates
- 13 Mar 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants who participated in the previous randomized controlled TIM study (children then aged 8- 12 years selfreporing elevated symptom levels of anxiety and/or depression)
Who cannot join
- all earlier participats from the TIM study may enter the follow up study
- participants who chose to not participate in the 5-year follow-up of the TIM study are excluded from the follow-up study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 5 Year- Follow up of Anxious and Sad Children
The project objectives are to investigate if a preventive intervention targeting anxious and sad children aged 8 to 12 years has haf the anticipated long-term effects, 5 years after receiving the intervention. Hence: will an indicated intervention reduce the incidence of common mental disorders in youth in the long term? The current study is a 5 year follow up of the previously completed RCT called the TIM-study (Clinical Trials identifier: NCT 02340637).
The aim of this study is to determine the long-term effects of the intervention to examine if true preventive effects are achieved as indicated by lower symptom levels, better functioning og fewer diagnosis of anxiety and depression 5 years after receiving an indicated preventiv intervention.
- Conditions
- Anxiety Disorders, Depression
- Being tested
- EMOTION Kids coping with anxiety and depression (Mestrende barn in Norwegian)
- Keywords
- Anxiety, Depression, School absenteeism, Youth
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMOTION Kids coping with anxiety and depression (Mestrende barn in Norwegian)Other
The intervention is transdiagnostic and based on cognitive behavioral therapy where the children and their parents meet i groups led of school health nurses. They are learning coping skills to meet challenging and avoided situations, learning about emotion regulation, physical symptoms conitive restructuring and exposure/behavioral activation. Te manual is publshed in a US/English version and in a Norwegian version.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | Youth in this arm received the intervention over 10 weeks during one semester (recruiting children over 6 semesters in total), children meeting in groups of approx. seven children. The groups were led by school health nurses.
At the same time parents met for 7 group sessions, with the children participating in four of these Receives: Other: EMOTION Kids coping with anxiety and depression (Mestrende barn in Norwegian) |
| Control arm | No intervention | The youth in the control condition received treatment as usual, e.g. talks with school health nurses or no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional anxiety scale for children
This 39-item, child self-report, assesses anxiety in youth ages 8 - 19, 0 - 117, higher score, higher anxiety
Measured: 5- year follow up
The Mood and Feelings Questionnaire Short version
SMFQ comprised of 13 questions assessing cognitive, affective and behavioral-related depressive symptoms in youth ages 8 - 18 during the last two weeks, 0 - 26, higher score indicating higher levels of depression
Measured: 5-year follow up
The ADIS (Anxiety Disorders Interview Schedule)
Relevant sections of this semi-structured interview (anxiety and depression), categorical outcome, have diagnosis/does not have diagnosis
Measured: 5-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start13 Mar 2023
- Primary completion29 Feb 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies 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
- This study is a long-term follow-up of the TIM study, a cluster randomized controlled trial evaluating the EMOTION intervention for children with elevated symptoms of anxiety and depression. Thirty-six Norwegian schools from rural and urban areas were randomized to either the EMOTION intervention or treatment as usual. Children aged 8-12 years were screened using validated measures of anxiety and depressive symptoms, and high-scoring children (N = 795) were included. The intervention consisted of a 10-week cognitive-behavioral group program delivered during school hours, with parallel parent sessions. Assessments were conducted at screening (T1), post-intervention (T2), and 1-year follow-up (T3). The current study represents a longitudinal observational follow-up (T4) assessing long-term mental health outcomes and diagnostic status using questionnaires and diagnostic interviews.
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- The Dam Foundation
- Responsible party
- Principal investigator, Kristin Martinsen, University of Oslo
- Investigators
- Jo Magne Ingul, PhD, Principal investigator, Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU), Trondheim, NorwayFrode Adolfsen, PhD, Principal investigator, Regional Centre for Child and Youth Mental Health and Child Welfare North, UiT, Tromsø, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766072
- Sponsor's protocol ID
- 426598
- Acronym
- FOPPT4
- Status last verified
- Feb 2025
- First submitted
- 1 Mar 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Angold, A., Costello, E. J., Messer, S. C., & Pickles, A. (1995). Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. International Journal of Methods in Psychiatric Research, 5(4), 237-249.
Kendall, P. C., Stark, K. D., Martinsen, K., O'Neil, K. A., & Arora, P. (2013). EMOTION:
March, J. S. (1997). MASC - Multidimensional Anxiety Scale for Children - Technical Manual. Toronto, Canada: Multi-Health Systems.
Martinsen, K. D., Kendall, P. C., Stark, K. D., Rodriguez, K. A. O. N., & Arora, P. (2014). Mestrende barn, gruppeledermanual barn. Oslo, Norway: Gyldendal Akademisk.
Patras J, Martinsen KD, Holen S, Sund AM, Adolfsen F, Rasmussen LP, Neumer SP. Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression. BMC Psychol. 2016 Sep 26;4(1):48. doi: 10.1186/s40359-016-0155-y.
PubMed 27671742Silverman, W. K., Albano, A.M. Anxiety Disorders Interview Schedule (ADIS-IV): Child Interview Schedules. Oxford University Press, 2010).
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5 Year- Follow up of Anxious and Sad Children
- ClinicalTrials.gov ID
- NCT05766072
- Acronym / sponsor ID
- FOPPT4 / 426598
- Conditions
- Anxiety Disorders, Depression
- Keywords
- Anxiety, Depression, School absenteeism, Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- The Dam Foundation
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 13 Mar 2023 (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.
The project objectives are to investigate if a preventive intervention targeting anxious and sad children aged 8 to 12 years has haf the anticipated long-term effects, 5 years after receiving the intervention. Hence: will an indicated intervention reduce the incidence of common mental disorders in youth in the long term? The current study is a 5 year follow up of the previously completed RCT called the TIM-study (Clinical Trials identifier: NCT 02340637).
The aim of this study is to determine the long-term effects of the intervention to examine if true preventive effects are achieved as indicated by lower symptom levels, better functioning og fewer diagnosis of anxiety and depression 5 years after receiving an indicated preventiv intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a long-term follow-up of the TIM study, a cluster randomized controlled trial evaluating the EMOTION intervention for children with elevated symptoms of anxiety and depression. Thirty-six Norwegian schools from rural and urban areas were randomized to either the EMOTION intervention or treatment as usual. Children aged 8-12 years were screened using validated measures of anxiety and depressive symptoms, and high-scoring children (N = 795) were included. The intervention consisted of a 10-week cognitive-behavioral group program delivered during school hours, with parallel parent sessions. Assessments were conducted at screening (T1), post-intervention (T2), and 1-year follow-up (T3). The current study represents a longitudinal observational follow-up (T4) assessing long-term mental health outcomes and diagnostic status using questionnaires and diagnostic interviews.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Other: EMOTION Kids coping with anxiety and depression (Mestrende barn in Norwegian)Youth in this arm received the intervention over 10 weeks during one semester (recruiting children over 6 semesters in total), children meeting in groups of approx. seven children. The groups were led by school health nurses. At the same time parents met for 7 group sessions, with the children participating in four of these |
| Control arm | No intervention | –The youth in the control condition received treatment as usual, e.g. talks with school health nurses or no intervention |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants who participated in the previous randomized controlled TIM study (children then aged 8- 12 years selfreporing elevated symptom levels of anxiety and/or depression)
Key exclusion criteria (2 listed)
- all earlier participats from the TIM study may enter the follow up study
- participants who chose to not participate in the 5-year follow-up of the TIM study are excluded from the follow-up study.
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 |
|---|---|---|
| EMOTION Kids coping with anxiety and depression (Mestrende barn in Norwegian)The intervention is transdiagnostic and based on cognitive behavioral therapy where the children and their parents meet i groups led of school health nurses. They are learning coping skills to meet challenging and avoided situations, learning about emotion regulation, physical symptoms conitive restructuring and exposure/behavioral activation. Te manual is publshed in a US/English version and in a Norwegian version. | Other | Intervention arm |
Primary outcome
Multidimensional anxiety scale for children
Time frame: 5- year follow up
This 39-item, child self-report, assesses anxiety in youth ages 8 - 19, 0 - 117, higher score, higher anxiety
The Mood and Feelings Questionnaire Short version
Time frame: 5-year follow up
SMFQ comprised of 13 questions assessing cognitive, affective and behavioral-related depressive symptoms in youth ages 8 - 18 during the last two weeks, 0 - 26, higher score indicating higher levels of depression
The ADIS (Anxiety Disorders Interview Schedule)
Time frame: 5-year follow up
Relevant sections of this semi-structured interview (anxiety and depression), categorical outcome, have diagnosis/does not have diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- BackgroundAngold, A., Costello, E. J., Messer, S. C., & Pickles, A. (1995). Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. International Journal of Methods in Psychiatric Research, 5(4), 237-249.
- BackgroundKendall, P. C., Stark, K. D., Martinsen, K., O'Neil, K. A., & Arora, P. (2013). EMOTION:
- BackgroundMarch, J. S. (1997). MASC - Multidimensional Anxiety Scale for Children - Technical Manual. Toronto, Canada: Multi-Health Systems.
- BackgroundMartinsen, K. D., Kendall, P. C., Stark, K. D., Rodriguez, K. A. O. N., & Arora, P. (2014). Mestrende barn, gruppeledermanual barn. Oslo, Norway: Gyldendal Akademisk.
- Background: PubMed 27671742Patras J, Martinsen KD, Holen S, Sund AM, Adolfsen F, Rasmussen LP, Neumer SP. Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression. BMC Psychol. 2016 Sep 26;4(1):48. doi: 10.1186/s40359-016-0155-y.
- BackgroundSilverman, W. K., Albano, A.M. Anxiety Disorders Interview Schedule (ADIS-IV): Child Interview Schedules. Oxford University Press, 2010).
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Jo Magne Ingul, PhD principal investigator
Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU), Trondheim, Norway
Frode Adolfsen, PhD principal investigator
Regional Centre for Child and Youth Mental Health and Child Welfare North, UiT, Tromsø, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMOTION Kids coping with anxiety and depression (Mestrende barn in Norwegian) in people with Anxiety Disorders and Depression, run by University of Oslo at 1 site in Norway.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 13 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional anxiety scale for children (time frame: 5- year follow up). The study lists 3 primary outcomes in all. 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 NCT05766072, which also lists 6 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 13 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.