Early Intervention Coping Kids (TIM) Follow up Study

Depression Clinical Trial

— FOPPT4  

Official title:

5 Year- Follow up of Anxious and Sad Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05766072
• Other study ID #: 426598
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2023
• Source: University of Oslo
• Contact: Kristin D. Oslo, PhD
• Phone: +479586031
• Email: k.d.martinsen[@]psykologi.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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), se also Patras et al, 2016.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 22 Years

Eligibility

Inclusion Criteria:

• Participants who participated in the previous randomized controlled TIM study

Exclusion Criteria: all participats may enter the follow up study but participants who chose withdraw from the follow-up study of the TIM study are excluded

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Related Conditions & MeSH terms

• Anxiety Disorders
• Depression

Intervention

Other:
• EMOTION Kids coping with anxiety and depression (Kendall et. al, 2013) (Mestrende barn in Norwegian) Martinsen et al, 2014
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

References & Publications (5)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multidimensional anxiety scale for children - MASC C/P (March, 1997)	This 39-item, child self-report, assesses anxiety in youth ages 8 - 19	5- year follow up
Primary	The Mood and Feelings Questionnaire Short version (SMFQ:Angold et al., 1995)	SMFQ comprised of 13 questions assessing cognitive, affective and behavioral-related depressive symptoms in youth ages 8 - 18 during the last two weeks	5-year follow up
Primary	The ADIS (Anxiety Disorders Interview Schedule (Albano & Silverman, 2010)	Relevant sections of this semi-structured interview (anxiety and depression)	5-year follow up