Clinical trial NCT05766072: Early Intervention Coping Kids (TIM) Follow up Study
Official title: 5 Year- Follow up of Anxious and Sad Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Depression
Keywords: Anxiety
Depression
School absenteeism
Youth
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: The Dam Foundation
First posted: 2023-03-13
Enrollment: 450
Sex: ALL
Minimum age (years): 13
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Multidimensional anxiety scale for children
timeFrame: 5- year follow up
measure: The Mood and Feelings Questionnaire Short version
timeFrame: 5-year follow up
measure: The ADIS (Anxiety Disorders Interview Schedule)
timeFrame: 5-year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
state: Norge
Study officials:
affiliation: Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU), Trondheim, Norway
name: Jo Magne Ingul, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Centre for Child and Youth Mental Health and Child Welfare North, UiT, Tromsø, Norway
name: Frode Adolfsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kendall, P. C., Stark, K. D., Martinsen, K., O'Neil, K. A., & Arora, P. (2013). EMOTION:
citation: March, J. S. (1997). MASC - Multidimensional Anxiety Scale for Children - Technical Manual. Toronto, Canada: Multi-Health Systems.
citation: 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.
citation: 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.
citation: Silverman, W. K., Albano, A.M. Anxiety Disorders Interview Schedule (ADIS-IV): Child Interview Schedules. Oxford University Press, 2010).