Early Intervention Coping Kids (TIM) Follow up Study

NCT05766072 | Active Not Recruiting DMC

• 1 other identifier: 426598
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depression

Keywords

Anxiety; Depression; School absenteeism; Youth

Outcome Measures

Primary Outcomes (3)

• Multidimensional anxiety scale for children

  This 39-item, child self-report, assesses anxiety in youth ages 8 - 19, 0 - 117, higher score, higher anxiety

  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

  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

  5-year follow up

Study Arms (2)

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

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

Interventions

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.

Intervention arm

Eligibility Criteria

• Age: 13 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oslo: lead
• The Dam Foundation: collaborator

Study Sites (1)

University of Oslo

Oslo, Norge, 0373, Norway

Location

Related Publications (6)

• 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.

  BACKGROUND

• Kendall, P. C., Stark, K. D., Martinsen, K., O'Neil, K. A., & Arora, P. (2013). EMOTION:

  BACKGROUND

• March, J. S. (1997). MASC - Multidimensional Anxiety Scale for Children - Technical Manual. Toronto, Canada: Multi-Health Systems.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27671742 BACKGROUND

• Silverman, W. K., Albano, A.M. Anxiety Disorders Interview Schedule (ADIS-IV): Child Interview Schedules. Oxford University Press, 2010).

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jo Magne Ingul, PhD

  Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU), Trondheim, Norway

  PRINCIPAL INVESTIGATOR

• Frode Adolfsen, PhD

  Regional Centre for Child and Youth Mental Health and Child Welfare North, UiT, Tromsø, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: March 13, 2023
• Primary Completion: February 29, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

NO (1)