Early Intervention Coping Kids (TIM) Follow up Study

Not Applicable

Active, not recruiting

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

• Registration Number: NCT05766072
• Lead Sponsor: University of Oslo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Study Start: 2023-03-13
• Study First Posted: 2023-03-13
• Primary Completion: 2024-02-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-10
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	EMOTION Kids coping with anxiety and depression (Kendall et. al, 2013) (Mestrende barn in Norwegian) Martinsen et al, 2014	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

Primary Outcome Measures

Name	Time	Method
Multidimensional anxiety scale for children	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	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)	5-year follow up	Relevant sections of this semi-structured interview (anxiety and depression), categorical outcome, have diagnosis/does not have diagnosis

Trial Locations

Locations (1)

University of Oslo; 🇳🇴 Oslo, Norge, Norway