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Early Intervention Coping Kids (TIM) Follow up Study

5 Year- Follow up of Anxious and Sad Children

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05766072
Acronym
FOPPT4
Enrollment
217
Registered
2023-03-13
Start date
2023-03-13
Completion date
2024-04-01
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Depression

Keywords

Anxiety, Depression, School absenteeism, Youth

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.

Interventions

OTHEREMOTION 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.

Sponsors

University of Oslo
Lead SponsorOTHER
The Dam Foundation
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Due to the long-term follow-up design, participants and parents are aware of their original allocation to intervention or treatment-as-usual conditions from the previous TIM study. Therefore, masking of participants and care providers is not feasible in the current follow-up study.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
13 Years to 22 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Multidimensional anxiety scale for children5- year follow upThis 39-item, child self-report, assesses anxiety in youth ages 8 - 19, 0 - 117, higher score, higher anxiety
The Mood and Feelings Questionnaire Short version5-year follow upSMFQ 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 upRelevant sections of this semi-structured interview (anxiety and depression), categorical outcome, have diagnosis/does not have diagnosis

Countries

Norway

Contacts

PRINCIPAL_INVESTIGATORJo Magne Ingul, PhD

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

PRINCIPAL_INVESTIGATORFrode Adolfsen, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026