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Completed

NCT Number: NCT05766072

Early Intervention Coping Kids (TIM) Follow up Study

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.

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Key information

Conditions

Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

13 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, Norge, 0373, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Multidimensional anxiety scale for children

    Time frame: 5- year follow up

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

  2. The Mood and Feelings Questionnaire Short version

    Time frame: 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

  3. The ADIS (Anxiety Disorders Interview Schedule)

    Time frame: 5-year follow up

    Relevant sections of this semi-structured interview (anxiety and depression), categorical outcome, have diagnosis/does not have diagnosis

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • The Dam Foundation

Registry information

Official study title

5 Year- Follow up of Anxious and Sad Children

Acronym: FOPPT4

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2023
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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