Early Intervention Coping Kids (TIM) Follow up Study

N/AActive Not RecruitingNCT05766072

University of Oslo450 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

450

Conditions

Anxiety Disorders Depression

Interventions

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.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 22 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Multidimensional anxiety scale for children

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

Time frame: 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

Time frame: 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