Early Intervention Coping Kids (TIM) Follow up Study

Study Overview
=================
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), se also Patras et al, 2016. 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.

Official Title
-----------------
5 Year- Follow up of Anxious and Sad Children

Conditions
-----------------
Anxiety Disorders, Depression

Intervention / Treatment
-----------------
* Other: EMOTION Kids coping with anxiety and depression (Kendall et. al, 2013) (Mestrende barn in Norwegian) Martinsen et al, 2014


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who participated in the previous randomized controlled TIM study Exclusion Criteria: all participats may enter the follow up study but participants who chose withdraw from the follow-up study of the TIM study are excluded -

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention arm<br>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 (Kendall et. al, 2013) (Mestrende barn in Norwegian) Martinsen et al, 2014<br>* 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.<br>|
| No Intervention: Control arm<br>The youth in the control condition received treatment as usual, e.g. talks with school health nurses or no intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional anxiety scale for children - MASC C/P (March, 1997) | This 39-item, child self-report, assesses anxiety in youth ages 8 - 19 | 5- year follow up | 
| The Mood and Feelings Questionnaire Short version (SMFQ:Angold et al., 1995) | SMFQ comprised of 13 questions assessing cognitive, affective and behavioral-related depressive symptoms in youth ages 8 - 18 during the last two weeks | 5-year follow up | 
| The ADIS (Anxiety Disorders Interview Schedule (Albano & Silverman, 2010) | Relevant sections of this semi-structured interview (anxiety and depression) | 5-year follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, Depression, school absentism, youth