FOPPT4: Early Intervention Coping Kids (TIM) Follow up Study

Sponsor

University of Oslo (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05766072

Collaborator

(none)

450

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders Depression	Other: EMOTION Kids coping with anxiety and depression (Kendall et. al, 2013) (Mestrende barn in Norwegian) Martinsen et al, 2014	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

5 Year- Follow up of Anxious and Sad Children

Anticipated Study Start Date :

Mar 31, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention arm 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 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.
No Intervention: Control arm The youth in the control condition received treatment as usual, e.g. talks with school health nurses or no intervention

Arm

Intervention/Treatment

Active Comparator: Intervention arm

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

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.

No Intervention: Control arm

The youth in the control condition received treatment as usual, e.g. talks with school health nurses or no intervention

Outcome Measures

Primary Outcome Measures

Multidimensional anxiety scale for children - MASC C/P (March, 1997) [5- year follow up]
This 39-item, child self-report, assesses anxiety in youth ages 8 - 19
The Mood and Feelings Questionnaire Short version (SMFQ:Angold et al., 1995) [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
The ADIS (Anxiety Disorders Interview Schedule (Albano & Silverman, 2010) [5-year follow up]
Relevant sections of this semi-structured interview (anxiety and depression)

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 22 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Oslo

Investigators

Principal Investigator: Jo Magne Ingul, PhD, Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU), Trondheim, Norway
Principal Investigator: Frode Adolfsen, PhD, Regional Centre for Child and Youth Mental Health and Child Welfare North, UiT, Tromsø, Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Kristin Martinsen, Principal Investigator, University of Oslo

ClinicalTrials.gov Identifier:

NCT05766072

Other Study ID Numbers:

426598

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kristin Martinsen, Principal Investigator, University of Oslo

Anxiety, Depression, school absentism, youth

Additional relevant MeSH terms:

Depression

Anxiety Disorders

Study Results

No Results Posted as of Mar 13, 2023