Coping Kids: Early Intervention for Anxiety and Depression (TIM)

May 15, 2020 updated by: Simon-Peter Neumer, Regionsenter for barn og unges psykiske helse

Coping Kids: A Randomized Controlled Study of a New Indicated Preventive Intervention for Children With Symptoms of Anxiety and Depression

The purpose of this study is to provide knowledge regarding the effect of early intervention and prevention on the development of anxiety and depression in children. The focus of the intervention is to reduce symptoms of anxiety and depression and help children develop skills to enhance self-esteem in order to improve life quality. Gender and ethnicity will be studied as moderating factors. Primary care givers will be trained in the use of evidence based methods for children with internalizing difficulties. Children in need will be identified and receive improved services, based on international standards. Active collaboration will be established nationally between three Centers for child and adolescent mental health (RKBU/RBUP) and internationally with Philip C. Kendall at the Temple University in Philadelphia and Kevin Stark at University of Texas at Austin.

Primary aims are to examine if an indicated group and school based program, Coping Kids, is more effective than treatment as usual (TAU) in reducing high levels of symptoms of both anxiety and depression among 8-12 year old schoolchildren, and if the the effects are stable over 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

873

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0484
        • Regionsenter for barn og unges psykiske helse
      • Tromsø, Norway, 9037
        • Regional kunnskapssenter for barn og unge - Nord
      • Trondheim, Norway, 7491
        • Regional kunnskapssenter for barn og unge - Midt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children at the intervention schools indicating a symptom level of, at minimum, one standard deviation above mean on anxiety and/or depression on self-report measures will be offered participation in an intervention group

Exclusion Criteria:

  • Children who for different reasons may not benefit from a group-process intervention (e.g. mental retardation) will be considered individually and the reasons for exclusion will be documented in the Consort flow-chart.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coping Kids

A Program for Managing Anxiety and Depression (P.C Kendall et al., 2013) is a newly developed group intervention targeting children aged 8 to 13 years who experience difficulty with symptoms of anxiety, depression, or both. The program is designed as an indicated prevention intervention to reduce the symptom levels and reduce the likelihood of the development of an anxiety disorder and/or depression.

The youth-focused sessions are designed for implementation in school settings, and the program includes parent group meetings.

All groupleaders participate in a three days training, followed by supervision. Manuals and workbooks are provided by the project. In addition is the same presentation as in TAU offered to the schools.
Behavioral: Coping Kids
The first half (10 sessions) of Coping Kids focuses on building skills that are common to both anxiety and depression. The children practice strategies to regulate their mood, learn problem-solving, and behavioral activation is used to break the cycle of withdrawal. The second half of Coping Kids (10 sessions) is focused on the youth's specific problem; for depressive symptoms, building a positive self-schema and behavioral activation; for anxiety problems, gradual exposure to fear-inducing situations. Cognitive restructuring directed at different maladaptive thoughts is also emphasized.
Other Names:
  • TIM
Active Comparator: TAU
The teachers and school-nurses in the control schools will conduct treatment as usual (TAU).The project offers a 2,5 hours presentation to the schools, providing general information about the research study, the prevalence of emotional disorders and how to handle emotional disorders in treatment as usual. No materials are provided by the project.
Behavioral: TAU
Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MASC-C (Multidimensional Anxiety Scale for Children)
Time Frame: baseline, 10 weeks, 12 month
Children: (1) MASC-C (March, 1997): A 40- items self-report assessing change in anxiety in children and adolescents between 8 and 19 years.
baseline, 10 weeks, 12 month
MFQ (Mood and Feelings Questionnaire-short version)
Time Frame: baseline, 10 weeks, 12 months
Children: (2) MFQ short Version (Angold et al., 1994): A 13-items measure assessing change in cognitive, affective and behavioral-related symptoms of depression in children 8 to 18 years, with one added question about suicidality.
baseline, 10 weeks, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regionsenter for barn og unges psykiske helse

Collaborators

The Research Council of Norway
Regional kunnskapssenter for barn og unge - Midt
Regional kunnskapssenter for barn og unge - Nord

Investigators

  • Principal Investigator: Simon-Peter Neumer, Dr. phil, Regionsenter for barn og unge psykiske helse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2014

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Actual)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 15, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 228846/H10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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