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

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ClinicalTrials.gov Identifier: NCT02340637
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : May 18, 2020
Sponsor:
Collaborators:
The Research Council of Norway
Regional kunnskapssenter for barn og unge - Midt
Regional kunnskapssenter for barn og unge - Nord
Information provided by (Responsible Party):
Simon-Peter Neumer, Regionsenter for barn og unges psykiske helse

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Coping Kids Behavioral: TAU Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 873 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Coping Kids: A Randomized Controlled Study of a New Indicated Preventive Intervention for Children With Symptoms of Anxiety and Depression
Actual Study Start Date : March 3, 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: 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




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340637


Locations
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Norway
Regionsenter for barn og unges psykiske helse
Oslo, Norway, 0484
Regional kunnskapssenter for barn og unge - Nord
Tromsø, Norway, 9037
Regional kunnskapssenter for barn og unge - Midt
Trondheim, Norway, 7491
Sponsors and Collaborators
Regionsenter for barn og unges psykiske helse
The Research Council of Norway
Regional kunnskapssenter for barn og unge - Midt
Regional kunnskapssenter for barn og unge - Nord
Investigators
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Principal Investigator: Simon-Peter Neumer, Dr. phil Regionsenter for barn og unge psykiske helse
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Simon-Peter Neumer, Senior Researcher, Regionsenter for barn og unges psykiske helse
ClinicalTrials.gov Identifier: NCT02340637    
Other Study ID Numbers: 228846/H10
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders