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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

Tracking Information
First Submitted Date  ICMJE June 12, 2014
First Posted Date  ICMJE January 16, 2015
Last Update Posted Date May 18, 2020
Actual Study Start Date  ICMJE March 3, 2014
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coping Kids: Early Intervention for Anxiety and Depression
Official Title  ICMJE Coping Kids: A Randomized Controlled Study of a New Indicated Preventive Intervention for Children With Symptoms of Anxiety and Depression
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Anxiety
  • Depression
Intervention  ICMJE
  • 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
  • Behavioral: TAU
    Treatment as usual
Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: Coping Kids
  • 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.
    Intervention: Behavioral: TAU
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2019)
873
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2015)
560
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02340637
Other Study ID Numbers  ICMJE 228846/H10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Simon-Peter Neumer, Regionsenter for barn og unges psykiske helse
Study Sponsor  ICMJE Regionsenter for barn og unges psykiske helse
Collaborators  ICMJE
  • The Research Council of Norway
  • Regional kunnskapssenter for barn og unge - Midt
  • Regional kunnskapssenter for barn og unge - Nord
Investigators  ICMJE
Principal Investigator: Simon-Peter Neumer, Dr. phil Regionsenter for barn og unge psykiske helse
PRS Account Regionsenter for barn og unges psykiske helse
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP