CClinicalTrials.gg
CompletedNCT02340637TIMUpdated May 18, 2020

Coping Kids: Early Intervention for Anxiety and Depression

An interventional study of Coping Kids and TAU in Anxiety and Depression, sponsored by Regionsenter for barn og unges psykiske helse. Completed at 3 sites in Norway. Open to participants aged 8 Years to 13 Years. Per ClinicalTrials.gov, last updated 2020-05-18.

Sponsored by Regionsenter for barn og unges psykiske helse · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2014, registered Jun 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
873
Allocation
Randomized
Ages
8 Years to 13 Years
Sex
All
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Study 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.

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Conditions studied

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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 873 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Regionsenter for barn og unges psykiske helse is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
873 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralCoping 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.

    Also known as: TIM

  • BehavioralTAU

    Treatment as usual

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What researchers measure

Primary outcomes

  1. MASC-C (Multidimensional Anxiety Scale for Children)

    Children: (1) MASC-C (March, 1997): A 40- items self-report assessing change in anxiety in children and adolescents between 8 and 19 years.

    Time frame: baseline, 10 weeks, 12 month

  2. MFQ (Mood and Feelings Questionnaire-short version)

    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.

    Time frame: baseline, 10 weeks, 12 months

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Study locations

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

Publications

  • Patras J, Martinsen KD, Holen S, Sund AM, Adolfsen F, Rasmussen LP, Neumer SP. Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression. BMC Psychol. 2016 Sep 26;4(1):48. doi: 10.1186/s40359-016-0155-y. PubMed 27671742 ↗
  • Martinsen KD, Neumer SP, Holen S, Waaktaar T, Sund AM, Kendall PC. Self-reported quality of life and self-esteem in sad and anxious school children. BMC Psychol. 2016 Sep 13;4(1):45. doi: 10.1186/s40359-016-0153-0. PubMed 27624487 ↗
  • Pedersen ML, Jozefiak T, Sund AM, Holen S, Neumer SP, Martinsen KD, Rasmussen LMP, Patras J, Lydersen S. Psychometric properties of the Brief Problem Monitor (BPM) in children with internalizing symptoms: examining baseline data from a national randomized controlled intervention study. BMC Psychol. 2021 Nov 27;9(1):185. doi: 10.1186/s40359-021-00689-1. PubMed 34838153 ↗
  • Rasmussen LP, Patras J, Handegard BH, Neumer SP, Martinsen KD, Adolfsen F, Sund AM, Martinussen M. Evaluating Delivery of a CBT-Based Group Intervention for Schoolchildren With Emotional Problems: Examining the Reliability and Applicability of a Video-Based Adherence and Competence Measure. Front Psychol. 2021 Jun 28;12:702565. doi: 10.3389/fpsyg.2021.702565. eCollection 2021. PubMed 34262514 ↗
  • Martinsen KD, Rasmussen LP, Wentzel-Larsen T, Holen S, Sund AM, Pedersen ML, Lovaas MES, Patras J, Adolfsen F, Neumer SP. Change in quality of life and self-esteem in a randomized controlled CBT study for anxious and sad children: can targeting anxious and depressive symptoms improve functional domains in schoolchildren? BMC Psychol. 2021 Jan 21;9(1):8. doi: 10.1186/s40359-021-00511-y. PubMed 33478593 ↗
  • Loevaas MES, Lydersen S, Sund AM, Neumer SP, Martinsen KD, Holen S, Patras J, Adolfsen F, Rasmussen LP, Reinfjell T. A 12-month follow-up of a transdiagnostic indicated prevention of internalizing symptoms in school-aged children: the results from the EMOTION study. Child Adolesc Psychiatry Ment Health. 2020 Apr 22;14:15. doi: 10.1186/s13034-020-00322-w. eCollection 2020. PubMed 32336987 ↗
  • Pedersen ML, Holen S, Lydersen S, Martinsen K, Neumer SP, Adolfsen F, Sund AM. School functioning and internalizing problems in young schoolchildren. BMC Psychol. 2019 Dec 23;7(1):88. doi: 10.1186/s40359-019-0365-1. PubMed 31870462 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02340637
Lead 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
Responsible party
Simon-Peter Neumer (Senior Researcher, Regionsenter for barn og unges psykiske helse) — Principal investigator
First posted
Jan 16, 2015
Start date
Mar 3, 2014
Primary completion
Jul 2017
Completion
Jul 2017
Last update
May 18, 2020

Study contacts

Simon-Peter Neumer, Dr. phil
principal investigator · Regionsenter for barn og unge psykiske helse

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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