Coping Kids: Early Intervention for Anxiety and Depression

NCT ID: NCT02340637

Last Updated: 2020-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

873 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-03

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Coping Kids

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

TAU

Intervention Type BEHAVIORAL

Treatment as usual

Interventions

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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.

Intervention Type BEHAVIORAL

TAU

Treatment as usual

Intervention Type BEHAVIORAL

Other Intervention Names

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TIM

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Research Council of Norway

OTHER

Sponsor Role collaborator

Regional kunnskapssenter for barn og unge - Midt

UNKNOWN

Sponsor Role collaborator

Regional kunnskapssenter for barn og unge - Nord

UNKNOWN

Sponsor Role collaborator

Regionsenter for barn og unges psykiske helse

OTHER

Sponsor Role lead

Responsible Party

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Simon-Peter Neumer

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon-Peter Neumer, Dr. phil

Role: PRINCIPAL_INVESTIGATOR

Regionsenter for barn og unge psykiske helse

Locations

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Regionsenter for barn og unges psykiske helse

Oslo, , Norway

Site Status

Regional kunnskapssenter for barn og unge - Nord

Tromsø, , Norway

Site Status

Regional kunnskapssenter for barn og unge - Midt

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 27671742 (View on PubMed)

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.

Reference Type RESULT
PMID: 27624487 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34838153 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34262514 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33478593 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32336987 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31870462 (View on PubMed)

Other Identifiers

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228846/H10

Identifier Type: -

Identifier Source: org_study_id

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