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Clinical Trials/NCT02340637
NCT02340637
Completed
N/A

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

Regionsenter for barn og unges psykiske helse3 sites in 1 country873 target enrollmentMarch 3, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
Regionsenter for barn og unges psykiske helse
Enrollment
873
Locations
3
Primary Endpoint
MASC-C (Multidimensional Anxiety Scale for Children)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2014
End Date
July 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Regionsenter for barn og unges psykiske helse
Responsible Party
Principal Investigator
Principal Investigator

Simon-Peter Neumer

Senior Researcher

Regionsenter for barn og unges psykiske helse

Eligibility 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.

Outcomes

Primary Outcomes

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.

Study Sites (3)

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