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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||873 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
Treatment as usual
- 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.
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
|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|
|Principal Investigator:||Simon-Peter Neumer, Dr. phil||Regionsenter for barn og unge psykiske helse|