Coping Kids: Early Intervention for Anxiety and Depression

Depression Clinical Trial

— TIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340637
• Other study ID #: 228846/H10
• Status: Completed
• Phase: N/A
• Start date: March 3, 2014
• Est. completion date: July 2017

Study information

• Verified date: May 2020
• Source: Regionsenter for barn og unges psykiske helse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 873
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

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.
• TAU
Treatment as usual

Locations

Country	Name	City	State
Norway	Regionsenter for barn og unges psykiske helse	Oslo
Norway	Regional kunnskapssenter for barn og unge - Nord	Tromsø
Norway	Regional kunnskapssenter for barn og unge - Midt	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Regionsenter for barn og unges psykiske helse	Regional kunnskapssenter for barn og unge - Midt, Regional kunnskapssenter for barn og unge - Nord, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 10 weeks, 12 month
Primary	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.	baseline, 10 weeks, 12 months