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School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02134730
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : January 30, 2015
Information provided by (Responsible Party):
Uppsala University

Brief Summary:

Mental illness is a major health problem in children and young people, and there is evidence that mental illness is increasing among young people in the population. More than 80 % of the cost to society of mental illness in children in Sweden is the cost of treatment and care.

Anxiety and depression are the most common psychiatric problems in children and adolescents.

In comparison with the treatment of mental disorders, there is relatively limited knowledge about prevention. There are at least two very important reasons to investigate further preventive interventions for anxiety and depression. (1) Only about 20% of children and adolescents with anxiety or depression use health services. (2) Some children stop treatment and almost 40% do still fulfill criteria for the disorder after treatment.

FRIENDS for life is one of the most evaluated prevention programs internationally. The program has shown promising results in research. The overall aim of the present study is to evaluate FRIENDS for Life in Sweden.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: FRIENDS for life Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 695 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial Using the FRIENDS for Life Manual
Study Start Date : September 2013
Actual Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: Wait list
Schools in waitlist condition will be offered the intervention after the 12-months follow up. Waitlist means that the schools work as usual with issues of mental health.
Experimental: FRIENDS for life
The intervention is delivered for 10 consecutive weeks, 60 minutes per session.
Behavioral: FRIENDS for life
Friends for life (FFL). The FFL is a prevention program created by professor Paula Barrett, Brisbane, Australia. It is based on cognitive behavioral treatment strategies, for example the link between thoughts and feelings, negative and positive thoughts, breathing and relaxing exercises, support from others, breaking challenging situation in smaller steps, and problem-solving techniques. The children's workbook comprises practice-sheets for use during class, and homework assignments. The group leader manual comprises detailed instructions to all exercises.

Primary Outcome Measures :
  1. Change in SCAS (Spence Children's Anxiety Scale) [ Time Frame: Participants are assessed pre intervention, post intervention and up to 12-months ]
    Additional assessments using a short version of the SCAS (12 items out of 44) are made at two occasions during intervention (october and november 2013)

Secondary Outcome Measures :
  1. The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) [ Time Frame: Assessed up to 12-months ]
  2. Change in Children's Depression Inventory (CDI) [ Time Frame: Assessed pre intervention, post intervention and up to 12 months ]
  3. Change in Strengths and Difficulties Questionnaire (SDQ) [ Time Frame: Assessed pre intervention, post intervention and up to 12 months follow-up ]
    SDQ is rated by participants' parents and teachers

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Written parental consent

Exclusion Criteria:

  • No other exclusion criteria since of universal prevention

Information from the National Library of Medicine

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 identifier (NCT number): NCT02134730

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Department of Psychology, Uppsala University
Uppsala, Sweden, 75142
Sponsors and Collaborators
Uppsala University
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Principal Investigator: Ata Ghaderi, Dr. Karolinska Institutet
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Responsible Party: Uppsala University Identifier: NCT02134730    
Other Study ID Numbers: AGJA-01
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015
Keywords provided by Uppsala University:
FRIENDS for life
universal prevention
school children
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders