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Primary registry and trial identifying number
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ISRCTN registry ISRCTN19700389
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Date of registration in primary registry
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6 October 2015
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Secondary identifying numbers
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Protocol/serial number: 238081
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Source(s) of monetary or material support
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The Norwegian Research Council
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Primary sponsor
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The Norwegian Research Council
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Secondary sponsor(s)
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The Norwegian Center for Child Behavioral Development
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Contact for public queries
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Görel Bringedal g.e.bringedal@atferdssenteret.no
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Contact for scientific queries
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Thormod Idsoe thormod.idsoe@atferdssenteret.no
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Public title
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Effectiveness study of a CBT based adolescent coping with depression course
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Scientific title
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Effectiveness study of a CBT based adolescent coping with depression course to prevent dropout in upper secondary school
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Countries of recruitment
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Norway
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Health condition(s) or problem(s) studied
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Mild/moderate depression among adolescents
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Intervention(s)
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Active comparator: CBT-based group intervention, 8 consecutive weekly sessions of 120 min, two follow-up sessions conducted about 3 and 6 weeks after the last session, lasting approximately 90 min
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Placebo comparator: Usual care
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Key inclusion and exclusion criteria
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Cluster-randomized design where the course-leaders are recruited from the School Health Service, Public Health Nurses, the Educational and Psychological Counselling Services (PPT). They are then taught how to recruit a group of 1st or second year students from Upper Secondary School (Videregående skole). A complete assessment of possible participants (adolescents) has to be made by the course instructors before acceptance into the study.
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Inclusion criteria for adolescents:
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1. First or second year of upper secondary school (about 16–17 years old)
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2. Who have subclinical depression or mild to moderate major depressive disorder (MDD), according to the criteria of the DSM
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3. Normal intellectual functioning
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4. Normal reading abilities, and that was evaluated through the interview.
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Exclusion criteria for adolescents:
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1. Bipolar disorder
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2. Psychosis
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3. Substance-use
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4. ADHD or ADD
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5. Brain damage
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6. Danger of suicide
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7. Adolescents who are easily agitated
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8. Adolescents who lack the ability to function in a group
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Study type
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Single-centre cluster-randomized effectiveness trial with active control. Primary study design
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Interventional, Secondary study design
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Cluster randomised trial
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Date of first enrolment
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01/11/2015
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Target sample size
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35 clusters with 8–12 adolescents within each cluster
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Recruitment status
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Recruiting
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Primary outcome(s)
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1. Center for Epidemiological Studies Depression Scale, CES-D for adolescents, at Pre-test, T1, T2, T3, T4
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2. Dysfunctional Attitudes Scale (DAS) (short version) at Pre-test, T2, T3, T4
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3. Automatic Thoughts Questionnaire (ATQ) (short version) at Pre-test, T2, T3, T4
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4. Ruminative Response Scale (RRS) (short version) at Pre-test, T2, T3, T4
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5. Emotion regulation at Pre-test, T2, T3, T4
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6. Dropout (from school and official registries) at T1, T2, T3, T4
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7. Grades at T1, T2, T3, T4
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Key secondary outcomes
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1. Intentions to quit school at Pre-test, T2, T3, T4
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2. Social and Cognitive Competence at Pre-test, T2, T3, T4
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3. Life events at Pre-test, T2, T3, T4
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