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