- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04128644
Thoughts and Health - Preventing Depression in Adolescents
Study Overview
Status
Intervention / Treatment
Detailed Description
Clinical depression is a crucial problem among adolescents. In eighth grade more than half of all students experience headaches, stomach pain, stress, feeling down, and difficulties sleeping. Adolescents affected by depression at a young age are at greater risk of experiencing depressive symptoms as adults, with serious impacts on their quality of life and ability to work. Recent reports from the National Board of Health and Welfare have shown that depression is increasing among adolescents and there is now focus on implementing practice-oriented preventative programs for youth.
Studies by members of our research team have shown that a cognitive-behavioral, developmentally-based intervention program, called "Thoughts and Health", prevented initial episodes of depression and/or dysthymia in adolescents for up to 12 months after program completion.
This study aims to test the feasibility of implementing that program in a Swedish school setting, while also collecting and analyzing preliminary results regarding the potential impact of the program on number of students developing depressive symptoms and the number passing junior high school with full grades.
This is an intervention study with a control group. Students from two Swedish junior high schools will be identified as "at-risk" and invited to participate in the program (n=40), while students from two other schools will act as controls (n=40). All participating students will be followed from study start (baseline) and 1, 6, 12, and 18 months after program completion. Results will include quantitative clinical measures, qualitative focus group discussions, and students' final grades. Two courses of the program will be run over two school years. This study involves close collaboration between academia, primary care, and the community.
This is to our knowledge the first study in Sweden that employs a longitudinal design to evaluate the effects of a school program aimed at preventing depression in adolescents.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Josefine Lilja, PhD
- Phone Number: +46769402969
- Email: josefine.lilja@vgregion.se
Study Contact Backup
- Name: Carl Wikberg, PhD
- Phone Number: +46703821660
- Email: carl.wikberg@allmed.gu.se
Study Locations
-
-
-
Göteborg, Sweden, 41119
- Recruiting
- FoU Research and Development
-
Contact:
- Carl Wikberg
- Email: carl.wikberg@allmed.gu.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Eight grader (school)
- Completed Childrens Depression Inventory (CDI) screening
- Able to understand Swedish both orally and written to a level that he/she can complete forms and questionnaires by themselves
Exclusion Criteria:
- Current or past depression
- Unable to function in a group session
- Current psychotherapeutic treatment
- Past or current suicidal thoughts or attempts
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Standard of care+Thoughts & health
12 sessions of Thoughts & Health.
Baseline questionnaires and follow up assessments
|
12 sessions of Thoughts & Health.
Baseline questionaires and follow up assessments
Baseline questionnaires and follow up assessments, intervention as usual, Student Health
|
Other: Standard of care
Baseline questionnaires and follow up assessments, intervention as usual Student Health
|
Baseline questionnaires and follow up assessments, intervention as usual, Student Health
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive episode
Time Frame: 18 months
|
Number of participants that have scores that indicate a depressive episode.
Questionnaire CDI (Children Depression Inventory), CDI has 27 items scores, each item range from 0-3, above the 90th percentile indicate depressive problems, 90th percentile indicate depressive episode.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete grades
Time Frame: 18 months
|
Measures if participants have complete grades from ninth grade when finishing school.
Will be collected through public school registers.
|
18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Life quality
Time Frame: 18 month
|
Collect data from participants through questionnaire: MHC- SF (Mental health continuum), MHC-SF consists of 14 items asking about the frequency of experiences the last month.
There are three items on emotional well-being such as feelings of being happy, interested in life and satisfied, five items on social well-being referring to acceptance, actualization, contribution, coherence and integration and six items on psychological well-being capturing purpose in life, environmental mastery, autonomy, personal growth, positive relations and self-acceptance.
Answers are given on a 6-point Likert scale from 0-6.
|
18 month
|
Social adjustment
Time Frame: 18 month
|
Collect data from participants through questionnaire: EWSAS (Education Work Social Adjustment Scale), EWSAS consists of 5 items asking if and to what amount the mental health issues are affecting friendships, family relationships, school environment and social activities.
Likert scale from 0-8.
|
18 month
|
Mental health
Time Frame: 18 month
|
Collect data from participants through questionnaire: RCADS (Revised Anxiety and Depression Scale), It is designed to assess clinical syndromes of anxiety as well as depression, building on the DSM-IV criteria.
The RCADS provides two total scores, and 6 subscales: Separation Anxiety Disorder (SAD), Social Phobia (SoP), Obsessive Compulsive Disorder (OCD), Panic Disorder (PD), (GAD) and Major Depressive Disorder (MDD).
The higher the score the more symptoms of mental health issues.
The scale grades from 0-141.
|
18 month
|
Mental Clinical Assessment
Time Frame: 18 month
|
Assessment through Clinical interview: MINI-KID (Mini International Neuropsychiatric Interview)
|
18 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Josefine Lilja, PhD, Vastra Gotaland Region
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-03347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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