- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03274934
The Effectiveness of the Mobile-based Youth COMPASS Program to Promote Adolescent Well-being and Life-control (YouthCOMPASS)
The Effectiveness of the Novel Web- and Mobile-based Acceptance- and Commitment Therapy Program Youth COMPASS to Promote Adolescent Well-being and Life-control
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jyväskylä, Finland, 40014
- Department of Psychology, UNiversity of Jyvaskyla
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adolescents (n = 120) who have risk for school failure (learning difficulties or low grade point average without learning difficulties)
- Randomly chosen adolescents (n=120) from the same classrooms who have no risk for school failure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Face-to-face and online support group
Behavioral: Structured web- and mobile-based intervention with Youth COMPASS program to support adolescents' well-being, career preparation and life-control and subsequently support successful transition to upper secondary education.
The Youth COMPASS is the five-week online program according to principles of Acceptance and Commitment Therapy aiming to enhance adolescents' psychological flexibility by guiding adolescents in exploring their values and setting goals and changing behaviors according to their goals (week 1), and learning acceptance defusion and mindfulness skills (weeks 2-3) and integrating these skills into their personal life (weeks 4-5).
The participants in this condition receive weekly online support and feedback from their individually assigned coach.
In addition, they meet their coach twice in the face-to-face meetings.
The aim of the meetings is to increase adolescents' internal motivation and thereby participation in the program.
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5-week intervention according to Acceptance and Commitment Therapy principles with the web-and mobile-based Youth COMPASS program, face-to-face support (2 meetings) and weekly online mobile support and feedback from the individually assigned coach (one third of the participants is randomly assigned to this group)
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Experimental: Only online support group
Behavioral: web- and mobile-based intervention with Youth COMPASS program to support adolescents' well-being, career preparation and life-control and subsequently support successful transition to upper secondary education.
The Youth COMPASS is a five-week online program according to principles of Acceptance and Commitment Therapy aiming to enhance adolescents' psychological flexibility by guiding adolescents in exploring their values and setting goals and changing behaviors according to their goals (week 1), and learning acceptance defusion and mindfulness skills (weeks 2-3) and integrating these skills into their personal life (weeks 4-5).
The participants in this condition receive weekly online support and feedback from their individually assigned coach.
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5-week intervention according to ACT principles with the web-and mobile-based Youth COMPASS program, no face-to-face support, weekly mobile online support and feedback from the individually assigned coach (one third of the participants is randomly assigned to this group)
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Experimental: Control group
Behavioral: No intervention, school counseling as usual
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Control group, no intervention, school counseling as usual.
(one third of the participants is randomly assigned to this group)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Life satisfaction (Diener et al., 1985)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Self-esteem (Rosenberg, 1965),
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Depressive symptoms (Salokangas et al., 1995)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Stress (Elo et al., 2003)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Difficulties and Strenghts questionnaire (SDQ, Goodman et al. 1997) measuring emotional symptoms, hyperactivity, conduct problems and prosociality
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Well-being in school (World Health Organization)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Career choice preparedness (Koivisto et al., 2011)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Educational expectations
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Psychological flexibility (Greco et al., 2008)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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|
Mindfulness skills (Ciarrochi et al., 2011)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Identity formation (DIDS; Luyckx et al., 2008; see also Marttinen et al., 2016)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention
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In addition to self-reports, also school register information is collected regarding academic performance, school absences and progress in studies.
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Change from baseline at 2, 6, 12 and 18 months after the intervention
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Truancy
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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School grades
Time Frame: Four years from the baseline.
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In addition to self-reports, also school register information is collected.
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Four years from the baseline.
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Initiation of upper secondary education
Time Frame: Four years from the baseline.
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In addition to self-reports, also school register information is collected.
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Four years from the baseline.
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Progress in upper secondary studies
Time Frame: Four years from the baseline.
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In addition to self-reports, also school register information is collected.
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Four years from the baseline.
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Changes in study field in upper secondary education
Time Frame: Four years from the baseline.
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In addition to self-reports, also school register information is collected.
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Four years from the baseline.
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Staying in vs. dropping out of education
Time Frame: Four years from the baseline.
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In addition to self-reports, also school register information is collected.
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Four years from the baseline.
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Graduation time
Time Frame: Four years from the baseline.
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In addition to self-reports, also school register information is collected.
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Four years from the baseline.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Achievement strategies (Nurmi et al., 1995)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Academic buoyancy (Martin & Marsh, 2008)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Recovery from school work (see also Winwood et al., 2005)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Child-Parent relationship (Pianta, 1992)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Student-Teacher relationship (Pianta, 2001)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Best Friend-Student (Bukowski et al., 1994) relationship
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Temperament (Rothbart & Ellis, 2001)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Substance use (Rimpelä et al., 2003)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Loneliness (World Health Organization)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Health behaviors (World Health Organization)
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Dating
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Having hobbies
Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
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Change from baseline at 2, 6, 12 and 18 months after the intervention.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Noona Kiuru, PhD, Department of Psychology, University of Jyväskylä, Finland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 21000039071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Other researchers are encouraged to use the data; however, it requires a research plan and the permission of the research team. Also, at least one of the team members, who know the data well, should be a co-author in all the articles that are written from the data.
After 10 years of the data collection, those parts of the data that are not too sensitive (e.g., part of the questionnaire data), will be prepared in collaboration with a Finnish Social Science data Archive in a format that is easily accessible for other researchers. However, using data requires a research plan and the permission of the research team. Also, at least one of the team members, who know the data well, should be a co-author in all the articles that are written from the data.
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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