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History of Changes for Study: NCT03274934
The Effectiveness of the Mobile-based Youth COMPASS Program to Promote Adolescent Well-being and Life-control (YouthCOMPASS)
Latest version (submitted April 1, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 4, 2017 None (earliest Version on record)
2 September 11, 2017 Study Description, Eligibility, Conditions and Study Status
3 October 26, 2017 Study Status
4 May 3, 2018 Study Status
5 April 1, 2020 Recruitment Status, Study Status and Study Design
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Study NCT03274934
Submitted Date:  September 4, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: 21000039071
Brief Title: The Effectiveness of the Mobile-based Youth COMPASS Program to Promote Adolescent Well-being and Life-control (YouthCOMPASS)
Official Title: The Effectiveness of the Novel Web- and Mobile-based Acceptance- and Commitment Therapy Program Youth COMPASS to Promote Adolescent Well-being and Life-control
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2017
Overall Status: Enrolling by invitation
Study Start: September 21, 2017
Primary Completion: December 20, 2017 [Anticipated]
Study Completion: December 31, 2019 [Anticipated]
First Submitted: September 1, 2017
First Submitted that
Met QC Criteria:
September 4, 2017
First Posted: September 7, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
September 4, 2017
Last Update Posted: September 7, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Jyvaskyla
Responsible Party: Sponsor
Collaborators: the Finnish Cultural Foundation, Central Finland Regional Fund
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The aim of this randomized control trial is to examine effectiveness of individually tailored web- and mobile-based Acceptance- and Commitment Therapy interventions to promote adolescents' well-being and life-control and subsequently support their successful transition from basic education to upper secondary education. Our additional aim is to examine to what extent the effectiveness of the intervention varies according to intervention intensity and according to risk for school failure. The five-week structured intervention is delivered using the novel web-and mobile-based program Youth COMPASS following the principles of the Acceptance and Commitment Therapy (ACT). The Internet context is assumed to be particularly motivating for youth who enjoy spending time online using different social media (Best et al., 2013). Internet-based interventions have several advantages; they can include more information and treatment components than traditionally delivered treatments and that intervention programs are accessible at any time and at any place (Andersson et al., 2009). Another unique aspect of the Youth COMPASS is the fact that it is individually-tailored. Each participant have an individually assigned online coach who provides support and encouragement, reminds about Youth COMPASS, sends individualized feedback, and recommends different exercises. The study hypothetizes that the Youth COMPASS is more effective than school counseling as usual. More specifically, the Youth COMPASS is expected to be more effective when it is combined with face-to-face support than when support and feedback are provided only via the Internet (Andersson, 2009). Also, the Youth COMPASS with no face-to-face support (online only) is expected to be more effective than receiving only regular school counseling (Lappalainen et al., 2015). Finally, the Youth COMPASS is expected to be more effective for students at risk for school failure than for students without risk for school failure, especially when at risk-adolescents receive more intensive support (i.e., both online and face-to-face support).
Detailed Description: The aim of this randomized control trial is to examine effectiveness of individually tailored web- and mobile-based Acceptance- and Commitment Therapy interventions to promote adolescents' well-being and life-control and subsequently support their successful transition from basic education to upper secondary education. Our additional aim is to examine to what extent the effectiveness of the intervention varies according to intervention intensity and according to risk for school failure. The five-week structured intervention is delivered using the novel web-and mobile-based program Youth COMPASS following the principles of the Acceptance and Commitment Therapy (ACT). The Internet context is assumed to be particularly motivating for youth who enjoy spending time online using different social media (Best et al., 2013). Internet-based interventions have several advantages; they can include more information and treatment components than traditionally delivered treatments and that intervention programs are accessible at any time and at any place (Andersson et al., 2009). Another unique aspect of the Youth COMPASS is the fact that it is individually-tailored. Each participant have an individually assigned online coach who provides support and encouragement, reminds about Youth COMPASS, sends individualized feedback, and recommends different exercises. The study hypothetizes that the Youth COMPASS is more effective than school counseling as usual. More specifically, the Youth COMPASS is expected to be more effective when it is combined with face-to-face support than when support and feedback are provided only via the Internet (Andersson, 2009). Also, the Youth COMPASS with no face-to-face support (online only) is expected to be more effective than receiving only regular school counseling (Lappalainen et al., 2015). Finally, the Youth COMPASS is expected to be more effective for students at risk for school failure than for students without risk for school failure, especially when at risk-adolescents receive more intensive support (i.e., both online and face-to-face support). The participants of the effectiveness study of the Youth COMPASS are selected from the participants of the broader longitudinal STAIRWAY (TIKAPUU in Finnish) - From Primary School to Secondary School study, which follows a community sample of Finnish adolescents (n~850) across critical educational transitions (Ahonen & Kiuru, 2013-2017; www.jyu.fi/stairway). The overall aim of the STAIRWAY project is to broaden our understanding of the individual- and environment-related factors that promote learning, well-being and successful educational transitions.
Open or close this module Conditions
Conditions: Well-being
Lifecontrol
Career Preparation
Keywords: Adolescents
Web- and mobile-based intervention
Acceptance and Commitment therapy
Psychological well-being
Career preparation
Lifecontrol
Successful educational transitions
Learning difficulties
Psychological flexibility and mindfulness skills
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Treatment, Parallel assessment, Randomized, Efficacy study
Number of Arms: 3
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 240 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Behavioral: Experimental: face-to-face and online support group:
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)
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.
Behavioral: Experimental: only online support group:
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)
Experimental: Control group
Behavioral: No intervention, school counseling as usual
Behavioral: Control
Control group, no intervention, school counseling as usual. (one third of the participants is randomly assigned to this group)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Life satisfaction (Diener et al., 1985)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
2. Self-esteem (Rosenberg, 1965),
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
3. Depressive symptoms (Salokangas et al., 1995)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
4. Stress (Elo et al., 2003)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
5. 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. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
6. Well-being in school (World Health Organization)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
7. Career choice preparedness (Koivisto et al., 2011)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
8. Educational expectations
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Secondary Outcome Measures:
1. Psychological flexibility (Greco et al., 2008)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
2. Mindfulness skills (Ciarrochi et al., 2011)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
3. 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 ]

In addition to self-reports, also school register information is collected regarding academic performance, school absences and progress in studies.
4. Truancy
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
5. School grades
[ Time Frame: Four years from the baseline. ]

In addition to self-reports, also school register information is collected.
6. Initiation of upper secondary education
[ Time Frame: Four years from the baseline. ]

In addition to self-reports, also school register information is collected.
7. Progress in upper secondary studies
[ Time Frame: Four years from the baseline. ]

In addition to self-reports, also school register information is collected.
8. Changes in study field in upper secondary education
[ Time Frame: Four years from the baseline. ]

In addition to self-reports, also school register information is collected.
9. Staying in vs. dropping out of education
[ Time Frame: Four years from the baseline. ]

In addition to self-reports, also school register information is collected.
10. Graduation time
[ Time Frame: Four years from the baseline. ]

In addition to self-reports, also school register information is collected.
Other Outcome Measures:
1. Achievement strategies (Nurmi et al., 1995)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
2. Academic buoyancy (Martin & Marsh, 2008)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
3. 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. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
4. Child-Parent relationship (Pianta, 1992)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
5. Student-Teacher relationship (Pianta, 2001)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
6. Best Friend-Student (Bukowski et al., 1994) relationship
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
7. Temperament (Rothbart & Ellis, 2001)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
8. Substance use (Rimpelä et al., 2003)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
9. Loneliness (World Health Organization)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
10. Health behaviors (World Health Organization)
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
11. Dating
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
12. Having hobbies
[ Time Frame: Change from baseline at 2, 6, 12 and 18 months after the intervention. ]

Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Open or close this module Eligibility
Minimum Age: 14 Years
Maximum Age: 16 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

The two groups of participants are randomly selected from the Finnish adolescents participating in the STAIRWAY-From Primary School to Secondary School study (n~850):

  1. Adolescents (n = 120) who have risk for school failure (learning difficulties or low grade point average without learning difficulties)
  2. Randomly chosen adolescents (n=120) from the same classrooms who have no risk for school failure

Adolescents from both groups are randomly assigned in three conditions: (a) school counseling as usually offered by school+five weeks of Youth COMPASS with face-to-face support (altogether two face-to-face meetings); b) school counseling as usual+five-weeks of Youth COMPASS with Internet feedback only; or (c) school counseling as usual only. At the baseline the participants are ninth-graders facing the transition to upper secondary education.

Open or close this module Contacts/Locations
Study Officials: Noona Kiuru, PhD
Principal Investigator
Department of Psychology, University of Jyväskylä, Finland
Locations: Finland
Department of Psychology, University of Jyväskylä
Jyväskylä, Finland, 40014
Open or close this module IPDSharing
Plan to Share IPD: Yes

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.

Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
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Links:
Available IPD/Information:

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