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The Effectiveness of the Mobile-based Youth COMPASS Program to Promote Adolescent Well-being and Life-control (YouthCOMPASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03274934
Recruitment Status : Completed
First Posted : September 7, 2017
Last Update Posted : April 2, 2020
Sponsor:
Collaborator:
the Finnish Cultural Foundation, Central Finland Regional Fund
Information provided by (Responsible Party):
University of Jyvaskyla

Tracking Information
First Submitted Date  ICMJE September 1, 2017
First Posted Date  ICMJE September 7, 2017
Last Update Posted Date April 2, 2020
Actual Study Start Date  ICMJE September 21, 2017
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • School grades [ Time Frame: Four years from the baseline. ]
    In addition to self-reports, also school register information is collected.
  • Initiation of upper secondary education [ Time Frame: Four years from the baseline. ]
    In addition to self-reports, also school register information is collected.
  • Progress in upper secondary studies [ Time Frame: Four years from the baseline. ]
    In addition to self-reports, also school register information is collected.
  • 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.
  • 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.
  • Graduation time [ Time Frame: Four years from the baseline. ]
    In addition to self-reports, also school register information is collected.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 4, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of the Mobile-based Youth COMPASS Program to Promote Adolescent Well-being and Life-control
Official Title  ICMJE The Effectiveness of the Novel Web- and Mobile-based Acceptance- and Commitment Therapy Program Youth COMPASS to Promote Adolescent Well-being and Life-control
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. 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. 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. Also, the Youth COMPASS with no face-to-face support (online only) is expected to be more effective than receiving only regular school counseling. 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. 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. 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. Also, the Youth COMPASS with no face-to-face support (online only) is expected to be more effective than receiving only regular school counseling. 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. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Treatment, Parallel assessment, Randomized, Efficacy study
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Well-being
Intervention  ICMJE
  • 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)
  • 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)
  • Behavioral: Control
    Control group, no intervention, school counseling as usual. (one third of the participants is randomly assigned to this group)
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Experimental: face-to-face and online support 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.
    Intervention: Behavioral: Experimental: only online support group:
  • Experimental: Control group
    Behavioral: No intervention, school counseling as usual
    Intervention: Behavioral: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2020)
249
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2017)
240
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03274934
Other Study ID Numbers  ICMJE 21000039071
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.

Current Responsible Party University of Jyvaskyla
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Jyvaskyla
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE the Finnish Cultural Foundation, Central Finland Regional Fund
Investigators  ICMJE
Principal Investigator: Noona Kiuru, PhD Department of Psychology, University of Jyväskylä, Finland
PRS Account University of Jyvaskyla
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP