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

April 1, 2020 updated by: University of Jyvaskyla

The Effectiveness of the Novel Web- and Mobile-based Acceptance- and Commitment Therapy Program Youth COMPASS to Promote Adolescent Well-being and Life-control

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
249

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Jyväskylä, Finland, 40014
        • Department of Psychology, UNiversity of Jyvaskyla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
School grades
Time Frame: Four years from the baseline.
In addition to self-reports, also school register information is collected.
Four years from the baseline.
Initiation of upper secondary education
Time Frame: Four years from the baseline.
In addition to self-reports, also school register information is collected.
Four years from the baseline.
Progress in upper secondary studies
Time Frame: Four years from the baseline.
In addition to self-reports, also school register information is collected.
Four years from the baseline.
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.
Four years from the baseline.
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.
Four years from the baseline.
Graduation time
Time Frame: Four years from the baseline.
In addition to self-reports, also school register information is collected.
Four years from the baseline.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.
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.
Change from baseline at 2, 6, 12 and 18 months after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Jyvaskyla

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
the Finnish Cultural Foundation, Central Finland Regional Fund

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Noona Kiuru, PhD, Department of Psychology, University of Jyväskylä, Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21000039071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

No

Studies a U.S. FDA-regulated device product

No

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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