Psychological FlexibilityYouthCompass+NCT04340206
Youth Compass Plus
A study testing face-to-face support and Chatbot online support group and only chat-robot online support group in people with Psychological Flexibility and Psychological Well-being, run by University of Jyvaskyla at 1 site in Finland.
Trial summary
The aim of this randomized control trial is to examine the effectiveness of a novel web- and mobile-based Acceptance and Commitment Therapy program (Youth Compass plus) to promote adolescents' psychological flexibility and well-being and subsequently support their successful transition from basic education to upper… Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Flexibility, Psychological Well-being
- What is being tested?
- face-to-face support and Chatbot online support group and only chat-robot online support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteFinland
- Study dates
- 8 Sep 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Approximately 600-1000 Finnish 14-16 year old adolescents from non-clinical school-age population will fill in a pre-questionnaire. Based on this data the participants for the randomized control trial will be selected from the two gender-balanced groups of Finnish adolescents:
- Adolescents (n = 150) who have heightened (pre-clinical) level of symptoms of stress/anxiety/depression in the screening measures (no diagnosis is required for participation).
- Randomly chosen adolescents (n=150) who have no symptoms of stress/anxiety/depression in the screening measures
- Adolescents from both groups are randomly assigned in three conditions: (a) five weeks of Youth Compass plus with support from chatbot + face-to-face support (altogether two face-to-face meetings); b) five-weeks of Youth Compass plus with support from chatbot only; or (c) no intervention. At the baseline (fall 2020) the participants will be ninth-graders facing the transition to upper secondary education.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Psychology University of Jyvaskyla
Jyväskylä, 40014
About this study
Official title: The Effectiveness of the Youth Compass Plus: The Novel Five-week Web- and Mobile-based Acceptance- and Commitment Therapy Program to Promote Adolescent Psychological Flexibility and Well-being
The aim of this randomized control trial is to examine the effectiveness of a novel web- and mobile-based Acceptance and Commitment Therapy program (Youth Compass plus) to promote adolescents' psychological flexibility and well-being and subsequently support their successful transition from basic education to upper secondary education. Our aim is also to compare the efficacy of Youth Compass plus using either an eCoach providing automated personal support to the user or an eCoach and a Human Coach providing personal support to the user. Additionally, we will investigate whether the efficacy of the Youth Compass plus varies according to different individual and contextual factors.
Using the internet to deliver interventions is assumed to be particularly motivating for youth who enjoy spending time online using different social media. Web-based interventions have several advantages; they can include more information and treatment components than traditionally delivered treatments and they are accessible at any time and place. The five-week structured intervention is delivered using the novel web- and mobile-based program Youth Compass plus. Youth Compass plus has been developed based on the feedback for the Youth COMPASS pilot program (see ClinicalTrials.gov, NCT03274934). The exercises of Youth Compass plus have been modified, visual aspects have been improved and new game-based interactive elements have been developed. In the Youth COMPASS pilot study, psychology students acted as (human) coaches for the users. While interaction with a personal coach increases commitment to the program, the need to train and supervise coaches limits large scale dissemination. To provide an alternative that is less demanding in terms of resources, we have developed a chatbot (eCoach) as a new feature within the new Youth Compass plus program. The automated eCoach provides personal support within the program and via text messages. The eCoach provides support and encouragement, reminds about using Youth Compass plus, sends individualized feedback, and recommends different exercises.
Read the detailed description
The aim of this randomized trial is to examine whether Youth Compass plus enhances adolescents' (a) psychological skills, particularly with respect to finding a purpose, and psychological flexibility and adaptation skills as the ACT process outcomes; (b) career preparation and psychological well-being as the proximal outcomes; and (c) the initiation of upper secondary education studies and engagement in upper secondary education as the distal outcomes.
In addition, our aim is to investigate the ACT processes and mediating mechanisms of the Youth Compass plus program, and to explore the extent to which the effectiveness of the Youth Compass plus varies according to the differences in various individual and contextual factors.
H1: The study expects that the Youth Compass plus is more effective than no intervention. Youth Compass plus is expected to promote ACT proximal youth outcomes, as well as the youth distal outcomes.
H2: In addition, the study expects that the Youth Compass plus will promote the distal outcomes through enhancing the ACT process outcomes and the proximal outcomes.
H3: The study expects that Youth Compass plus is more effective for those adolescents who accept the intervention well, take part intensively and diversely in different exercises, as well as among the adolescents who are initially highly emotionally reactive.
- Being tested
- face-to-face support and Chatbot online support group, only chat-robot online support group, Control group, no intervention
- Keywords
- Adolescents, Acceptance Commitment Therapy, Web- and mobile-based intervention, Psychological flexibility, Psychological well-being, Career preparation, Successful educational transitions
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
face-to-face support and Chatbot online support groupBehavioural
Behavioral: Structured web- and mobile-based intervention with Youth Compass plus program to support adolescents' psychological flexibility, well-being, and subsequently support successful transition to upper secondary education. The Youth Compass plus is a five-week online program 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 and social life (weeks 4-5). The participants in this condition receive weekly online support and feedback from the eCoach built within the program. In addition, they meet and get support from their human coach (i.e., psychology student) twice in the face-to-face meetings.
only chat-robot online support groupBehavioural
Behavioral: Structured web- and mobile-based intervention with Youth Compass plus program to adolescents' psychological flexibility, well-being, and subsequently support successful transition to upper secondary education. The Youth Compass plus is a five-week online program 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 and social life (weeks 4-5). The participants in this condition receive weekly online support and feedback from the eCoach built within the program.
Control group, no interventionBehavioural
Behavioral: No intervention
| Study group | Role | What they receive |
|---|---|---|
| face-to-face support and Chatbot online support group | Experimental | Experimental, Intervention Group A: face-to-face support and Chatbot online support group: 5-week intervention according to ACT principles with the web- and mobile-based Youth Compass plus program, face-to-face support (2 meetings) and weekly online support and feedback from the Chabot eCoach built within the program (one third of the participants is randomly assigned to this group) Receives: Behavioral: face-to-face support and Chatbot online support group |
| only chat-robot online support group | Experimental | Experimental, Intervention Group B: only chat-robot online support group: 5-week intervention according to ACT principles with the web-and mobile-based Youth Compass plus program, no face-to-face support, and weekly online support and feedback from the chatbot eCoach built within the program (one third of the participants is randomly assigned to this group) Receives: Behavioral: only chat-robot online support group |
| Experimental Control | Experimental | Experimental Control:
Control group, no intervention (one third of the participants is randomly assigned to this group) Receives: Behavioral: Control group, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychological flexibility
Comprehensive assessment of Acceptance and Commitment Therapy processes, CompACT; Francis et al., 2016
Measured: Change from baseline at 2 and 6 months after the intervention
psychological flexibility
Cognitive Fusion Questionnaire (Gillanders et al., 2014)
Measured: Change from baseline at 2 and 6 months after the intervention
life satisfaction
Satisfaction with Life Scale, SWLS, Diener et al., 1985
Measured: Change from baseline at 2 and 6 months after the intervention
mental well-being
Warwick-Edinburgh Mental Well-being Scale WEMWBS; THL 2011
Measured: Change from baseline at 2 and 6 months after the intervention
stress symptoms
Perceived Stress Scale, PSS-10; Cohen et al., 1983
Measured: Change from baseline at 2 and 6 months after the intervention
anxiety symptoms
short-form of the state scale of the Spielberger State-Trait Anxiety Inventory, STAI; Marteau \& Becker, 1992
Measured: Change from baseline at 2 and 6 months after the intervention
depressive symptoms
Depression Scale, DEPS; Salokangas et al., 1995
Measured: Change from baseline at 2 and 6 months after the intervention
Career choice preparedness
career choice self-efficacy, career-related insecurity, preparation against setbacks, Koivisto et al., 2011
Measured: Change from baseline at 2 and 6 months after the intervention
Secondary outcomes (8)
perfectionism
The Child-Adolescent; Perfectionism Scale, CAPS; Gordon et al., 2016
Measured: Change from baseline at 2 and 6 months after the intervention
self-compassion
Self-Compassion Scale - Short Form; Raes et al., 2011
Measured: Change from baseline at 2 and 6 months after the intervention
prosocial aspirations
short form of the Aspirations Index, Marshall, 2019
Measured: Change from baseline at 2 and 6 months after the intervention
academic buoyancy
short Academic buoyancy scale; Martin \& Marsh, 2008
Measured: Change from baseline at 2 and 6 months after the intervention
school well-being
school satisfaction, anti-school attitude, school-related stress, WHO
Measured: Change from baseline at 2 and 6 months after the intervention
academic performance
grade point average
Measured: Change from baseline at 2 and 6 months after the intervention
truancy and school absences
truancy and school absences, Finnish School Health Questionnaire
Measured: Change from baseline at 2 and 6 months after the intervention
educational attainment, information from school registers
initiation of upper secondary education, progress in studies, changes in study field, graduation time,
Measured: 2020-2025 (not possible to provide more specitic time frame)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start8 Sep 2020
- Primary completion15 Dec 2020
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological FlexibilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Efficacy study
- Masking
- None (open label)
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Finland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340206
- Sponsor's protocol ID
- 324638
- Acronym
- YouthCompass+
- Status last verified
- May 2022
- First submitted
- 1 Apr 2020
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ownership of the data will reside with the University of Jyväskylä and the data are managed by the PI and her research team. Research co-operation agreements will be made with the collaborators about confidentiality issues, data management principles, and use of data in publications. Other researchers are encouraged to use the data; however, it requires a research plan and the permission of the research team. Principally, the PI or someone else from the research team will be one of the co-authors in all publications written from the data.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Youth Compass Plus: The Novel Five-week Web- and Mobile-based Acceptance- and Commitment Therapy Program to Promote Adolescent Psychological Flexibility and Well-being
- ClinicalTrials.gov ID
- NCT04340206
- Acronym / sponsor ID
- YouthCompass+ / 324638
- Keywords
- Adolescents, Acceptance Commitment Therapy, Web- and mobile-based intervention, Psychological flexibility, Psychological well-being, Career preparation, Successful educational transitions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Collaborators
- Academy of Finland
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized control trial is to examine the effectiveness of a novel web- and mobile-based Acceptance and Commitment Therapy program (Youth Compass plus) to promote adolescents' psychological flexibility and well-being and subsequently support their successful transition from basic education to upper secondary education. Our aim is also to compare the efficacy of Youth Compass plus using either an eCoach providing automated personal support to the user or an eCoach and a Human Coach providing personal support to the user. Additionally, we will investigate whether the efficacy of the Youth Compass plus varies according to different individual and contextual factors.
Using the internet to deliver interventions is assumed to be particularly motivating for youth who enjoy spending time online using different social media. Web-based interventions have several advantages; they can include more information and treatment components than traditionally delivered treatments and they are accessible at any time and place. The five-week structured intervention is delivered using the novel web- and mobile-based program Youth Compass plus. Youth Compass plus has been developed based on the feedback for the Youth COMPASS pilot program (see ClinicalTrials.gov, NCT03274934). The exercises of Youth Compass plus have been modified, visual aspects have been improved and new game-based interactive elements have been developed. In the Youth COMPASS pilot study, psychology students acted as (human) coaches for the users. While interaction with a personal coach increases commitment to the program, the need to train and supervise coaches limits large scale dissemination. To provide an alternative that is less demanding in terms of resources, we have developed a chatbot (eCoach) as a new feature within the new Youth Compass plus program. The automated eCoach provides personal support within the program and via text messages. The eCoach provides support and encouragement, reminds about using Youth Compass plus, sends individualized feedback, and recommends different exercises.
Detailed description
The aim of this randomized trial is to examine whether Youth Compass plus enhances adolescents' (a) psychological skills, particularly with respect to finding a purpose, and psychological flexibility and adaptation skills as the ACT process outcomes; (b) career preparation and psychological well-being as the proximal outcomes; and (c) the initiation of upper secondary education studies and engagement in upper secondary education as the distal outcomes.
In addition, our aim is to investigate the ACT processes and mediating mechanisms of the Youth Compass plus program, and to explore the extent to which the effectiveness of the Youth Compass plus varies according to the differences in various individual and contextual factors.
H1: The study expects that the Youth Compass plus is more effective than no intervention. Youth Compass plus is expected to promote ACT proximal youth outcomes, as well as the youth distal outcomes.
H2: In addition, the study expects that the Youth Compass plus will promote the distal outcomes through enhancing the ACT process outcomes and the proximal outcomes.
H3: The study expects that Youth Compass plus is more effective for those adolescents who accept the intervention well, take part intensively and diversely in different exercises, as well as among the adolescents who are initially highly emotionally reactive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Efficacy study
| Arm | Type | Receives |
|---|---|---|
| face-to-face support and Chatbot online support group | Experimental | Behavioral: face-to-face support and Chatbot online support groupExperimental, Intervention Group A: face-to-face support and Chatbot online support group: 5-week intervention according to ACT principles with the web- and mobile-based Youth Compass plus program, face-to-face support (2 meetings) and weekly online support and feedback from the Chabot eCoach built within the program (one third of the participants is randomly assigned to this group) |
| only chat-robot online support group | Experimental | Behavioral: only chat-robot online support groupExperimental, Intervention Group B: only chat-robot online support group: 5-week intervention according to ACT principles with the web-and mobile-based Youth Compass plus program, no face-to-face support, and weekly online support and feedback from the chatbot eCoach built within the program (one third of the participants is randomly assigned to this group) |
| Experimental Control | Experimental | Behavioral: Control group, no interventionExperimental Control: Control group, no intervention (one third of the participants is randomly assigned to this group) |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Approximately 600-1000 Finnish 14-16 year old adolescents from non-clinical school-age population will fill in a pre-questionnaire. Based on this data the participants for the randomized control trial will be selected from the two gender-balanced groups of Finnish adolescents:
- Adolescents (n = 150) who have heightened (pre-clinical) level of symptoms of stress/anxiety/depression in the screening measures (no diagnosis is required for participation).
- Randomly chosen adolescents (n=150) who have no symptoms of stress/anxiety/depression in the screening measures
- Adolescents from both groups are randomly assigned in three conditions: (a) five weeks of Youth Compass plus with support from chatbot + face-to-face support (altogether two face-to-face meetings); b) five-weeks of Youth Compass plus with support from chatbot only; or (c) no intervention. At the baseline (fall 2020) the participants will be ninth-graders facing the transition to upper secondary education.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| face-to-face support and Chatbot online support groupBehavioral: Structured web- and mobile-based intervention with Youth Compass plus program to support adolescents' psychological flexibility, well-being, and subsequently support successful transition to upper secondary education. The Youth Compass plus is a five-week online program 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 and social life (weeks 4-5). The participants in this condition receive weekly online support and feedback from the eCoach built within the program. In addition, they meet and get support from their human coach (i.e., psychology student) twice in the face-to-face meetings. | Behavioural | face-to-face support and Chatbot online support group |
| only chat-robot online support groupBehavioral: Structured web- and mobile-based intervention with Youth Compass plus program to adolescents' psychological flexibility, well-being, and subsequently support successful transition to upper secondary education. The Youth Compass plus is a five-week online program 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 and social life (weeks 4-5). The participants in this condition receive weekly online support and feedback from the eCoach built within the program. | Behavioural | only chat-robot online support group |
| Control group, no interventionBehavioral: No intervention | Behavioural | Experimental Control |
Primary outcome
psychological flexibility
Time frame: Change from baseline at 2 and 6 months after the intervention
Comprehensive assessment of Acceptance and Commitment Therapy processes, CompACT; Francis et al., 2016
psychological flexibility
Time frame: Change from baseline at 2 and 6 months after the intervention
Cognitive Fusion Questionnaire (Gillanders et al., 2014)
life satisfaction
Time frame: Change from baseline at 2 and 6 months after the intervention
Satisfaction with Life Scale, SWLS, Diener et al., 1985
mental well-being
Time frame: Change from baseline at 2 and 6 months after the intervention
Warwick-Edinburgh Mental Well-being Scale WEMWBS; THL 2011
stress symptoms
Time frame: Change from baseline at 2 and 6 months after the intervention
Perceived Stress Scale, PSS-10; Cohen et al., 1983
anxiety symptoms
Time frame: Change from baseline at 2 and 6 months after the intervention
short-form of the state scale of the Spielberger State-Trait Anxiety Inventory, STAI; Marteau \& Becker, 1992
depressive symptoms
Time frame: Change from baseline at 2 and 6 months after the intervention
Depression Scale, DEPS; Salokangas et al., 1995
Career choice preparedness
Time frame: Change from baseline at 2 and 6 months after the intervention
career choice self-efficacy, career-related insecurity, preparation against setbacks, Koivisto et al., 2011
8 secondary outcomes
perfectionism
Time frame: Change from baseline at 2 and 6 months after the intervention
self-compassion
Time frame: Change from baseline at 2 and 6 months after the intervention
prosocial aspirations
Time frame: Change from baseline at 2 and 6 months after the intervention
academic buoyancy
Time frame: Change from baseline at 2 and 6 months after the intervention
school well-being
Time frame: Change from baseline at 2 and 6 months after the intervention
academic performance
Time frame: Change from baseline at 2 and 6 months after the intervention
truancy and school absences
Time frame: Change from baseline at 2 and 6 months after the intervention
educational attainment, information from school registers
Time frame: 2020-2025 (not possible to provide more specitic time frame)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No. Ownership of the data will reside with the University of Jyväskylä and the data are managed by the PI and her research team. Research co-operation agreements will be made with the collaborators about confidentiality issues, data management principles, and use of data in publications. Other researchers are encouraged to use the data; however, it requires a research plan and the permission of the research team. Principally, the PI or someone else from the research team will be one of the co-authors in all publications written from the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing face-to-face support and Chatbot online support group and only chat-robot online support group in people with Psychological Flexibility and Psychological Well-being, run by University of Jyvaskyla at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological flexibility (time frame: Change from baseline at 2 and 6 months after the intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022; AzTrials last refreshed its copy on 27 Oct 2026.