NCT04340206

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
348

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

April 1, 2020

Last Update Submit

May 20, 2022

Conditions

Keywords

AdolescentsAcceptance Commitment TherapyWeb- and mobile-based interventionPsychological flexibilityPsychological well-beingCareer preparationSuccessful educational transitions

Outcome Measures

Primary Outcomes (8)

  • psychological flexibility

    Comprehensive assessment of Acceptance and Commitment Therapy processes, CompACT; Francis et al., 2016

    Change from baseline at 2 and 6 months after the intervention

  • psychological flexibility

    Cognitive Fusion Questionnaire (Gillanders et al., 2014)

    Change from baseline at 2 and 6 months after the intervention

  • life satisfaction

    Satisfaction with Life Scale, SWLS, Diener et al., 1985

    Change from baseline at 2 and 6 months after the intervention

  • mental well-being

    Warwick-Edinburgh Mental Well-being Scale WEMWBS; THL 2011

    Change from baseline at 2 and 6 months after the intervention

  • stress symptoms

    Perceived Stress Scale, PSS-10; Cohen et al., 1983

    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

    Change from baseline at 2 and 6 months after the intervention

  • depressive symptoms

    Depression Scale, DEPS; Salokangas et al., 1995

    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

    Change from baseline at 2 and 6 months after the intervention

Secondary Outcomes (8)

  • perfectionism

    Change from baseline at 2 and 6 months after the intervention

  • self-compassion

    Change from baseline at 2 and 6 months after the intervention

  • prosocial aspirations

    Change from baseline at 2 and 6 months after the intervention

  • academic buoyancy

    Change from baseline at 2 and 6 months after the intervention

  • school well-being

    Change from baseline at 2 and 6 months after the intervention

  • +3 more secondary outcomes

Other Outcomes (4)

  • learning-related expectations and behaviours

    Change from baseline at 2 and 6 months after the intervention

  • educational expectations

    Change from baseline at 2 and 6 months after the intervention

  • quality of close relationships

    Change from baseline at 2 and 6 months after the intervention

  • +1 more other outcomes

Study Arms (3)

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)

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)

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)

Behavioral: Control group, no intervention

Interventions

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.

face-to-face support and Chatbot online support group

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.

only chat-robot online support group

Behavioral: No intervention

Experimental Control

Eligibility Criteria

Age14 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology University of Jyvaskyla

Jyväskylä, 40014, Finland

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Efficacy study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 9, 2020

Study Start

September 8, 2020

Primary Completion

December 15, 2020

Study Completion

August 31, 2021

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

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.

Locations