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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04340206
Other study ID # 324638
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 8, 2020
Est. completion date August 31, 2021

Study information

Verified date May 2022
Source University of Jyvaskyla
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 348
Est. completion date August 31, 2021
Est. primary completion date December 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 16 Years
Eligibility Inclusion and Exclusion Criteria: 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: 1. 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). 2. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
face-to-face support and Chatbot online support group
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 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.
Control group, no intervention
Behavioral: No intervention

Locations

Country Name City State
Finland Department of Psychology University of Jyvaskyla Jyvaskyla

Sponsors (2)

Lead Sponsor Collaborator
University of Jyvaskyla Academy of Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Other learning-related expectations and behaviours success expectations, task-focused behavior and planning; Nurmi et al., 1995 Change from baseline at 2 and 6 months after the intervention
Other educational expectations educational expectations Change from baseline at 2 and 6 months after the intervention
Other quality of close relationships conflict and closeness in child-parent, child-teacher, and child-best relationships (Pianta) Change from baseline at 2 and 6 months after the intervention
Other personality short Big Five, Gostling et al., 2003) Change from baseline at 2 and 6 months after the intervention
Primary 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
Primary psychological flexibility Cognitive Fusion Questionnaire (Gillanders et al., 2014) Change from baseline at 2 and 6 months after the intervention
Primary life satisfaction Satisfaction with Life Scale, SWLS, Diener et al., 1985 Change from baseline at 2 and 6 months after the intervention
Primary mental well-being Warwick-Edinburgh Mental Well-being Scale WEMWBS; THL 2011 Change from baseline at 2 and 6 months after the intervention
Primary stress symptoms Perceived Stress Scale, PSS-10; Cohen et al., 1983 Change from baseline at 2 and 6 months after the intervention
Primary 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
Primary depressive symptoms Depression Scale, DEPS; Salokangas et al., 1995 Change from baseline at 2 and 6 months after the intervention
Primary 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 perfectionism The Child-Adolescent; Perfectionism Scale, CAPS; Gordon et al., 2016 Change from baseline at 2 and 6 months after the intervention
Secondary self-compassion Self-Compassion Scale - Short Form; Raes et al., 2011 Change from baseline at 2 and 6 months after the intervention
Secondary prosocial aspirations short form of the Aspirations Index, Marshall, 2019 Change from baseline at 2 and 6 months after the intervention
Secondary academic buoyancy short Academic buoyancy scale; Martin & Marsh, 2008 Change from baseline at 2 and 6 months after the intervention
Secondary school well-being school satisfaction, anti-school attitude, school-related stress, WHO Change from baseline at 2 and 6 months after the intervention
Secondary academic performance grade point average Change from baseline at 2 and 6 months after the intervention
Secondary truancy and school absences truancy and school absences, Finnish School Health Questionnaire Change from baseline at 2 and 6 months after the intervention
Secondary educational attainment, information from school registers initiation of upper secondary education, progress in studies, changes in study field, graduation time, 2020-2025 (not possible to provide more specitic time frame)
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