Randomized Controlled Trial on the Efficacy of a Transdiagnostic Online Prevention Approach in Adolescents (EMPATIA)
Overview
- Phase
- N/A
- Intervention
- EMPATIA 1
- Conditions
- Mental Health Issue
- Sponsor
- University of Bern
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Level of self-reported general psychopathology
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
The goal of this randomized controlled clinical trial is to investigate the efficacy of the internet-delivered intervention EMPATIA on general psychopathology of adolescents with subclinical symptoms compared to a Care As Usual (CAU) control group. The primary objective is to:
- investigate the efficacy of the internet-delivered intervention on general psychopathology of adolescents with subclinical symptoms compared to CAU.
- secondary objectives include: clinician-rated interviews and self-report questionnaires on the level of social and role functioning, time until onset of a mental disorder and service use. Furthermore, changes in subclinical symptoms, transdiagnostic mechanisms and therapeutic as well as safety measures are assessed by online self-reports
Participants will use the internet-delivered intervention EMPATIA during eight weeks.
Researchers will compare intervention group to a Care As Usual (CAU) group to investigate the efficacy of the internet-delivered intervention EMPATIA on general psychopathology.
Detailed Description
The overall objective of this study is to develop and evaluate an internet-delivered indicated prevention program for adolescents with subclinical symptoms designed to target transdiagnostic mechanisms of change. The internet-delivered program will be evaluated in a RCT compared to Care As Usual (CAU) including a 1-year follow-up period. The online program EMPATIA aims to strengthen the well-being and mental health of young people in the long term. For example, in this program, young people learn, among other things, how to better deal with worries, stress, low self-confidence, conflicts with other people, or even unpleasant feelings such as anger, fear, or sadness. These are skills that are known to be helpful for the further development of all adolescents and make them more resilient to stress. In this study, the investigators want to investigate whether the program is helpful, how it works, and which adolescents profit most. For the study, 152 adolescents from Switzerland are asked to participate in the EMPATIA-program online. In order to study the effectiveness scientifically, all adolescents will be randomly divided into two groups, so the differences can be compared. One group will get access to the EMPATIA-program already at the beginning, the other group after 12 months. The contents of the EMPATIA-Program are evidence-based and well-established cognitive-behavioural interventions targeting transdiagnostic mechanisms that have been repeatedly identified to underlie several mental disorders in adolescents: behavioral avoidance, repetitive negative thinking including rumination, worry and intolerance of uncertainty, emotion regulation, self-critical perfectionism and rejection sensitivity. The program consists of 8 modules. It is recommended to complete one module every week with each module lasting about 60 minutes and to make use of additional examples, exercises for everyday life and diaries as often as possible. Furthermore, age- and gender specific topics and main testimonials are offered and can be selected by each participant. The intervention allows tailoring contents through topics that can be additionally selected, such as interpersonal conflicts, self-esteem, and social support and additional examples (e.g., if the predominant emotion experienced is anger vs. sadness). Information will generally be presented via short video-clips, examples from testimonials, audio files, interactive elements, and cartoons instead of text-based parts. At the end of the modules, there is a short quiz that allows participants to review and solidify what they have learned. Participants will be guided (via program integrated chat function) throughout the intervention by e-coaches who are advanced master-students in Clinical Child and Adolescent Psychology.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed Consent signed by the subject (if the participant is ≥ 14 years) or signed by the legal guardians (if the participant is 12 or 13 years old).
- •Subjects are between 12 and 18 years old.
- •Subjects experience at least mild self-reported symptoms by scoring above the cut-off in at least one of the respective screening-instruments as assessed at the 12-month follow-up of the EMERGE- study.
- •Subjects have access to the internet and a smart phone, tablet or personal computer.
- •Subjects have sufficient knowledge of German.
Exclusion Criteria
- •Current or lifetime diagnosis according to the "Diagnostic Interview for Mental Disorders for Children and Adolescents" (Kinder-DIPS, Margraf et al., 2017; Schneider et al., 2017) at baseline.
- •Score of '3' on the suicide item of the PHQ-A (Johnson et al., 2002) or active suicidal plans in the diagnostic telephone interview (Kinder- DIPS, Margraf et al., 2017; Schneider et al., 2017) at baseline.
Arms & Interventions
EMPATIA
Participants in this group will access the online prevention program EMPATIA as a self-help online program during eight weeks.
Intervention: EMPATIA 1
Care As Usual
Participants in this group will gain access to the online prevention program EMPATIA after 12 months. All other kinds of interventions during participation are allowed and will be recorded using the Client Sociodemographic and Service Receipt Inventory
Outcomes
Primary Outcomes
Level of self-reported general psychopathology
Time Frame: Month 12
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Level of self-reported general psychopathology
Time Frame: Baseline
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Level of self-reported general psychopathology
Time Frame: Month 2
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Level of self-reported general psychopathology
Time Frame: Month 6
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Level of self-reported general psychopathology
Time Frame: Month 9
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Secondary Outcomes
- Obsessive-compulsive symptoms (SOCS; Piqueras et al., 2015)(Baseline, Month 2, 6, 9 and 12)
- Psychotic-like experiences (CAPE-P15; Capra et al., 2013).(Baseline, Month 2, 6, 9 and 12)
- Alcohol/Substance abuse (CRAFFTd; Tossman et al., 2009)(Baseline, Month 2, 6, 9 and 12)
- Eating behavior (ChEDE-Q8; Kliem et al., 2016)(Baseline, Month 2, 6, 9 and 12)
- Level of social functioning(Baseline and month 12)
- Time until onset of a mental disorder(Baseline and month 12)
- Depression(Baseline, Month 2, 6, 9 and 12)
- Hypomania/bipolar symptoms (ASRM; Altman et al., 1997)(Baseline, Month 2, 6, 9 and 12)
- Non-suicidal self-injurious behavior(Baseline, Month 2, 6, 9 and 12)
- Somatic symptoms (SSS8; Gierk et al., 2014)(Baseline, Month 2, 6, 9 and 12)
- Repetitive negative thinking (RTQ-10; McEvoy et al., 2017)(Baseline, Month 2, 6, 9 and 12)
- Anxiety (GAD-7; Löwe et al., 2008)(Baseline, Month 2, 6, 9 and 12)
- Emotion regulation (DERS-16; Bjureberg et al., 2016)(Baseline, Month 2, 6, 9 and 12)
- Intolerance of Uncertainty (IUS-12; Carleton et al., 2012)(Baseline, Month 2, 6, 9 and 12)
- Working Alliance (WAI-CA; Figueiredo, 2016)(Week 2, 4, 6, 8)
- Conduct disorder (SDQ-s; Becker et al., 2018)(Baseline, Month 2, 6, 9 and 12)
- Behavioral avoidance (CEASE-A; Fairholm & Ehrenreich, 2008)(Baseline, Month 2, 6, 9 and 12)
- Self-perfectionism (F-MPS-B; Burgess et al., 2016)(Baseline, Month 2, 6, 9 and 12)
- Adherence to the online-intervention(During the eight-week online-intervention)
- Adjustment to daily life (WSAS-Y; Jassi et al., 2020)(Baseline, Month 2, 6, 9 and 12)
- Satisfaction with the intervention (ZUF-8; Schmidt et al., 1989)(Week 8)
- Current stress level (PSS-4; Herrero & Meneses, 2006)(Baseline, Month 2, 6, 9 and 12)
- Rejection sensitivity (C-RSQ; Downey et al., 2013)(Baseline, Month 2, 6, 9 and 12)
- Negative Intervention Effects (INEP; Ladwig, Rief & Nestoriuc, 2014)(Week 8)
- Acute suicidality(Baseline, Week 2, 4, 6, Month 2, 6, 9, 12)
- Level of role functioning(Baseline and month 12)
- Service Use(Month 12)
- Therapy Motivation (MYTS; Breda & Riemer, 2012)(Baseline, Week 2, 4, 6, 8)
- Adherence(During the eight-week online-intervention)
- Acute suicidality(Baseline, Month 12)