App-Based Coaching to Prevent Addictive Behaviors among Young Adults
Study Protocol of a Cluster-Randomized Controlled Trial
Abstract
Abstract:Background: Vocational students have an increased risk to engage in health-risk behaviors compared to same-aged peers. To date, evidence-based digital prevention approaches that address multiple health-risk behaviors are rare. Method: The randomized-controlled trial (RCT) “Prevention of at-risk substance and Internet use disorders among vocational students” (PARI) investigates the efficacy of an app-based prevention approach compared to a waitlist-control condition. The aim is to prevent substance-related and behavioral addictions and improve life skills. An existing app (ready4life) was adapted under consideration of focus groups with teachers, prevention experts, and students. A Delphi expert group rated the quality of the approach. The efficacy of the modified ready4life app is currently being tested in a RCT. The proactive recruitment takes place in German vocational schools. After participating in an app-based screening (T0), participants get individualized feedback and will be cluster-randomized per class to the intervention group (IG; n=1.250) or control group (CG; n=1.250). The IG chooses two out of six modules: Social competence, stress management, cannabis, tobacco, alcohol, social media/gaming. The CG receives information on how to improve health behaviors. Follow-ups are conducted after 6 months (T1) and 12 months (T2). Conclusion: This RCT provides data on a multibehavioral prevention approach for vocational students. Final results are expected in 2023.
Zusammenfassung:Hintergrund: Berufsschüler_innen weisen gegenüber Gleichaltrigen ein erhöhtes Risiko für gesundheitsgefährdende Verhaltensweisen auf. Bislang gibt es nur wenige evidenzbasierte, digitale Präventionsansätze, die mehrere gesundheitsgefährdende Verhaltensweisen gleichzeitig adressieren. Methode: Die randomisiert-kontrollierte Studie (RCT) „Prävention bei Auszubildenden in Bezug auf Rauschmittelkonsum und Internetbezogene Störungen“ (PARI) untersucht die Wirksamkeit eines app-basierten Präventionsansatzes gegenüber einer Warteliste-Kontrollbedingung. Ziel ist es, substanz- und verhaltensbezogene Suchterkrankungen zu verhindern und Lebenskompetenzen zu verbessern. Eine bestehende App (ready4life) wurde unter Berücksichtigung von Fokusgruppen mit Lehrer_innen, Präventionsexpert_innen und Schüler_innen angepasst. Eine Delphi-Expertengruppe bewertete die Qualität des Ansatzes. Die Wirksamkeit der modifizierten ready4life-App wird derzeit in einem RCT getestet. Die proaktive Rekrutierung findet in deutschen Berufsschulen statt. Nach der Teilnahme an einem app-basierten Screening (T0) erhalten die Teilnehmer_innen ein individuelles Feedback und werden cluster-randomisiert auf Klassenebene der Interventionsgruppe (IG; n=1.250) oder der Kontrollgruppe (KG; n=1.250) zugeordnet. Schüler_innen in der IG wählen zwei von sechs Modulen aus: Soziale Kompetenz, Stressbewältigung, Cannabis, Tabak, Alkohol, soziale Medien/Gaming. Schüler_innen in der KG erhalten einmalig Informationen zur Verbesserung des Gesundheitsverhaltens. Nachuntersuchungen werden nach 6 Monaten (T1) und 12 Monaten (T2) durchgeführt. Schlussfolgerung: Dieses RCT liefert Daten zur Wirksamkeit eines multibehavioralen Präventionsansatzes bei Berufsschüler_innen. Die endgültigen Ergebnisse werden Mitte 2023 erwartet.
Background
Health-Risk Behaviors in Emerging Adulthood
Typically, the period of emerging adulthood is associated with an increased readiness to engage in health-risk behaviors (Jordan & Andersen, 2017; Stockings et al., 2016). In the last years, research on the co-occurrence of multiple health-risk behaviors of adolescents and young adults (AYA) has received growing attention (Kotyuk et al., 2020; Velasco et al., 2021). In general, school settings are of high importance for the implementation of effective prevention approaches since many AYA can be reached with comparatively little effort. To date, most preventive approaches relate to regular schools. In Germany, however, a substantial part of AYA leaves the regular school system to start a vocational education. Vocational education typically takes place in a “dual system” that consists of a practical part in a company and a theoretical part in vocational schools. Previous studies found that vocational students are at increased risk to engage in multiple health-risk behaviors compared to other same-aged peers (Montag et al., 2015; Haug et al., 2013; Velasco et al., 2021). In a German sample of vocational students (M = 19.4 years; SD = 3.9; range 15–55 years; 45 % female), 40.7 % reported daily tobacco smoking, 45.0 % were screened positive for at-risk alcohol consumption, and the 30-days-prevalence of cannabis use was 7.5 % (Montag et al., 2015). Regarding pathological Internet use behavior, a prevalence rate of 3 % can be assumed among German adolescents (Wartberg et al., 2015). Since health-risk behaviors may have a synergetic effect on each other, effective prevention concepts that simultaneously address multiple risk behaviors in vocational school settings are required. In a Cochrane systematic review of 70 studies, universal school prevention programs addressing multiple health-risk behaviors were found to be beneficial compared to those addressing only one specific health-risk behavior (MacArthur et al., 2018). However, due to the poor quality of several included studies, the authors of this review underpin the importance of further intervention studies addressing multiple health-risk behaviors for strengthening the evidence base (MacArthur et al., 2018). To date, school-based prevention programs typically focus on single behavioral domains and behavioral outcomes (Velasco et al., 2021).
Prevention Concepts in School Settings
In vocational school settings, preventive goals usually cannot be achieved by primary prevention approaches. Instead, indicated prevention programs are more appropriate due to high prevalence rates of at-risk behaviors. In previous studies, the additional inclusion of life skills training in existing addiction prevention concepts had a positive effect on risky substance use and harmful Internet use (Durlak et al., 2011; Foxcroft & Tsertsvadze, 2011; Thomas et al., 2013). Besides, meta-analyses found that indicated prevention approaches for AYA that include individual brief interventions under consideration of individual needs were beneficial compared to universal group prevention approaches (Carey et al., 2007; Hennessy et al., 2019; Hennessy & Tanner-Smith, 2015). In particular, the combination of personalized feedback and individualized behavioral interventions (e. g., identification of individual risk situations, inclusion of goal-setting strategies) were found to be most effective (Scott-Sheldon et al., 2014). Furthermore, differences in the efficacy of school-based prevention programs are systematically related to age-specific psychological needs of those addressed (Onrust et al., 2016).
In recent years, several prevention concepts based on digital information and communication technology have been developed. Despite limited human and time resources, such low-threshold digital approaches can be easily implemented in school settings (Dotson et al., 2015) and may enable a better accessibility, attractiveness, adoption, and retention rate compared to usual school prevention concepts (Haug et al., 2017a, 2017b; Tait & Christensen, 2010; Whittaker et al., 2016). To date, however, existing prevention concepts in Germany are usually self-developed by schools and depend on local personnel resources. Systematic data on the efficacy of digital multibehavioral prevention approaches in German vocational schools are lacking.
Ready4life: An Example of an App-Based Prevention Approach in Vocational School Settings
Ready4life is an example of an app-based prevention program developed in Switzerland and designed to prevent addictive behaviors among vocational students and to promote life skills (Haug et al., 2020). After taking part in a screening on health behaviors via the ready4life app, an individualized risk and competence profile for each vocational student will be created. In the original app version, each vocational student can choose two modules that match individual interests (stress, social competence, tobacco, and alcohol). Over a period of four months, two to four individualized short message services (SMS) per week that are tailored to individual needs will be sent to the participants. To increase retention rates, interactive elements such as quizzes, contests, and contact to experts (“Ask the expert” function) are available.
Based on established theories of health behavior, the social cognitive theory (Bandura, 1986), and the Health Action Process Approach (Schwarzer, 1992), ready4life was developed and evaluated by the Swiss Institute for Addiction and Health Research at the University of Zurich in collaboration with the Swiss Lung League and vocational schools.
To date, systematic evaluations of ready4life in Germany are lacking. Additionally, the prevention of harmful Internet use has not yet been implemented in multibehavioral digital prevention approaches. Furthermore, the original version of ready4life did not include cannabis use. To increase the acceptance and acknowledge the schools’ efforts, it seems important to link addiction prevention approaches with local school projects and to include students and teachers in the development of the prevention approach.
Aim of this Trial
Summing up, addiction prevention approaches in school settings should (1) address life skills, (2) address multiple behaviors, (3) be economical and implementable with limited personnel capacities, (4) provide an indicated prevention approach for high-risk groups, (5) offer individualized interventions, and (6) may optionally include digital interventions. Based on these requirements, the PARI trial (“Prevention of at-risk substance and Internet use disorders among vocational students”) aims to test the efficacy of a modified digital prevention approach (ready4life) that has already been evaluated in its previous form in vocational schools in Switzerland.
Methods and Trial Design
Study Design
The study is divided into two phases: (1) The first phase, which is already completed, included the modification of an existing Swiss prevention approach (ready4life) and the extension of the app by two modules (Social media/gaming and cannabis) under consideration of qualitative focus groups with students, teachers, and addiction prevention experts. (2) The second ongoing phase includes the cluster-randomized controlled trial to investigate the efficacy of the modified ready4life app.
Phase 1: Participatory Modification of an Established Digital Prevention Approach
In addition to the already existing ready4life app, further two modules which are of importance to the target group (“Social media/gaming” and “Cannabis”) were developed and tested by the project team.
Focus Groups
For the participatory further optimization of the prevention approach, separate focus groups with students, teachers, and addiction prevention experts were conducted. The aim of the student focus group (n=8 students) was to adapt the content of the existing ready4life app and increase students’ readiness to participate while the purpose of the teachers focus group (n=5) was to assess the feasibility of the program and to optimize the inclusion of teachers in the program, the embedding in the already existing prevention school concepts as well as the readiness of schools to participate. The focus group with addiction prevention experts (n=5) was conducted to assess the expected efficacy, the feasibility, and to discuss implementation strategies in the German vocational school context. All focus groups were conducted between December 2019 and January 2020, audio-recorded and evaluated by two independent raters. Constructive ideas for change were considered in the further development of the ready4life app. The final concept is displayed in Table 1.
Delphi Study
To evaluate the feasibility of the ready4life concept in Germany, a Delphi study was conducted with (1) experts in the fields of prevention, addiction, pedagogy, and education, and (2) scientists in the field of addiction. All experts were recruited in the federal state of Lower Saxony, based on a list of addiction prevention experts in Lower Saxony which was provided by the Lower Saxony State Office for Addiction Issues. In the selection process of potential participants, a wide spatial distribution across the state of Lower Saxony as well as different institutional affiliations was ensured. Experts in the field of prevention, addiction, pedagogy, and education who had previously participated in focus group discussions of other projects in this working group were excluded. Furthermore, school psychologists employed by the Lower Saxony State School Authority were invited to participate. Scientists in the field of addiction were recruited nationwide.
In total, 44 experts and scientists were informed about the Delphi study via mail in August, 2020. Of these, 23 were addiction prevention specialists, 10 were school psychologists, and 11 were scientists. Those who were willing to participate (n=21) received another mail with a brief description of ready4life and the planned implementation strategy in vocational schools. Additionally, an online questionnaire was designed to obtain expert assessments. In total, six topics were covered with a total of 32 items: Evaluation concept, anticipated efficacy, the attractiveness of the program and expected willingness to participate, reaching different groups of vocational students, acceptance of ready4life, and potential difficulties and possibilities for improvement. Data assessment was anonymous. There was no incentive for the participants. Of 21 experts who agreed to participate, 17 completed the online questionnaire (response rate: 81 %). Overall, the modified ready4life program was perceived to be attractive and effective. The recruitment strategy was perceived to be feasible. Minor changes in terms of the implementation strategy in vocational school settings were made in line with the recommendations provided by the participants.
Phase 2: Cluster-Randomized Controlled Trial to Test the Efficacy of the App-Based Prevention Approach
To test the efficacy of the modified ready4life app, a two-arm cluster-randomized controlled trial is currently being conducted, including an intervention group (IG) and a waitlist-control group (CG) with pre-post and follow-up assessments.
Sample, Procedure and Study Setting
The modified ready4life program and the PARI study are implemented in vocational school classes in at least four German federal states, reflecting the heterogeneity of the Federal Republic of Germany. Depending on the local conditions, the aim and the procedure of the PARI study are presented in the classes by trained teachers, trained local school social workers/ addiction experts, or members of the PARI project team. The person who presents the app and the trial does not know if the class is cluster-randomized to the control or intervention group. All vocational students who are at least 16 years old and willing to participate can download the app with a password that is created for each class by the project team. After taking part in the app-based screening (all assessments are shown in Table 2), each student receives an individualized risk and resource profile. The whole class is cluster-randomized (T0) either to the intervention group (IG; n=1.250) or the control group (CG; n=1.250) to avoid spill-over effects. Each participant in the IG chooses two out of six modules: (1) Social competence, (2) stress management, (3) cannabis, (4) tobacco, (5) alcohol, or (6) social media/gaming. New content is posted via a chatbot once a week over a period of eight weeks per module. The CG receives a link in the app with information on how to improve health behaviors. Follow-ups take place after 6 months (T1) and 12 months (T2). After the second follow-up, the app-based prevention is available for the CG. As incentives, vouchers with a total worth of 20 000 Euro are raffled among all participants. The study procedure is displayed in Figure 1. An insight into the app is shown in Figure 2.
Follow-Up and Outcome Measures
Alcohol consumption, tobacco use, cannabis use, Internet Use Disorders (IUD), social competence, and stress management will be assessed with standardized valid and reliable instruments. An overview of all measures at baseline (T0) and both follow-ups (T1, T2) is displayed in Table 2. For the follow-ups, all participants receive a link via SMS or email that leads to an online assessment. To increase the participation rate, participants who did not complete the follow-up get a reminder via SMS or email. Besides, participants will be contacted via telephone by the project team to provide the option to complete the follow-up during a telephone interview.
Analyses
The primary endpoint is a composite outcome, including changes between baseline, 6- and 12-month follow-ups with respect to tobacco smoking, alcohol, cannabis, and internet-related problems. To investigate changes in addictive behaviors from baseline to 6 and 12 months longitudinal structural equation modeling will be used. A latent factor at each of the three assessment points will be estimated using tobacco smoking, alcohol, cannabis, and IUD as indicators. Secondary endpoints are as follows: Frequency of tobacco, alcohol and cannabis consumption, frequency of binge drinking, number of cigarettes per day, internet-related problems, stress load, social competence, days of absence from company/vocational school, and drop-out.
Power Calculation
Based on a sample of 5.000 students and an estimated participation rate of 50 %, 1.250 students need to be assigned to the IG and 1.250 students to the CG. With the cluster-randomized sample, a loss of statistical power has to be taken into account, resulting in a design effect of 1.55 by assuming 12 participants per class and an intra-cluster correlation (ICC) of 0.05. This procedure ensures that even small effects (d=0.2) will be identified. The power calculation was conducted with Gpower.
Quality Ensurance
Standard operating procedures (SOPs) for the implementation in vocational schools were provided. All project members who are included in the recruitment process were trained in advance.
Ethics
Informed consent will be obtained from all participants prior to study enrollment. Underaged participants are advised that their caregivers must be informed about study participation. For this purpose, a link with relevant information about the study is provided in the app. Participation in the study is voluntary. Information about the study’s purpose and procedures, data protection, and the option to withdraw from the study at any time without any given reason will be provided. Approval for the study was obtained from the ethics committee of the University of Lübeck (number 19-419) and the University of Greifswald (BB 024/20). Prior to data collection, an authorization of the ministries of education and cultural affairs of each Federal state in Germany involved in the PARI study was collected. The study is conducted in accordance with CONSORT guidelines and in line with the Declaration of Helsinki. After the second follow-up, the intervention is also available for the CG.
Discussion
To date, low-threshold approaches aimed to prevent addictive behaviors by improving life skills in vocational school settings are rare. The present PARI study aims to investigate the efficacy of an app-based coaching program (ready4life). This approach has already been evaluated in its previous form in vocational schools in Switzerland (Haug et al., 2017a, 2017b, 2017c). For this cluster-randomized controlled trial in Germany, however, the existing ready4life app has been supplemented with the modules social media/ gaming and cannabis. Although the representativeness of the sample cannot be guaranteed, a broad range of heterogeneous vocational sectors (e. g., service industries, business professions, and industrial-technical professions) from different federal states across Germany will be included. Results of this cluster-randomized controlled trial are expected in 2023. The results will be published and presented at congresses. If the results indicate that this approach is feasible and effective, it can be distributed in German vocational schools. All materials (explanation video, app, website) are designed to require minimal effort and resources for schools and teachers.
We would like to thank all our students in Lübeck, Greifswald, and Hannover who helped us test the modified ready4life app, recruit vocational schools, and present the PARI study in vocational classes. Besides, we would like to thank all experts, students, and teachers who helped us with the modification and implementation of this approach.
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