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The present study aims to evaluate the effectiveness of a new model-based standardized online intervention program, the Resource-Strengthening Training for Adolescents with Problematic Digital-Media Use, and their Parents (Res@t digital) in an outpatient setting. The Res@t digital intervention group (IG) will be compared with a waiting control group (CG). The IG will receive the Res@t digital intervention, and both groups will receive treatment as usual (TAU) during the study period. The waitlist CG will be offered access to the intervention after individual data collections are completed. It is hypothesized that Res@t digital + TAU is superior to TAU only and will lead to a decrease in adolescent DMUD (i.e., GD, SMUD, or VSD) symptoms. In the case of an adolescent being affected by more than one DMUD or hazardous use pattern, the clinician will identify the most prominent phenomenon that will be focused on within the targeted intervention. Moreover, Res@t digital will reduce mental-health-related problems in adolescents and increase parental self-efficacy.

There are three primary hypotheses structured hierarchically which address the one most prominent DMUD or hazardous use pattern in the individual adolescent identified by the clinician (i.e., PG, PSMU, or PVS). This is referred to the term “specific” DMUD:

First primary hypothesis: Res@t + TAU reduces symptoms of specific DMUD in adolescents compared with TAU, measured as change from screening to post-intervention. Second primary hypothesis: Res@t + TAU reduces symptoms of specific DMUD in adolescents assessed by their parents compared with TAU, measured as change from screening to post-intervention. Third primary hypothesis: Res@t + TAU reduces symptoms of specific DMUD in adolescents assessed by their treating clinicians compared with TAU, measured as change from screening to post-intervention.

To the best of our knowledge, although positive effects of online interventions have been repeatedly suggested to fill substantial treatment gaps for mental health issues in adults (27–29) and adolescents (30–32) including addictive behavior (33–35), no comparable intervention for adolescents with DMUD and their parents is available yet. Therefore, Res@t strives to close a significant void.

The current study is a multicenter, prospective, cluster randomized-controlled, observer-blind clinical trial on the effectiveness of Res@t regarding symptom reduction in adolescents with DMUD. A two-arm study design will be applied with an IG and a waitlist CG with pre–post follow-up assessments. All patients will receive surveillance by a child and adolescent psychiatrist and psychotherapist who offers TAU in regular treatment parallel to the study.

Adolescents aged 10 to 19 years (based on the WHO definition of adolescence) and their respective parents, i.e., caregivers, will be recruited for the study by their child and adolescent psychiatrists and/or psychotherapists. Recruitment sites will include 10 outpatient departments of participating clinics (five university hospitals, five large care clinics) and approximately 40 practices throughout Germany (coordinated via the Professional Association for Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy in Germany e.V., BKJPP).

All eligible recruitment sites will be assigned randomly to IG or CG. Sites randomized to CG will have the opportunity to use Res@t after study recruitment and follow-up are completed.

In addition to introducing the study in regular appointments, advertisements will be carried out via five health insurance companies and the German Society for Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy (DGKJP) who support the study. Adolescents and parents who are interested in the study will be referred to participating clinics and practices, an appointment for screening and diagnosis will be made, and they will be informed about study details.

Screening for DMUD will take place for all patients within regular child and adolescent psychiatric diagnostics. If a DMUD is confirmed during clinical examination, adolescents and parents will be informed verbally and in writing about the study purpose and procedure including intervention, assessments, and recruitment-site-associated randomized group allocation. Further information concerns confidentiality and data protection procedures including pseudonymization, anonymous data storage at the study center (German Center for Addiction Research in Childhood and Adolescence, DZSKJ, University Clinic Hamburg-Eppendorf, UKE) for 10 years after study completion, possible advantages and disadvantages of participation, and the option to withdraw from the study at any time and without any given reason. Before study enrolment, adolescents and parents give their informed consent and receive all necessary documents on the study.

Since all participants are patients in regular treatment, they will not be financially compensated. However, patients will be offered a voucher for a large selection of online shops as incentive for full questionnaire completion with graded values according to assessment points.

Patient recruitment (first patient in to last patient out) is planned from January 2024 to May 2025. This includes a recruitment period of 12 months and a treatment and follow-up period of 17 months in total.

Recruitment sites have been selected based on the following criteria:

Participants will be included in the study if they:

OR

Participants will be excluded from the study if they:

The sample size was computed with the procedure tests for Two Means in a Cluster-Randomized Design in PASS 16.0.4 (NCSS, LLC. Kaysville, Utah, United States). A small standardized mean difference (Cohen’s d = 0.2) between IG and CG in symptom reduction measured as change from baseline to post-intervention is assumed. The number of study centers is assumed to be 50, each recruiting 27 patients on average. This leads to a feasible sample size of 667 per group. The coefficient of variation of the cluster sizes is set to 0.4 because recruitment is assumed to be heterogeneous due to the different sizes of the study sites. The intra-cluster correlation (ICC) is set to 0.005. With the achievable sample size of 667 patients with respective parents in each of the two groups (N_dyads = 667) and a two-sided type I error of 5%, the power will be 77%. A dropout rate of 40% before post-intervention assessment (10 weeks) and 20% before follow-up (20 weeks) is assumed. The sample size calculation refers to the three primary hypotheses, taking into account the hierarchical structure. A drop-out rate of 40% before post-intervention assessment (week 10) is considered. With an estimated proportion of adolescents in the outpatient setting with hazardous or disordered digital media use of 20% and a participation rate of 50%, N = 13,340 patients must be initially screened. Due to the novelty of the study, conservative estimates were chosen for the assumed effect size and drop-out and participation rates. Digital CBT-based intervention studies with comparable adolescent age groups reported small to medium effect sizes regarding the reduction in depression and anxiety symptoms (36, 37).

Three nuisance parameters (drop-out rate, coefficient of variation, and intraclass correlation coefficient) enter the sample size planning, the assumptions of which are not known with certainty. Therefore, a blinded interim analysis will be performed after the collection of post-intervention data from half of the planned patients (200 per group, 400 total) to estimate the nuisance parameters and possibly adjust the sample size.

A stratified cluster randomization will be employed, resulting in each recruitment site (outpatient department or practice) being randomly allocated to the intervention or waitlist control. Stratification is performed according to recruitment site size (annual patient number ≤ 600, > 600 and ≤ 1,600, and > 1,600) and location (urban or rural). An independent statistician at the Institute of Medical Biometry and Epidemiology (IMBE) at the University Medicine Hamburg-Eppendorf will randomly allocate recruitment sites using computerized random number generations within each stratum to IG or CG based on internal standard operating procedures, without knowledge of the identity of recruitment sites (with variable block length). Cluster randomization will be applied to avoid contamination between IG and CG conditions regarding TAU. Based on the resulting allocation, the intervention will be made available immediately (IG) or after the recruitment phase and follow-up data collection is completed (CG).

Clinical assessments with the adolescents and respective parents will be realized at screening, baseline, week 10 (post-intervention), and week 20 (follow-up). By the latter, the durability of the treatment effect should be estimated. Screening and baseline visits should not be apart by more than 4 weeks, otherwise a clinical reevaluation will become necessary. In addition to clinical diagnosis and post-treatment evaluation, all assessments are performed digitally via standardized questionnaires, which are provided on an online platform without the involvement of the clinician. They will be automatically presented to the participants at the time points according to the study protocol. Participants will receive e-mail reminders just before and during the scheduled time frame. All data will be initially stored in a patient dossier on the ISO-certified e-mental health platform run by Embloom¹ before pseudonymization and secure transfer to the central study center. Regular visits with the clinician will take place within TAU. These should support compliance and adherence to keep the drop-out rate as low as possible. Figure 1 shows all study phases including assessment time points. Table 1 shows all questionnaires and items used in the current study. Table 2 shows the schedule of the questionnaire application.

Practitioners will be informed whether their recruitment site has been assigned to IG or CG at the beginning of the study. Once a patient has been identified to be eligible for study participation and the family gave informed consent to participate, the practitioner will individually inform about the assignment to IG or CG. Evaluating data analysists at IMBE will be blinded and will receive blinded datasets only.

Compliance and adherence will be fostered by the treating clinician who observes the participants regularly within the context of normal treatment. Moreover, automatic reminders will be presented via the online app to the participating adolescents and parents. To all participants in the CG, the Res@t intervention will be offered after the completion of study recruitment. Incentives are planned for participants and clinicians to compensate for additional effort. These measures should increase study motivation and reduce drop-out rates.

Res@t digital is the app-based translation of a manualized CBT-based treatment package comprising offline programs for adolescents with GD (Res@t–A offline) and their parents (Res@t–P offline (64)). A detailed description of the original program package and its further development can be found in a recent publication by Paschke et al. (22). For better readability, a short summary is given by:

Res@t was created within the theoretical framework of the Trias model of addiction (20) based on clinical experiences and up-to-date research findings on the etiology of DMUD and potentially effective treatment components. During the developmental process, qualitative interviews and focus groups had been conducted with clinical experts, affected adolescents, and their parents on needs and program requirements (26, 64). The findings were considered for the final Res@t version. Original content was adapted to fit digital demands, and specific elements for the treatment of SMUD and VSD have been added. Res@t digital is comprised of nine weekly sessions and one booster session in week 15 of approximately 20 min processing time each. Additionally, participants are encouraged to complete a daily calendar on usage times, non-digital activities, mood, and sleep.

Table 3 gives an overview of the Res@t session contents as offered to adolescents and parents. Modules with adaption to address the type of DMUD are indicated.

The digital application in the adolescent and the parental versions will be made available via app stores. It is hosted in the secure Embloom platform environment. Based on the study arm allocation, the app, i.e., the intervention content, will be made available directly (for IG) or after individual data collection is completed (for CG). Figure 2 shows examples of the Res@t digital interface (in German language).

All data will be collected on an ongoing basis via the Res@t application and stored within the ISO-certified Embloom platform on secure servers with regular backups. Data will be pseudonymized before transferring it in an encrypted form to the secure UKE server. Sensitive participant data will be accessible only to the treating practitioner within individual digital patient folders (within the recruitment center) and authorized admins of Embloom (across the recruitment centers). The latter will have the primary responsibility for verifying the integrity of the database and securing pseudonymized data transfer. A statistician at the UKE who is independent of the evaluation team will monitor trial conduct and data collection manually in addition to automatic monitoring of data completeness by the software. Moreover, pseudonymized data will be reprocessed to fit all structural requirements for the analyses. The principal study center at the DZSKJ will be responsible for managing and archiving the transferred database after analysis. All participant data will be always handled confidentially and in accordance with the General Data Protection Regulation (GDPR).

Data will be analyzed by the independent statisticians at the IMBE with sophisticated experience in multicenter therapy studies. Descriptive statistics will be presented with respect to both the entire sample and group-wise. The primary analysis is based on the intention-to-treat (ITT) approach with all randomized patients. The significance level will be set at 5% (two-sided). All three primary hypotheses are structured hierarchically. The second primary hypothesis will only be evaluated in a confirmatory way if the first primary hypothesis leads to a significant test result. The third primary hypothesis will only be evaluated in a confirmatory way if the second primary hypothesis leads to a significant test result. For the analysis of each primary hypothesis, a linear mixed model with implicit maximum likelihood correction of missing values under the missing-at-random assumption will be calculated, respectively. The change in DMUD symptoms from baseline to post-treatment will be used as an outcome variable, randomization group, type of DMUD (social media, gaming, streaming), recruitment site size and location as fixed effects, individual recruitment site and patient nested within site as random effects, and the baseline DMUD score as a covariate. The interaction between the randomization group and media usage pattern (hazardous vs. pathological) as well as effects of incomplete dyads will be tested within secondary analyses.

To examine the impact of missing values on the outcome of the primary analysis, sensitivity analyses will be performed using multiple imputation methods to replace missing values. The primary endpoint at follow-up and the secondary endpoints will be investigated exploratorily using analogous methods, which are adequate for the scale type. The following subgroup analyses are planned: severity of DMUD, sex, education, and socioeconomic status. Qualitative assessments of treatment provider satisfaction will be supplemented. Details of the analysis will be specified in a statistical analysis plan. The analysis will be performed with the latest version of the software package R (70).

All recruitment sites will be supervised by and stay in close contact with the principal study center at UKE during the complete course of the study.

At the beginning of the recruitment, a Data Safety Monitoring Board (DSMB) will be implemented with meetings during initiation, regular monitoring visits, and after study closeout. The DSMB will be comprised of experienced scientists not otherwise involved in the study. Members will be independent of the investigarors and the trial sponsor and will have no conflicts of interests. The DSMB will frequently oversee trial processes and data collection based on the requirements of Good Clinical Practice. These include monitoring of study and recruitment progress, considering adherence to the inclusion criteria, study procedure, recruitment rate, completeness of study documents, protocol deviations, loss-to-follow-up data, serious adverse events (SAEs), adverse events (AEs), and/or newly emerged evidence of potential harmful effects of the intervention, and all potential study problems. Meetings will be held in closed and open manner. The latter includes the discussion of management issues with the coordinating investigator at the principal study center. Recommendations on study continuation, necessary design changes, or the end of the trial will be given by the DSMB without the involvement of the coordinating investigator.

Data safety is secured via confirmation with the Information Security Management System Standard (ISO/IEC 27001:2013y) in accordance with the Declaration of Applicability v 2.0 d.d. 22/10/2019. This certificate is valid within the scope of information security related to the development and management of e-health applications for healthcare providers and the purpose of measuring, monitoring, and treating psychological and physical symptoms. Data collection, transfer, and storage are described within a data protection concept, which has been approved by the data protection officer at the UKE.

Participant safety, especially the safety of minor-aged patients, is secured primarily by the clinicians during regular treatment. They will continuously monitor adverse events (AEs) and serious adverse events (SAEs) and report these as an (S)AE comment within the case report form of Embloom software. (S)AEs will be rated based on the NCI Common Terminology Criteria for Adverse Events (71). They will be carefully monitored, documented, and reported to the coordinating investigator and the Data Safety Monitoring Board (DSMB) members within 1 week of the initial observation. DSMB experts will comment on potential causal study relations to identify serious study-related events (SSREs), to determine benefit–risk of trial continuation and adequate participant support. SSREs might include suicidal ideation and behavior, self-harming behavior, worsening of general wellbeing, mental distress, or psychiatric comorbidities with an indication for hospitalization. SAEs and SSREs will be reported to the local ethics committees.

The trial is registered on the German Clinical Trials Register (DRKS00031043, https://drks.de).