Digital and school-based Cognitive Behavioral Therapy (CBT) for youth anxiety: a randomized controlled trial.
- Introduction
Summary
Currently, it is of great concern that most anxious youth worldwide, including Norway, do not often receive evidence-based treatment in the primary health services. Overall, the results of the proposed study hold strong promise to lead to increased availability of empirically supported, school-based cognitive behavioral therapy (CBT) interventions, with the central aim of increasing the number of anxious youth being helped. This proposal expands an ongoing project between the department of children and adolescent mental health (ABUP) at Sørlandet hospital and the Kristiansand municipality where CBT school-based groups (Mini-RISK) for anxious youth are implemented at all 47 schools in this municipality. The aim of the study is to compare the effectiveness of two low-threshold (e.i., delivered in schools without requiring outside referrals) interventions for youth (age 12–17) anxiety, digital-assisted CBT (e-RISK) and group face-to-face CBT (Mini-RISK). No studies have directly compared digital CBT and school-based or low-threshold CBT. Currently, we lack knowledge about how the interventions compare in effectiveness and how individual factors affect treatment outcomes. This knowledge will aid in the delivery of treatments for youth anxiety, ensuring that treatments achieve the intended outcomes and are tailored to individual needs. If this project generates scientific evidence supporting the effectiveness of digital e-RISK, demonstrating similar outcomes as school-based CBT(Mini-RISK), it will be of utmost significance. The advantage of assisted digital CBT lies in its ability to deliver it using fewer resources from the school health service, a service that has limited resources available to manage the epidemic of youth mental health problems in Norway.
State of the art
Anxiety disorders are considered the most common mental health problem in children and adolescents and affects approximately 6-18% of youths aged 6-17. Anxiety is a significant mental health issue among young individuals, both in terms of its prevalence and the long-term personal and economic consequences it entails (1, 2). The impact of the COVID-19 pandemic has further exacerbated anxiety levels among the youth (3). Early-onset anxiety disorders in young individuals tend to be persistent and often chronic (4). Moreover, these disorders have been associated with decreased functioning across various domains, such as academic performance, social interactions, quality of life, and even suicidal ideation (5, 6). Given these circumstances, it is crucial to develop and disseminate interventions that can reduce the burden of anxiety symptoms in youth. Cognitive Behavioral Therapy (CBT) has demonstrated its effectiveness in preventing and treating anxiety among young individuals (7, 8). However, there is a shortage of professionals who possess expertise in CBT, resulting in limited access to effective anxiety treatments (9). Consequently, a significant number of young individuals with anxiety do not receive appropriate care from healthcare services and lack access to effective, evidence based treatments (10, 11).
School-based CBT versus assisted digital CBT.
The effectiveness of cognitive-behavioral therapy (CBT) in treating youth anxiety is well established. However, despite its success, accessibility to CBT remains a challenge. Stepped care approaches have emerged as a promising solution to this problem, providing low-threshold versions of standard CBT to a wider audience (12). These approaches aim to ensure that more youth receive the best available treatment at an earlier stage, which has both therapeutic and preventative effects. Two low-threshold treatments have shown promise in treating youth anxiety: clinician-assisted digital CBT and school based CBT (13, 14). Clinician-assisted digital CBT involves self-help material completed at one’s own pace, with chat or telephone assistance from clinicians to increase compliance to treatment and troubleshoot difficulties. School-based CBT consists of face-to-face CBT delivered by school and/or health personnel in school settings, which is typically regarded as a targeted preventative intervention, but may also be considered treatment for persons already experiencing anxiety difficulties. While both approaches are effective, they have different advantages and disadvantages. For example, clinician assisted digital CBT is readily available to youths in everyday life, and is expected to be easier to disseminate and require fewer resources than face-to-face CBT (15). However, face-to-face, school based CBT may be a better approach for difficult cases and for those who experience individualized require case-specific tailoring to fit the needs of a given child. Despite the promise of these treatments, to our knowledge, no studies have directly compared digital CBT and school-based CBT. Therefore, it is difficult to ascertain when to recommend one instead of the other. As a result, more knowledge is needed regarding the relative effectiveness of school-based CBT and assisted digital CB in a school setting. In particular, there is a need to understand how these interventions are affected by individual-level factors. This knowledge will aid in the delivery of treatments for youth anxiety, ensuring that treatments achieve intended outcomes and are tailored to individual needs.
Previous Achievements of the Group and Structures in Place:
Since 2013, the researchers and clinicians at ABUP have made significant progress in developing an intensive, manualized, multi-family cognitive-behavioral therapy (CBT) intervention for anxious youths. This intervention involves high parental and school involvement, along with extensive exposure to anxiety-provoking situations, with all aspects of treatment totaling 38 hours of face-to-face intervention with a clinician. Exposure practice, which entails confronting fears, is considered the core element of anxiety treatment (24). This intensive multi-family CBT program, known as “RISK,” encourages participants to take risks by facing their fears during treatment for anxiety. In a recent study conducted in a regular outpatient clinic (N=94), we found that one year after treatment, 86.7% of youths exposed to RISK were free from all anxiety diagnoses (25). Since 2013, over 400 youths have participated inRISK groups at the hospital. It is important to note that RISK stands out due to its unique characteristics, including a high degree of exposure practice and the involvement of parents and schools.
Expansion to the School Health Service: Building upon our successful results, we developed a shorter version of hospital-based RISK in 2019, specifically designed for implementation in the school health service. This abbreviated version, called “Mini-RISK,” adheres to the same principles as the specialty clinic-based RISK but but achives similar positive outcomes with 15 hours of therapy delivered by school personnel (e.g., public health nurses and social work teachers). Despite its shorter length, Mini RISK retains the same unique elements of its predecessor, emphasizing a high degree of exposure practice and involvement of parents and schools.
Collaboration with Kristiansand Municipality: Currently, ABUP is engaged in a major collaboration project with the Kristiansand municipality already funded by the Kavli Fund. The primary objective of this partnership was to implement Mini-RISK groups in all 47 schools within the municipality.
Increasing Availability through e-RISK: Despite the progress made through the collaboration project mentioned above, feedback from public health nurses suggests that the capacity to run Mini-RISK groups does not meet the large service demand in today’s schools, and some youth may not prefer face to-face group treatment. To address this issue and expand access to evidence-supported anxiety treatment for youth, we have developed a digital version of RISK called “e-RISK.” Funding from Helse-Sør Øst and the Cultiva Foundation has supported the development of e-RISK, which is now complete and available at www.erisk.no. e-RISK comprises three modules targeting youth, parents, and teachers. Notably, e-RISK features a substantial collection of professionally produced video clips, including seven documentaries featuring youth who have completed RISK. These testimonials highlight the value of RISK-based strategies in managing anxiety. To inspire and engage anxious youth, e-RISK incorporates a high level of user involvement, including two of the youths from the documentaries who act as hosts and guide users through the various youth sub-modules. More details about e-RISK can be found on page 4. In summary, there is a general need for studies comparing the effectiveness of assisted digital CBT and school-based CBT.
- Needs description -Potential impact of the proposed research.
Societal impact: The study, if successful, will provide the health services with an evidence-based and cost-effective low threshold treatment for anxiety among adolescents, and has great potential to improve current practices. If this project generates scientific evidence supporting the effectiveness of digital e-RISK, demonstrating similar outcomes as school-based CBT, it will be of utmost significance. The advantage of assisted digital CBT lies in its ability to utilize fewer resources from the school health service. If this project finds that e-RISK is comparable to Mini-RISK it would mean that an effective evidence-based treatment could become widely available. Specifically, municipalities could easily deliver e-RISK to 8-10 pupils per school annually, extending evidence-based help to 500-700 anxious youth each year. This project will make a substantial contribution towards improving access to evidence-based health services for anxious youth in Norway, thereby enhancing their long-term well being and quality of life.
Novelty and ambition. The proposed project addresses a knowledge gap in several ways. The ongoing project is the first to directly compare the resource-conserving digital CBT (e-RISK) and school-based CBT for anxious youth in schools (MiniRISK), which is crucial in order to evaluate best approaches for disseminating CBT for anxious youth. The project is also unique in Norway in that the school and parents are deeply involved in treatment and that the school personnel are involved as RISK providers. As far as we know, e-RISK is the first Norwegian digital tool for coping with anxiety in youths that includes help for all anxiety disorders. The ultimate ambition of this project is to develop competence for delivering sustainable evidence-based anxiety interventions in municipality health services.
2.Hypothesis, aims and objectives
The primary objective of this proposed project is to assess the relative effectiveness of two low threshold interventions, namely assisted digital CBT (e-RISK) and school-based CBT (Mini-RISK), in treating anxious youth. Through a randomized controlled trial (RCT) design, we aim to investigate the comparative efficacy of Mini-RISK and e-RISK. It is crucial to explore how different formats of CBT compare to each other and how they impact youth with diverse anxiety disorders to ensure that appropriate treatment is provided at the right time. To address these objectives, we will pursue the following research questions and their respective hypotheses:
Research questions (RQ):
RQ1: Is e-RISK equivalent in effect compared to Mini-RISK for youth anxiety?
Hypothesis: e-RISK is equivalent in effect compared to Mini-RISK for youth anxiety.
RQ2: Do family factors, age, gender, type of anxiety or severity of symptoms moderate the outcome of digital CBT and school-based CBT?
Hypothesis: Family factors, age, gender, type of anxiety and severity of symptoms moderate the outcome of digital CBT and school-based CBT
RQ3: Is e-RISK and Mini-RISK equivalent in terms of effectiveness at 1-year follow-up? Hypothesis: e-RISK and Mini-RISK are equivalent in terms of effectiveness at 1-year follow-up.
3 Project methodology
3.1 Project arrangements, method selection and analyses
Design. The research design for this project involves a randomized controlled trial (RCT) that aims to compare the outcomes of e-RISK and Mini-RISK. Participants enrolled in both interventions will undergo assessments at pre-treatment, post-treatment, and a 12-month follow-up period. The reason why we not use wait-list condition is that ample evidence already supports the superior effectiveness of CBT interventions like e-RISK and Mini-RISK over waitlist and treatment as usual, as discussed in the introduction.
Sample/recruitment plan. The recruitment phase of this study is scheduled to commence in spring 2024, with the interventions being implemented in the Autumn 2024 by school personnel and public health nurses, who will serve as RISK providers. To ensure smooth implementation and eligibility assessment, the RISK facilitator (which is already funded) will aid. Eligible youth will be randomly assigned to either the e-RISK intervention with telephone support or the Mini-RISK intervention. The recruitment process will continue until December 2025, allowing for a comprehensive participant pool. During the recruitment process, eligible participants will be informed about the study and provided with necessary details. Informed consent will be obtained from participants above the age of 16, while parental consent and youth assent will be obtained for participants below the age of 16. The inclusion criteria specify that participants should be between the ages of 12 and 18 and express a desire for assistance with anxiety symptoms. However, individuals displaying suicidal behavior, psychotic behavior, or severe developmental disabilities will be excluded from participation. These criteria ensure the safety and appropriateness of the study population.
Interventions.
Mini-RISK is a CBT intervention for youth anxiety conducted as group therapy with parental involvement, conducted by two group leaders, primarily a public health nurse and a school social worker. The groups consist of 4–6 youths and last 8 sessions, for a total of 15 hours. The treatment includes standard CBT interventions including psychoeducation, homework and challenging negative thought patterns. Additionally, the treatment includes a large degree of exposure practice (i.e., facing one’s fears) and focuses on conducting as much on within session, exposure practice as possible (e.g. two 3-hour exposure practice sessions with the youths and parents). The youths participate in 7 sessions (2–8) the parents in four sessions (1,4, 6, 8) and teachers participate in two of the eight sessions (1,8).
e-RISK is based on the general RISK intervention, adapted to a digital setting. The e-RISK intervention consists of three modules, one for the youths, one for parents, and one for teachers. The youth module consists of seven sub-modules: 1. General information about anxiety, 2. Treatment principles, 3. How to screen your anxiety, 4. Thoughts and feelings, 5. Exposure practice, 6. Who can help, and 7. How to prevent relapse. Through the modules the youth will receive psychoeducation about anxiety and assignments to challenge negative thought patterns and face feared situations. The parent and teacher modules consist of three sub-modules each where the focus is how to appropriately support the youth during treatment. Both parents and the contact teacher will complete their modules during the e-RISK course. e-RISK will be provided as assisted digital CBT. Assistance entails individual contact by phone 5 times (weeks 1, 2, 4, 6, 8) by a RISK provider for 15 minutes to answer questions and to provide support on how to follow the e-RISK program. In three of the sessions, a parent will receive a 15 minute phone call (week 3, 5, 7) and the contact teacher will be telephoned twice for 15 minutes (week 1 and 8). In total, e-RISK providers spend 2.5 hours assisting each participant in e-RISK.
Training. As part of the current implementation of Mini-RISK in Kristiansand municipality, RISK providers have already received training in the use of Mini-RISK. The training is conducted at the University of Agder and consists of 8 days of teaching and 23 hours of video-based supervision delivered over the course of a year by trained RISK therapists from ABUP. In addition, all RISK providers will get training in the use of the e-RISK manual consisting of participation in two workshops (total 6 hours training). To maintain a high degree of fidelity during the RCT, RISK providers will receive group supervision with the local RISK facilitator twice per school semester. Before startup in August 2024, 90 RISK providers will have completed the training in both Mini-RISK and e-RISK.
Procedure. Recruitment for the study will happen through schools’ information channels and through teachers and social nurses trained in Mini-RISK. The study will be described and presented to all students in the school’s information channels (e.i., moodle, itslearning etc.). The messages will include recommendation to contact their local RISK provider (e.g., school personnel) if they are experiencing troubles related to anxiety. Participants will be informed of the study when contacting mini-RISK providers for help with their anxiety symptoms. During the session where participants are informed of the study, they will also be assessed for eligibility. This procedure is similar to regular practice, and current experiences suggest that each school can recruit 4-8 participants per year. After the RISK providers have assembled a group cohort, the RISK provider will contact the RISK facilitator which will inform them whether to deliver Mini-RISK to the group or e-RISK to the individuals. The RISK facilitator will make this decision based on a random number generator, thus randomly assigning to either Mini-RISK or e-RISK. Before e-RISK starts, the youth and their parent(s) receive 45 minutes instruction from a RISK provider on how to use the e-RISK platform. All RISK providers will conduct both e-RISK and Mini-RISK and the sessions will be audiotaped /videotaped and treatment fidelity will be assessed by the facilitator using the Competence and Adherence Scale for CBT (27). RISK providers with a low degree of fidelity will receive guidance from a facilitator on how to improve fidelity. Online questionnaires will be completed before treatment begins. Online questionnaires will be collected using Checkware, which is a secure tool used nationally by hospitals to collect person sensitive information online. After 8 weeks of commencing the treatment and after one year, both those assigned to e-RISK and Mini-RISK will fill out online questionnaires.
Risks and challenges. Usually, it is demanding to recruit sufficient anxious youths to participate in school-based interventions. However, the management in Kristiansand has clearly expressed a desire to establish Mini-RISK at all schools. The experience so far is that there are few problems recruiting youth to the Mini-RISK and already we have 35 schools that can offer Mini-RISK.
Statistics. Research questions will be addressed using hierarchical regression (i.e., multilevel equivalence tests), and Structural equation modeling (SEM). Hierarchical regression will be used to assess effectiveness of e-RISK and Mini-RISK and determine whether they are equivalent on symptom outcomes. Hierarchical regression and SEM will be used to assess the moderating effects of family factors, age, gender, type of anxiety and severity of symptoms. All analyzes will be performed using intent-to-treat samples, with missing data being handled by full-information maximum likelihood procedures.
Measurements:
Primary outcomes measure: A/Y = Adult version/ Youth version
● The Spence Children’s Anxiety Scale SCAS, is used to assess child and parent-reported anxiety symptoms. This measure contains 38 items that load on a single factor (range from 0 to 114). (A/Y) (19)
Secondary outcomes
● The Child Anxiety Life Interference Scale CALIS, (20), is used to assess to what degree youth anxiety affects the daily life of the child and his/her family. (A/Y)
● Family Accommodation Scale Anxiety (FASA). Measures maladaptive parental accommodation across childhood anxiety disorders (22)
● Short Mood & Feeling Questionnaire (SMFQ) -Costello et al, 1991) is a 13-item version of MFQ assessing depressive symptoms over the last two weeks. (Y)
Competence and Adherence Scale for CBT (CAS-CBT). Competence and Adherence Scale for Cognitive Behavioral Therapy for anxiety disorders in youth. (18)
Sample size and power. The minimal clinical differences were defined based on experiences from previous studies as what would constitute measurable change (17, 23). For the primary outcome measure the minimal clinical difference was defined as Cohen’s d = 0.4, which would correspond as having a complete reduction of at least 2 anxiety symptoms or partial reduction of 3 on the Spence Children’s Anxiety Scale. Power calculations were performed under the very conservative expectation of 20% missing data and with the ability to detect minimal clinical difference based on (17, 23) and type I error-rate of .05 and the type II error-rate of .10. Required sample sizes are shown in table below (see below). We expect that at least 30 schools will participate during the 1.5-year study period. We expect that all schools will conduct at least one Mini-RISK group (4 participants) and one cohort of 4 e-RISK participants each year. Thus, we would expect 360 individual participants if no data is missing.
Power analysis
| Outcome measures | Minimal clinical difference (Cohen’s d) | Required total sample size |
|---|---|---|
| 1 & 3 : Equivalence in effectiveness in reducing anxiety symptoms at post-treatment and 1-year follow-up (SCAS) | 0.4 | 150 |
| 2: Moderation of effectiveness in reducing anxiety symptoms: | ||
| Family Accommodation (FASA) | 0.6 | 89 |
| Age | 0.3 | 298 |
| Gender | 0.4 | 177 |
| Type of Anxiety (SCAS) | 0.5 | 126 |
| Pre-treatment severity of anxiety (SCAS) | 0.6 | 89 |
| Depression symptoms (BDI-II) | 0.4 | 177 |
- Participants, organization and collaborations
See table below for summary of structures already in place.
Overview of structures in place
| Structure | Progress |
|---|---|
| Mini-RISK | 90 individuals trained. Available in 45 schools |
| e-RISK | Released and ready for use at www.e-risk.no |
| RISK facilitator | Employed and funded (70% until 2024, then 20%) |
| Project manager (Professor Åshild Telefsen) | Tenure at ABUP with 20% dedicated to e-RISK/MiniRISK research |
| Statistical supervisor (Thomas Bertelsen Ph.D) | Tenure at ABUP with 20% dedicated to e-RISK/Mini-risk research |
The project manager: Ashild Haaland is a psychologist and a professor of psychology at the University of Agder and researcher at Sorlandet Hospital, She is head of the research group on anxiety/OCD at ABUP. Haaland has been involved in several large-scale projects focusing on implementation and effectiveness of CBT for anxiety disorders. Her main responsibility will be to ensure the quality of the project structure, budget, methods, and dissemination, and further ensure well organized communication between the project partners. She is the main supervisor for the Ph.D. student. Åshild has a tenure position at ABUP, with 20% time dedicated specifically to the e RISK/Mini-RISK projects.
The research group: Joseph Himle, Associate Dean for Faculty Affairs at School of Social Work at University of Michigan University and Professor of both Social Work and Psychiatry. He has had a consulting position at Sørlandet Hospital since 2011, and he is part of the research group on anxiety and OCD in ABUP. He is considered one of the world’s renowned researchers on anxiety and has led or been involved in many large studies aimed at implementing CBT for adults and children in the primary health care service. In this project, he will contribute to article writing, and participate regularly in research meetings digitally or physically as a mentor. Thomas B. Bertelsen Psychologist, PhD, UIB. Bertelsen wrote his Ph.D on the effectiveness of hospital-RISK. His research area is child and adolescent mental health, and he has focused on the treatment of anxiety and has especially high competence in statistical methods. He is intended to supervise and assist in statistical aspects of the study. Thomas has a tenure position at ABUP with 20% dedicated specifically to the e-RISK/Mini RISK project. The Ph.D candidate, Ingrid Osland, is a psychologist and currently part of the Anxiety and OCD team at ABUP, Kristiansand. The PhD student will join the PhD program in Health sciences at the University of Agder.
Collaborators: Tine Nordgreen, Associate professor at Department of Global public health and Primary care and Center director of Research center for digital mental health, Helse Bergen, She has comprehensive project management experiences within research and digital innovations. She has also been Head of implementation of eMeistring which is implemented in most mental health clinics for adults in Norway. She will be part of the advisory group and be a mentor for the project manager. Oskar Blakstad is psychologist and Director of Assistant Self-Help (AS), a company that create solutions and technologies with societal benefits in health, research and education. Their digital self help programs for anxiety and depression are implemented in 70 municipalities in Norway. His company has developed the digital platform for e-RISK. His role in the project is to be a mentor regarding the digital intervention e-RISK and make improvements if necessary.
Project organization and management
The project time frame is 4 years and includes one Ph.D. student.
Project-meetings will be held monthly and are led by the project manager and include the supervisors and the local facilitator. During the data collection period, there will be bi weekly meetings with the PhD student.
In our advisory group, we have included stakeholders from the municipality level and the specialist health service to ensure that the project has the necessary progression. The group will meet with the project staff twice per year and when relevant. The advisory group includes representatives from Kristiansand municipality (Municipal manager of upbringing, Jon Wergeland, Municipal manager of schools, Rune Heggstad and Head of health nurses Merethe Moy), head of the Department of Child and Adolescent Mental Health, Iris Anette Olsen) and Tine Nordgreen, Director of Center for Research-based Innovation on Mobile Mental Health (UIB and Helse Bergen).
The reference group will be consulted twice a year and if relevant for their advice and includes a health nurse and a school social worker, two previous Mini-RISK-participating youths, two previous Mini-RISK-participating parents, two head of family-help centers, and two principals of schools. Currently the reference group consists of Principal Jørn Lauvsland, school social workers Kari Nyman and Kjetil Lervik and Director for department of health in the municipality Turid Knudsen and Anette Løite.
Local facilitator in the ongoing Mini-RISK implementation project Lene Holmen Berg is a clinical social worker and has comprehensive experiences with running RISK and Mini-RISK groups. She is funded by the Kavli fund in a 70% position but for implementing, not research. Funding from Kavli fund will end in 2024, but Lene will continue to be funded by a 20% position. In any case, she will be a great resource for the proposed research project. Her main task is to encourage RISK providers to facilitate the implementation of Mini-RISK into schools and recruit RISK providers, as well as clinical supervision. She will attend the meetings in the project group and the reference group and collaborate with the project manager.
3.3 Budget
In the period between 2021 and 2024, we secured funding from the Kavli Fund and the Sørlandet Competence Fund to cover the expenses related to training RISK providers at the University of Agder (UIA) and a local RISK facilitator (e.i., a professional employed to aid in implementing mini-RISK in the municipality). To date, 70 public health nurses and school social workers have completed the Mini RISK training, with an additional 30 expected to finish by 2023/2024 before beginning the study.
- Plan for activities, visibility and dissemination
Measures for communication and exploitation
Research results will be disseminated in at least 3 scientific publications in international peer-review journals, in addition to popular science articles and chronicles. To ensure dissemination to a larger community, we will present the study findings in lectures accessible to the public and patient organizations.
Article 1: Effectiveness of Assisted Digital CBT and School-Based Group CBT on Youth Anxiety: An Equivalence RCT
Article 2: Examining the Moderating Role of Family and Youth Factors in the Outcome of Assisted Digital CBT and School-based CBT
Article 3: Long-Term Effectiveness of Assisted Digital CBT and School-Based Group CBT: A Comparative Study at 1-Year Follow-Up
Milestones
The research project will start during June 2024 and the entire project is planned to be finished by 2028. Training of RISK-providers and the RISK-facilitator have already been funded as part of the implementation project.
| MILESTONES | 2025 Q1 | 2025 Q2 | 2025 Q3 | 2025 Q4 | 2026 Q1 | 2026 Q2 | 2026 Q3 | 2026 Q4 | 2027 Q1 | 2027 Q2 | 2027 Q3 | 2027 Q4 | 2028 Q1 | 2028 Q2 | 2028 Q3 | 2028 Q4 | Resources |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ethical approval/Data management plan (CheckWare) | x | x | ÅTH, IO | ||||||||||||||
| Pilot data collection | x | x | |||||||||||||||
| Recruitment of participants and data collection | x | x | x | x | x | RF, IO, ÅTH | |||||||||||
| Data collection one year follow-up | x | x | x | x | RF, IO, ÅTH | ||||||||||||
| Data analysis | x | x | x | x | IO, TBB |
Resources Key (from image):
- ÅTH = Åshild Tellefsen Håland
- TBB = Thomas Bjerregaard Bertelsen
- RF = RISK Facilitator
- IO = Ingrid Osland
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Plan for implementation
Assuming that both e-RISK and Mini-RISK demonstrate effectiveness, the intention is to implement these interventions in other municipalities across the country. The hospital version of RISK has already been successfully implemented at a BUP in Trondheim and Oslo, which provides a solid foundation for the implementation of e-RISK and Mini-RISK, as it ensures access to competent supervisors. We also have plans to extend training for Mini-RISK to Oslo and Trondheim. Additionally, training seminars will be conducted to guide the implementation of the e-RISK manual as assisted self-help. In the therapist module of e-RISK, guided self-help e-RISK/Mini-RISK manuals will be made available to certified therapists. Furthermore, if e-RISK proves to be effective, there is potential for translation into other languages, which would enhance accessibility to youth worldwide.
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User-involvement
Users are involved in all phases of the project. Adolescents who have previously participated in RISK have been highly involved in the development of e-RISK as described above. Prior to this study, former adolescents, parents, and teachers have participated in focus group interviews where they were specifically asked what the school needs to become better at coping with anxiety in students and this information was used as a basis for research questions. Teachers, youths, and parents who have participated in Mini-RISK/e RISK will become members of the reference group in the project, which meets twice a year and otherwise if relevant.
- Ethical considerations
In our project we are attempting to sample from the general population of youth in Kristiansand. In this regard, we will provide information to youth participants and their families regarding what data is collected, how it will be used and stored, and how long we will store it. Participation is voluntary and the youths can withdraw from the study anytime. Should someone wish to withdraw their data, or have questions regarding the data collected, they can contact the RISK facilitator who will aid them.Treatment will continue as planned and there should be no consequences for the youth if they withdraw from the study. It is possible that some youth may experience treatment as unpleasant or difficult. In the case where youth require more help after e-RISK, they will be offered individual sessions by the public health nurse, if needed. If the youth need more help after Mini-RISK they will be advised to contact the local department of child and adolescent mental health at the hospital and assist in referral if needed. Additionally, if self-harm or suicidal behavior is suspected, RISK providers will be instructed to contact the RISK facilitator who will assist in referral to the acute care division of the department of child and adolescent mental health.
References
- Essau CA, Lewinsohn PM, Lim JX, Ho M-HR, Rohde P. Incidence, recurrence and comorbidity of anxiety disorders in four major developmental stages. J Affect Disord. 2018 Mar 1;228:248–53.
- Pella JE, Slade EP, Pikulski PJ, Ginsburg GS. Pediatric anxiety disorders: A cost of illness analysis. J Abnorm Child Psychol. 2020 Apr;48(4):551–9.
- Racine N, McArthur BA, Cooke JE, Eirich R, Zhu J, Madigan S. Global Prevalence of Depressive and Anxiety Symptoms in Children and Adolescents During COVID-19: A Meta-analysis. JAMA Pediatr. 2021 Nov 1;175(11):1142–50.
- Woodward LJ, Fergusson DM. Life course outcomes of young people with anxiety disorders in adolescence. J Am Acad Child Adolesc Psychiatry. 2001 Sep;40(9):1086–93.
- Essau CA, Conradt J, Petermann F. Frequency, comorbidity, and psychosocial impairment of anxiety disorders in German adolescents. J Anxiety Disord. 2000 Jun;14(3):263–79.
- O’Neil KA, Puleo CM, Benjamin CL, Podell JL, Kendall PC. Suicidal ideation in anxiety-disordered youth. Suicide Life Threat Behav. 2012 Jun;42(3):305–17.
- Christe a systematic review. J Prim Prev. 2010 Jun;31(3):139–70.
- James AC, Jamesnsen H, Pallister E, Smale S, Hickie IB, Calear AL. Community-based prevention programs for anxiety and depression in youth: G, Cowdrey FA, Soler A, Choke A. Cognitive behavioural therapy for anxiety disorders in children and adolescents. Cochrane Database Syst Rev. 2015 Feb 18;(2):CD004690.
- Shafran R, Clark DM, Fairburn CG, Arntz A, Barlow DH, Ehlers A, et al. Mind the gap: Improving the dissemination of CBT. Behav Res Ther. 2009 Nov;47(11):902–9.
- Heiervang E, Stormark KM, Lundervold AJ, Heimann M, Goodman R, Posserud M-B, et al. Psychiatric disorders in Norwegian 8- to 10-year-olds: an epidemiological survey of prevalence, risk factors, and service use. J Am Acad Child Adolesc Psychiatry. 2007 Apr;46(4):438–47.
- Chavira DA, Stein MB, Bailey K, Stein MT. Child anxiety in primary care: prevalent but untreated. Depress Anxiety. 2004;20(4):155–64.
- Williams C, Martinez R. Increasing Access to CBT: Stepped Care and CBT Self-Help Models in Practice. Behav Cogn Psychother. 2008 Nov;36(06):675.
- Franklin C, Kim JS, Beretvas TS, Zhang A, Guz S, Park S, et al. The Effectiveness of Psychosocial Interventions Delivered by Teachers in Schools: A Systematic Review and Meta-Analysis. Clin Child Fam Psychol Rev. 2017 Sep;20(3):333–50.
- Lehtimaki S, Martic J, Wahl B, Foster KT, Schwalbe N. Evidence on digital mental health interventions for adolescents and young people: systematic overview. JMIR Ment Health. 2021 Apr 29;8(4):e25847.
- Luik AI, Kyle SD, Espie CA. Digital Cognitive Behavioral Therapy (dCBT) for Insomnia: a State-of-the-Science Review. Curr Sleep Med Rep. 2017 May 8;3(2):48–56.
- Whiteside SPH, Sim LA, Morrow AS, Farah WH, Hilliker DR, Murad MH, et al. A meta-analysis to guide the enhancement of CBT for childhood anxiety: Exposure over anxiety management. Clin Child Fam Psychol Rev. 2020 Mar;23(1):102–21.
- Bertelsen, T.B. et al. (2022) ‘Benchmarked effectiveness of family and school involvement in group exposure therapy for adolescent anxiety disorder’, Psychiatry Research, 313, p. 114632. doi:10.1016/j.psychres.2022.114632.
- Bjaastad JF, Haugland BSM, Fjermestad KW, Torsheim T, Havik OE, Heiervang ER, et al. Competence and Adherence Scale for Cognitive Behavioral Therapy (CAS-CBT) for anxiety disorders in youth: Psychometric properties. 9 Psychol Assess. 2016 Aug;28(8):908–16.
- Spence SH. A measure of anxiety symptoms among children. Behav Res Ther. 1998 May;36(5):545–66.
- Lyneham HJ, Sburlati ES, Abbott MJ, Rapee RM, Hudson JL, Tolin DF, et al. Psychometric properties of the Child Anxiety Life Interference Scale (CALIS). J Anxiety Disord. 2013 Oct;27(7):711–9.
- Angold, A., & Costello, E. J. (1987). Mood and feelings questionnaire (MFQ). Durham: Developmental Epidemiology Program, Duke University.
- Lebowitz ER, Marin CE, Silverman WK. Measuring Family Accommodation of Childhood Anxiety: Confirmatory Factor Analysis, Validity, and Reliability of the Parent and Child Family Accommodation Scale - Anxiety. J Clin Child Adolesc Psychol. 2020 Dec;49(6):752–60.
- Knight, A. et al. (2014) ‘Pre-treatment predictors of outcome in childhood anxiety disorders: A systematic review’, Psychopathology Review, a1(1), pp. 77–129. doi:10.5127/pr.034613.