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Abstract
Introduction No evaluated therapeutic approaches, that can efficiently be established in routine mental healthcare, are currently available for traumatised adolescent refugees in Germany. This study evaluates the efficacy of the Stress-Traumasymptoms-Arousal-Regulation-Treatment (START) programme to reduce trauma-related symptoms and psychological distress in traumatised adolescent refugees based in Germany.
Methods and analysis This randomised, waiting-list-controlled, multicentre trial with a 12-week follow-up will include 174 refugee minors with partial or full post-traumatic stress disorder who are fluent in either Arabic, Dari, English, German or Somali. Eligible refugee minors will be randomised to the START or waiting-list control groups. The manualised 8-week START programme is based on techniques of dialectical behaviour therapy (DBT), fosters adaptive coping with emotional distress and traumatic symptoms and comprises eight therapy modules and a booster session. Study assessments are planned at baseline, post-treatment (ie, after programme participation or waiting time), booster session at week 12 or 12-week waiting time, and at the 12-week follow-up. Primary and coprimary outcomes are changes in psychological distress and traumatic symptoms at post-treatment and will be analysed as response variables in linear mixed regression models. Secondary outcomes are changes in further trauma-related and other psychopathological symptoms, emotion regulation and intermediate effects of the programme at follow-up. We will also assess effects of the programme with ecological momentary assessments and on neuroendocrine stress parameters using hair cortisol.
Ethics and dissemination This study has been approved by the lead ethics committee of Rhineland-Palatinate and the ethics committees of participating sites. The study results will be disseminated through peer-reviewed publications and scientific conferences.
Trial registration number DRKS00020771.
- child & adolescent psychiatry
- protocols & guidelines
- psychiatry
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Strengths and limitations of this study
Randomised waiting-list controlled multicentre trial with follow-up.
Manualised DBT-based psychotherapeutic programme with patient material available in Arabic, Dari, English, German and Somali.
Multimodal assessment approach of intervention effects on symptoms, functioning and daily living outcomes by psychometric evaluations, electronic ambulatory assessments (e-diaries) and neuroendocrine stress parameters.
Restriction of study participation to refugee minors with language skills in Arabic, Dari, English, German and Somali.
Background and rationale
Among the forcibly displaced persons worldwide there is a high number of children and adolescents under the age of 18 years.1 At the peak of the refugee influx in Germany in 2016, 261 386 of the 745 545 asylum applications recorded in total were filed from refugees under the age of 18 of which 49 786 applications were filed from unaccompanied refugee minors in the care of youth welfare services and without the company of parents or persons with the right of custody. The high percentage of asylum applications filed by refugee minors has remained stable since then though due to political changes the total number of refugees entering Germany has steadily decreased.2 3 Of all refugees, children and adolescents, and especially unaccompanied refugee minors, are the most vulnerable group. They are at particular risk of traumatisation before, during and after their flight as well as for mental health problems.4–6 Children and adolescents seeking asylum in Germany report an average of eight potentially traumatic experiences, with 98% of unaccompanied refugee minors reporting traumatic events.5–7 They are exposed to stress due to insecure legal status and adaptation to new environments, cultural demands and language, the loss of stability provided by their cultural background of origin as well as provided by their families and caregivers if unaccompanied.8 In addition to their often prevalent traumatisation, they are also confronted with age-related developmental tasks like peer group integration, identity formation, education, professional training and finding their role in the host society. Cross-sectional studies and reviews assessing mental health problems in refugee minors report prevalence rates of 17%–71% for post-traumatic stress disorder (PTSD), 12%–44% for depressive disorders, 18%–38% for anxiety disorders and 33%–72% for behaviour problems.9 10 Longitudinal studies suggest a high risk of chronic mental health problems and indicate that baseline symptom severity, sex, being unaccompanied and post-migration factors like asylum status and access to mental healthcare are predictors of future mental health status.6 11 Studies evaluating trauma-related therapy programmes in refugee minors have mostly reported significant effects on trauma and/or additional mental health symptoms. However, conclusive interpretation of the findings is limited by heterogeneous therapy approaches, lack of manualised programmes and methodological shortcomings like lack of power analyses, randomisation and control groups, small sample sizes or heterogeneous study settings such as clinical, school or community settings in high-income countries, but also refugee camps in war regions.12–17 Evidence from rigorous methodological approaches like randomised controlled trials (RCTs) is needed to cross-validate the available results in terms of validity, reliability, and generalisability of the programmes.
Study objectives
The manualised Stress-Traumasymptoms-Arousal-Regulation-Treatment (START) programme was developed from clinical work with traumatised unaccompanied refugee minors in Germany to promote coping with traumatic distress and emotional irritability.18–20 An uncontrolled pilot study in 22 traumatised refugee minors showed positive effects on emotion regulation, adaptive strategies, self-control, distress and good feasibility.18 A subsequent study confirmed the positive effects on adaptive emotion regulation strategies.21
The primary aim of this RCT is to evaluate the efficacy of the START programme in reducing psychological distress and trauma symptoms in traumatised adolescent refugees compared with a waiting-list control group (WL). Main secondary aims are to assess whether treatment effects will remain stable for at least 12 weeks after programme termination (follow-up at week 24) and to assess whether the participants of the START groups improve emotion regulation strategies and mental health compared with WL. As stress and emotions are context-dependent and highly dynamic,22 intervention effects are assessed by psychometric instruments and with electronic ambulatory assessment (e-diaries). Ambulatory assessment aims to reduce retrospective biases while gathering ecologically valid data from everyday life near real-time. It has been shown as superior to retrospective psychometric assessment in terms of predicting symptom and treatment outcome23–26 and assessing reliably everyday functioning.27 We also evaluate intervention effects on the neuroendocrine stress system by assessing hair cortisol, which reflects the cumulative cortisol release over the past months and has been shown to capture treatment effects in PTSD.28
The study is part of the START research consortium, which evaluates distress-reducing psychotherapeutic group and preventive family interventions in traumatised toddler, adolescent and young adult refugees and aims to contribute to improved evidence-based therapeutic interventions for refugees within a stepped mental healthcare approach. The consortium comprises the START Adolescent Study, the START Childcare Study,29 the START Young Adults Study, and the smartphone-based experience sampling study tracking symptoms and daily living functioning with the use of e-diaries across the START Adolescents and Childcare studies. For further information regarding the consortium, please see wwwmentalhealth4refugeesde. The presented paper reports on the START Adolescents protocol (V.4.0, 16 March 2020) and has been conceived according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.30 31 Please also refer to SPIRIT checklist (online supplemental file 1) and to table 1.
Supplemental material
SPIRIT flow diagram
Methods and analysis
Patient and public involvement
The original START programme was developed from clinical work with highly traumatised unaccompanied refugee minors of different countries of origin, who had recently arrived in Germany.18–20 The adapted and extended version of the programme, that is evaluated in this RCT, was redesigned according to the participants’ feedback of the pilot study groups, who were also traumatised refugee minors from different countries of origin. The public was not involved when designing the study.
Trial design and setting
The study is conducted as a 12 weeks, two-arm, randomised, WL-controlled, multicentre trial with a 12-week follow-up and six participating outpatient departments in Germany, all of which are experienced in treating traumatised adolescent refugees. The study is coordinated by the Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center, Johannes Gutenberg University, Mainz, Germany. The study intervention comprises an adapted version of the START programme.18–20 Languages used in the study for the intervention and the assessments are Arabic, Dari, English, German or Somali. Interpreters are involved if needed. The study is not blinded for the treatment condition, which will be evident to participants, caregivers and study therapists. Recruitment started 1 October 2020. We expect that the last participants will complete the study end of October 2022. Data base lock and analysis of primary outcomes are planned until end of December 2022.
Key stopping rules for patients are a withdrawal of informed consent, unwillingness to further participate in the trial, any factors affecting the patient’s or others’ well-being, for example, acute suicidality or acute endangerment to others, onset of other acute severe mental disorders, alcohol or substance abuse, inpatient treatment of over 2 days, start of concurrent psychotherapy and more than two psychotherapeutic crisis interventions. Key stopping rules for participating centres are non-adherence with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use: Guidelines for Good Clinical Practice (ICH-GCP)32 or the study protocol, insufficient recruitment of participants, or insufficient data quality. The key stopping rule of the trial is a change in the overall risk-benefit ratio.
Participants
We will allocate 174 participants to the trial and expect that we will have to screen 240 adolescent refugees for eligibility. Inclusion criteria are: informed consent by adolescents and caregivers, flight background, age between 13.00 and 17.11 years, verbal communication skills and reading comprehension in one of the study languages, non-verbal IQ ≥70, partial or full PTSD, PTSD symptoms are the clinically most impairing condition with at least moderate clinical symptom severity. We kept the exclusion criteria to a minimum, to foster the applicability of the programme in routine care as much as possible. Exclusion criteria are: current substance use disorder and/or harmful alcohol abuse, primary severe mental disorders other than PTSD, acute suicidality or danger to others, unstable psychotropic medication (change of psychotropic medication within the last 2 weeks before baseline assessment), current ongoing psychotherapy, inpatient status or study participation in another clinical trial, unaccompanied refugee minor without a legal representative, known pregnancy. Participants, who attend all assessment visits, will be given a study compensation. Participants will be insured by a clinical trial insurance during the time of study participation. Please see for detailed information about the assessment of eligibility criteria also the sections ‘screening’ and ‘psychometric instruments’. The participants’ study flow is provided in figure 1.
Participants‘ study flow. START, Stress-Traumasymptoms-Arousal-Regulation-Treatment.
Study conduct
Recruitment
For recruitment, study information is provided to schools, child and adolescent psychotherapists/psychiatrists, social workers, youth welfare providers, at conferences, professional working group meetings, in newspaper articles or interviews, on the institutions’ homepages and on social media. All participants’ information about the study is provided in a caregiver and adolescents’ version in all study languages.
Trial flow
For a summary of trial flow and assessment visits please see the SPIRIT flow diagram, table 1. All assessments are provided by trained study staff and are performed at the screening visit, baseline (T0), post-treatment (after 8-week START programme or 8-week waiting time; T1), after the booster session or 12-week waiting time (T2), and after 24 weeks at the 12-week follow-up (T3). The maximum time allowed between T0 and T3 is 26 weeks. After termination of the study, all participants are informed about their current diagnostic status and available interventions provided by child and adolescent psychiatric and psychotherapeutic routine care. Participants of the WL are given the opportunity to take part in independent START groups.
Screening visit
Assessment of informed consent for study participation, inclusion and exclusion criteria, demographic and medical data. Inclusion of eligible participants, randomisation to the intervention (START) or WL using a web-based randomisation system with permuted blocks stratified by centre (http://randomizer.at).
Baseline (T0), post-treatment (T1), booster session (T2), 12-week follow-up (T3) assessments
T0 takes place between one and 2 weeks after randomisation (WL) or before the first programme session (START), T1 within 1 week after the 8-week programme (START) or within 8–9 weeks after T0 (WL), T2 within 1 week after the booster session (START) or 4–5 weeks after T1 (WL) and T3 follow-up visits within 12 weeks after T2 (START/WL). At T0 only, the Post-Migration Living Difficulties Questionnaire (PMLD) and Questionnaire on Therapy Expectation are assessed. At the T0(T1)–T3 visits primary endpoints, trauma symptoms, emotion regulation, general psychopathology, overall clinical severity of mental disorders, suicidality and endangerment to others are assessed and 1 week e-diaries are applied. Hair cortisol is assessed at T0, T2 and T3. Adverse events are assessed at T0–T3 visits and weekly until T1.
Intervention
Details of the START Adolescents programme are provided in table 2. START Adolescents study groups comprise three to eight participants and are restricted to study participants, who have been randomised to the intervention group. The manualised START group programme is based on DBT-techniques with emphasis on coping with emotional distress and traumatic symptoms, resilience, adaptive functioning and self-efficacy, but not on confrontation with traumatic memories. The group therapy is provided by two therapists through twice-weekly 60 min sessions and interactions are based on validation and acceptance techniques. Written participant programme materials are available in all study languages and if necessary, translators will attend the group therapies.
Start adolescents programme, modules 1–8 and booster session
The original START Adolescents programme comprised five modules with psychoeducation on trauma, stress, distressing emotions and crises, mindfulness training, arousal regulation, stress reduction techniques, and handling nightmares. For the current study, the START manual18–20 was extended by the three additional modules 6–8 and a booster session. The additional modules provide an intensified training of stress reduction skills, mindfulness techniques and additional psychoeducation about emotions and interpersonal effectiveness. Each session follows a defined structure and comprises, as fixed repeated elements, mindfulness training, monitoring one’s own inner tension/stress (‘stress signal light’), reviewing experiences when applying the programme skills, new contents/psychoeducation and skills training. The final session in module 8 is dedicated to a farewell ceremony and to validating and rewarding the participants' efforts and achievements. During the booster session, which is scheduled 4 weeks after programme termination, participants review their experiences when applying the acquired skills and techniques, their open needs, and provide an outlook on their personal future wishes and goals. If standardised risk assessments or participants’ personal information reveal acute danger to the self or others, additional psychotherapeutic crisis interventions will be offered to the participant. Participants with ongoing acute suicidal tendencies or ongoing danger to others after two subsequent crisis interventions must be excluded from study participation and transferred to specific intense psychiatric care.
Assessments
Psychometric instruments
For details of the instruments including psychometric properties, please see online supplemental file 2. All self-report assessments are applied in the study languages, all interviews are applied with the help of interpreters if indicated.
Supplemental material
Inclusion and exclusion criteria
Inclusion and exclusion criteria are assessed with the Essen Trauma Inventory for Children and Adolescents,33 Clinical Global Impression Scale, severity of illness subscale (CGI-S34), the Kiddie-Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version,35–37 the Alcohol Use Disorders Identification Test,38 the Columbia-Suicide Severity Rating Scale,39 the Test of Nonverbal Intelligence, Fourth Edition,40 and the standardised Questionnaire to Assess Endangerment to Others.39
Primary endpoints
Psychological distress is assessed with the Perceived Stress Scale, 10-item version (PSS-10), a validated self-report questionnaire, that measures the intensity with which individuals appraise their daily life as stressful, unpredictable, uncontrollable and overloaded. Reliability and validity for the Arabic, English and German version have been shown to be sufficient or good.41–44 Traumatic symptoms are assessed with the Impact of Event Scale-Revised (IES-R), a validated, self-report questionnaire evaluating traumatic symptoms on the subscales intrusion, avoidance, hyperarousal and on an overall measure of traumatic distress. Reliability and validity for the Arabic, English and German version have been shown to be good.45–48
Secondary endpoints
We assess trauma-related psychosocial impairment and PTSD criteria according to Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) with the Child and Adolescent Trauma Screen-2,49 trauma-related cognitions with the Posttraumatic Cognitions Inventory-child version50–52 and frequency and intensity of nightmares with the Disturbing Dream and Nightmare Severity Index.53 54 Emotion regulation is assessed with the 18-item version of the Difficulties in Emotion Regulation Scale (DERS-1855), general psychopathology with the Strengths and Difficulties Questionnaire,56 57 and the Beck Depression Inventory, second edition.58 59 Overall severity of illness is assessed with the CGI-S.34
Additional psychometric assessments
We assess adverse life experiences related to migration with the adapted German version of the self-rated PMLD,60 61 and therapy expectations with a self-designed questionnaire comprising three questions that are answered on a 5-point Likert-type scale.
Ambulatory momentary assessment: electronic diaries
We use smartphone-based electronic (e)-diaries to assess aversive inner tension, emotional intensity, trauma symptoms (intrusions, hypervigilance), cognitive and behavioural avoidance of triggering situations in daily environments, sleep quality, stressfulness, content and number of nightmares, self-efficacy, self-esteem, rumination and somatisation.62–64 Filling in the answers takes a few minutes and items are available in all study languages. Rumination about cultural differences, social support and conflicts, discrimination experiences, and personally important events at school will be used as context variables to determine their associations with emotional distress and trauma symptoms. Participants receive a comprehensive explanation of the use of e-diaries as a spoken PowerPoint presentation and a written document in each participant’s respective language. After the presentation, the participant is asked to do a test trial on the smartphone. Smartphones are programmed with the e-diary app movisensXS65 and employ an hourly 1-week time-based e-diary design. Prompts are pseudorandomised within a time frame of 50–70 min to avoid expectancy effects. At the beginning of the study, participants are asked to enter their school schedules and determine their first prompt in the morning. On the weekends, e-diary assessments start at 10:00 hours no data are assessed during school hours. The prompts end at about 21:00 hours on school days and about 22:00 hours if there is no school the next day.
Hair cortisol
If additional informed consent for hair cortisol collection is provided by study participants and their legal representatives, we collect thin hair strands from the posterior vertex of the head cut as close to the scalp as possible. Hair strands are tied together, sealed, and stored in a dry and dark place. Prior to analyses, they will be cut into a 2 cm segment proximal to the scalp, representing cumulative cortisol secretion of the last 2 months.66
Quality assurance and monitoring
The study procedures are monitored by the Coordination Centre for Clinical Trials (KKS) Heidelberg according to the ICH-GCP32 with respect to a risk-based quality management strategy and ensure that the trial is conducted according to protocol and regulatory requirements. All data of the ongoing study are reviewed by an independent data monitoring committee once a year with special focus on safety issues.
Manual adherence across different therapists and participating centres is ensured by training all therapists on the START Adolescents programme and regular supervision with standardised assessments of manual adherence. We require a certain level of professional training from the therapists, of whom at least one per group must be a graduated psychologist, pedagogue, or physician.
The quality of psychometric assessments, tests and interviews is ensured by training the raters on the study assessments. Raters must have a bachelor’s or master’s degree in psychology or a comparable standard. Raters with a bachelor’s degree in psychology will administer questionnaires and psychological tests, raters with a Master‘s degree in psychology will administer the study interviews.
Data management
The KKS Heidelberg is responsible for data management and analysis as well as data security and data transfer processes. All procedures are implemented in accordance with ICH-GCP guidelines and the Declaration of Helsinki.32 67 The protection of private data is ensured by a pseudonymisation procedure, and all private data are handled with respect to the European General Data Protection Regulation.68 Data are assessed by an electronic case report form (eCRF) and paper-based self-report questionnaires. The latter are transferred in copy to the KKS Heidelberg for double entry into the eCRF. E-diary data are transferred to the Mental mHealth lab, Karlsruhe Institute of Technology, analysed there and saved in encrypted form. The smartphones for e-diaries are provided by the research facility; no private smartphones are used for study purposes.
Data availability
The research data generated during this study will be available on reasonable request by the study coordinating centre at the Department of Child and Adolescent Psychiatry, University Medical Center, Mainz, Germany. Anonymised data use by other researchers not involved in the study may be done with prior agreement.
Statistics
Sample size calculation
The sample size calculation is based on the coprimary outcomes of emotional distress (PSS-10) and traumatic symptoms (IES-R) at T1. Based on available studies69 70 we assume in our study an effect size of d=0.63 for the PSS-10 and of d=0.56 for the IES-R score at T1. This results in a required sample size of n=84 (PSS-10) and n=104 (IES-R) for a one-sided test at an α=0.025 level with a power of 80% to detect such differences. The START pilot trial showed a drop-out rate <10% and was conducted as a one-centre single-arm naturalistic trial with mostly inpatients.20 We, therefore, calculated the sample size on the assumption of 40% drop-outs between T0 and T1 to account for the multicentre, WL-controlled approach and unstable living conditions of the included population. This amounts to n=174 participants who need to be randomised in our trial.
Analysis population and analysis
All randomised participants will be included in the full-analysis set as allocated. All randomised participants, who finish the study according to the study protocol until T2 as planned with no missing values for T1 (primary endpoint) will be included in the per-protocol set for analysis as allocated. All randomised participants will be included in the safety population according to the applied intervention.
Baseline characteristics will be analysed descriptively for the safety, full-analysis, and per-protocol set in the intervention and control group. The primary and coprimary endpoints will be analysed in the full-analysis set. Missing values will be imputed. Endpoints will be assessed as response variables in linear mixed regression models with site and psychotherapeutic group as random effects, intervention group, sex and region of origin as fixed effects, and age, PSS-10 and IES-R baseline scores, respectively, as linear effects with a hierarchical testing procedure that maintains the overall significance level of α=0.025. The primary analysis will be repeated in the per-protocol population as a sensitivity analysis. Since the different timing of the T0 baseline examination in the study groups after randomisation could cause biases in the effect estimates, that cannot be estimated or modelled, additional sensitivity analyses will be performed, such as repeating the primary analysis using the screening value instead of the baseline value. Secondary outcomes will be analysed in the full-analysis set. Missing values will not be imputed. The stability of treatment effects up to T3 will be assessed by calculating confidence intervals on the T1–T3 and T2–T3 difference for the PSS-10 and IES-R total scores in the intervention group. Psychometric scales used for assessment of secondary outcomes and hair cortisol concentrations will be analysed according to primary endpoints or descriptively. For the analysis of e-diary data, multilevel models will be used to characterise momentary mechanisms and context-dependent affective experiences, which allow a nested data structure (momentary experiences within participants), and enable different numbers of ratings per participant to be handled quite well.71 Safety variables will be analysed in the safety and full-analysis population.
Ethics and dissemination
The study protocol, patient recruitment procedures, patients’ information and informed consent material have been approved by the lead ethics committee of Rhineland-Palatinate (ID 2019-14709) and the ethics committees of participating sites. For every substantial protocol modification approval of all ethics committees is required. The study will be conducted according to ICH-GCP32 and the Declaration of Helsinki.67 Study results will be published through peer-reviewed publications and presented at scientific and clinical conferences.
Trial status
Recruitment started 1 October 2020.
Discussion
Evidence-based, evaluated, low-threshold and culture-sensitive psychotherapeutic treatment programmes, that reduce distress caused by traumatic experiences that can be efficiently established in routine mental healthcare, would represent valuable therapeutic interventions to support refugee minors with trauma-related symptoms and emotion regulation difficulties. However, such interventions are currently lacking. The primary aim of this study is to evaluate the clinical efficacy and intermediate outcome of the distress-reducing psychotherapeutic START programme and to contribute to improved evidence-based therapeutic interventions for adolescent refugees within a stepped-care mental health approach in Germany. If shown to be effective, the first rigorously evaluated manualised intervention programme for traumatised adolescent refugees will be available, which will have widespread implications for clinical practice.
Some limitations for the application of the programme in mental health routine care in host countries may be that the therapeutic study groups are limited only to traumatised refugees, which may not reflect clinical reality. Another limitation is the restriction of study participation to refugee minors with language skills in Arabic, Dari, English, German and Somali. Thus, the study will not provide information on the effectiveness of the programme if applied to refugee minors with a different cultural or language background. However, since all programme materials are available in Arabic, Dari, English, German and Somali, the START programme will provide a treatment option not only in German-speaking or English-speaking host countries that care for refugee minors but also in refugee camps based in Arabic-speaking, Dari-speaking or Somali-speaking countries, where is a huge need for easy-to-apply psychotherapeutic treatment options.
Beyond effects on the symptom level, we will analyse intervention effects on psychosocial functioning and everyday behaviour through the use of e-diaries and on the neuroendocrine stress system by analysing hair cortisol. The multimodal assessment approach of symptoms, functioning, daily living outcomes, context variables and neuroendocrine effects, as well as the follow-up assessment, will enable us to analyse immediate and intermediate treatment effects not only on the phenomenological clinical level but also on the biological and daily living level. This will extend our understanding of intervention effects, influencing factors and the course of trauma-related mental health problems in refugee minors.
Ethics statements
Patient consent for publication
Acknowledgments
We would like to acknowledge Sarah Mannion, MA (Cantab) for reviewing the English, Bianca Brückner for the help with the recruitment, and Christa Hellmann for the technical help when preparing the manuscript.
References
Supplementary materials
Supplementary Data
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Footnotes
ES and FH contributed equally.
Contributors ES obtained the funding for the START adolescent project and the Consortium coordination, designed the study design for the trial and the structure of START Consortium. ES and FH drafted the first version of the manuscript and revised the manuscript several times. FH organised the START Adolescents study. AD and EM developed the START intervention, were involved in the adaptation of the programme for this study and revised the manuscript. AD heads the Idar-Oberstein site. EM heads the Kleinblittersdorf site. SK-H and UE-P designed the smartphone-based experience sampling study and critically revised the manuscript. UE-P obtained funding for the experience sampling study and is the head of the Mental mHealth lab, KIT. CJM designed the protocol for the assessment of neuroendocrine parameters and critically revised the manuscript. TI-A is the head of the Landau site and critically revised the manuscript. BP is the head of the Koblenz site and critically revised the manuscript. HC is the head of the Marburg site and critically revised the manuscript. DK was, SO and NF are involved in the coordination of this study and DK, SO and NF critically revised the manuscript. IB is responsible for biostatistics and critically revised the manuscript. MH coordinates the START consortium and was involved in critically revising the manuscript. All authors read and approved the final manuscript.
Funding With the exception of the hair cortisol assessments, which will be self-funded by the Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Mainz, Germany, the START Adolescents study is funded by the German Federal Ministry of Education and Research (BMBF); funding code: 01EF1807A. The trial sponsor is the University Medical Center Mainz, Langenbeckstraße 155131 Mainz, Germany, www.unimedizin-mainz.de.
Disclaimer The sponsor played no part in the study design and writing this report.
Competing interests All authors have completed the ICMJE uniform disclosure form. The first two authors, ES and FH, received article processing fees and travel grants for conferences from the Federal Ministry of Education and Research, Germany and are consultants of the Federal Ministry of Rhineland Palatinate for refugee issues. ES recieved funding for the START Adolescents study from the Federal Ministry of Education and Research, Germany. TI-A received a research grant from the Federal Ministry of Education and Research for research of non-suicidal self-injury in adolescents and is president of the German Society of Cognitive Behavioral Psychotherapy for Children and Adolescents (KJPVT e.V.), unpaid position. DK received travel grants for conferences from the Federal Ministry of Education and Research, Germany. MH recieved funding for the START Adolescents study from the Federal Ministry of Education and Research, Germany. All other authors declare that they have no competing interests.
Provenance and peer review Study protocol was externally peer reviewed.
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