ResilienceNCT05313581
START NOW WebApp: Skill Training for Promoting Resilience
A study testing START NOW WebApp in people with Resilience and Emotion Regulation, run by Prof. Christina Stadler at 1 site in Switzerland.
Trial summary
Almost every young person has experienced difficult situations, crises and stress in his or her life. It is difficult to cope with such situations and it is not uncommon for mental health to be affected. At the same time, those affected often do not get any help. There are too few offers of help. Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- Resilience, Emotion Regulation, Social Competence
- What is being tested?
- START NOW WebApp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Mar 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth and young adults in Residential Youth Care (RYC) or Correctional Institutions (CI)
- Age between 14-24 at time of screening
- Need for improvement: Avoidance and Fusion Questionnaire for Youth (AFQ-Y) equal or higher than 34.05, or
- Massachusetts Youth Screening Instrument-2 (MAYSI-2) subscale Angry-Irritable equal or higher than 5, or
- MAYSI-2 subscale Depressed-Anxious equal or higher than 3.
- Sufficient speaking, writing and reading skills in German or French
- (Written) informed consent
- No planned discharge before end of intervention phase; Exception: Self-Help condition
Who cannot join
- Suicidality: MAYSI-2 subscale Suicide Ideation equal or higher than 2
- Acute psychotic symptoms or mania: MAYSI-2 subscale Thought Disturbance equal or higher than 1
- Concurrent Cognitive Behavioral Therapy (CBT) based skills training similar to START NOW
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Psychiatric Clinic
Basel, Canton of Basel-City, 4002
About this study
Official title: Implementation of an E-version of the Skills Training START NOW for Promoting Emotion Regulation and Resilience in Residential Youth Care and Correctional Institutions: a Cluster Randomized Controlled Trial
Almost every young person has experienced difficult situations, crises and stress in his or her life. It is difficult to cope with such situations and it is not uncommon for mental health to be affected. At the same time, those affected often do not get any help. There are too few offers of help. That is why the investigators have developed the START NOW training and the corresponding WebAPP. With this training, young people can train their resilience, i.e. their psychological resistance. Resilient people cope better with difficult situations and remain psychologically healthy for longer. Because the START NOW training is now also available as a WebAPP, users can apply it practically, playfully and at any time. Furthermore, the WebAPP can be used as a prevention and treatment option in a resource-saving and cost-efficient way in institutions. The aim is to find out in a randomized study design with two treatment conditions and a waiting group whether START NOW is effective as a newly developed WebAPP. Specifically, the investigators will investigate whether a digital web-based self-help training can already achieve positive effects or whether a format in which accompanying guidance by a coach and social learning is possible (support by a trainer who guides young people during the training) is better for achieving sustainable changes.The project is funded by the Federal Office of Justice as part of a pilot project.
Read the detailed description
Psychological Flexibility (PF) is associated with improved mental health across a multitude of contexts and populations, while psychological inflexibility is associated with mental health problems, in particular depression and anxiety. Taking into consideration that prevalence rates of clinically significant anxiety and depression in large youth cohorts are high and even increased especially due to Covid-19, interventions aiming to enhance psychological flexibility are of particular importance. START NOW represents one approach that is well equipped to promote PF. It is an evidence-based, integrative skills training program, which offers a broad scope of applicability to different populations and contexts by promoting general psychological health and resilience.
Web-based health approaches are well established across settings, populations and a range of mental health outcomes and offer benefits such as cost-effectiveness, high accessibility and flexibility, direct and convenient use of resources, anonymity, decreased stigmatization and a feasible way to ensure continuity of care in transitional phases. Our project aims to develop and evaluate a web-based translation of the existing START NOW skills training that promotes PF in institutionalized youth.
The investigatorss will investigate the efficacy of web-based START NOW on PF in a randomized controlled trial comparing the following conditions: 1) Web-based group training guided by a trained START NOW facilitator (either face-to-face or through videoconferencing) 2) Web-based self-help without guidance 3) Treatment as usual (TAU)
- Conditions
- Resilience, Emotion Regulation, Social Competence, Stress
- Being tested
- START NOW WebApp
- Medical subject headings
- Emotional Regulation, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
START NOW WebAppBehavioural
The WebApp is based on the existing manualized START NOW skills training. START NOW aims to improve emotion- and stress regulation, social competence, effective management of encountered problems/crises, subjective well-being and resilience through improving an individual's level of psychological flexibility. It primarily employs a cognitive behaviourally oriented group skills training with integrated components from Dialectical Behavioural Therapy (DBT), Acceptance and Commitment Therapy (ACT), trauma-informed care and Motivational Interview (MI) techniques.
During the training, participants will encounter different exercises to help them train their skills. There are several mindfulness exercises in the form of audio tracks, containing, e.g., instructions on a breathing exercise. The skills training phase takes place over a period of 9 weeks (sessions 1+2, 9+10 and 11+12 are double session).
| Study group | Role | What they receive |
|---|---|---|
| START NOW as web-based group training guided by a facilitator | Active comparator | In condition 1, participants will be required to attend weekly sessions of the group training (period of 9 weeks; 3 double sessions;4 to12 participants) guided by a facilitator, either face-to-face or via videoconferencing. Facilitation will be provided either by a staff member (caretaker) of the institution who has received a 1.5 days training in START NOW (face-to-face setting), or by a member of the START NOW facilitator team of Universitäre Psychiatrische Kliniken (UPK) Basel (videoconference setting). All participants will have access to the START NOW Web application (WebApp) during the entire intervention and follow-up phase to complete additional exercises or review content.
Institutions randomized to group training guided by a facilitator condition will receive the complete pretraining (12 hours à 3 blocks: Theoretical Background; WebApp and Facilitator Material; Running Sessions) with individual coaching. Supervision will be provided twice during the intervention phase. Receives: Behavioral: START NOW WebApp |
| START NOW as web-based pure self-help training | Active comparator | Participants in condition 2 will use the START NOW web-based pure self-help training. Using the same session contents as in the group training guided by a facilitator, sessions have been adjusted so that participants can complete them individually and participants receive one session each week (session 1+2, 9+10 and 11+12 as double sessions). Institutions randomized to pure self-help training will receive the first block of the pretraining and the material from the second block (facilitator training material) prior to interventions start. Receives: Behavioral: START NOW WebApp |
| Treatment as usual (TAU) | No intervention | Participants in condition 3 will not receive any health promotion services during the skills training or follow-up period beyond what is offered at their respective institution. They will also be excluded from any group trainings similar to START NOW. For ethical reasons and to increase study-related commitment, they will be provided with the web-based pure self-help training after completion of the study. Institution staff will receive the first block of the pretraining and material from the second block after the end of the intervention. Supervision for participating caretakers and facilitators will not be provided during the intervention phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to web-based training: pre-post participation CHANGE in psychological inflexibility as measured by scores on the AFQ-Y questionnaire
The AFQ-Y is a widely used and validated self-rating questionnaire for assessing Psychological Flexibility in youth and young adults. Participants answer 17 items indicating how true each item is for them on a 5-point Likert scale (0 = not at all true; 4 = very true). Higher total scores indicate lower PF. Items are based on ACT models of human suffering representing the theoretical concept of psychological inflexibility due to high cognitive fusion and experiential avoidance. Data will be assessed within 2 weeks before start of skills training (baseline, T1), within 2 weeks after end of skills training (post-treatment assessment, T2), as well as at 12 weeks (+/- 2 weeks) (T3) and 24 weeks (+/- 2 weeks) (T4) post skills training. Primary endpoint is the change in total score between baseline (T1) and follow-up (T3). Total scores can range between 0 and 68. Accordingly, a change in score can range between -68 to +68.
Measured: Primary endpoint is the CHANGE in total score between baseline (T1) and follow-up (T3, 12 +/- 2 weeks after the end of the intervention)
Secondary outcomes (7)
change in resilience (all 3 conditions)
Increase in total score on the German version of the Connor-Davidson Resilience Scale (CD-RISC) in the 10-items version both in self-rating by participant and self-rating by caretaker. The CD-RISC refers to an individual's ability to endure difficult experiences. Answers are given on a 5-point Likert-Scale (0= not true at all; 4= true nearly all of the time). Total scores can range from 0 to 50, with change scores ranging from -50 to +50.
Measured: - between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)
change in self-reported psychological well-being (all 3 conditions)
Increase in total score on the World Health Organization - Five Well-Being Index (WHO-5) in self-rating by participant. The self-report questionnaire contains five items on a 6-point Likert-Scale (5= all of the time; 0= none of the time). Respondents are asked to indicate how often they felt well during the last two weeks. Total scores can range from 0 to 25, with higher scores indicating greater well-being. Accordingly, change scores range from -25 to +25.
Measured: - between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)
change in self-reported self-efficacy (all 3 conditions)
Increase in total score on the German 'General Self-Efficacy Scale - Skala zur Allgemeinen Selbstwirksamkeitserwartung' (SWE) in self-rating by participant. The questionnaire includes 10 Items and a 4-point Likert Scale (1= not true; 4= completely true). The scale reflects one's convictions on subjective controllability or competence expectations in different demand situations, with higher scores indicating a greater sense of self-efficacy. Total scores can range from 10 to 40, with change scores ranging from -40 to +40.
Measured: - between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)
change in general impairment (all 3 conditions)
Reduction of all sub scores and total score on the Columbia Impairment Scale (CIS) both in self-rating by participant and external rating by caretaker. The 13-item questionnaire captures functional impairment in four domains: interpersonal relations, broad psychopathological domains, functioning in school or at work, and use of leisure time. It will be answered both by the participant as a self-report questionnaire, and by the caretakers as external raters. Items are answered on a 5-point Likert-Scale (0= no problem; 4= a very big problem). Total score can range from 0 to 52, with change scores ranging from -52 to +52.
Measured: - between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)
change in depression and anxiety (all 3 conditions)
Reduction of total score on the Patient Health Questionnaire 4 (PHQ-4) in self-rating by participants. The PHQ-4 is a ultra- short questionnaire with the two subscales depression and anxiety, and was evaluated a s a reliable, valid and precise screening tools for self reported depression, anxiety and general psychological distress. Answers are given on 4-point Likert-Scale (0=not at all, 3= nearly every day). Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.
Measured: - between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)
change in anger-irritability (all 3 conditions)
Reduction of total score on Affective Reactivity Scale (ARI) both in self-rating by participant and external rating by caretaker. The ARI contains seven items to be scored on a 3-point Likert-Scale (0= not true, 1= somewhat true, 2= certainly true). As just the first six items are summed to the total score, it can range from 0 to 12, with change scores ranging from -12 to +12. The seventh item is analysed separately.
Measured: - between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)
change in substance use (all 3 conditions)
Reduction of total score on the Alcohol/Drug Use subscale of the MAYSI-2 in self-rating by participants. The MAYSI-2 is a brief screening tool designed for youth between the ages of 12-17 years, but it has been suggested that the screening tool may also be adequate for young adults as long as results are interpreted with caution.
The MAISY-2 contains 52 items across seven subscales: Alcohol/Drug Use, Anger-Irritability, Depression-Anxiety, Somatic Complaints, Suicide Ideation, Traumatic Experiences and Thought Disturbance. Respondents are asked about the presence of various thoughts, feelings or behaviours in the past few months, in a yes or no format. Each subscale contains different caution cut-offs.
Measured: between screening (T0) and 12 week follow-up (T3, 12 weeks after the end of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start24 Mar 2022
- Primary completion22 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ResilienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1\) Web-based group training guided by a trained START NOW facilitator(either face-to-face or through videoconferencing)2) Web-based self-help without guidance 3) Treatment as usual (TAU)
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Christina Stadler
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Prof. Christina Stadler, University Psychiatric Clinics Basel
- Investigators
- Christina Stadler, Prof. Dr., Principal investigator, University Psychiatric Clinics Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313581
- Sponsor's protocol ID
- 2022-00108
- Status last verified
- Apr 2024
- First submitted
- 16 Mar 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kersten L, Pratzlich M, Mannstadt S, Ackermann K, Kohls G, Oldenhof H, Saure D, Krieger K, Herpertz-Dahlmann B, Popma A, Freitag CM, Trestman RL, Stadler C. START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised controlled trial. Trials. 2016 Dec 1;17(1):568. doi: 10.1186/s13063-016-1705-6.
PubMed 27903282Kersten L, Cislo AM, Lynch M, Shea K, Trestman RL. Evaluating START NOW: A Skills-Based Psychotherapy for Inmates of Correctional Systems. Psychiatr Serv. 2016 Jan;67(1):37-42. doi: 10.1176/appi.ps.201400471. Epub 2015 Aug 17.
PubMed 26278230Stadler C, Freitag CM, Popma A, Nauta-Jansen L, Konrad K, Unternaehrer E, Ackermann K, Bernhard A, Martinelli A, Oldenhof H, Gundlach M, Kohls G, Pratzlich M, Kieser M, Limprecht R, Raschle NM, Vriends N, Trestman RL, Kirchner M, Kersten L. START NOW: a cognitive behavioral skills training for adolescent girls with conduct or oppositional defiant disorder - a randomized clinical trial. J Child Psychol Psychiatry. 2024 Mar;65(3):316-327. doi: 10.1111/jcpp.13896. Epub 2023 Oct 10.
PubMed 37814906Brunner D, Savary V, Burgin D, Kersten L, Alfano J, Rommers N, Lanz L, Chilla C, Papageorgiou A, Vriends N, Stadler C; START NOW Study Group. Implementation and effectiveness of the web-based skills training START NOW in adolescents in residential youth care: a cluster randomized controlled trial. Child Adolesc Psychiatry Ment Health. 2026 Jun 29. doi: 10.1186/s13034-026-01127-z. Online ahead of print.
PubMed 42374535Kersten L, Alfano J, Erlanger TE, Helfenstein F, Lanz L, Weiss S, Chilla C, von Planta B, Kapoor M, Borel N, Rocco T, Papageorgiou A, De Brito CF, Bajrami A, Savary V, Mayor M, Hurschler J, Traut A, Brunner D, Vriends N, Stadler C. START NOW WebApp-promoting emotion regulation and resilience in residential youth care and correctional institutions: study protocol for a cluster randomized controlled trial. Trials. 2024 May 22;25(1):341. doi: 10.1186/s13063-024-08180-z.
PubMed 38778383
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an E-version of the Skills Training START NOW for Promoting Emotion Regulation and Resilience in Residential Youth Care and Correctional Institutions: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05313581
- Acronym / sponsor ID
- 2022-00108
- Conditions
- Resilience, Emotion Regulation, Social Competence, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Prof. Christina StadlerResearch network
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Almost every young person has experienced difficult situations, crises and stress in his or her life. It is difficult to cope with such situations and it is not uncommon for mental health to be affected. At the same time, those affected often do not get any help. There are too few offers of help. That is why the investigators have developed the START NOW training and the corresponding WebAPP. With this training, young people can train their resilience, i.e. their psychological resistance. Resilient people cope better with difficult situations and remain psychologically healthy for longer. Because the START NOW training is now also available as a WebAPP, users can apply it practically, playfully and at any time. Furthermore, the WebAPP can be used as a prevention and treatment option in a resource-saving and cost-efficient way in institutions. The aim is to find out in a randomized study design with two treatment conditions and a waiting group whether START NOW is effective as a newly developed WebAPP. Specifically, the investigators will investigate whether a digital web-based self-help training can already achieve positive effects or whether a format in which accompanying guidance by a coach and social learning is possible (support by a trainer who guides young people during the training) is better for achieving sustainable changes.The project is funded by the Federal Office of Justice as part of a pilot project.
Detailed description
Psychological Flexibility (PF) is associated with improved mental health across a multitude of contexts and populations, while psychological inflexibility is associated with mental health problems, in particular depression and anxiety. Taking into consideration that prevalence rates of clinically significant anxiety and depression in large youth cohorts are high and even increased especially due to Covid-19, interventions aiming to enhance psychological flexibility are of particular importance. START NOW represents one approach that is well equipped to promote PF. It is an evidence-based, integrative skills training program, which offers a broad scope of applicability to different populations and contexts by promoting general psychological health and resilience.
Web-based health approaches are well established across settings, populations and a range of mental health outcomes and offer benefits such as cost-effectiveness, high accessibility and flexibility, direct and convenient use of resources, anonymity, decreased stigmatization and a feasible way to ensure continuity of care in transitional phases. Our project aims to develop and evaluate a web-based translation of the existing START NOW skills training that promotes PF in institutionalized youth.
The investigatorss will investigate the efficacy of web-based START NOW on PF in a randomized controlled trial comparing the following conditions: 1) Web-based group training guided by a trained START NOW facilitator (either face-to-face or through videoconferencing) 2) Web-based self-help without guidance 3) Treatment as usual (TAU)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1) Web-based group training guided by a trained START NOW facilitator(either face-to-face or through videoconferencing)2) Web-based self-help without guidance 3) Treatment as usual (TAU)
| Arm | Type | Receives |
|---|---|---|
| START NOW as web-based group training guided by a facilitator | Active comparator | Behavioral: START NOW WebAppIn condition 1, participants will be required to attend weekly sessions of the group training (period of 9 weeks; 3 double sessions;4 to12 participants) guided by a facilitator, either face-to-face or via videoconferencing. Facilitation will be provided either by a staff member (caretaker) of the institution who has received a 1.5 days training in START NOW (face-to-face setting), or by a member of the START NOW facilitator team of Universitäre Psychiatrische Kliniken (UPK) Basel (videoconference setting). All participants will have access to the START NOW Web application (WebApp) during the entire intervention and follow-up phase to complete additional exercises or review content. Institutions randomized to group training guided by a facilitator condition will receive the complete pretraining (12 hours à 3 blocks: Theoretical Background; WebApp and Facilitator Material; Running Sessions) with individual coaching. Supervision will be provided twice during the intervention phase. |
| START NOW as web-based pure self-help training | Active comparator | Behavioral: START NOW WebAppParticipants in condition 2 will use the START NOW web-based pure self-help training. Using the same session contents as in the group training guided by a facilitator, sessions have been adjusted so that participants can complete them individually and participants receive one session each week (session 1+2, 9+10 and 11+12 as double sessions). Institutions randomized to pure self-help training will receive the first block of the pretraining and the material from the second block (facilitator training material) prior to interventions start. |
| Treatment as usual (TAU) | No intervention | –Participants in condition 3 will not receive any health promotion services during the skills training or follow-up period beyond what is offered at their respective institution. They will also be excluded from any group trainings similar to START NOW. For ethical reasons and to increase study-related commitment, they will be provided with the web-based pure self-help training after completion of the study. Institution staff will receive the first block of the pretraining and material from the second block after the end of the intervention. Supervision for participating caretakers and facilitators will not be provided during the intervention phase. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Youth and young adults in Residential Youth Care (RYC) or Correctional Institutions (CI)
- Age between 14-24 at time of screening
- Need for improvement: Avoidance and Fusion Questionnaire for Youth (AFQ-Y) equal or higher than 34.05, or
- Massachusetts Youth Screening Instrument-2 (MAYSI-2) subscale Angry-Irritable equal or higher than 5, or
- MAYSI-2 subscale Depressed-Anxious equal or higher than 3.
Key exclusion criteria (3 listed)
- Suicidality: MAYSI-2 subscale Suicide Ideation equal or higher than 2
- Acute psychotic symptoms or mania: MAYSI-2 subscale Thought Disturbance equal or higher than 1
- Concurrent Cognitive Behavioral Therapy (CBT) based skills training similar to START NOW
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| START NOW WebAppThe WebApp is based on the existing manualized START NOW skills training. START NOW aims to improve emotion- and stress regulation, social competence, effective management of encountered problems/crises, subjective well-being and resilience through improving an individual's level of psychological flexibility. It primarily employs a cognitive behaviourally oriented group skills training with integrated components from Dialectical Behavioural Therapy (DBT), Acceptance and Commitment Therapy (ACT), trauma-informed care and Motivational Interview (MI) techniques. During the training, participants will encounter different exercises to help them train their skills. There are several mindfulness exercises in the form of audio tracks, containing, e.g., instructions on a breathing exercise. The skills training phase takes place over a period of 9 weeks (sessions 1+2, 9+10 and 11+12 are double session). | Behavioural | START NOW as web-based group training guided by a facilitator, START NOW as web-based pure self-help training |
Primary outcome
Response to web-based training: pre-post participation CHANGE in psychological inflexibility as measured by scores on the AFQ-Y questionnaire
Time frame: Primary endpoint is the CHANGE in total score between baseline (T1) and follow-up (T3, 12 +/- 2 weeks after the end of the intervention)
The AFQ-Y is a widely used and validated self-rating questionnaire for assessing Psychological Flexibility in youth and young adults. Participants answer 17 items indicating how true each item is for them on a 5-point Likert scale (0 = not at all true; 4 = very true). Higher total scores indicate lower PF. Items are based on ACT models of human suffering representing the theoretical concept of psychological inflexibility due to high cognitive fusion and experiential avoidance. Data will be assessed within 2 weeks before start of skills training (baseline, T1), within 2 weeks after end of skills training (post-treatment assessment, T2), as well as at 12 weeks (+/- 2 weeks) (T3) and 24 weeks (+/- 2 weeks) (T4) post skills training. Primary endpoint is the change in total score between baseline (T1) and follow-up (T3). Total scores can range between 0 and 68. Accordingly, a change in score can range between -68 to +68.
7 secondary outcomes
change in resilience (all 3 conditions)
Time frame: - between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)
change in self-reported psychological well-being (all 3 conditions)
Time frame: - between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)
change in self-reported self-efficacy (all 3 conditions)
Time frame: - between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)
change in general impairment (all 3 conditions)
Time frame: - between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)
change in depression and anxiety (all 3 conditions)
Time frame: - between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)
change in anger-irritability (all 3 conditions)
Time frame: - between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)
change in substance use (all 3 conditions)
Time frame: between screening (T0) and 12 week follow-up (T3, 12 weeks after the end of the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 27903282Kersten L, Pratzlich M, Mannstadt S, Ackermann K, Kohls G, Oldenhof H, Saure D, Krieger K, Herpertz-Dahlmann B, Popma A, Freitag CM, Trestman RL, Stadler C. START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised controlled trial. Trials. 2016 Dec 1;17(1):568. doi: 10.1186/s13063-016-1705-6.
- Background: PubMed 26278230Kersten L, Cislo AM, Lynch M, Shea K, Trestman RL. Evaluating START NOW: A Skills-Based Psychotherapy for Inmates of Correctional Systems. Psychiatr Serv. 2016 Jan;67(1):37-42. doi: 10.1176/appi.ps.201400471. Epub 2015 Aug 17.
- Background: PubMed 37814906Stadler C, Freitag CM, Popma A, Nauta-Jansen L, Konrad K, Unternaehrer E, Ackermann K, Bernhard A, Martinelli A, Oldenhof H, Gundlach M, Kohls G, Pratzlich M, Kieser M, Limprecht R, Raschle NM, Vriends N, Trestman RL, Kirchner M, Kersten L. START NOW: a cognitive behavioral skills training for adolescent girls with conduct or oppositional defiant disorder - a randomized clinical trial. J Child Psychol Psychiatry. 2024 Mar;65(3):316-327. doi: 10.1111/jcpp.13896. Epub 2023 Oct 10.
- Derived from this study: PubMed 42374535Brunner D, Savary V, Burgin D, Kersten L, Alfano J, Rommers N, Lanz L, Chilla C, Papageorgiou A, Vriends N, Stadler C; START NOW Study Group. Implementation and effectiveness of the web-based skills training START NOW in adolescents in residential youth care: a cluster randomized controlled trial. Child Adolesc Psychiatry Ment Health. 2026 Jun 29. doi: 10.1186/s13034-026-01127-z. Online ahead of print.
- Derived from this study: PubMed 38778383Kersten L, Alfano J, Erlanger TE, Helfenstein F, Lanz L, Weiss S, Chilla C, von Planta B, Kapoor M, Borel N, Rocco T, Papageorgiou A, De Brito CF, Bajrami A, Savary V, Mayor M, Hurschler J, Traut A, Brunner D, Vriends N, Stadler C. START NOW WebApp-promoting emotion regulation and resilience in residential youth care and correctional institutions: study protocol for a cluster randomized controlled trial. Trials. 2024 May 22;25(1):341. doi: 10.1186/s13063-024-08180-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Stadler, Prof. Dr. principal investigator
University Psychiatric Clinics Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing START NOW WebApp in people with Resilience and Emotion Regulation, run by Prof. Christina Stadler at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to web-based training: pre-post participation CHANGE in psychological inflexibility as measured by scores on the AFQ-Y questionnaire (time frame: Primary endpoint is the CHANGE in total score between baseline (T1) and follow-up (T3, 12 +/- 2 weeks after the end of the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05313581, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.