START NOW WebApp: Skill Training for Promoting Resilience
- Conditions
- Emotion RegulationResilienceSocial CompetenceStress
- Interventions
- Behavioral: START NOW WebApp
- Registration Number
- NCT05313581
- Lead Sponsor
- Prof. Christina Stadler
- Brief 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. 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description START NOW as web-based pure self-help training START NOW WebApp 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. START NOW as web-based group training guided by a facilitator START NOW WebApp 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.
- Primary Outcome Measures
Name Time Method Response to web-based training: pre-post participation CHANGE in psychological inflexibility as measured by scores on the AFQ-Y questionnaire 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.
- Secondary Outcome Measures
Name Time Method change in resilience (all 3 conditions) - 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) 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.
change in self-reported self-efficacy (all 3 conditions) - 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) 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.
change in general impairment (all 3 conditions) - 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) 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.
change in depression and anxiety (all 3 conditions) - 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) 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.
change in self-reported psychological well-being (all 3 conditions) - 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) 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.
change in anger-irritability (all 3 conditions) - 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) 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.
change in substance use (all 3 conditions) between screening (T0) and 12 week follow-up (T3, 12 weeks after the end of the intervention) 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.
Trial Locations
- Locations (1)
University Psychiatric Clinic
🇨🇭Basel, Basel-Stadt, Switzerland