Clinical trial NCT05313581: START NOW WebApp: Skill Training for Promoting Resilience
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resilience
Emotion Regulation
Social Competence
Stress
Lead sponsor: University Psychiatric Clinics Basel
Sponsor class: NETWORK
First posted: 2022-04-06
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: PREVENTION

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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Response to web-based training: pre-post participation CHANGE in psychological inflexibility as measured by scores on the AFQ-Y questionnaire
timeFrame: 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:
measure: change in resilience (all 3 conditions)
timeFrame: - 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)
measure: change in self-reported psychological well-being (all 3 conditions)
timeFrame: - 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)
measure: change in self-reported self-efficacy (all 3 conditions)
timeFrame: - 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)
measure: change in general impairment (all 3 conditions)
timeFrame: - 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)
measure: change in depression and anxiety (all 3 conditions)
timeFrame: - 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)
measure: change in anger-irritability (all 3 conditions)
timeFrame: - 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)
measure: change in substance use (all 3 conditions)
timeFrame: between screening (T0) and 12 week follow-up (T3, 12 weeks after the end of the intervention)
Other outcomes:
measure: Client Training Satisfaction (2 intervention conditions)
timeFrame: T2 (post intervention, ≤2 weeks after end of intervention)
measure: Trainer Satisfaction (facilitators of the group training)
timeFrame: T2 (post intervention, ≤2 weeks after end of intervention)
measure: Social Atmosphere
timeFrame: T1 and all following time points
measure: Checklist Baseline T1 and Checklist Monitoring
timeFrame: T1 and all following time points. NOTE: Monitoring purpose (Data Control), no aggregation of data
measure: Prior Experiences of Caretakers and Facilitator
timeFrame: For caretakers at baseline (T1), for facilitators at post-treatment assessment (T2, ≤2 weeks after end of intervention).
measure: Adherence
timeFrame: during one session (either live or via online connection)
Locations:
city: Basel
country: Switzerland
facility: University Psychiatric Clinic
state: Basel-Stadt
Study officials:
affiliation: University Psychiatric Clinics Basel
name: Christina Stadler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kersten 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.
citation: Stadler 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.