START NOW WebApp: Skill Training for Promoting Resilience

Stress Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05313581
• Other study ID #: 2022-00108
• Status: Completed
• Phase: N/A
• Start date: March 24, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: University Psychiatric Clinics Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 31, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Emotion Regulation
• Resilience
• Social Competence
• Stress

Intervention

Behavioral:
• START NOW WebApp
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).

Locations

Country	Name	City	State
Switzerland	University Psychiatric Clinic	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Christina Stadler

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View 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. Erratum In: Trials. 2017 Mar 2;18(1):95. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Client Training Satisfaction (2 intervention conditions)	Participants within the two intervention conditions can indicate their satisfaction with the training using the Client Satisfaction Questionnaire (CSQ) at T2 (post intervention). The CSQ was specifically developed to assess participants' experiences and satisfaction with START NOW. It contains eight items on a 4-point Likert-Scale (ranging from 0 to 3; response options are provided with smileys) and two open questions about what participants liked or would want to be changed within the training. Total scores can range from 0 to 24.	T2 (post intervention, =2 weeks after end of intervention)
Other	Trainer Satisfaction (facilitators of the group training)	Satisfaction of facilitators of the group training guided by a facilitator condition will be assessed with the Trainer Satisfaction Questionnaire (TSQ) at T2 (post intervention), a 5 Min self-rating questionnaire. After the end of the intervention, focused group discussions are planned for all interested institutions regarding implementation and experiences with START NOW. The group discussions will be conducted as guided interviews for 1 hour with a maximum of 3 institute employees and recorded for later transcription (audio and video; destroyed after transcription; text anonymized) and qualitative analyses.	T2 (post intervention, =2 weeks after end of intervention)
Other	Social Atmosphere	Social Atmosphere will be assessed by the German version of the Essen Climate Evaluation Schema (EssenCES). It is a short self-rating questionnaire, containing 17 items across three subscales: Therapeutic Hold, Patients' Cohesion and Mutual Support, and Experienced Safety. Responses are given on a 5-point Likert Scale (0= not at all, 1= little, 2= somewhat, 3= quite a lot, 4= very much). Total scores can range from 0 to 68 with higher scores indicating a better social climate. Accordingly, change scores can range between -68 to +68.	T1 and all following time points
Other	Checklist Baseline T1 and Checklist Monitoring	Inclusion/exclusion criteria throughout the course of the study (i.e., participation in concurrent CBT based skills training similar to START NOW., internet access, external placements/discharge, unauthorized leaves) will be screened/monitored with two specially designed Checklists.	T1 and all following time points. NOTE: Monitoring purpose (Data Control), no aggregation of data
Other	Prior Experiences of Caretakers and Facilitator	The professional qualification of involved caretakers and facilitators, their experiences with START NOW or other forms of resilience trainings will be assessed with a short questionnaire.	For caretakers at baseline (T1), for facilitators at post-treatment assessment (T2, =2 weeks after end of intervention).
Other	Adherence	For each institution, the quality of the group training guided by a facilitator will be rated by a START NOW facilitator during one session (either live or via online connection) using a Quality Assurance Form.	during one session (either live or via online connection)
Primary	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.	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	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.	- 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)
Secondary	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.	- 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)
Secondary	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.	- 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)
Secondary	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.	- 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)
Secondary	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.	- 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)
Secondary	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.	- 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)
Secondary	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.	between screening (T0) and 12 week follow-up (T3, 12 weeks after the end of the intervention)