START NOW WebApp: Skill Training for Promoting Resilience

NCT05313581 | Completed DMC

• 1 other identifier: 2022-00108
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Resilience; Emotion Regulation; Social Competence; Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (6)

• Client Training Satisfaction (2 intervention conditions)

  T2 (post intervention, ≤2 weeks after end of intervention)

• Trainer Satisfaction (facilitators of the group training)

  T2 (post intervention, ≤2 weeks after end of intervention)

• Social Atmosphere

  T1 and all following time points

Study Arms (3)

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.

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.

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.

Interventions

START NOW WebApp BEHAVIORAL

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).

START NOW as web-based group training guided by a facilitator; START NOW as web-based pure self-help training

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Christina Stadler: lead

Study Sites (1)

University Psychiatric Clinic

Basel, Canton of Basel-City, 4002, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 27903282 BACKGROUND

• 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.

  PMID: 26278230 BACKGROUND

• 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.

  PMID: 37814906 BACKGROUND

• Kersten 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.

  PMID: 38778383 DERIVED

MeSH Terms

Conditions

Emotional Regulation; Social Skills

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Christina Stadler, Prof. Dr.

  University Psychiatric Clinics Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Professor for Developmental Psychopathology (Full professorship), Department of Child and Adolescent Psychiatry (UPK-KJ), Psychiatric University Clinics Basel (UPK)

Model Details: 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 Record Dates

• First Submitted: March 16, 2022
• First Posted: April 6, 2022
• Study Start: March 24, 2022
• Primary Completion: March 22, 2024
• Study Completion: March 31, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)