START NOW WebApp: Skill Training for Promoting Resilience

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-24

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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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

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Resilience Emotion Regulation Social Competence Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

open

Study Groups

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START NOW as web-based group training guided by a facilitator

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.

Group Type ACTIVE_COMPARATOR

START NOW WebApp

Intervention Type 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 pure self-help training

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.

Group Type ACTIVE_COMPARATOR

START NOW WebApp

Intervention Type 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).

Treatment as usual (TAU)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Prof. Christina Stadler

Principal Investigator, Professor for Developmental Psychopathology (Full professorship), Department of Child and Adolescent Psychiatry (UPK-KJ), Psychiatric University Clinics Basel (UPK)

Responsibility Role SPONSOR_INVESTIGATOR