Learn to Dare! Leiden
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorLeiden University
About this trial
Research shows that many children face anxiety and stress related problems. However, as much as 70-80% of children do not receive help. The aim of this project is to offer a training for children who are hindered by their shyness or fears, so that all children can develop freely without being held back and so that the risk of escalation of fear and stress in the long term can be prevented. In this project the prevention training 'Learn to Dare!' will be offered to children between the ages of 8 and 18 where the long-term outcomes and the program itself will be evaluated for attractiveness and satisfaction. With the evidence-based program 'Learn to Dare!\' children between the ages of 8 and 12 learn to stand up for themselves in a safe environment, to face the situations that they find exciting and to be more confident in their own abilities. This project aims to adapt the program so that it can be available up to and including 18 years in the future.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Cut-off scores of the SCARED: for girls 31 and for boys 27.
Disqualifiers
Currently under treatment for anxiety complaints or under treatment in the mental health care system for other internalizing complaints.
Anxiety problems or comorbid problems that require attention or treatment (including a 6 or higher on the severity index (CSR) of the ADIS and a score above the clinical cut-off on the Child Depression Inventory.)
Difficulty in understanding the training.
Trial design
Design model
Sequential
Treatments tested in this trial
Leer te Durven!
Behavioral'Leer te Durven!' is an eight-week preventative group training for children between the ages of 8 and 12. This training is evidence-based and is based on the principles of Cognitive Behavioral Therapy. With this program children learn to stand up for themselves in a safe environment, to face the situations that they find exciting and to be more confident in their own abilities. The training consists, among other things, of psychoeducation, exposure, and relaxation.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Training GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in anxiety severity in children (SCARED-child)
The Screen for Child Anxiety Related Disorders (SCARED) will be administered to the children. Scores on the SCARED range between 0-142. A higher score means higher anxiety levels.
Time frame
During baseline 1, baseline 2, post-training, and the follow-ups (6, 12, and 24 months after the training)2
Change in anxiety severity in children (SCARED-parent)
The Screen for Child Anxiety Related Disorders (SCARED) will be administered to the parents. Scores on the SCARED range between 0-142. A higher score means higher anxiety levels.
Time frame
During baseline 1, baseline 2, post-training, and the follow-ups (6, 12, and 24 months after the training)3
Change in severity of anxiety in children (SCID-parent)
Severity of anxiety will be assessed using the Structured Clinical Interview for DSM Disorders (SCID) in combination with the severity index (Clinician Severity Rating) of the Anxiety Disorder Interview Schedule (ADIS-V). The CSR-score is a score between 0 and 8, with higher scores indicating a higher severity and interference of anxiety. The SCID will be administered to the parents.
Time frame
From baseline to the end of the training and follow-up (6, 12, and 24 months post-training).4
Change in severity of anxiety in children (SCID-child)
Severity of anxiety will be assessed using the Structured Clinical Interview for DSM Disorders (SCID) in combination with the severity index (Clinician Severity Rating) of the Anxiety Disorder Interview Schedule (ADIS-V). The CSR-score is a score between 0 and 8, with higher scores indicating a higher severity and interference of anxiety. The SCID will be administered to the children.
Time frame
From baseline to the end of the training and follow-up (6, 12, and 24 months post-training).Secondary outcomes
1
Change in self-efficacy of the children (WIRK-ALL child version)
The WIRK-all will be administered to the children to assess their change in self-efficacy. The WIRK-ALL is a short questionnaire and is an adaptation of the General Self-Efficacy Scale. The scores on the WIRK-ALL range between 10 and 40, with higher scores indicating higher self-efficacy.
Time frame
From baseline to the end of the training and follow-up (6, 12, and 24 months post-training).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Leiden University
Lead sponsor
Leids Universitair Behandel en Expertise Centrum (LUBEC)
Collaborator
Source ClinicalTrials.gov