Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609824
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Learn to Dare Leiden
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Learn to Dare Leiden
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Dare39 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
Detailed Description:
Participants are recruited via the Knowledge Centre Anxiety and Stress in youth KAS telephone line by a research assistant or via the waiting list of LUBEC Following recruitment a research assistant conducts a screening call with the parents lasting approximately half an hour to determine the child39s eligibility for the project Subsequently the research assistant collaborates with a therapist from KASLUBEC to evaluate the case If both agree that the child meets the criteria of the 39Learn to Dare39 program the research assistant proceeds to conduct a diagnostic interview with both the child and parents When the child still meets the requirements for 39Learn to Dare39 the therapist from LUBEC who is going to give the trainings will do an intake with the child and parents
When the child still meets the criteria after this intake a subsequent appointment will take place at LUBEC in Leiden that serves as an opportunity for parents and children to familiarize themselves with the therapist and complete the baseline 1 measurement This appointment will take about 15-2 hours Two research assistants will administer questionnaires to the parents and the child demographics questionnaire SCARED CDI WIRK-ALL In addition they will administer the anxiety scale of the SCID in combination with the ADIS severity index to the parents and the child
After baseline 1 there will be a waiting period of 4 weeks After this period the child and parents complete the SCARED questionnaire online 30 minutes before commencing the treatment phase The treatment comprises eight group sessions of 39Learn to Dare39 one session per week 15 hours each along with assigned homework After those eight weeks of treatment the post-treatment session will take place at LUBEC 15-2 hours The therapist will meet with the child and the parents to evaluate the treatment together The research assistants will administer the anxiety scale of the SCID in combination with the ADIS severity index to the parents and the child In addition a couple of questionnaires will be administered SCARED CDI WIRK-ALL Training Evaluation Questionnaire Lastly there will be three follow-ups 6 12 and 24 months after treatment 15 hours per follow-up Parents have the option to conduct these follow-ups either at LUBEC or online The anxiety scale of the SCID along with the severity index of the ADIS questionnaire is administered along with supplementary questionnaires SCARED CDI WIRK-ALL
When the child still meets the criteria after this intake a subsequent appointment will take place at LUBEC in Leiden that serves as an opportunity for parents and children to familiarize themselves with the therapist and complete the baseline 1 measurement This appointment will take about 15-2 hours Two research assistants will administer questionnaires to the parents and the child demographics questionnaire SCARED CDI WIRK-ALL In addition they will administer the anxiety scale of the SCID in combination with the ADIS severity index to the parents and the child
After baseline 1 there will be a waiting period of 4 weeks After this period the child and parents complete the SCARED questionnaire online 30 minutes before commencing the treatment phase The treatment comprises eight group sessions of 39Learn to Dare39 one session per week 15 hours each along with assigned homework After those eight weeks of treatment the post-treatment session will take place at LUBEC 15-2 hours The therapist will meet with the child and the parents to evaluate the treatment together The research assistants will administer the anxiety scale of the SCID in combination with the ADIS severity index to the parents and the child In addition a couple of questionnaires will be administered SCARED CDI WIRK-ALL Training Evaluation Questionnaire Lastly there will be three follow-ups 6 12 and 24 months after treatment 15 hours per follow-up Parents have the option to conduct these follow-ups either at LUBEC or online The anxiety scale of the SCID along with the severity index of the ADIS questionnaire is administered along with supplementary questionnaires SCARED CDI WIRK-ALL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None