Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352463
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-26
Brief Title:
Intervention Social Anxiety Combining Parent-child Treatment
Sponsor:
Leiden University
Organization:
Leiden University Medical Center
Study Overview
Official Title:
More Than the Sum of Its Parts Investigating a Combined Parent-child Treatment for Children With Social Anxiety
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISA
Brief Summary:
The aim of this pilot project is to investigate a treatment program for children with social anxiety in which children and their parents parallel to each other follow separate evidence-based interventions The added value of this pilot project is that the investigators are examining how both programs interact when offered simultaneously
Detailed Description:
After a diagnostic trajectory and a 2-week reflection period children and their parents are invited to come into the lab for baseline 1 During baseline 1 children and their parents will be interviewed and they will fill in some questionnaires They will then be randomly assigned to a 2- 4- or 6-week waiting period During this waiting period they will fill in Experience Sampling Method ESMs daily every other week One week before the end of the waiting period baseline 2 will take place After the waiting period children and their parents will start their separate treatments in parallel Children will get an individually tailored cognitive behavioural therapy CBT-protocol for social anxiety and parents will get SPACE In the treatment period they will fill in ESMs daily There is another assessment with interviews and questionnaires at mid-treatment after 6 sessions and post-treatment after 12 sessions as well as 1- and 2-months after treatment has ended After the treatment period the frequency of the ESMs will go back to daily every other week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None