Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
Cultural Adaptation and Implementation of DBT for Adolescents With Emotional Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cultural Adaptation and Implementation of Dialectical Behavior Therapy Skills Training Group for Adolescents With Emotional Disorders a Feasibility Study and a Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
The goal of this study is to learn if Dialectical behavior therapy Skills
Training for Adolescents DBT-A-ST works on emotional disorders in adolescents The main questions it aims to answer are
Does DBT-A-ST produce faster improvements ie steeper slopes compared to ASG on primary and secondary outcome measures during treatment and 3-month follow-up
Does DBT-A-ST produce greater improvements compared to ASG on primary and secondary outcome measures
Participants will
Randomly assigned to a a culturally adapted DBT-A-ST or b activities-based support group ASG
Received five assessments before the start of the trial T1 after 4 8 sessions T2 T3 at post-intervention T4 and 3-month follow-up T5
Training for Adolescents DBT-A-ST works on emotional disorders in adolescents The main questions it aims to answer are
Does DBT-A-ST produce faster improvements ie steeper slopes compared to ASG on primary and secondary outcome measures during treatment and 3-month follow-up
Does DBT-A-ST produce greater improvements compared to ASG on primary and secondary outcome measures
Participants will
Randomly assigned to a a culturally adapted DBT-A-ST or b activities-based support group ASG
Received five assessments before the start of the trial T1 after 4 8 sessions T2 T3 at post-intervention T4 and 3-month follow-up T5
Detailed Description:
A randomized controlled trial will be conducted in a medical centers child adolescent psychiatry department Participants aged 12-17 years with current depressive or anxiety disorders as diagnosed using the K-SADS-E will be recruited and randomly allocated 11 to one of two study arms a culturally adapted DBT-A-ST group b Activities-based support group Both interventions are in group format and include 15 weekly sessions 120 mineach session Based on power calculation a target sample size of 160 youths will be included Assessments will occur before the trial starts at the 4th and 8th treatment sessions in the end and at the 3-month follow-up
Primary outcomes are the severity of depression and anxiety rated by blind assessors Secondary outcomes include general psychopathology number of DSM-5 disorders quality of life and self-reported measures The treatment mechanisms and implementation processes will also be examined
Primary outcomes are the severity of depression and anxiety rated by blind assessors Secondary outcomes include general psychopathology number of DSM-5 disorders quality of life and self-reported measures The treatment mechanisms and implementation processes will also be examined
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