Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-01-09 @ 11:46 PM
Study NCT ID:
NCT07231406
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Narrative Therapy Among Young People With Moderate Level of Mental Distress in Hong Kong
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
A Cluster Randomized Controlled Trial of Narrative Therapy Among Young People With Moderate Level of Mental Distress in Hong Kong
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
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:
None
Brief Summary:
This cluster randomized controlled trial (cRCT) aims to evaluate the effectiveness of a narrative therapy (NT) intervention in (i) reducing mental distress, depressive symptoms, and anxiety, as well as (ii) enhancing perceived control and fostering a stronger sense of self among at-risk youth in Hong Kong. Participants are youths with moderate mental health concerns, indicated by K6 scores ranging from 11 to 14.
The study involves seven clusters, each based on community hubs, which will be randomly assigned to either the intervention group or a wait-list control group. Clusters assigned to the intervention group will receive six face-to-face sessions led by trained youth workers. Control clusters will receive the same intervention after the initial follow-up period.
Participants will be evaluated at baseline, post-intervention, and one-month follow-up. An interim analysis is built for the sake of evaluation of the collected data from the ongoing trial, in which the primary research question is addressed, and which has the potential for modifying the conduct of the study. Furthermore, a qualitative follow-up will be conducted after the trial, involving both participants and the workers delivering the NT intervention. This qualitative component aims to gather feedback on participants' experiences, and inform potential revisions to enhance future implementation.
It is hypothesized that youths receiving the NT intervention will show significantly greater improvements in perceived control and sense of self, along with reductions in mental distress, as well as depressive and anxiety symptoms, compared to those in the wait-list control group.
The study involves seven clusters, each based on community hubs, which will be randomly assigned to either the intervention group or a wait-list control group. Clusters assigned to the intervention group will receive six face-to-face sessions led by trained youth workers. Control clusters will receive the same intervention after the initial follow-up period.
Participants will be evaluated at baseline, post-intervention, and one-month follow-up. An interim analysis is built for the sake of evaluation of the collected data from the ongoing trial, in which the primary research question is addressed, and which has the potential for modifying the conduct of the study. Furthermore, a qualitative follow-up will be conducted after the trial, involving both participants and the workers delivering the NT intervention. This qualitative component aims to gather feedback on participants' experiences, and inform potential revisions to enhance future implementation.
It is hypothesized that youths receiving the NT intervention will show significantly greater improvements in perceived control and sense of self, along with reductions in mental distress, as well as depressive and anxiety symptoms, compared to those in the wait-list control group.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: