Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623682
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Study of Self-Help and Support Services for Student Mental Health in Tertiary Institutions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy Cost-effectiveness and Implementation of an Integrated Self-help and Support Services for Student Mental Health in Tertiary Institutions JCTH Pragmatic Cluster RCT
Status:
NOT_YET_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:
This proposed study aims to evaluate the implementation of integrating the existing services in tertiary education institutions with the JCTH platform The study aims to evaluate the efficacy of JCTH on students mental health outcomes as compared to service as usual and to assess the cost-utility of the platform to determine whether the benefits of implementing the platform justify the costs associated It is hypothesized that participants who receive integrated self-help and support services will show H1 a greater reduction in mental health symptoms and H2 better mental well-being compared with participants in the control condition ie service-as-usual SAU
Detailed Description:
This study is a parallel pragmatic cluster-randomized control trial evaluating the efficacy and cost-utility of a JCTH-integrated services as compared to service-as-usual among tertiary education institutions in Hong Kong Randomisation will be carried out at institution level based on a computer-generated sequence The estimated sample size will be 1684 with 842 participants per condition A factorial design will be adopted with all eligible participants completing assessments at 7 timepoints baseline 4 months post-test 8- 12- 16- 20- and 24-months follow-up The primary endpoint is 4 months at post-test after baseline assessment Concurrently all staff involved in the project will be interviewed qualitatively at 12 months and 24 months from enrolment to understand their experience in the integration process and effectiveness of implementation
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