Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04624074
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2020-11-04
Brief Title:
Pilot Testing the Check Up
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Pilot Testing a TMCU Adapted for Young Adults With First Episode Psychosis
Status:
RECRUITING
Status Verified Date:
2024-09
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:
We propose to pilot test an adapted version of the Teen Marijuana Check Up TMCU for persistent cannabis users with first episode psychosis FEP in Coordinated Specialty Care CSC The adapted version of the TMCU will include tailoring to risks of persistent cannabis use in FEP providing education on lower risk cannabis use and adding a session to address collaborative planning to maintain CSC engagement and antipsychotic adherence and to reduce harm associated with cannabis use
Detailed Description:
We propose to adapt the Teen Marijuana Check Up for persistent cannabis users with FEP in CSC Dr Walker the developer of the TMCU will be a consultant Adaptations will include tailoring content of assessment and feedback to risks of persistent cannabis use in FEP providing education on lower risk cannabis use and adding a session to address collaborative planning to maintain CSC engagement and antipsychotic adherence and to reduce harm associated with cannabis use We will also develop guidelines for integrating continued collaborative harm-reduction focused discussion of cannabis use into CSC consider adding booster or check-in sessions and specify how family members can be brought into the check-up process To inform these adaptations we will collect quantitative data from cannabis-using FEP patients n of 40 and conduct qualitative interviews with cannabis-using patients family members and CSC clinicians 15 of each about their perspectives on cannabis use and CSC participation Aim 1 We will use these data as part of an iterative process to specify the adapted intervention that will integrate information gathered from team discussion and focus groups with FEP patients and family members and vetting of intervention components by key stakeholders Aim 2 Finally we will conduct a pilot of the adapted intervention n of 40 cannabis-using FEP patients compared to matched controls to examine feasibility acceptability fidelity and preliminary impact on intervention targets and outcomes Aim 3 If results are promising the intervention can be tested in a large RCT across the EPINET
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