TMCU for Young Adults With First Episode Psychosis

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Recruiting
CT.gov ID
NCT04624074
Collaborator
(none)
40
1
1
41.9
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Teen Marijuana Check Up
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Pilot Testing a TMCU Adapted for Young Adults With First Episode Psychosis
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Teen Marijuana Checkup - adapted

Teen Marijuana Checkup will be adapted for youth and young adults with first episode psychosis. The Teen Marijuana Checkup includes two intervention sessions. In Session 1, the interventionist uses motivational interviewing skills to hear the adolescent's history and current concerns with marijuana. The personalized feedback report generated from the baseline assessment is reviewed. In Session 2, the interventionist elicits change talk and guides discussion on making changes to reduce or stop marijuana use.

Behavioral: Teen Marijuana Check Up
Teen Marijuana Checkup will be adapted for youth and young adults with first episode psychosis. The Teen Marijuana Checkup includes two intervention sessions. In Session 1, the interventionist uses motivational interviewing skills to hear the adolescent's history and current concerns with marijuana. The personalized feedback report generated from the baseline assessment is reviewed. In Session 2, the interventionist elicits change talk and guides discussion on making changes to reduce or stop marijuana use.

Outcome Measures

Primary Outcome Measures

  1. Timeline Followback [baseline, immediately after the intervention]

    Change in cannabis use

  2. Modified Colorado Symptom Index [baseline, immediately after the intervention]

    Change in psychosis symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age 13-35

  2. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, other specified schizophrenia spectrum and other psychotic disorder, and unspecified schizophrenia spectrum and other psychotic disorder

  3. Duration of illness: ≤ 2 years

  4. Enrolled at a Coordinated Specialty Care program

  5. Report current use of cannabis

  6. Ability and willingness to provide informed consent to participate

Exclusion Criteria:
  1. Individuals who do not meet all inclusion criteria are excluded.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Maryland School of Medicine Baltimore Maryland United States 21021

Sponsors and Collaborators

  • University of Maryland, Baltimore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Melanie Bennett, Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT04624074
Other Study ID Numbers:
  • 1R01MH120550-01A1
First Posted:
Nov 10, 2020
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022