Pilot Testing the Check Up

Pilot Testing a TMCU Adapted for Young Adults With First Episode Psychosis

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.

Study Overview

• Status: Recruiting
• Conditions: Cannabis Use Disorder
• Intervention / Treatment: Behavioral: Teen Marijuana Check Up

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melanie Bennett, PhD; Phone Number: 410-706-0892; Email: mbennett@som.umaryland.edu
• Study Contact Backup: Name: Brian Brandler; Email: bbrandler@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21021
      • Recruiting
      • University of Maryland School of Medicine
      • Contact: Melanie Bennett; Phone Number: 410-706-0892; Email: mbennett@som.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeline Followback	Change in cannabis use	baseline, immediately after the intervention
Modified Colorado Symptom Index	Change in psychosis symptoms	baseline, immediately after the intervention

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders
• Other Study ID Numbers: 1R01MH120550-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No