Skills for Talking About Cannabis for Families of Young Adults With Psychosis
STAC
Talking About Cannabis: Developing an Intervention for Family Members of Young Adults With FEP to Support Reduced Cannabis Use
2 other identifiers
interventional
40
1 country
1
Brief Summary
The objectives of this research is to (1) create a family intervention and provider manual to train family members of young people with psychosis (YP-P) who are heavy cannabis users new communication skills to motivate change in the YP-P's cannabis use, (2) pre-test the intervention with 10 family member participants and adapt the intervention based on their recommendations, and (3) evaluate the feasibility and acceptability of the intervention in a randomized pilot trial (n=40). The investigators anticipate that the intervention will improve family participants' communication skills, decrease expressed emotion and caregiver burden. The investigators anticipate that improvements in communication skills, expressed emotion and caregiver burden will lead to decreases in the cannabis use of their YP-P.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2025
CompletedFirst Posted
Study publicly available on registry
May 8, 2025
CompletedStudy Start
First participant enrolled
October 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
September 11, 2025
September 1, 2025
1.3 years
April 24, 2025
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Cannabis and psychosis knowledge
Cannabis knowledge test. This measure does not use a scale; multiple choice items test understanding of cannabis products, consumption, and impacts. Higher scores indicate higher level of cannabis knowledge.
baseline, 3 month follow-up
Caregiver Burden Index
The CBI is a 24-item assessment of both objective (time away from work for caregiving) and subjective (psychological impact) burden of caregiving in a Likert-format scale (0-4) that measures five dimensions of caregiver burden: time dependence, developmental, physical, social, and emotional burden. Each sub scale ranges from 0 (low ) to 20 (high).
baseline, 3 month follow-up
Family Attitudes Scale (FAS)
The FAS is a 30-item self-report measure of expressed emotion (EE) using a Likert scale (e.g., 1 to 5); higher scores indicate more positive attitudes towards family dynamics, while lower scores suggests negative attitudes.
baseline, 3 month follow-up
Timeline Followback - Collateral version (TLFB-C)
The TLFB will ask participants to complete a calendar for the past 30 days indicating the days they believe their YA-P used cannabis and other substances.
baseline, 3 month follow up
Motivational Interviewing Treatment Integrity (MITI)
Participants will complete an audio-recorded encounter with a standardized patient who will remain in character as a YA-P who uses cannabis.
baseline, post-treatment (6 week)
Secondary Outcomes (1)
Client Satisfaction Questionnaire (CSQ-8)
3 month follow up
Study Arms (2)
Cannabis Conversation Skills for Families (CCSF)
EXPERIMENTALThe purpose of the intervention is to train family members in communication skills that may increase contemplation of change in their loved one with first episode psychosis to reduce cannabis use, decrease conflict surrounding these discussions, and provide skills to understand when and how to approach their loved one about cannabis use and encourage treatment. Six sessions (90 minutes each) will be held weekly in a closed group format via Zoom, with the same therapist leading each group. Group size will be 3-8 participants, with an average wait time of 4 weeks. Assessments will occur at baseline, post-treatment, and at a 3-month follow-up.
Treatment as Usual (TAU) Control
NO INTERVENTIONIn this project, treatment as usual will consist of psychoeducation on cannabis and its impacts on psychosis and family services otherwise provided to participants through their participation in the coordinated specialty care program at which their loved one is enrolled. The investigators will track what each family receives and characterize the content and dose in analysis.
Interventions
The purpose of the intervention is to train family members in communication skills that may increase contemplation of change in their loved one with first episode psychosis to reduce cannabis use, decrease conflict surrounding these discussions, and provide skills to understand when and how to approach their loved one about cannabis use and encourage treatment. Because families report confusion from the mixed messages they receive about cannabis and also desire research-based information, CCSF will involve psychoeducation on the risks and relationship of cannabis to psychosis to increase participants motivation to engage in the intervention. frequency of cannabis use as it relates to psychosis treatment outcomes.
Eligibility Criteria
You may qualify if:
- aged 18 years or older,
- has a loved one who is both in CSC treatment for FEP and has used cannabis in the past 30 days,
- has regular contact with their loved one with FEP. It is assumed that YA-P will be aged 13-40 with schizophrenia spectrum disorder given criteria for CSC enrollment.
You may not qualify if:
- Unable to read study materials and communicate feedback in English
- Do not have access to Zoom
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denise Walker, Ph.D.
Arizona State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor
Study Record Dates
First Submitted
April 24, 2025
First Posted
May 8, 2025
Study Start
October 31, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
- Time Frame
- Data will be shared with the general research community at the time of an associated publication, or the end of the award/support period, whichever comes first.
- Access Criteria
- The data will be made available for sharing with the general research community via the NDA website. Investigators at institutions with a Federal Wide Assurance (FWA) will be able to gain access to NDA data by submitting a data access request in accordance with applicable NDA policies.
All scientific data (survey response data) will be both preserved and shared. Data will be made publicly available to the research community. This will include but may not be limited to (a) survey items and corresponding response options (including missingness coding), (b) a codebook for scoring survey items and composite scales, (c) a detailed description of internally computed variables (e.g., time spent viewing intervention content), and (d) documentation of intervention components that participants were exposed to (both treatment and control conditions). Public use and restricted access study data and associated documentation will be made available to the research community free of charge through the NIAAA Data Archive.