Skills for Talking About Cannabis for Families of Young Adults With Psychosis

Not Applicable

Not yet recruiting

• Conditions: Caregiver Burden; Cannabis Use; Expressed Emotion; Communications Skills

• Registration Number: NCT06961877
• Lead Sponsor: University of Washington

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.

Detailed Description

The objectives of this research will be implemented in two phases. Phase II will develop a family intervention informed by a Stakeholder Advisory Board and pre-test the intervention will be adapted with 10 family member participants. The intervention based on recommendations in phase 1. 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.

Phase 2 will evaluate the acceptability, feasibility, and preliminary effect sizes of the intervention in a pilot randomized controlled trial comparing it to treatment as usual (TAU) with 40 family participants. This pilot test is consistent with the stated purpose of Stage 1B of the NIH Stage Model for behavioral intervention development and the R34 mechanism of "providing resources for evaluating the feasibility, tolerability, acceptability and safety and preliminary effectiveness of approaches to improve mental health/functional outcomes". The purpose of this pilot study is to develop and test the feasibility and acceptability of the intervention protocol, study procedures, and recruitment plan. Secondarily, the investigators intend to collect data to inform effect size estimates on outcomes to plan for an R01.

Study Timeline

• Study First Submitted: 2025-04-24
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-05
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Study Start: 2025-07
• Primary Completion: 2027-02
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. aged 18 years or older,
2. has a loved one who is both in CSC treatment for FEP and has used cannabis on at least 9 days in the past 30,
3. has at least 10 hours of contact per week 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.

Exclusion Criteria

1. Unable to read study materials and communicate feedback in English
2. Do not have access to Zoom

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cannabis and psychosis knowledge	baseline, 3 month follow-up	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.
Caregiver Burden Index	baseline, 3 month follow-up	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).
Family Attitudes Scale (FAS)	baseline, 3 month follow-up	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.
Timeline Followback - Collateral version (TLFB-C)	baseline, 3 month follow up	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.
Motivational Interviewing Treatment Integrity (MITI)	baseline, post-treatment (6 week)	Participants will complete an audio-recorded encounter with a standardized patient who will remain in character as a YA-P who uses cannabis.

Secondary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire (CSQ-8)	3 month follow up	Intervention satisfaction will be assessed with the CSQ-8, a widely used instrument, consisting of eight items each answered on a 4-point scale. The possible scores range from 8 to 32, with higher scores indicating a greater level of overall satisfaction with the services received.

Trial Locations

Locations (1)

The University of Washington; 🇺🇸 Seattle, Washington, United States