Clinical trial NCT06961877: Skills for Talking About Cannabis for Families of Young Adults With Psychosis
Official title: Talking About Cannabis: Developing an Intervention for Family Members of Young Adults With FEP to Support Reduced Cannabis Use
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caregiver Burden
Cannabis Use
Expressed Emotion
Communications Skills
Keywords: coordinated specialty care
cannabis use disorder
first episode psychosis
caregiver burden
cannabis use
communication skills
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cannabis and psychosis knowledge
timeFrame: baseline, 3 month follow-up
measure: Caregiver Burden Index
timeFrame: baseline, 3 month follow-up
measure: Family Attitudes Scale (FAS)
timeFrame: baseline, 3 month follow-up
measure: Timeline Followback - Collateral version (TLFB-C)
timeFrame: baseline, 3 month follow up
measure: Motivational Interviewing Treatment Integrity (MITI)
timeFrame: baseline, post-treatment (6 week)
Secondary outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 3 month follow up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: The University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Denise Walker, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: