Skills for Talking About Cannabis for Families of Young Adults With Psychosis (STAC)

University of Washington

Status: Begins enrollment in 1 month

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

Treatments: Behavioral: Cannabis Conversation Skills for Families (CCSF)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06961877

1R34MH133684-01A1 (U.S. NIH Grant/Contract)

STUDY00022601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cannabis Conversation Skills for Families (CCSF)

Experimental group

Description:

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. 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:

Behavioral: Cannabis Conversation Skills for Families (CCSF)

Treatment as Usual (TAU) Control

No Intervention group

Description:

In 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.