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

NCT ID: NCT06961877

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-07-31

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.

Conditions

Caregiver Burden; Cannabis Use; Expressed Emotion; Communications Skills

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cannabis Conversation Skills for Families (CCSF)

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.

Group Type: EXPERIMENTAL

Cannabis Conversation Skills for Families (CCSF)

Intervention Type: BEHAVIORAL

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.

Treatment as Usual (TAU) Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cannabis Conversation Skills for Families (CCSF)

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.

Intervention Type: BEHAVIORAL

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 in the past 30 days,

3. 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.

Exclusion Criteria

1. Unable to read study materials and communicate feedback in English

2. Do not have access to Zoom

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Denise Walker

Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denise Walker, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

The University of Washington

Seattle, Washington, United States

Countries

United States

Central Contacts

Denise Walker, Ph.D.

Role: CONTACT

denise.walker@asu.edu

602-496-1735

Ty Tristao, BA

Role: CONTACT

tt88@uw.edu

(503) 451-3725‬

Other Identifiers

1R34MH133684-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00022601

Identifier Type: -

Identifier Source: org_study_id