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NCT Number: NCT06961877

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

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.

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Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Cannabis Use Communications Skills Expressed Emotion Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Unable to read study materials and communicate feedback in English
  • Do not have access to Zoom

Treatment and study plan

Cannabis Conversation Skills for Families (CCSF)

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.

Primary outcomes

  1. Cannabis and psychosis knowledge

    Time frame: 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.

  2. Caregiver Burden Index

    Time frame: 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).

  3. Family Attitudes Scale (FAS)

    Time frame: 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.

  4. Timeline Followback - Collateral version (TLFB-C)

    Time frame: 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.

  5. Motivational Interviewing Treatment Integrity (MITI)

    Time frame: 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 outcomes

  1. Client Satisfaction Questionnaire (CSQ-8)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Denise Walker, Ph.D.

CONTACT

[email protected]

602-496-1735

Ty Tristao, BA

CONTACT

[email protected]

(503) 451-3725‬

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Talking About Cannabis: Developing an Intervention for Family Members of Young Adults With FEP to Support Reduced Cannabis Use

Acronym: STAC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 8, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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