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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 w

Первичные конечные точки

• Cannabis and psychosis knowledge [Срок оценки: baseline, 3 month follow-up]
• Caregiver Burden Index [Срок оценки: baseline, 3 month follow-up]
• Family Attitudes Scale (FAS) [Срок оценки: baseline, 3 month follow-up]
• Timeline Followback - Collateral version (TLFB-C) [Срок оценки: baseline, 3 month follow up]
• Motivational Interviewing Treatment Integrity (MITI) [Срок оценки: baseline, post-treatment (6 week)]

Вторичные конечные точки (1)

• Client Satisfaction Questionnaire (CSQ-8) [Срок оценки: 3 month follow up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Washington — Seattle

Идентификаторы

NCT: NCT06961877 · STUDY00022601 · 1R34MH133684-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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