NCT05380583

Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) and Substance Use: A Pilot Study

Treatment Engagement in Families With Substance Use and Psychosis: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) for families experiencing early psychosis and substance use delivered exclusively or primarily via telehealth (video conferencing).

Detailed description

The intervention aims to improve treatment engagement, substance use patterns, and family wellbeing. To assess preliminary outcomes of the intervention, this study compares CRAFT-EP plus treatment as usual (TAU) compared to TAU alone. Family members will be randomized to CRAFT-EP + TAU or TAU alone. Data on family members and clients with psychosis will be collected for assessment purposes; if a client with psychosis does not have a family member participating in the study, the client with psychosis will be automatically be assigned to the TAU alone group. Total target enrollment is 40 family members and 40 clients with psychosis. Given that family members may participate without a corresponding client with psychosis due to fear of disclosing their participation in the study to the client or client lack of interest, and because the intervention works directly with family members and indirectly with clients, data collected from clients with or without a corresponding family member participating in the study will be hypothesis generating.

Conditions

• Psychosis
• Substance Use
• Substance Use Disorders
• Family
• Cannabis
• Marijuana
• Alcohol
• Schizophrenia
• Schizoaffective Disorder
• Bipolar Disorder
• Mental Disorder

Interventions

Type	Name	Description
BEHAVIORAL	CRAFT-EP	CRAFT-EP is a behavioral intervention delivered via telehealth with the option for one in-person session (when local guidelines allow in-person care without masks). The coaching session topics include self-care, communication, functional analysis, positive reinforcement, treatment engagement, natural consequences, problem solving, and planning next steps. The intervention is designed for families of individuals experiencing psychosis and substance use who are enrolled or seeking enrollment in early psychosis outpatient services. Participants will be asked to complete assessments at pre-, mid- (approximately week 4), post-intervention, and a follow-up assessment approximately 12 weeks post-intervention.
BEHAVIORAL	TAU	Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.

Timeline

• Start date: 2022-05-19
• Primary completion: 2024-12-20
• Completion: 2026-01-23
• First posted: 2022-05-19
• Last updated: 2026-02-27
• Results posted: 2026-02-27

Locations

1 site across 1 country: United States