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

Not Applicable

Recruiting

• Conditions: Alcohol; Bipolar Disorder; Substance Use; Schizoaffective Disorder; Cannabis; Schizophrenia; Mental Disorder; Psychosis; Substance Use Disorders; Family
• Interventions: Behavioral: CRAFT-EP; Behavioral: TAU

• Registration Number: NCT05380583
• Lead Sponsor: Mclean Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-13
• Study Start: 2022-05-19
• Study First Posted: 2022-05-19
• Status Verified: 2024-05
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRAFT-EP + TAU	TAU	Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching + Treatment as Usual (TAU).
CRAFT-EP + TAU	CRAFT-EP	Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching + Treatment as Usual (TAU).
Treatment as Usual	TAU	Treatment as Usual

Primary Outcome Measures

Name	Time	Method
Family Wellbeing: Depression	Baseline, mid-intervention (week 4), post-intervention (week 8)	Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms.

Secondary Outcome Measures

Name	Time	Method
Family Wellbeing: Anxiety	Baseline, mid-intervention (week 4), post-intervention (week 8)	State-Trait Anxiety Inventory-Short Form; total scores range from 6 to 24 with higher scores representing more severe anxiety symptoms.
Family Wellbeing: Relationship	Baseline, mid-intervention (week 4), post-intervention (week 8)	General Happiness item on Relationship Happiness Scale; scores range from 1 to 10 with higher scores representing greater relationship happiness.

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States