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

NCT ID: NCT05380583

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-19
• Study Completion Date: 2026-03-30

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.

Conditions

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

Study Design

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

Study Groups

CRAFT-EP + TAU

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

Group Type: EXPERIMENTAL

CRAFT-EP

Intervention Type: BEHAVIORAL

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.

TAU

Intervention Type: BEHAVIORAL

Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.

Treatment as Usual

Treatment as Usual

Group Type: ACTIVE_COMPARATOR

TAU

Intervention Type: BEHAVIORAL

Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.

Interventions

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.

Intervention Type: BEHAVIORAL

TAU

Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.

Intervention Type: BEHAVIORAL

Other Intervention Names

Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP); Treatment as Usual (TAU)

Eligibility Criteria

Inclusion Criteria

• Ages 18-70.
• Having a relative who:

1. Is a client with early course psychosis (schizophrenia, schizoaffective disorder, schizophreniform, psychosis not otherwise specified (NOS), delusional disorder, brief psychotic disorder, major depression with psychosis, and bipolar disorder with psychosis (as reported by family member, clinician, or chart review)) with first onset in the past 6 years, and

2. Used alcohol or cannabis in the past 30 days and/or has no apparent immediate interest in abstinence (responding "No" to "Do you think they want to quit right now?" in reference to overall substance use).

3. Family member has concerns about the relative's substance use.

• The person(s) who can best describe the client with psychosis.
• At least 4 days per month contact with the client.
• Access to a computer with internet or mobile phone with video conferencing capabilities.
• Ability to provide written informed consent.
• Speak and read English.

• Ages 18-35.
• First episode psychosis onset in the past 6 years with a Diagnostic and Statistical Manual (DSM)-5 diagnosis of affective (bipolar disorder or major depressive disorder with psychotic features) or non- affective psychosis (schizophrenia spectrum disorder)
• Used alcohol or cannabis in the past 30 days and/or has no apparent immediate interest in abstinence (responding "No" to "Do you want to quit right now?" in reference to overall substance use).
• They or others have concerns about the client's substance use.
• Ability to provide written informed consent (or assent with their legal guardian providing informed consent)
• Speak and read English.

Exclusion Criteria

• DSM-5 moderate or severe substance use disorder in the past year.
• Lifetime psychotic disorder.
• History of domestic violence with the client relative that would interfere with the ability to safely follow through with the intervention plan.
• Psychiatric, cognitive, or medical impairments that would interfere with the ability to follow through with the intervention plan.
• Prior participation of a family member of the client in the study program.
• Significant prior experience with CRAFT (e.g., having completed a CRAFT course prior to study enrollment)

• N/A

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Julie McCarthy, Ph.D.

Assistant Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie M McCarthy, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Julie M McCarthy, PhD

Role: CONTACT

jmccarthy@mclean.harvard.edu

617-855-3521

Dost Öngür, MD, PhD

Role: CONTACT

dongur@partners.org

617-855-3922

Facility Contacts

Julie M McCarthy, PhD

Role: primary

Other Identifiers

K23DA050808

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020P000220-A

Identifier Type: -

Identifier Source: org_study_id