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

NCT05380583 | Completed Results

• 2 other identifiers: 2020P000220-AK23DA050808
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Family Wellbeing: Depression

  Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms.

  Baseline, mid-intervention (week 4), post-intervention (week 8)

Secondary Outcomes (2)

• Family Wellbeing: Anxiety

  Baseline, mid-intervention (week 4), post-intervention (week 8)

• Family Wellbeing: Relationship

  Baseline, mid-intervention (week 4), post-intervention (week 8)

Study Arms (2)

CRAFT-EP + TAU

EXPERIMENTAL

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

Behavioral: CRAFT-EP; Behavioral: TAU

Treatment as Usual

ACTIVE COMPARATOR

Treatment as Usual

Behavioral: TAU

Interventions

CRAFT-EP 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.

Also known as: Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP)

CRAFT-EP + TAU

TAU BEHAVIORAL

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

Also known as: Treatment as Usual (TAU)

CRAFT-EP + TAU; Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• 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.
• \- N/A

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Substance-Related Disorders; Marijuana Abuse; Schizophrenia; Bipolar Disorder; Mental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Chemically-Induced Disorders; Bipolar and Related Disorders; Mood Disorders

Results Point of Contact

• Title: Julie M. McCarthy, PhD
• Organization: McLean Hospital / Harvard Medical School

jmccarthy@mclean.harvard.edu

617-855-3521

Study Officials

• Julie M McCarthy, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 19, 2022
• Study Start: May 19, 2022
• Primary Completion: December 20, 2024
• Study Completion: January 23, 2026
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)