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

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).

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Cannabis; Substance Use; Substance Use Disorders; Psychosis; Mental Disorder; Family; Marijuana; Alcohol
• Intervention / Treatment: Behavioral: CRAFT-EP; Behavioral: TAU

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie M McCarthy, PhD; Phone Number: 617-855-3521; Email: jmccarthy@mclean.harvard.edu
• Study Contact Backup: Name: Dost Öngür, MD, PhD; Phone Number: 617-855-3922; Email: dongur@partners.org

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Recruiting
      • McLean Hospital
      • Contact: Julie M McCarthy, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for Family Members:

• 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.

Exclusion Criteria for Family Members:

• 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)

Inclusion Criteria for Client Relatives:

• 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 for Client Relatives:

- N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.; Other Names: Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP); Behavioral: TAU; Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.; Other Names: Treatment as Usual (TAU)
Active Comparator: Treatment as Usual	Behavioral: TAU; Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.; Other Names: Treatment as Usual (TAU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean readiness to change substance use	Mean readiness to cutdown/quit using [most problematic substance] for the client with psychosis using importance-confidence-readiness rulers (0 = not at all to 10 = extremely).	Baseline, mid-intervention (week 4), post-intervention (week 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Session Attendance	Percentage of treatment sessions attended by the client with psychosis in past 30 days.	Baseline, mid-intervention (week 4), post-intervention (week 8)
Substance Use	Client Timeline Follow Back (TLFB) past 30 day substance use, urine toxicology screen for drugs of abuse.	Baseline, mid-intervention (week 4), post-intervention (week 8)
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)
Family Wellbeing: Anxiety	State-Trait Anxiety Inventory-Short Form; total scores range from 6 to 24 with higher scores representing more severe anxiety symptoms.	Baseline, mid-intervention (week 4), post-intervention (week 8)
Family Wellbeing: Relationship	General Happiness item on Relationship Happiness Scale; scores range from 1 to 10 with higher scores representing greater relationship happiness.	Baseline, mid-intervention (week 4), post-intervention (week 8)

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Julie M McCarthy, PhD, McLean Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Substance-Related Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Bipolar Disorder
• Other Study ID Numbers: 2020P000220-A; K23DA050808 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No