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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05380583
• Other study ID #: 2020P000220-A
• Secondary ID: K23DA050808
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Mclean Hospital
• Contact: Julie M McCarthy, PhD
• Phone: 617-855-3521
• Email: jmccarthy[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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	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)
Secondary	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)