Anxiety & Depression Association of America

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

Purpose

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

Eligibility

Eligible Ages: Between 18 Years and 70 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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 Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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	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)

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Mclean Hospital

Study Contact

Julie M McCarthy, PhD
617-855-3521
jmccarthy@mclean.harvard.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.