Clinical trial NCT05380583: Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) and Substance Use: a Pilot Study
Official title: Treatment Engagement in Families with Substance Use and Psychosis: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Substance Use
Substance Use Disorders
Family
Cannabis
Marijuana
Alcohol
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Mental Disorder
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-05-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Family Wellbeing: Depression
timeFrame: Baseline, mid-intervention (week 4), post-intervention (week 8)
Secondary outcomes:
measure: Family Wellbeing: Anxiety
timeFrame: Baseline, mid-intervention (week 4), post-intervention (week 8)
measure: Family Wellbeing: Relationship
timeFrame: Baseline, mid-intervention (week 4), post-intervention (week 8)
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Julie M McCarthy, PhD
role: PRINCIPAL_INVESTIGATOR
References: