N/A
N=65
Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) and Substance Use: A Pilot Study
Psychosis · Substance Use · Substance Use Disorders · Family · Cannabis
Bottom Line
View on ClinicalTrials.gov: NCT05380583 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Family Wellbeing: Depression — 14.19; 10.82; 9.76; 11.67 score on a scale — p=0.026
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CRAFT-EP (Behavioral); TAU (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mclean Hospital
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Family Wellbeing: Depression |
14.19; 10.82; 9.76; 11.67; 6.53; 8.64 | 0.026 sig |
| SECONDARY Family Wellbeing: Anxiety |
45.30; 41.82; 38.73; 45.24; 32.81; 42.42 | 0.003 sig |
| SECONDARY Family Wellbeing: Relationship |
3.71; 4.23; 5.43; 4.00; 6.05; 5.00 | 0.091 |
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).
Eligibility Criteria
Inclusion Criteria for Family Members:
- 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.
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
Data sourced from ClinicalTrials.gov (NCT05380583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.