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Search / Trial NCT05380583

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

Launched by MCLEAN HOSPITAL · May 13, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The CRAFT-EP clinical trial is exploring a new program called Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP). This program is designed to help families who have a loved one experiencing early psychosis and substance use issues, and it is delivered mainly through video calls. The goal is to support families in managing these challenges together, especially when the person with psychosis may also be using substances like alcohol or cannabis.

To participate in this study, family members must be between the ages of 18 and 70 and have a relative aged 18 to 35 who has been diagnosed with early onset psychosis within the last six years and has used substances recently. Participants will need to have regular contact with their relative and access to technology for video conferencing. The study is currently recruiting participants, and those who join can expect to learn useful strategies in a supportive environment. It's important to note that individuals with a severe substance use disorder or a history of violent behavior related to the client cannot participate to ensure everyone's safety during the study.

Gender

ALL

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

About Mclean Hospital

McLean Hospital, a leading psychiatric affiliate of Harvard Medical School, is dedicated to advancing mental health care through innovative research and clinical trials. Renowned for its commitment to scientific excellence, McLean harnesses a multidisciplinary approach to address a wide range of psychiatric disorders, including depression, anxiety, and schizophrenia. With state-of-the-art facilities and a team of expert clinicians and researchers, the hospital aims to develop effective treatment strategies and improve patient outcomes. Its robust clinical trial program fosters collaboration and contributes to the broader understanding of mental health, ultimately enhancing therapeutic options for individuals in need.

Locations

Belmont, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Julie M McCarthy, PhD

Principal Investigator

Mclean Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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