Telehealth intervention for families dealing with early psychosis and substance use
Treatment Engagement in Families with Substance Use and Psychosis: a Pilot Study
This study tests a telehealth program for families dealing with early psychosis and substance use to see if it helps them more than just regular treatment alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 1 site (Belmont, Massachusetts) |
| Trial ID | NCT05380583 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) intervention, focusing on families affected by early psychosis and substance use. The study compares the outcomes of families receiving CRAFT-EP alongside treatment as usual (TAU) to those receiving TAU alone. Participants will be randomized into these groups, and data will be collected from both family members and clients with psychosis to assess treatment engagement and substance use patterns. The intervention is delivered primarily through telehealth, allowing for greater accessibility.
Who should consider this trial
Good fit: Ideal candidates include family members of individuals with early course psychosis who have substance use concerns and can engage in the study via telehealth.
Not a fit: Patients who do not have a family member participating in the study or those without substance use issues may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could enhance treatment engagement and improve the wellbeing of families affected by early psychosis and substance use.
How similar studies have performed: Similar studies have shown promise in using family-based interventions for psychosis and substance use, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Belmont, Massachusetts
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Julie M McCarthy, PhD — Mclean Hospital
- Study coordinator: Julie M McCarthy, PhD
- Email: jmccarthy@mclean.harvard.edu
- Phone: 617-855-3521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.