PsychosisNCT05380583
Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) and Substance Use: A Pilot Study
A study testing CRAFT-EP and TAU in people with Psychosis and Substance Use, run by Mclean Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis, Substance Use, Substance Use Disorders
- What is being tested?
- CRAFT-EP and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2022to 23 Jan 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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)
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Engagement in Families With Substance Use and Psychosis: A Pilot Study
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).
Read the 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.
- Conditions
- Psychosis, Substance Use, Substance Use Disorders, Family, Cannabis, Marijuana
- Being tested
- CRAFT-EP, TAU
- Medical subject headings
- Psychotic Disorders, Substance-Related Disorders, Marijuana Abuse, Schizophrenia, Bipolar Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRAFT-EPBehavioural
Also called Community Reinforcement and Family Training for Early Psychosis (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.
TAUBehavioural
Also called Treatment as Usual (TAU)
Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.
| Study group | Role | What they receive |
|---|---|---|
| CRAFT-EP + TAU | Experimental | Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching + Treatment as Usual (TAU). Receives: Behavioral: CRAFT-EP; Behavioral: TAU |
| Treatment as Usual | Active comparator | Treatment as Usual Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Wellbeing: Depression
Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms.
Measured: Baseline, mid-intervention (week 4), post-intervention (week 8)
Secondary outcomes (2)
Family Wellbeing: Anxiety
State-Trait Anxiety Inventory-Short Form; total scores range from 6 to 24 with higher scores representing more severe anxiety symptoms. Raw total scores transformed to the original 20-item scale range from 20 to 80 with higher scores representing more severe anxiety symptoms.
Measured: Baseline, mid-intervention (week 4), post-intervention (week 8)
Family Wellbeing: Relationship
General Happiness item on Relationship Happiness Scale; scores range from 1 to 10 with higher scores representing greater relationship happiness.
Measured: Baseline, mid-intervention (week 4), post-intervention (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start19 May 2022
- Primary completion20 Dec 2024
- Study completion23 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Julie McCarthy, Ph.D., Mclean Hospital
- Investigators
- Julie M McCarthy, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380583
- Sponsor's protocol ID
- 2020P000220-A
- Other IDs
- K23DA050808
- Status last verified
- Jan 2026
- First submitted
- 9 May 2022
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No