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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Engagement in Families With Substance Use and Psychosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT05380583
- Acronym / sponsor ID
- 2020P000220-A
- Conditions
- Psychosis, Substance Use, Substance Use Disorders, Family, Cannabis, Marijuana
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 19 May 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRAFT-EP + TAU | Experimental | Behavioral: CRAFT-EP, Behavioral: TAUCommunity Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching + Treatment as Usual (TAU). |
| Treatment as Usual | Active comparator | Behavioral: TAUTreatment as Usual |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Ages 18-70.
- Having a relative who:
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRAFT-EPAlso: 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. | Behavioural | CRAFT-EP + TAU |
| TAUAlso: Treatment as Usual (TAU)Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions. | Behavioural | CRAFT-EP + TAU, Treatment as Usual |
Primary outcome
Family Wellbeing: Depression
Time frame: Baseline, mid-intervention (week 4), post-intervention (week 8)
Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms.
2 secondary outcomes
Family Wellbeing: Anxiety
Time frame: Baseline, mid-intervention (week 4), post-intervention (week 8)
Family Wellbeing: Relationship
Time frame: Baseline, mid-intervention (week 4), post-intervention (week 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie M McCarthy, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRAFT-EP and TAU in people with Psychosis and Substance Use, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Wellbeing: Depression (time frame: Baseline, mid-intervention (week 4), post-intervention (week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.