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| ID | Type | Description | Link |
|---|---|---|---|
| K23DA050808 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Treatment as Usual | Active Comparator | Treatment as Usual |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRAFT-EP | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Family Wellbeing: Depression | Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms. | Baseline, mid-intervention (week 4), post-intervention (week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, mid-intervention (week 4), post-intervention (week 8) |
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Inclusion Criteria for Family Members:
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.
Ability to provide written informed consent.
Speak and read English.
Exclusion Criteria for Family Members:
Inclusion Criteria for Client Relatives:
Exclusion Criteria for Client Relatives:
- N/A
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| Name | Affiliation | Role |
|---|---|---|
| Julie M McCarthy, PhD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
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Family member participant data are reported in the Results Outcome Measures Section. Clients with psychosis were enrolled and completed assessments for hypothesis generating purposes. They did not complete the intervention, and they have no pre-specified primary or secondary outcome data; thus, no data from client with psychosis are reported in the Results Outcome Measures Section.
Participants were recruited from May 2022 through August 2025 from the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | CRAFT-EP + TAU | Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching + Treatment as Usual (TAU). 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. TAU: Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 2, 2024 | Dec 16, 2025 |
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| TAU | Behavioral | Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions. |
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| Family Wellbeing: Relationship | General Happiness item on Relationship Happiness Scale; scores range from 1 to 10 with higher scores representing greater relationship happiness. | Baseline, mid-intervention (week 4), post-intervention (week 8) |
| FG001 | Treatment as Usual | Treatment as Usual TAU: Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions. |
| FG002 | CRAFT-EP + TAU Clients With Psychosis | Clients with psychosis who had a family member assigned to the CRAFT-EP + TAU condition. |
| FG003 | Treatment as Usual Clients With Psychosis | Clients with psychosis who had a family member assigned to the Treatment as Usual condition or who had no family member participating in the study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CRAFT-EP + TAU | Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching + Treatment as Usual (TAU). 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. TAU: Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions. |
| BG001 | Treatment as Usual | Treatment as Usual TAU: Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions. |
| BG002 | CRAFT-EP + TAU Clients With Psychosis | Clients with psychosis who had a family member assigned to the CRAFT-EP + TAU condition. |
| BG003 | Treatment as Usual Clients With Psychosis | Clients with psychosis who had a family member assigned to the Treatment as Usual condition or who had no family member participating in the study. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Family Wellbeing: Depression | Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms. | Family member participant data are reported in the Results Outcome Measures Section. Clients with psychosis were enrolled and completed assessments for hypothesis generating purposes. They did not complete the intervention, and they have no pre-specified primary or secondary outcome data; thus, no data from client with psychosis are reported in the Results Outcome Measures Section. Part 1 of the IRB study protocol was already reported in clinicaltrials.gov record 2020P000220 (NCT04284813). | Posted | Mean | Standard Deviation | score on a scale | Baseline, mid-intervention (week 4), post-intervention (week 8) |
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| Secondary | 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. | Family member participant data are reported in the Results Outcome Measures Section. Clients with psychosis were enrolled and completed assessments for hypothesis generating purposes. They did not complete the intervention, and they have no pre-specified primary or secondary outcome data; thus, no data from client with psychosis are reported in the Results Outcome Measures Section. Part 1 of the IRB study protocol was already reported in clinicaltrials.gov record 2020P000220 (NCT04284813). | Posted | Mean | Standard Deviation | score on a scale | Baseline, mid-intervention (week 4), post-intervention (week 8) |
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| Secondary | Family Wellbeing: Relationship | General Happiness item on Relationship Happiness Scale; scores range from 1 to 10 with higher scores representing greater relationship happiness. | Family member participant data are reported in the Results Outcome Measures Section. Clients with psychosis were enrolled and completed assessments for hypothesis generating purposes. They did not complete the intervention, and they have no pre-specified primary or secondary outcome data; thus, no data from client with psychosis are reported in the Results Outcome Measures Section. Part 1 of the IRB study protocol was already reported in clinicaltrials.gov record 2020P000220 (NCT04284813). | Posted | Mean | Standard Deviation | score on a scale | Baseline, mid-intervention (week 4), post-intervention (week 8) |
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Baseline through 12-week follow-up; 5 months.
Inpatient psychiatric hospitalization was not considered an adverse event given that the study recruited participants who were inpatients at the time of enrollment and recurrence of subsequent hospitalization is common among participants who have a psychotic disorder.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CRAFT-EP + TAU | Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching + Treatment as Usual (TAU). 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. TAU: Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions. | 0 | 21 | 0 | 21 | 1 | 21 |
| EG001 | Treatment as Usual | Treatment as Usual TAU: Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions. | 0 | 22 | 0 | 22 | 3 | 22 |
| EG002 | CRAFT-EP + TAU Clients With Psychosis | Clients with psychosis who had a family member assigned to the CRAFT-EP + TAU condition. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG003 | Treatment as Usual Clients With Psychosis | Clients with psychosis who had a family member assigned to the Treatment as Usual condition or who had no family member participating in the study. | 0 | 18 | 0 | 18 | 6 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Residential alcohol use disorder treatment program | Psychiatric disorders | Non-systematic Assessment |
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| Increase in Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
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| Car Accident | Psychiatric disorders | Non-systematic Assessment | Resulted in emotional distress and no physical harm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie M. McCarthy, PhD | McLean Hospital / Harvard Medical School | 617-855-3521 | jmccarthy@mclean.harvard.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2025 | Dec 16, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent - Family | Apr 24, 2025 | Dec 16, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent - Client | Apr 24, 2025 | Dec 16, 2025 | ICF_003.pdf |
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D019966 | Substance-Related Disorders |
| D002189 | Marijuana Abuse |
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D064419 | Chemically-Induced Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Post-intervention |
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| OG001 | Treatment as Usual | Treatment as Usual TAU: Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions. |
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| OG001 | Treatment as Usual | Treatment as Usual TAU: Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions. |
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