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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA050808-01 | 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 develop and evaluate an intervention that adapts Community Reinforcement and Family Training (CRAFT) for families experiencing first episode psychosis and substance use delivered via telemedicine (video conferencing). The intervention aims to improve treatment engagement and reduce distress, and it will be delivered via telemedicine (CRAFT-FT). To assess feasibility of the intervention, family members will complete the sessions and provide feedback to refine the treatment manual. Data on client relatives with psychosis will be collected for preliminary assessment purposes. Client relatives will not complete the research study intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine | Experimental | Community Reinforcement and Family Training for first episode psychosis delivered via telemedicine (CRAFT-FT) with 6-8 weekly sessions of 60-minute therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRAFT-FT | Behavioral | CRAFT-FT will be delivered via telemedicine. Topics include building motivation, self-care, communication, understanding patterns of behavior, positive reinforcement, and negative consequences. The intervention will be tailored to families of individuals experiencing psychosis and substance use who are enrolled in first episode psychosis outpatient services. Participants will be asked to completed assessments at pre-treatment, mid-treatment (approximately week 3), post-treatment, and a follow-up assessment approximately 3 month post-treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Sessions Completed | Percentage of sessions completed during the intervention | Post-intervention, approximately Week 6-8 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Session Satisfaction Rating | Participants will report weekly satisfaction ratings following each session on the Session Survey. Ratings will range from 1 (poor) to 5 (excellent) for overall experience and convenience. | Up to 8 weeks |
| Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats |
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Inclusion Criteria:
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:
Inclusion Criteria for Client Relatives:
Ages 18-35.
First episode psychosis (FEP) onset in the past 6 years with a DSM-5 diagnosis of affective (bipolar disorder or major depressive disorder with psychotic features) or non-affective psychosis (schizophrenia spectrum disorder).
a. Used tobacco, alcohol, or cannabis within the past 90 days and/or has no apparent immediate interest in abstinence.
Ability to provide written informed consent.
Speak/read English
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie McCarthy, PhD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10689661 | Background | Meyers RJ, Miller WR, Hill DE, Tonigan JS. Community reinforcement and family training (CRAFT): engaging unmotivated drug users in treatment. J Subst Abuse. 1998;10(3):291-308. doi: 10.1016/s0899-3289(99)00003-6. |
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Family member participant data are reported in the Results Section. Clients with psychosis (n=8) were enrolled for preliminary assessment 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 Section.
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| ID | Title | Description |
|---|---|---|
| FG000 | Telemedicine | Community Reinforcement and Family Training for first episode psychosis delivered via telemedicine (CRAFT-FT) with 6-8 weekly sessions of 60-minute therapy. CRAFT-FT: CRAFT-FT will be delivered via telemedicine. Topics include building motivation, self-care, communication, understanding patterns of behavior, positive reinforcement, and negative consequences. The intervention will be tailored to families of individuals experiencing psychosis and substance use who are enrolled in first episode psychosis outpatient services. Participants will be asked to completed assessments at pre-treatment, mid-treatment (approximately week 3), post-treatment, and a follow-up assessment approximately 3 month post-treatment. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2022 |
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Percentage of participant preference for in-person, telemedicine, or both sessions formats as assessed categorically during the Treatment Satisfaction Interview. |
| Up to 8 weeks |
| COMPLETED |
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| NOT COMPLETED |
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Family members who started the CRAFT-FT Arm/Group are included in the analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Telemedicine | Community Reinforcement and Family Training for first episode psychosis delivered via telemedicine (CRAFT-FT) with 6-8 weekly sessions of 60-minute therapy. CRAFT-FT: CRAFT-FT will be delivered via telemedicine. Topics include building motivation, self-care, communication, understanding patterns of behavior, positive reinforcement, and negative consequences. The intervention will be tailored to families of individuals experiencing psychosis and substance use who are enrolled in first episode psychosis outpatient services. Participants will be asked to completed assessments at pre-treatment, mid-treatment (approximately week 3), post-treatment, and a follow-up assessment approximately 3 month post-treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Sessions Completed | Percentage of sessions completed during the intervention | All participants who started the intervention were included in analysis. One family member participant did not start the intervention due to withdrawal by subject. | Posted | Number | percentage of intervention sessions | Post-intervention, approximately Week 6-8 |
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| Secondary | Mean Session Satisfaction Rating | Participants will report weekly satisfaction ratings following each session on the Session Survey. Ratings will range from 1 (poor) to 5 (excellent) for overall experience and convenience. | All participants who started the intervention were included in analysis. One family member participant did not start the intervention due to withdrawal by subject. | Posted | Mean | Standard Deviation | score on a scale | Up to 8 weeks |
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| Secondary | Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats | Percentage of participant preference for in-person, telemedicine, or both sessions formats as assessed categorically during the Treatment Satisfaction Interview. | All participants who started the intervention were included in analysis. One family member participant did not start the intervention due to withdrawal by subject. | Posted | Count of Participants | Participants | Up to 8 weeks |
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Baseline through 3-month follow-up; 5 months.
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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 | Telemedicine | Community Reinforcement and Family Training for first episode psychosis delivered via telemedicine (CRAFT-FT) with 6-8 weekly sessions of 60-minute therapy. CRAFT-FT: CRAFT-FT will be delivered via telemedicine. Topics include building motivation, self-care, communication, understanding patterns of behavior, positive reinforcement, and negative consequences. The intervention will be tailored to families of individuals experiencing psychosis and substance use who are enrolled in first episode psychosis outpatient services. Participants will be asked to completed assessments at pre-treatment, mid-treatment (approximately week 3), post-treatment, and a follow-up assessment approximately 3 month post-treatment. | 0 | 21 | 1 | 21 | 3 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant safety concern | Social circumstances | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac evaluation-hospitalization | Cardiac disorders | Non-systematic Assessment | Unexpected, unrelated. |
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| Interview distress | Psychiatric disorders | Systematic Assessment | Expected, related. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie M. McCarthy, PhD | McLean Hospital/Harvard Medical School | 6178553521 | jmccarthy@mclean.harvard.edu |
| Aug 23, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2022 | Aug 23, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D019966 | Substance-Related Disorders |
| D064424 | Tobacco Use |
| D014029 | Tobacco Use Disorder |
| D000073865 | Cigarette Smoking |
| D002189 | Marijuana Abuse |
| D000437 | Alcoholism |
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D064419 | Chemically-Induced Disorders |
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D019973 | Alcohol-Related Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| Unknown or Not Reported |
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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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