Alcohol, Alcohol Use Disorder, Bipolar Disorder, Cannabis, Cigarette Smoking, Family, Marijuana, Mental Disorder, Nicotine Use Disorder, Psychosis, Schizoaffective Disorder, Schizophrenia, Substance Use, Substance Use Disorders, Tobacco Use
Conditions
Keywords
Family, Substance Use Disorder, Psychosis
Brief summary
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.
Interventions
BEHAVIORALCRAFT-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.
Sponsors
National Institute on Drug Abuse (NIDA)
Mclean Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 18-70. * Having a relative who: 1. Is a patient with early course psychosis (DSM-5 schizophrenia, schizoaffective disorder, schizophreniform, psychosis not otherwise specified (NOS), delusional disorder, brief psychotic disorder, major depression with psychosis, and bipolar disorder with psychosis) with first onset in the past 6 years, and 2. Uses tobacco, alcohol, or cannabis in the past 90 days and/or has no apparent immediate interest in abstinence. * 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
* DSM-5 moderate or severe substance use disorder in the past year. * Lifetime psychotic disorder. * History of domestic violence with the identified patient (IP). * Psychiatric, cognitive, or medical impairments that would interfere with the ability to follow through with the treatment plan. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Sessions Completed | Post-intervention, approximately Week 6-8 | Percentage of sessions completed during the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Session Satisfaction Rating | Up to 8 weeks | 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. |
| Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats | Up to 8 weeks | Percentage of participant preference for in-person, telemedicine, or both sessions formats as assessed categorically during the Treatment Satisfaction Interview. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Telemedicine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 54.29 years STANDARD_DEVIATION 8.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 3 / 21 |
| serious Total, serious adverse events | 1 / 21 |
Outcome results
Primary
Percentage of Sessions Completed
Percentage of sessions completed during the intervention
Time frame: Post-intervention, approximately Week 6-8
Population: All participants who started the intervention were included in analysis. One family member participant did not start the intervention due to withdrawal by subject.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine | Percentage of Sessions Completed | 100 percentage of intervention sessions |
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.
Time frame: Up to 8 weeks
Population: All participants who started the intervention were included in analysis. One family member participant did not start the intervention due to withdrawal by subject.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemedicine | Mean Session Satisfaction Rating | 4.9 score on a scale | Standard Deviation 0.3 |
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.
Time frame: Up to 8 weeks
Population: All participants who started the intervention were included in analysis. One family member participant did not start the intervention due to withdrawal by subject.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telemedicine | Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats | In-person | 1 Participants |
| Telemedicine | Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats | Telemedicine | 9 Participants |
| Telemedicine | Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats | Both Session Formate (Hybrid) | 10 Participants |