Trial Outcomes & Findings for Families With Substance Use and Psychosis: A Pilot Study (NCT NCT04284813)

NCT ID: NCT04284813

Last Updated: 2022-10-12

Results Overview

Percentage of sessions completed during the intervention

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: Post-intervention, approximately Week 6-8
• Results posted on: 2022-10-12

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

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.

Overall Study Withdrawal by Subject

1

Baseline Characteristics

Families With Substance Use and Psychosis: A Pilot Study

Baseline characteristics by cohort

Measure	Telemedicine n=21 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	54.29 years STANDARD_DEVIATION 8.43 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Percentage of sessions completed during the intervention

Outcome measures

Measure

Telemedicine n=20 Participants 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.

Percentage of Sessions Completed

100 percentage of intervention sessions

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

Telemedicine n=20 Participants 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.

Mean Session Satisfaction Rating

4.9 score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 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.

Percentage of participant preference for in-person, telemedicine, or both sessions formats as assessed categorically during the Treatment Satisfaction Interview.

Outcome measures

Measure	Telemedicine n=20 Participants 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.
Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats In-person	1 Participants
Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats Telemedicine	9 Participants
Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats Both Session Formate (Hybrid)	10 Participants

Adverse Events

Telemedicine

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure

Telemedicine n=21 participants at risk 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.

Social circumstances Participant safety concern

4.8% 1/21 • Number of events 1 • Baseline through 3-month follow-up; 5 months.

Other adverse events

Measure	Telemedicine n=21 participants at risk 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.
Cardiac disorders Cardiac evaluation-hospitalization	4.8% 1/21 • Number of events 1 • Baseline through 3-month follow-up; 5 months.
Psychiatric disorders Interview distress	9.5% 2/21 • Number of events 2 • Baseline through 3-month follow-up; 5 months.

Additional Information

Julie M. McCarthy, PhD

McLean Hospital/Harvard Medical School

Phone: 6178553521

Email: jmccarthy@mclean.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place