Trial Outcomes & Findings for Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) and Substance Use: A Pilot Study (NCT NCT05380583)

Last Updated: 2026-02-27

Results Overview

Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

Baseline, mid-intervention (week 4), post-intervention (week 8)

Results posted on

2026-02-27

Participant Flow

Participants were recruited from May 2022 through August 2025 from the United States.

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.

Participant milestones

Participant milestones
Measure	CRAFT-EP + TAU Clients With Psychosis Clients with psychosis who had a family member assigned to the CRAFT-EP + TAU condition.	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.	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.	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.
Overall Study STARTED	4	18	21	22
Overall Study COMPLETED	2	11	19	22
Overall Study NOT COMPLETED	2	7	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CRAFT-EP + TAU Clients With Psychosis Clients with psychosis who had a family member assigned to the CRAFT-EP + TAU condition.	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.	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.	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.
Overall Study Withdrawal by Subject	0	0	2	0
Overall Study Lost to Follow-up	2	7	0	0

Baseline Characteristics

Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) and Substance Use: A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CRAFT-EP + TAU n=21 Participants 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.	Treatment as Usual n=22 Participants Treatment as Usual TAU: Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.	CRAFT-EP + TAU Clients With Psychosis n=4 Participants Clients with psychosis who had a family member assigned to the CRAFT-EP + TAU condition.	Treatment as Usual Clients With Psychosis n=18 Participants 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.	Total n=65 Participants Total of all reporting groups
Age, Continuous	56.90 years STANDARD_DEVIATION 9.69 • n=24 Participants	53.95 years STANDARD_DEVIATION 6.29 • n=20 Participants	24.50 years STANDARD_DEVIATION 2.08 • n=40 Participants	23.83 years STANDARD_DEVIATION 4.77 • n=565 Participants	44.75 years STANDARD_DEVIATION 16.58 • n=349 Participants
Sex: Female, Male Female	20 Participants n=24 Participants	21 Participants n=20 Participants	2 Participants n=40 Participants	8 Participants n=565 Participants	51 Participants n=349 Participants
Sex: Female, Male Male	1 Participants n=24 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants	10 Participants n=565 Participants	14 Participants n=349 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=565 Participants	0 Participants n=349 Participants
Race (NIH/OMB) Asian	2 Participants n=24 Participants	1 Participants n=20 Participants	0 Participants n=40 Participants	2 Participants n=565 Participants	5 Participants n=349 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=565 Participants	0 Participants n=349 Participants
Race (NIH/OMB) Black or African American	1 Participants n=24 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants	0 Participants n=565 Participants	2 Participants n=349 Participants
Race (NIH/OMB) White	16 Participants n=24 Participants	18 Participants n=20 Participants	2 Participants n=40 Participants	15 Participants n=565 Participants	51 Participants n=349 Participants
Race (NIH/OMB) More than one race	1 Participants n=24 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants	1 Participants n=565 Participants	4 Participants n=349 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=24 Participants	2 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=565 Participants	3 Participants n=349 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=24 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=565 Participants	1 Participants n=349 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=24 Participants	22 Participants n=20 Participants	4 Participants n=40 Participants	17 Participants n=565 Participants	64 Participants n=349 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=565 Participants	0 Participants n=349 Participants
Region of Enrollment United States	21 participants n=24 Participants	22 participants n=20 Participants	4 participants n=40 Participants	18 participants n=565 Participants	65 participants n=349 Participants

PRIMARY outcome

Timeframe: Baseline, mid-intervention (week 4), post-intervention (week 8)

Population: 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).

Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms.

Outcome measures

Outcome measures
Measure	CRAFT-EP + TAU n=21 Participants 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.	Treatment as Usual n=22 Participants Treatment as Usual TAU: Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.
Family Wellbeing: Depression Mid-intervention	9.76 score on a scale Standard Deviation 6.76	11.67 score on a scale Standard Deviation 5.88
Family Wellbeing: Depression Post-intervention	6.53 score on a scale Standard Deviation 7.39	8.64 score on a scale Standard Deviation 5.40
Family Wellbeing: Depression Baseline	14.19 score on a scale Standard Deviation 9.52	10.82 score on a scale Standard Deviation 7.36

SECONDARY outcome

Timeframe: Baseline, mid-intervention (week 4), post-intervention (week 8)

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.

Outcome measures

Outcome measures
Measure	CRAFT-EP + TAU n=21 Participants 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.	Treatment as Usual n=22 Participants Treatment as Usual TAU: Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.
Family Wellbeing: Anxiety Mid-intervention	38.73 score on a scale Standard Deviation 11.52	45.24 score on a scale Standard Deviation 16.79
Family Wellbeing: Anxiety Post-intervention	32.81 score on a scale Standard Deviation 10.08	42.42 score on a scale Standard Deviation 16.62
Family Wellbeing: Anxiety Baseline	45.30 score on a scale Standard Deviation 15.99	41.82 score on a scale Standard Deviation 17.27

SECONDARY outcome

Timeframe: Baseline, mid-intervention (week 4), post-intervention (week 8)

General Happiness item on Relationship Happiness Scale; scores range from 1 to 10 with higher scores representing greater relationship happiness.

Outcome measures

Outcome measures
Measure	CRAFT-EP + TAU n=21 Participants 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.	Treatment as Usual n=22 Participants Treatment as Usual TAU: Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.
Family Wellbeing: Relationship Baseline	3.71 score on a scale Standard Deviation 2.55	4.23 score on a scale Standard Deviation 2.72
Family Wellbeing: Relationship Mid-intervention	5.43 score on a scale Standard Deviation 2.60	4.00 score on a scale Standard Deviation 1.95
Family Wellbeing: Relationship Post-intervention	6.05 score on a scale Standard Deviation 2.32	5.00 score on a scale Standard Deviation 2.81

Adverse Events

CRAFT-EP + TAU

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

CRAFT-EP + TAU Clients With Psychosis

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Treatment as Usual Clients With Psychosis

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CRAFT-EP + TAU n=21 participants at risk 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.	Treatment as Usual n=22 participants at risk Treatment as Usual TAU: Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.	CRAFT-EP + TAU Clients With Psychosis n=4 participants at risk Clients with psychosis who had a family member assigned to the CRAFT-EP + TAU condition.	Treatment as Usual Clients With Psychosis n=18 participants at risk 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.
Psychiatric disorders Residential alcohol use disorder treatment program	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/22 • 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.	0.00% 0/4 • 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.	0.00% 0/18 • 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.
Psychiatric disorders Increase in Suicidal Ideation	0.00% 0/21 • 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.	13.6% 3/22 • Number of events 3 • 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.	50.0% 2/4 • Number of events 2 • 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.	27.8% 5/18 • Number of events 5 • 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.
Psychiatric disorders Car Accident	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/22 • 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.	0.00% 0/4 • 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.	5.6% 1/18 • Number of events 1 • 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.

Additional Information

Julie M. McCarthy, PhD

McLean Hospital / Harvard Medical School

Phone: 617-855-3521

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place