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

Sponsor

Mclean Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05380583

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

36.4

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Psychosis Substance Use Substance Use Disorders Family Cannabis Marijuana Alcohol Schizophrenia Schizoaffective Disorder Bipolar Disorder Mental Disorder	Behavioral: CRAFT-EP Behavioral: TAU	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment Engagement in Families With Substance Use and Psychosis: A Pilot Study

Actual Study Start Date :

May 19, 2022

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Behavioral: 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. Other Names: Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) Behavioral: TAU Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions. Other Names: Treatment as Usual (TAU)
Active Comparator: Treatment as Usual Treatment as Usual	Behavioral: TAU Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions. Other Names: Treatment as Usual (TAU)

Arm

Intervention/Treatment

Experimental: 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).

Behavioral: 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.

Other Names:

Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP)

Behavioral: TAU

Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.

Other Names:

Treatment as Usual (TAU)

Active Comparator: Treatment as Usual

Treatment as Usual

Behavioral: TAU

Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.

Other Names:

Treatment as Usual (TAU)

Outcome Measures

Primary Outcome Measures

Mean readiness to change substance use [Baseline, mid-intervention (week 4), post-intervention (week 8)]
Mean readiness to cutdown/quit using [most problematic substance] for the client with psychosis using importance-confidence-readiness rulers (0 = not at all to 10 = extremely).

Secondary Outcome Measures

Percentage of Session Attendance [Baseline, mid-intervention (week 4), post-intervention (week 8)]
Percentage of treatment sessions attended by the client with psychosis in past 30 days.
Substance Use [Baseline, mid-intervention (week 4), post-intervention (week 8)]
Client Timeline Follow Back (TLFB) past 30 day substance use, urine toxicology screen for drugs of abuse.
Family Wellbeing: Depression [Baseline, mid-intervention (week 4), post-intervention (week 8)]
Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms.
Family Wellbeing: Anxiety [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.
Family Wellbeing: Relationship [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for Family Members:

Ages 18-70.
Having a relative who:

Is a client with early course psychosis (schizophrenia, schizoaffective disorder, schizophreniform, psychosis not otherwise specified (NOS), delusional disorder, brief psychotic disorder, major depression with psychosis, and bipolar disorder with psychosis (as reported by family member, clinician, or chart review)) with first onset in the past 6 years, and
Used alcohol or cannabis in the past 30 days and/or has no apparent immediate interest in abstinence (responding "No" to "Do you think they want to quit right now?" in reference to overall substance use).
Family member has concerns about the relative's substance use.

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:

DSM-5 moderate or severe substance use disorder in the past year.
Lifetime psychotic disorder.
History of domestic violence with the client relative.
Psychiatric, cognitive, or medical impairments that would interfere with the ability to follow through with the intervention plan.
Prior participation of a family member of the client in the study program.

Inclusion Criteria for Client Relatives:

Ages 18-35.
First episode psychosis onset in the past 6 years with a Diagnostic and Statistical Manual (DSM)-5 diagnosis of affective (bipolar disorder or major depressive disorder with psychotic features) or non- affective psychosis (schizophrenia spectrum disorder)
Used alcohol or cannabis in the past 30 days and/or has no apparent immediate interest in abstinence (responding "No" to "Do you want to quit right now?" in reference to overall substance use).
They or others have concerns about the client's substance use.
Ability to provide written informed consent (or assent with their legal guardian providing informed consent)
Speak and read English.