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

Primary Purpose

Psychosis, Substance Use, Substance Use Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRAFT-EP
TAU
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Family Members:

  • Ages 18-70.
  • Having a relative who:

    1. 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
    2. 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).
    3. 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.

Exclusion Criteria for Client Relatives:

- N/A

Sites / Locations

  • McLean HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CRAFT-EP + TAU

Treatment as Usual

Arm Description

Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching + Treatment as Usual (TAU).

Treatment as Usual

Outcomes

Primary Outcome Measures

Mean readiness to change substance use
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
Percentage of treatment sessions attended by the client with psychosis in past 30 days.
Substance Use
Client Timeline Follow Back (TLFB) past 30 day substance use, urine toxicology screen for drugs of abuse.
Family Wellbeing: Depression
Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms.
Family Wellbeing: Anxiety
State-Trait Anxiety Inventory-Short Form; total scores range from 6 to 24 with higher scores representing more severe anxiety symptoms.
Family Wellbeing: Relationship
General Happiness item on Relationship Happiness Scale; scores range from 1 to 10 with higher scores representing greater relationship happiness.

Full Information

First Posted
May 9, 2022
Last Updated
October 4, 2023
Sponsor
Mclean Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05380583
Brief Title
Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) and Substance Use: A Pilot Study
Official Title
Treatment Engagement in Families With Substance Use and Psychosis: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Substance Use, Substance Use Disorders, Family, Cannabis, Marijuana, Alcohol, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Mental Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CRAFT-EP + TAU
Arm Type
Experimental
Arm Description
Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching + Treatment as Usual (TAU).
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Treatment as Usual
Intervention Type
Behavioral
Intervention Name(s)
CRAFT-EP
Other Intervention Name(s)
Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TAU
Other Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.
Primary Outcome Measure Information:
Title
Mean readiness to change substance use
Description
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).
Time Frame
Baseline, mid-intervention (week 4), post-intervention (week 8)
Secondary Outcome Measure Information:
Title
Percentage of Session Attendance
Description
Percentage of treatment sessions attended by the client with psychosis in past 30 days.
Time Frame
Baseline, mid-intervention (week 4), post-intervention (week 8)
Title
Substance Use
Description
Client Timeline Follow Back (TLFB) past 30 day substance use, urine toxicology screen for drugs of abuse.
Time Frame
Baseline, mid-intervention (week 4), post-intervention (week 8)
Title
Family Wellbeing: Depression
Description
Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms.
Time Frame
Baseline, mid-intervention (week 4), post-intervention (week 8)
Title
Family Wellbeing: Anxiety
Description
State-Trait Anxiety Inventory-Short Form; total scores range from 6 to 24 with higher scores representing more severe anxiety symptoms.
Time Frame
Baseline, mid-intervention (week 4), post-intervention (week 8)
Title
Family Wellbeing: Relationship
Description
General Happiness item on Relationship Happiness Scale; scores range from 1 to 10 with higher scores representing greater relationship happiness.
Time Frame
Baseline, mid-intervention (week 4), post-intervention (week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Significant prior experience with CRAFT (e.g., having completed a CRAFT course prior to study enrollment) 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. Exclusion Criteria for Client Relatives: - N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie M McCarthy, PhD
Phone
617-855-3521
Email
jmccarthy@mclean.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dost Öngür, MD, PhD
Phone
617-855-3922
Email
dongur@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie M McCarthy, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie M McCarthy, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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