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Community Reinforcement Approach and Family Training for Substance Use in Early Psychosis Intervention (CRAFT-EPI)

Primary Purpose

Psychosis, Schizophrenia and Related Disorders, Schizophrenia Spectrum and Other Psychotic Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group-Based Community Reinforcement Approach and Family Training-Early Psychosis Intervention (CRAFT-EPI)
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Group therapy, Community Reinforcement Approach and Family Training

Eligibility Criteria

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

Inclusion Criteria:

Concerned significant other (CSO)

  • Adult (at least 18 years) family member of an identified patient (IP) enrolled in SCEI treatment. The IP should be aged 16-29 years with clinician diagnosis of early psychosis (schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, major depressive disorder with psychotic features, substance-induced psychotic disorder, or unspecified schizophrenia spectrum and other psychotic disorder). The IP does NOT need to be enrolled in the study in order for the CSO to participate. Up to 2 CSOs associated with the same IP may participate.
  • Has completed the program's introductory psychoeducation group
  • Concerned about substance use in the IP enrolled in the early psychosis intervention program

Identified patient

  • Enrolled in the early psychosis intervention program, aged 16-29 years with clinician diagnosis of early psychosis (schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, major depressive disorder with psychotic features, substance-induced psychotic disorder, or unspecified schizophrenia spectrum and other psychotic disorder)
  • Not currently receiving specialized substance use treatment (i.e. by a clinician other than their NAVIGATE clinicians)

Exclusion Criteria:

Concerned significant other

  • Inability to provide informed consent
  • Inability to communicate in basic oral and written English.
  • There are already 2 CSOs associated with a given IP that are participating in the CRAFT-EPI study.
  • Lack of a device for videoconferencing and a secure Wi-Fi connection
  • Unwilling to turn camera on for weekly group sessions (except in the case of a poor Wi-Fi connection, or other similar circumstances)

Identified patient

  • Does not have a CSO that is enrolled in the CRAFT-EPI study
  • Inability to provide informed consent
  • Inability to communicate in basic oral and written English

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

Family member/concerned significant other

Outcomes

Primary Outcome Measures

Rate of treatment entry for substance use
Treatment entry for substance use by the identified patient as reported by their family member (concerned significant other)
Rates of recruitment
Number of family member and identified patient participants who consent to participation
Rates of retention
Number of family member participants who complete 6 intervention sessions and booster session
Rates of assessment completion
Proportion of assessments completed by consented family members and identified patients, averaged over 3 timepoints

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-9) total score
Symptoms of depression
Happiness Scale total score
Experience of happiness
Perceived Stress Scale-14 item total score
Experience of stress
Ontario Perception of Care Tool-Mental Health and Addictions section scores
Perceptions of care, satisfaction with the model
Contemplation Ladder total score
Readiness to change substance use
National Institute on Drug Abuse (NIDA)-Modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) V2.0 total score
Substance use
Generalized Anxiety Disorder-7 (GAD-7) total score
Symptoms of anxiety

Full Information

First Posted
February 10, 2022
Last Updated
September 13, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
Mclean Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05300633
Brief Title
Community Reinforcement Approach and Family Training for Substance Use in Early Psychosis Intervention
Acronym
CRAFT-EPI
Official Title
Adapting Community Reinforcement Approach and Family Training to Target Substance Use in Early Psychosis Intervention: A Pilot Study of Group Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
September 28, 2022 (Actual)
Study Completion Date
September 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Mclean Hospital

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 goal of this pilot feasibility and proof of concept study is to evaluate whether Community Reinforcement and Family Training (CRAFT) as adapted for group delivery in an early psychosis intervention (EPI) program has a clinically significant impact on the concerned significant other (CSO) and Identified patient (IP), and whether a larger, definitive trial is feasible. The intervention aims to improve treatment engagement and reduce distress, as reported by the CSO. To assess feasibility of the intervention for a definitive trial of CRAFT-EPI, the investigators will evaluate recruitment, retention, and assessment completion rates.
Detailed Description
Substance use has a major impact on the prevalence and course of early psychosis in young people. Substance use disorders occur in over 40% of people with schizophrenia spectrum disorders. There is increasing evidence to support the fact that cannabis can trigger and worsen psychosis. Young people with psychosis who have comorbid substance use disorders are known to experience worse outcomes, with a three-fold risk of psychosis relapse compared to those without substance use disorders. Current Canadian guidelines recommend integration of substance use treatments in early psychosis intervention programs and specifically suggest integrating addiction-based psychosocial interventions, and involving families in care, but there is limited evidence to support any one specific psychosocial intervention in this population. Studies show that around half of young people with psychosis who use substances significantly reduce their use with the general education and advice provided in early psychosis intervention programs, but it is unclear how programs should intervene to support the other half of clients who continue to struggle. Community Reinforcement Approach and Family Training (CRAFT) grew out of the understanding that individuals with substance use disorders often struggle with treatment-seeking motivation, whereas their family members are typically highly motivated to get help for them. Having a young person in the family with a substance use disorder can be a very distressing experience, leading to marital and family conflict, physical and verbal abuse, financial problems, and mental health problems for their family members. CRAFT helps family members change the family environment in such a way that a non-substance using lifestyle is more rewarding than one focused on the use of substances. CRAFT aims to improve family members' understanding of addiction, learn about their own behaviors that may unintentionally be promoting substance use, and to modify their own behavior to foster a supportive environment. The ultimate goals are to increase the motivation of the person with the substance use disorder to seek help, and to decrease their substance use. CRAFT teaches family members, who often lack support, how to better take care of themselves and their mental health, and increase their happiness independent of whether their loved one enters substance use treatment. The efficacy of CRAFT has been demonstrated in multiple research trials, with high rates of individuals with substance use disorders entering treatment. Importantly, the treatment engagement outcomes are effective regardless of the age of the family member or their relationship to the identified patient, and the identified patient's substance of choice. While the therapy is typically provided to families one at a time, it has been adapted to be delivered in groups with equivalent efficacy and the added advantage of reaching more families and built-in peer support. Families who have completed a basic psychoeducation group at the Centre for Addiction and Mental Health (CAMH) Slaight Centre for Early Intervention (SCEI) and are concerned about their identified patient's substance use will be offered participation in a study of group CRAFT. The intervention has been adapted for early psychosis by Dr. Julie McCarthy at McLean Hospital. It will consist of an individual orientation session, 6 weekly group sessions, and a booster session. Families' satisfaction with this model, changes in their level of stress, quality of life, and other outcomes, and the patients' readiness to change, substance use, and engagement in substance use treatment will be evaluated. Families and patients will complete assessments at baseline, post-intervention, and 12-week follow-up. Families will additionally be invited to participate in a focus group that explores their experience of the intervention. The goal of this pilot feasibility and proof of concept study is to evaluate whether CRAFT as adapted for group delivery in an EPI program has a clinically significant impact on the family and identified patient, and whether a larger, definitive trial is feasible. This intervention has the potential to fill a major gap in early psychosis intervention, improving outcomes for both youth and families.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Schizophrenia and Related Disorders, Schizophrenia Spectrum and Other Psychotic Disorders, Substance Use, Substance Use Disorders
Keywords
Group therapy, Community Reinforcement Approach and Family Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm pilot study recruiting family member/concerned significant other participants to receive the intervention and complete outcome measures and identified patients to complete outcome measures only
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Family member/concerned significant other
Intervention Type
Behavioral
Intervention Name(s)
Group-Based Community Reinforcement Approach and Family Training-Early Psychosis Intervention (CRAFT-EPI)
Intervention Description
Behavioral therapy adapted for families of young people experiencing early psychosis delivered via telemedicine to groups following an individual orientation. Group session topics include self-care, communication, functional analysis, positive reinforcement, treatment engagement, natural consequences, and problem solving. A happiness scale will be completed at each session. Will be provided in the context of an early psychosis intervention program that provides coordinated specialty care to 16- to 29-year-olds experiencing any diagnosis that can manifest as early psychosis.
Primary Outcome Measure Information:
Title
Rate of treatment entry for substance use
Description
Treatment entry for substance use by the identified patient as reported by their family member (concerned significant other)
Time Frame
18 weeks
Title
Rates of recruitment
Description
Number of family member and identified patient participants who consent to participation
Time Frame
Baseline
Title
Rates of retention
Description
Number of family member participants who complete 6 intervention sessions and booster session
Time Frame
18 weeks
Title
Rates of assessment completion
Description
Proportion of assessments completed by consented family members and identified patients, averaged over 3 timepoints
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9) total score
Description
Symptoms of depression
Time Frame
Baseline, 6 weeks, 18 weeks
Title
Happiness Scale total score
Description
Experience of happiness
Time Frame
Baseline, 6 weeks, 18 weeks
Title
Perceived Stress Scale-14 item total score
Description
Experience of stress
Time Frame
Baseline, 6 weeks, 18 weeks
Title
Ontario Perception of Care Tool-Mental Health and Addictions section scores
Description
Perceptions of care, satisfaction with the model
Time Frame
6 weeks, 18 weeks
Title
Contemplation Ladder total score
Description
Readiness to change substance use
Time Frame
Baseline, 6 weeks, 18 weeks
Title
National Institute on Drug Abuse (NIDA)-Modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) V2.0 total score
Description
Substance use
Time Frame
Baseline, 6 weeks, 18 weeks
Title
Generalized Anxiety Disorder-7 (GAD-7) total score
Description
Symptoms of anxiety
Time Frame
Baseline, 6 weeks, 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Concerned significant other (CSO) Adult (at least 18 years) family member of an identified patient (IP) enrolled in SCEI treatment. The IP should be aged 16-29 years with clinician diagnosis of early psychosis (schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, major depressive disorder with psychotic features, substance-induced psychotic disorder, or unspecified schizophrenia spectrum and other psychotic disorder). The IP does NOT need to be enrolled in the study in order for the CSO to participate. Up to 2 CSOs associated with the same IP may participate. Has completed the program's introductory psychoeducation group Concerned about substance use in the IP enrolled in the early psychosis intervention program Identified patient Enrolled in the early psychosis intervention program, aged 16-29 years with clinician diagnosis of early psychosis (schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, major depressive disorder with psychotic features, substance-induced psychotic disorder, or unspecified schizophrenia spectrum and other psychotic disorder) Not currently receiving specialized substance use treatment (i.e. by a clinician other than their NAVIGATE clinicians) Exclusion Criteria: Concerned significant other Inability to provide informed consent Inability to communicate in basic oral and written English. There are already 2 CSOs associated with a given IP that are participating in the CRAFT-EPI study. Lack of a device for videoconferencing and a secure Wi-Fi connection Unwilling to turn camera on for weekly group sessions (except in the case of a poor Wi-Fi connection, or other similar circumstances) Identified patient Does not have a CSO that is enrolled in the CRAFT-EPI study Inability to provide informed consent Inability to communicate in basic oral and written English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Kozloff, MD, SM
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J1H1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10689661
Citation
Meyers RJ, Miller WR, Hill DE, Tonigan JS. Community reinforcement and family training (CRAFT): engaging unmotivated drug users in treatment. J Subst Abuse. 1998;10(3):291-308. doi: 10.1016/s0899-3289(99)00003-6.
Results Reference
result

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Community Reinforcement Approach and Family Training for Substance Use in Early Psychosis Intervention

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