PsychosisCRAFT-EPINCT05300633
Community Reinforcement Approach and Family Training for Substance Use in Early Psychosis Intervention
A study testing Group-Based Community Reinforcement Approach and Family Training-Early Psychosis Intervention (CRAFT-EPI) in people with Psychosis and Schizophrenia and Related Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychosis, Schizophrenia and Related Disorders, Schizophrenia Spectrum and Other Psychotic Disorders
- What is being tested?
- Group-Based Community Reinforcement Approach and Family Training-Early Psychosis Intervention (CRAFT-EPI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 8 Feb 2022to 28 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapting Community Reinforcement Approach and Family Training to Target Substance Use in Early Psychosis Intervention: A Pilot Study of Group Therapy
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.
Read the 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.
- Conditions
- Psychosis, Schizophrenia and Related Disorders, Schizophrenia Spectrum and Other Psychotic Disorders, Substance Use, Substance Use Disorders
- Being tested
- Group-Based Community Reinforcement Approach and Family Training-Early Psychosis Intervention (CRAFT-EPI)
- Keywords
- Group therapy, Community Reinforcement Approach and Family Training
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-Based Community Reinforcement Approach and Family Training-Early Psychosis Intervention (CRAFT-EPI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Family member/concerned significant other Receives: Behavioral: Group-Based Community Reinforcement Approach and Family Training-Early Psychosis Intervention (CRAFT-EPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18 weeks
Rates of recruitment
Number of family member and identified patient participants who consent to participation
Measured: Baseline
Rates of retention
Number of family member participants who complete 6 intervention sessions and booster session
Measured: 18 weeks
Rates of assessment completion
Proportion of assessments completed by consented family members and identified patients, averaged over 3 timepoints
Measured: 18 weeks
Secondary outcomes (7)
Patient Health Questionnaire (PHQ-9) total score
Symptoms of depression
Measured: Baseline, 6 weeks, 18 weeks
Happiness Scale total score
Experience of happiness
Measured: Baseline, 6 weeks, 18 weeks
Perceived Stress Scale-14 item total score
Experience of stress
Measured: Baseline, 6 weeks, 18 weeks
Ontario Perception of Care Tool-Mental Health and Addictions section scores
Perceptions of care, satisfaction with the model
Measured: 6 weeks, 18 weeks
Contemplation Ladder total score
Readiness to change substance use
Measured: Baseline, 6 weeks, 18 weeks
National Institute on Drug Abuse (NIDA)-Modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) V2.0 total score
Substance use
Measured: Baseline, 6 weeks, 18 weeks
Generalized Anxiety Disorder-7 (GAD-7) total score
Symptoms of anxiety
Measured: Baseline, 6 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start8 Feb 2022
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Mclean Hospital
- Responsible party
- Sponsor
- Investigators
- Nicole Kozloff, MD, SM, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300633
- Sponsor's protocol ID
- 127-2021
- Acronym
- CRAFT-EPI
- Status last verified
- Sep 2023
- First submitted
- 10 Feb 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10689661
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Community Reinforcement Approach and Family Training to Target Substance Use in Early Psychosis Intervention: A Pilot Study of Group Therapy
- ClinicalTrials.gov ID
- NCT05300633
- Acronym / sponsor ID
- CRAFT-EPI / 127-2021
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Mclean Hospital
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Group-Based Community Reinforcement Approach and Family Training-Early Psychosis Intervention (CRAFT-EPI)Family member/concerned significant other |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-Based Community Reinforcement Approach and Family Training-Early Psychosis Intervention (CRAFT-EPI)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. | Behavioural | Intervention arm |
Primary outcome
Rate of treatment entry for substance use
Time frame: 18 weeks
Treatment entry for substance use by the identified patient as reported by their family member (concerned significant other)
Rates of recruitment
Time frame: Baseline
Number of family member and identified patient participants who consent to participation
Rates of retention
Time frame: 18 weeks
Number of family member participants who complete 6 intervention sessions and booster session
Rates of assessment completion
Time frame: 18 weeks
Proportion of assessments completed by consented family members and identified patients, averaged over 3 timepoints
7 secondary outcomes
Patient Health Questionnaire (PHQ-9) total score
Time frame: Baseline, 6 weeks, 18 weeks
Happiness Scale total score
Time frame: Baseline, 6 weeks, 18 weeks
Perceived Stress Scale-14 item total score
Time frame: Baseline, 6 weeks, 18 weeks
Ontario Perception of Care Tool-Mental Health and Addictions section scores
Time frame: 6 weeks, 18 weeks
Contemplation Ladder total score
Time frame: Baseline, 6 weeks, 18 weeks
National Institute on Drug Abuse (NIDA)-Modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) V2.0 total score
Time frame: Baseline, 6 weeks, 18 weeks
Generalized Anxiety Disorder-7 (GAD-7) total score
Time frame: Baseline, 6 weeks, 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Results publication: PubMed 10689661Meyers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Kozloff, MD, SM principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-Based Community Reinforcement Approach and Family Training-Early Psychosis Intervention (CRAFT-EPI) in people with Psychosis and Schizophrenia and Related Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of treatment entry for substance use (time frame: 18 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05300633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.