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

NCT05300633 | Completed

• 1 other identifier: 127-2021
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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)

  18 weeks

• Rates of recruitment

  Number of family member and identified patient participants who consent to participation

  Baseline

• Rates of retention

  Number of family member participants who complete 6 intervention sessions and booster session

  18 weeks

• Rates of assessment completion

  Proportion of assessments completed by consented family members and identified patients, averaged over 3 timepoints

  18 weeks

Secondary Outcomes (7)

• Patient Health Questionnaire (PHQ-9) total score

  Baseline, 6 weeks, 18 weeks

• Happiness Scale total score

  Baseline, 6 weeks, 18 weeks

• Perceived Stress Scale-14 item total score

  Baseline, 6 weeks, 18 weeks

• Ontario Perception of Care Tool-Mental Health and Addictions section scores

  6 weeks, 18 weeks

• Contemplation Ladder total score

  Baseline, 6 weeks, 18 weeks

Study Arms (1)

Intervention arm

EXPERIMENTAL

Family member/concerned significant other

Behavioral: Group-Based Community Reinforcement Approach and Family Training-Early Psychosis Intervention (CRAFT-EPI)

Interventions

Group-Based Community Reinforcement Approach and Family Training-Early Psychosis Intervention (CRAFT-EPI) BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Mclean Hospital: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H1, Canada

Location

Related Publications (1)

• 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.

  PMID: 10689661 RESULT

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Chemically-Induced Disorders

Study Officials

• Nicole Kozloff, MD, SM

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 29, 2022
• Study Start: February 8, 2022
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)