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Completed

NCT Number: NCT04284813

Families With Substance Use and Psychosis: A Pilot Study

The purpose of this study is to develop and evaluate an intervention that adapts Community Reinforcement and Family Training (CRAFT) for families experiencing first episode psychosis and substance use delivered via telemedicine (video conferencing). The intervention aims to improve treatment engagement and reduce distress, and it will be delivered via telemedicine (CRAFT-FT). To assess feasibility of the intervention, family members will complete the sessions and provide feedback to refine the treatment manual. Data on client relatives with psychosis will be collected for preliminary assessment purposes. Client relatives will not complete the research study intervention.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18-70.
  • Having a relative who:
  • Is a patient with early course psychosis (DSM-5 schizophrenia, schizoaffective disorder, schizophreniform, psychosis not otherwise specified (NOS), delusional disorder, brief psychotic disorder, major depression with psychosis, and bipolar disorder with psychosis) with first onset in the past 6 years, and
  • Uses tobacco, alcohol, or cannabis in the past 90 days and/or has no apparent immediate interest in abstinence.
  • 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

  • DSM-5 moderate or severe substance use disorder in the past year.
  • Lifetime psychotic disorder.
  • History of domestic violence with the identified patient (IP).
  • Psychiatric, cognitive, or medical impairments that would interfere with the ability to follow through with the treatment plan.

Inclusion criteria

for Client Relatives:

  • Ages 18-35.
  • First episode psychosis (FEP) onset in the past 6 years with a DSM-5 diagnosis of affective (bipolar disorder or major depressive disorder with psychotic features) or non-affective psychosis (schizophrenia spectrum disorder).

a. Used tobacco, alcohol, or cannabis within the past 90 days and/or has no apparent immediate interest in abstinence.

  • Ability to provide written informed consent.
  • Speak/read English

Exclusion criteria

  • N/A

Treatment and study plan

CRAFT-FT

Behavioral

CRAFT-FT will be delivered via telemedicine. Topics include building motivation, self-care, communication, understanding patterns of behavior, positive reinforcement, and negative consequences. The intervention will be tailored to families of individuals experiencing psychosis and substance use who are enrolled in first episode psychosis outpatient services. Participants will be asked to completed assessments at pre-treatment, mid-treatment (approximately week 3), post-treatment, and a follow-up assessment approximately 3 month post-treatment.

Primary outcomes

  1. Percentage of Sessions Completed

    Time frame: Post-intervention, approximately Week 6-8

    Percentage of sessions completed during the intervention

Secondary outcomes

  1. Mean Session Satisfaction Rating

    Time frame: Up to 8 weeks

    Participants will report weekly satisfaction ratings following each session on the Session Survey. Ratings will range from 1 (poor) to 5 (excellent) for overall experience and convenience.

  2. Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats

    Time frame: Up to 8 weeks

    Percentage of participant preference for in-person, telemedicine, or both sessions formats as assessed categorically during the Treatment Satisfaction Interview.

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 26, 2020
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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