McLean Hospital
Belmont, Massachusetts, 02478, United States
NCT Number: NCT05380583
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).
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Belmont, Massachusetts, 02478, United States
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. Given that family members may participate without a corresponding client with psychosis due to fear of disclosing their participation in the study to the client or client lack of interest, and because the intervention works directly with family members and indirectly with clients, data collected from clients with or without a corresponding family member participating in the study will be hypothesis generating.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Family Members:
Exclusion criteria
for Family Members:
Inclusion criteria
for Client Relatives:
Exclusion criteria
for Client Relatives:
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.
Other names: Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP)
Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.
Other names: Treatment as Usual (TAU)
Time frame: Baseline, mid-intervention (week 4), post-intervention (week 8)
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)
State-Trait Anxiety Inventory-Short Form; total scores range from 6 to 24 with higher scores representing more severe anxiety symptoms. Raw total scores transformed to the original 20-item scale range from 20 to 80 with higher scores representing more severe anxiety symptoms.
Time frame: Baseline, mid-intervention (week 4), post-intervention (week 8)
General Happiness item on Relationship Happiness Scale; scores range from 1 to 10 with higher scores representing greater relationship happiness.
Mclean Hospital
Other
Treatment Engagement in Families With Substance Use and Psychosis: A Pilot Study
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.
Published trials that share one or more normalized conditions with this study.
NCT04284813
Alcohol, Alcohol Use Disorder
Belmont, Massachusetts, United States
View Trial DetailsNCT05877716
Bipolar Disorder, Bipolar and Related Disorders
Minneapolis, Minnesota, United States
View Trial DetailsNCT04298450
Affective Disorders, Psychotic, Bipolar Disorder
Toronto, Ontario, Canada
View Trial DetailsNCT05243160
Bipolar Disorder, Bipolar and Related Disorders
Slagelse, Denmark
View Trial Details