Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) and Substance Use: A Pilot Study

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Mclean Hospital
Study ID
NCT05380583
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • CRAFT-EP — BEHAVIORAL
    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.
  • TAU — BEHAVIORAL
    Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.

Study Details

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).

Key Dates

Start date
May 19, 2022
Status verified
Jan 2026
Primary completion
Dec 20, 2024
Completion
Jan 23, 2026

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CRAFT-EP + TAU
    Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching + Treatment as Usual (TAU).
  • Active Comparator: Treatment as Usual
    Treatment as Usual

Primary Outcome Measure

Family Wellbeing: Depression [ Time Frame: Baseline, mid-intervention (week 4), post-intervention (week 8) ]

Locations (1)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478-

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