DMHI for At-Risk College Students

University of Washington

Status: Invitation-only

Conditions: Prodromal Symptoms; Psychosis

Treatments: Behavioral: SPARK Coping

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06608498

P50MH115837 (U.S. NIH Grant/Contract)

STUDY00019663

Details and patient eligibility

About

The goal of this clinical trial is to learn if a single-session digital intervention (SPARK Coping) is acceptable, usable, and demonstrates a preliminary signal of efficacy in reducing symptom-related distress and increasing positive treatment-seeking attitudes among college students reporting subthreshold symptoms associated with risk for psychosis. Research questions inclue:

• Does SPARK Coping reduce symptom-related distress and increase positive treatment seeking attitudes (primary outcomes) relative to a waitlist control condition?
• Does SPARK Coping increase adaptive coping and reduce internalized stigma (primary targets) relative to a waitlist control condition?

Researchers will compare provision of SPARK Coping to a waitlist control condition and collect data from participants on each of the variables described above. Participants will:

• Complete questionnaires and surveys remotely at the start of the study and two weeks later
• Be offered access to the SPARK Coping intervention either after completion of their baseline assessment (intervention arm) or after two weeks (waitlist control arm).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptoms indicating risk for psychosis (a distress score >= 20 on the Prodromal Questionnaire, Brief [PQ-B], per Savill et al., 2018; Early Intervention in Psychiatry and a positive frequency average score >= 1.47 on the Community Assessment of Psychic Experiences (CAPE-P15), per Jaya et al., 2021 and Bukenaite et al., 2017)
• Residence in the United States
• Currently enrolled in a post-secondary college program.

Exclusion criteria

• Inconsistent or implausible reporting of symptoms at screening as determined by empirically-determined methods for detecting malingering or inconsistency
• Failure to demonstrate understanding of study details in comprehension screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Intervention (SPARK Coping)

Active Comparator group

Description:

Participants will be given a link to SPARK Coping immediately following their baseline assessments are complete.

Treatment:

Behavioral: SPARK Coping

Waitlist Control

No Intervention group

Description:

Participants will wait until their follow-up assessment to be given access to the SPARK Coping intervention.