Prodromal SymptomsNCT06608498
DMHI for At-Risk College Students
A study testing SPARK Coping in people with Prodromal Symptoms and Psychosis, run by University of Washington at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Prodromal Symptoms, Psychosis
- What is being tested?
- SPARK Coping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2024to 6 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 at the University of Washington.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: User-Centered Design of a Single-Module Digital Mental Health Intervention for College Students at Risk for Psychosis
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?
Read more
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).
- Conditions
- Prodromal Symptoms, Psychosis
- Being tested
- SPARK Coping
- Keywords
- College student mental health
- Medical subject headings
- Prodromal Symptoms, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARK CopingBehavioural
SPARK Coping is a single-session intervention providing psychoeducation and structured practices related to stigma reduction, cognitive restructuring, behavioral activation, and effective coping. It is a self-guided website powered by research data capture software.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (SPARK Coping) | Active comparator | Participants will be given a link to SPARK Coping immediately following their baseline assessments are complete. Receives: Behavioral: SPARK Coping |
| Waitlist Control | No intervention | Participants will wait until their follow-up assessment to be given access to the SPARK Coping intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in coping self-efficacy
Caregiver coping self-efficacy will be assessed with the Coping Self-Efficacy Scale, a 26-item self-report questionnaire measuring the perceived ability of coping with various life challenges. Responses are rated on a 0 to 10 scale, and scores range from 0 to 260, with higher scores denoting a greater sense of self-efficacy in coping.
Measured: Baseline, 2 weeks
Change in internalized stigma
Internalized stigma will be assessed with the Internalized Stigma of Mental Health Inventory, Brief (ISMI-9). The ISMI-9 is a nine-item self-report short form, where each item is rated on a four-point Likert scale (1 = Strongly disagree, 4 = Strongly agree), and higher scores indicate more severe internalization of mental illness stigma.
Measured: Baseline, 2 weeks
Change in attitudes toward treatment
Help-Seeking Attitudes will be measured using the treatment and treatment-seeking subscales of the Endorsed and Anticipated Stigma Inventory (EASI). The full EASI is a 40-item self-reported questionnaire with subscales measuring beliefs about mental illness, beliefs about mental health treatment, beliefs about mental health treatment seeking, concerns about stigma from loved ones, and concerns about stigma from the workplace. The subscales are scored by summing the ratings from the eight individual items in each subscale (5-point scale with 1 = Strongly disagree, 5 = Strongly agree), with lower scores indicating less stigma, and more positive attitudes towards treatment and treatment-seeking. We will assess attitudes toward treatment and treatment-seeking by administering those two subscales. Total scores combining these two scales range from 16 to 80.
Measured: Baseline, 2 weeks
Change in positive psychosis symptom frequency and distress
Distress related to positive psychosis symptoms will be assessed with the CAPE-P15, a 15-item measure of positive symptoms of psychosis and psychosis risk as well as distress associated with such experiences. These 15 items are rated both on frequency (1 = Never to 4 = Nearly always) and distress (1 = Not distressed to 4 = Very distressed).
Measured: Baseline, 2 weeks
Secondary outcomes (2)
Change in recovery
Recovery will be assessed using the Choice of Outcome in CBT for Psychoses, Short Form (CHOICE-SF). The CHOICE-SF is an 11-item self-report form developed to assess recovery-related goals for therapy. Participants rate themselves in different therapy-focused areas such as "self-confidence" or "ways of dealing with everyday stress" on a scale (0 = Worst, 10 = Best).
Measured: Baseline, 2 weeks
Change in general psychopathology / distress
General psychopathology / distress will be assessed with General Health Questionnaire (GHQ), a 12-item questionnaire assessing general psychological morbidity. Respondents indicate agreement on a four-point scale (0 = Not at all; 3 = More than usual) and total scores ranging from 0 to 36 with higher scores indicating more severe psychological morbidity.
Measured: Baseline, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start4 Oct 2024
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prodromal SymptomsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Benjamin Buck, University of Washington
- Investigators
- Ben Buck, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608498
- Sponsor's protocol ID
- STUDY00019663
- Other IDs
- P50MH115837
- Status last verified
- Dec 2025
- First submitted
- 19 Sep 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User-Centered Design of a Single-Module Digital Mental Health Intervention for College Students at Risk for Psychosis
- ClinicalTrials.gov ID
- NCT06608498
- Acronym / sponsor ID
- STUDY00019663
- Conditions
- Prodromal Symptoms, Psychosis
- Keywords
- College student mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (SPARK Coping) | Active comparator | Behavioral: SPARK CopingParticipants will be given a link to SPARK Coping immediately following their baseline assessments are complete. |
| Waitlist Control | No intervention | –Participants will wait until their follow-up assessment to be given access to the SPARK Coping intervention. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 at the University of Washington.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPARK CopingSPARK Coping is a single-session intervention providing psychoeducation and structured practices related to stigma reduction, cognitive restructuring, behavioral activation, and effective coping. It is a self-guided website powered by research data capture software. | Behavioural | Intervention (SPARK Coping) |
Primary outcome
Change in coping self-efficacy
Time frame: Baseline, 2 weeks
Caregiver coping self-efficacy will be assessed with the Coping Self-Efficacy Scale, a 26-item self-report questionnaire measuring the perceived ability of coping with various life challenges. Responses are rated on a 0 to 10 scale, and scores range from 0 to 260, with higher scores denoting a greater sense of self-efficacy in coping.
Change in internalized stigma
Time frame: Baseline, 2 weeks
Internalized stigma will be assessed with the Internalized Stigma of Mental Health Inventory, Brief (ISMI-9). The ISMI-9 is a nine-item self-report short form, where each item is rated on a four-point Likert scale (1 = Strongly disagree, 4 = Strongly agree), and higher scores indicate more severe internalization of mental illness stigma.
Change in attitudes toward treatment
Time frame: Baseline, 2 weeks
Help-Seeking Attitudes will be measured using the treatment and treatment-seeking subscales of the Endorsed and Anticipated Stigma Inventory (EASI). The full EASI is a 40-item self-reported questionnaire with subscales measuring beliefs about mental illness, beliefs about mental health treatment, beliefs about mental health treatment seeking, concerns about stigma from loved ones, and concerns about stigma from the workplace. The subscales are scored by summing the ratings from the eight individual items in each subscale (5-point scale with 1 = Strongly disagree, 5 = Strongly agree), with lower scores indicating less stigma, and more positive attitudes towards treatment and treatment-seeking. We will assess attitudes toward treatment and treatment-seeking by administering those two subscales. Total scores combining these two scales range from 16 to 80.
Change in positive psychosis symptom frequency and distress
Time frame: Baseline, 2 weeks
Distress related to positive psychosis symptoms will be assessed with the CAPE-P15, a 15-item measure of positive symptoms of psychosis and psychosis risk as well as distress associated with such experiences. These 15 items are rated both on frequency (1 = Never to 4 = Nearly always) and distress (1 = Not distressed to 4 = Very distressed).
2 secondary outcomes
Change in recovery
Time frame: Baseline, 2 weeks
Change in general psychopathology / distress
Time frame: Baseline, 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Buck, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPARK Coping in people with Prodromal Symptoms and Psychosis, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in coping self-efficacy (time frame: Baseline, 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.