SuicideAFSP RESTEPSNCT07898631
Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
A study testing RESTEPS in people with Suicide and Mental Health Stigma, run by Butler Hospital at 1 site in United States.
Trial summary
A mental health program, called RESTEPS, will be developed for patients with early psychosis being treated in outpatient mental health centers, focusing on reducing suicide risk by targeting mental health stigma and social support. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Suicide, Mental Health Stigma
- What is being tested?
- RESTEPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 15-25 years of age
- Schizophrenia-spectrum disorder diagnosis (e.g., schizophreniform, schizoaffective disorder, schizophrenia, delusional disorder) or mood disorder with psychotic features (e.g., major depressive disorder with psychotic features, bipolar disorder with psychotic features) confirmed via Structured Clinical Interview for the DSM-5
- Positive psychotic symptom duration of < 2 years OR currently receiving treatment in an early psychosis or first-episode psychosis clinic.
- Suicide risk defined as any lifetime suicide attempt or suicidal ideation (yes to Questions 1, 2, 3, 4, or 5 on the Columbia Suicide Severity Rating Scale or C-SSRS)
- For participants younger than 18 only, parent/guardian significant other willing to participate in the study
- Ability to speak and read English sufficiently to complete study procedures.
Who cannot join
- Psychotic symptoms due solely to substance intoxication or withdrawal (otherwise, comorbid substance use disorders will be allowed) or a known medical condition
- Severe current psychotic symptoms preventing the participant from providing informed consent/assent and/or being able to engage in the study procedures
- Involuntary hospital at the time of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brandon Gaudiano, PhD contact
United States1 site
Butler Hospital
Providence, Rhode Island, 02906
Ana Rabasco, 929-399-9124, ana_rabasco@brown.edu
Ana Rabasco, PhD
About this study
A mental health program, called RESTEPS, will be developed for patients with early psychosis being treated in outpatient mental health centers, focusing on reducing suicide risk by targeting mental health stigma and social support. Youth (n = 35) with psychosis and current/past suicidal thoughts or behaviors will be recruited from community mental health centers to complete an initial open trial examining the feasibility and acceptability of RESTEPS, an 8-session intervention. Participants will be assessed at baseline, mid-intervention, post-intervention, and at a 6-month follow-up.
- Conditions
- Suicide, Mental Health Stigma
- Being tested
- RESTEPS
- Keywords
- open trial, treatment development, early psychosis, suicide intervention
- Medical subject headings
- Suicide, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESTEPSBehavioural
RESTEPS is an 8-session intervention for youth with early psychosis in community treatment. It addresses social support and mental health stigma. A family member/friend of the participant is invited to participate in half of the treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| RESTEPS | Experimental | RESTEPS is an 8-session intervention for youth with early psychosis in community treatment. It addresses social support and mental health stigma. A family member/friend of the participant is invited to participate in half of the treatment sessions. Receives: Behavioral: RESTEPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
The CSQ-8 is a brief, 8-item self-report measure global client satisfaction. Items are measured on a 4-point Likert scale, with higher scores indicating higher levels of satisfaction. The CSQ-8 demonstrates internal consistency, in addition to predictive and convergent validity. A mean CSQ-8 score of ≥ 3 will be used as the satisfaction threshold in the current project.
Measured: At post-intervention (8 weeks post-enrollment) and study follow-up (24 weeks post-enrollment)
Suicidal Ideation Questionnaire (SIQ)
The SIQ is a 15-item self-report measure of suicidal ideation over the past month. Items are rated on a 7- point scale assessing for frequency of thoughts ("almost every day" to "I never had this thought"). Scores range from 0 to 90, with a published clinical cut-off score of 31. It was developed for youth and has established convergent and predictive validity.
Measured: At baseline, mid-intervention (4 weeks post enrollment), post-intervention (8 weeks post-enrollment), and study follow-up (24 weeks post-enrollment)
Secondary outcomes (1)
Brief Psychiatric Rating Scale (BPRS)
The BPRS is an 18-item clinical interview measure of psychopathology, including symptoms of psychosis (e.g., paranoia, hallucinations, delusions), over the past week. Each item is rated on a scale from 1 (not present) to 7 (extremely severe). A higher score on the BPRS suggests higher severity of psychopathology. The BPRS is commonly used in first-episode psychosis intervention studies and has established validity and reliability. The BPRS was designed for adults and the BPRS-C was designed for children/adolescents.
Measured: At baseline, mid-intervention (4 weeks post enrollment), post-intervention (8 weeks post-enrollment), and study follow-up (24 weeks post-enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Responsible party
- Sponsor
- Investigators
- Ana Rabasco, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898631
- Sponsor's protocol ID
- ECR-0-125-23
- Acronym
- AFSP RESTEPS
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Inter-university Consortium for Political and Social Research (ICPSR)
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
- ClinicalTrials.gov ID
- NCT07898631
- Acronym / sponsor ID
- AFSP RESTEPS / ECR-0-125-23
- Conditions
- Suicide, Mental Health Stigma
- Keywords
- open trial, treatment development, early psychosis, suicide intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 27 Oct 2026 (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.
A mental health program, called RESTEPS, will be developed for patients with early psychosis being treated in outpatient mental health centers, focusing on reducing suicide risk by targeting mental health stigma and social support. Youth (n = 35) with psychosis and current/past suicidal thoughts or behaviors will be recruited from community mental health centers to complete an initial open trial examining the feasibility and acceptability of RESTEPS, an 8-session intervention. Participants will be assessed at baseline, mid-intervention, post-intervention, and at a 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RESTEPS | Experimental | Behavioral: RESTEPSRESTEPS is an 8-session intervention for youth with early psychosis in community treatment. It addresses social support and mental health stigma. A family member/friend of the participant is invited to participate in half of the treatment sessions. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 15-25 years of age
- Schizophrenia-spectrum disorder diagnosis (e.g., schizophreniform, schizoaffective disorder, schizophrenia, delusional disorder) or mood disorder with psychotic features (e.g., major depressive disorder with psychotic features, bipolar disorder with psychotic features) confirmed via Structured Clinical Interview for the DSM-5
- Positive psychotic symptom duration of < 2 years OR currently receiving treatment in an early psychosis or first-episode psychosis clinic.
- Suicide risk defined as any lifetime suicide attempt or suicidal ideation (yes to Questions 1, 2, 3, 4, or 5 on the Columbia Suicide Severity Rating Scale or C-SSRS)
- For participants younger than 18 only, parent/guardian significant other willing to participate in the study
Key exclusion criteria (3 listed)
- Psychotic symptoms due solely to substance intoxication or withdrawal (otherwise, comorbid substance use disorders will be allowed) or a known medical condition
- Severe current psychotic symptoms preventing the participant from providing informed consent/assent and/or being able to engage in the study procedures
- Involuntary hospital at the time of consent
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 |
|---|---|---|
| RESTEPSRESTEPS is an 8-session intervention for youth with early psychosis in community treatment. It addresses social support and mental health stigma. A family member/friend of the participant is invited to participate in half of the treatment sessions. | Behavioural | RESTEPS |
Primary outcome
Acceptability
Time frame: At post-intervention (8 weeks post-enrollment) and study follow-up (24 weeks post-enrollment)
The CSQ-8 is a brief, 8-item self-report measure global client satisfaction. Items are measured on a 4-point Likert scale, with higher scores indicating higher levels of satisfaction. The CSQ-8 demonstrates internal consistency, in addition to predictive and convergent validity. A mean CSQ-8 score of ≥ 3 will be used as the satisfaction threshold in the current project.
Suicidal Ideation Questionnaire (SIQ)
Time frame: At baseline, mid-intervention (4 weeks post enrollment), post-intervention (8 weeks post-enrollment), and study follow-up (24 weeks post-enrollment)
The SIQ is a 15-item self-report measure of suicidal ideation over the past month. Items are rated on a 7- point scale assessing for frequency of thoughts ("almost every day" to "I never had this thought"). Scores range from 0 to 90, with a published clinical cut-off score of 31. It was developed for youth and has established convergent and predictive validity.
1 secondary outcome
Brief Psychiatric Rating Scale (BPRS)
Time frame: At baseline, mid-intervention (4 weeks post enrollment), post-intervention (8 weeks post-enrollment), and study follow-up (24 weeks post-enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. Inter-university Consortium for Political and Social Research (ICPSR)
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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.
Brandon Gaudiano, PhD contact
Ana Rabasco, PhD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESTEPS in people with Suicide and Mental Health Stigma, run by Butler Hospital 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Rabasco, PhD (929-399-9124, ana_rabasco@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: At post-intervention (8 weeks post-enrollment) and study follow-up (24 weeks post-enrollment)). The study lists 2 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 29 Oct 2026.