ClinicalTrials.gg
Not yet recruitingNCT07898631AFSP RESTEPSUpdated Oct 29, 2026

Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide

An interventional study of RESTEPS in Suicide and Mental Health Stigma, sponsored by Butler Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 15 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Primary conditionPsychotic DisordersRegistry: SuicideReclassifiedWhy we changed it
Registry
Suicide — the first condition term the registry derived for this study.
ClinicalTrials.gg
Psychotic Disorders
Why
  1. Suicide is a broad heading, used only when no more specific condition is named.
  2. The study's title name Psychotic Disorders.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Butler Hospital · Not applicable, Interventional, and Treatment

Updated Oct 29, 2026Eligibility revisedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
15 Years to 25 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Suicide
  • Mental Health Stigma

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Keywords

  • open trial
  • treatment development
  • early psychosis
  • suicide intervention
03

In context

Psychotic Disorders Reclassified

1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.

This study's planned enrollment of 35 is below the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

Butler Hospital is the lead sponsor of 119 studies on the registry; 14 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Compared within Psychotic Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Suicide. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

The criteria were revised on the registry on Oct 29, 2026. See what changed

Ages eligible
15 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 /assent and/or being able to engage in the study procedures
  • Involuntary hospital at the time of consent
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    RESTEPS

    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.

    Behavioral: RESTEPS

Interventions

  • BehavioralRESTEPS

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At post-intervention (8 weeks post-enrollment) and study follow-up (24 weeks post-enrollment)

  2. 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.

    Time frame: 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.

    Time frame: At baseline, mid-intervention (4 weeks post enrollment), post-intervention (8 weeks post-enrollment), and study follow-up (24 weeks post-enrollment)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — Inter-university Consortium for Political and Social Research (ICPSR)

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Jun 2028, 18 months later.

Of 455 non-industry interventional studies with no phase under Psychotic Disorders, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 18 months is below that.

Counting every sponsor, half of 457 studies reached it within 34 months; a quarter within 19 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2026
First posted
Oct 27, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Jun 2028
CompletionEst.
Jun 2028
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
1 inclusion criterion edited, 5 added; 1 exclusion criterion edited, 2 added
What changed in the criteria
Inclusion criteria
  • Added15-25 years of age
  • EditedInclusion Criteria: 1) 15-25 years of age; 2) schizophreniaSchizophrenia-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; 3) positive psychotic symptom duration of < 2 years OR currently receiving treatment in an early psychosis or first-episode psychosis clinic. 4) 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); 4) for participants younger than 18 only, parent/guardian significant other willing to participate in the study; 5) ability to speak and read English sufficiently to complete study procedures.
  • AddedPositive psychotic symptom duration of < 2 years OR currently receiving treatment in an early psychosis or first-episode psychosis clinic.
  • AddedSuicide 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)
  • AddedFor participants younger than 18 only, parent/guardian significant other willing to participate in the study
  • AddedAbility to speak and read English sufficiently to complete study procedures.
Exclusion criteria
  • EditedExclusion Criteria: 1) psychoticPsychotic symptoms due solely to substance intoxication or withdrawal (otherwise, comorbid substance use disorders will be allowed) or a known medical condition; 2) severe current psychotic symptoms preventing the participant from providing informed consent/assent and/or being able to engage in the study procedures; or 3) involuntary hospital at the time of consent.
  • AddedSevere current psychotic symptoms preventing the participant from providing informed consent/assent and/or being able to engage in the study procedures
  • AddedInvoluntary hospital at the time of consent
Oct 29, 2026
Registered
First appeared on the registry
Oct 27, 2026
Show all 2 updates
  1. Oct 29, 2026
    Eligibility 1 inclusion criterion edited, 5 added; 1 exclusion criterion edited, 2 added
    What changed in the criteria
    Inclusion criteria
    • Added15-25 years of age
    • EditedInclusion Criteria: 1) 15-25 years of age; 2) schizophreniaSchizophrenia-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; 3) positive psychotic symptom duration of < 2 years OR currently receiving treatment in an early psychosis or first-episode psychosis clinic. 4) 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); 4) for participants younger than 18 only, parent/guardian significant other willing to participate in the study; 5) ability to speak and read English sufficiently to complete study procedures.
    • AddedPositive psychotic symptom duration of < 2 years OR currently receiving treatment in an early psychosis or first-episode psychosis clinic.
    • AddedSuicide 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)
    • AddedFor participants younger than 18 only, parent/guardian significant other willing to participate in the study
    • AddedAbility to speak and read English sufficiently to complete study procedures.
    Exclusion criteria
    • EditedExclusion Criteria: 1) psychoticPsychotic symptoms due solely to substance intoxication or withdrawal (otherwise, comorbid substance use disorders will be allowed) or a known medical condition; 2) severe current psychotic symptoms preventing the participant from providing informed consent/assent and/or being able to engage in the study procedures; or 3) involuntary hospital at the time of consent.
    • AddedSevere current psychotic symptoms preventing the participant from providing informed consent/assent and/or being able to engage in the study procedures
    • AddedInvoluntary hospital at the time of consent
    + 1 other change: description
  2. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07898631
Lead sponsor
Butler Hospital
Collaborators
American Foundation for Suicide Prevention
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Oct 29, 2026

Study contacts

Ana Rabasco, PhD
Contact
ana_rabasco@brown.edu
929-399-9124
Brandon Gaudiano, PhD
Contact
brandon_gaudiano@brown.edu
Ana Rabasco, PhD
principal investigator · Butler Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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