Psychoeducation for Suicidal Youth

(STEP Trial)

Recruiting at 2 trial locations

Overseen By Shirley Yen, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Disqualifiers: Active psychotic disorder, cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

216 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Enhanced TAU, Enhanced Treatment As Usual, ETAU, STEP, Skills to Enhance Positivity for suicidal youth?

Research shows that the Skills to Enhance Positivity (STEP) program, which is part of the treatment, has been effective in increasing positive feelings and reducing suicidal events in adolescents. In a pilot study, adolescents who participated in STEP reported high engagement and fewer suicide attempts compared to similar studies, suggesting that this approach may help reduce suicidal behaviors. ^{1 2 3 4 5}

Is psychoeducation for suicidal youth safe?

Research on psychoeducation programs like Skills to Enhance Positivity (STEP) shows they are generally safe, with high engagement and satisfaction among participants. Minimal distress changes were reported, and fewer suicide events occurred compared to standard treatments, suggesting a positive safety profile. ^{1 2 5 6 7}

How is the STEP treatment different from other treatments for suicidal youth?

STEP is unique because it focuses on increasing positive emotions and experiences, rather than just addressing negative feelings or crisis intervention. It combines in-person sessions with remote support through phone calls and text messages, which helps maintain engagement and practice of skills. ^{2 4 5 7 8}

What is the purpose of this trial?

This is a Hybrid Type I Effectiveness-Implementation design. Specifically, this study proposes to test the effectiveness of STEP in reducing suicidal events and ideation in 216 adolescents, admitted to inpatient psychiatric care due to suicide risk. Participants will be randomized to either STEP or ETAU. STEP involves 4 in-person sessions (3 individual, 1 family) focused on psychoeducation regarding positive and negative affect, mindfulness meditation, gratitude, and savoring. Mood monitoring prompts and skill reminders will be sent daily for the first month post-discharge and three times a week for the following two months. The ETAU condition will receive reminders to log into a safety resource app, matched in frequency to the STEP group. Effectiveness aspects of the design include using clinical staff as interventionists and having very few exclusion criteria.

Eligibility Criteria

This trial is for adolescents and adults aged 12-60 who are hospitalized for suicide risk, have had recent suicidal thoughts or attempts, and can use a smartphone. They must understand English or Spanish. Stakeholders working with these individuals can also participate.

Inclusion Criteria

I am proficient in English or Spanish.

Patients with access to a smart phone

I am between 12 and 60 years old and hospitalized for suicide risk.

Exclusion Criteria

Patients being discharged to a residential facility.

Patients with active psychotic disorder

Patients with significant cognitive impairment or deficits

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either STEP or ETAU intervention during inpatient psychiatric admission, including 4 in-person sessions for STEP

4 weeks

4 in-person sessions

Post-discharge Monitoring

Mood monitoring and skill reminders sent daily for the first month post-discharge and three times a week for the following two months

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, and 12 months

12 months

Treatment Details

Interventions

• Enhanced TAU
• STEP

Trial Overview The study compares STEP—a program with in-person sessions on positive thinking skills and mood monitoring—to Enhanced TAU (usual care plus safety app reminders). Participants will be randomly assigned to one of the two groups to assess effectiveness.

Participant Groups

Group I: STEP: Positivity skill enhancement Experimental Treatment 1 Intervention

This intervention includes the Enhanced TAU described below plus it entails 4 in-person sessions delivered during an inpatient psychiatric admission, followed by mood monitoring and skills messages delivered post-discharge via app, to promote the practice of increasing attention to positive affect and experiences as a means of reducing risk for suicidal behavior.

Group II: Enhanced TAU Active Control 1 Intervention

his comparison intervention involves regular programming of the inpatient psychiatric unit, followed by safety plan and resources loaded onto an app that the participant has access to post-discharge.

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

Findings from Research

A quality improvement project involving 134 veterans hospitalized for suicidal thoughts showed that a new single-session suicide-focused psychoeducation group was highly acceptable and perceived as useful by participants.

After attending the group, veterans reported increased hope and motivation to learn coping skills for their suicidal thoughts, indicating the potential effectiveness of this intervention in an inpatient setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding suicide: Development and pilot evaluation of a single-session inpatient psychoeducation group. Gebhardt, HM., Ammerman, BA., Carter, SP., et al.[2022]

The Skills to Enhance Positivity (STEP) intervention aims to increase positive affect in adolescents at risk of suicide and has shown promise in a pilot study by reducing suicidal events and ideation.

The ongoing randomized controlled trial will compare STEP to Enhanced Treatment as Usual (ETAU) to determine its effectiveness in decreasing suicidal behaviors and improving positive emotional experiences over a 6-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skills to Enhance Positivity in adolescents at risk for suicide: Protocol for a randomized controlled trial. Yen, S., Suazo, N., Doerr, J., et al.[2023]

A psychoeducational suicide prevention group for 250 psychiatrically hospitalized adolescents was effective, with nearly all participants reporting they learned helpful strategies to prevent future suicide attempts.

The creation of a 'Reasons To Live List' was particularly beneficial for participants, while a 'Safety List' was considered less helpful, indicating that different therapeutic tools may have varying impacts based on individual experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescent perceptions of a suicide prevention group on an inpatient unit. Esposito-Smythers, C., McClung, TJ., Fairlie, AM.[2022]

Psycho-educational programs for suicide prevention in students aged 14 to 18 significantly improved knowledge about suicide and positively influenced attitudes towards suicidal individuals.

However, these programs did not have an impact on coping styles or levels of hopelessness, indicating that while they can enhance understanding and attitudes, they may not address all aspects of mental health related to suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide prevention in adolescents: a controlled study of the effectiveness of a school-based psycho-educational program. Portzky, G., van Heeringen, K.[2015]

The 'Skills to Enhance Positivity' (STEP) program, which includes both in-person and remote sessions, showed high engagement among adolescents at risk for suicide, with an 81% attendance rate and a 73.6% response rate to text messages.

In the 6 months following the intervention, only one participant attempted suicide and five were readmitted for suicidality, suggesting that STEP may effectively reduce suicidal behaviors, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skills to Enhance Positivity in Suicidal Adolescents: Results From an Open Development Trial. Yen, S., Ranney, ML., Tezanos, KM., et al.[2020]

The LINC to LIFE Safety Planning (L2L SP) training program, which lasts 150 minutes, significantly improved mental health providers' knowledge, perceived behavioral control (PBC), and intentions regarding safety planning for suicidal clients immediately after the training.

At a six-month follow-up, improvements in attitudes, PBC, and emotional responses were noted, suggesting that the training has lasting benefits, although declines in knowledge indicate a need for refresher sessions to maintain effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LINC to Life: Evaluation of a Safety Planning Training Program with Clinicians and Mental Health Staff. Bender, AM., Schuck, A., Peterson, AL., et al.[2022]

The Skills to Enhance Positivity (STEP) intervention, which includes in-person sessions and ongoing support through text messages, was well-received by adolescents, with 83% session completion and high satisfaction ratings.

Participants in the STEP program experienced significantly fewer suicide events (6) compared to those receiving enhanced treatment as usual (ETAU) (13) over a six-month follow-up, suggesting its potential effectiveness in reducing suicidal behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skills to Enhance Positivity in Suicidal Adolescents: Results from a Pilot Randomized Clinical Trial. Yen, S., Ranney, ML., Krek, M., et al.[2021]

Proactive suicide risk screening and psychoeducation have made significant strides in helping to identify at-risk youth, which is crucial since suicide is the second leading cause of death among this age group in the U.S.

While there is still limited empirical support for specific interventions targeting youth suicide risk, promising psychotherapeutic approaches are being developed, emphasizing the need for continued research and improvement in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saving Lives: Recognizing and Intervening with Youth at Risk for Suicide. Arango, A., Gipson, PY., Votta, JG., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Understanding suicide: Development and pilot evaluation of a single-session inpatient psychoeducation group. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Skills to Enhance Positivity in adolescents at risk for suicide: Protocol for a randomized controlled trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Adolescent perceptions of a suicide prevention group on an inpatient unit. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Suicide prevention in adolescents: a controlled study of the effectiveness of a school-based psycho-educational program. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Skills to Enhance Positivity in Suicidal Adolescents: Results From an Open Development Trial. [2020]

6. England pubmed.ncbi.nlm.nih.gov

LINC to Life: Evaluation of a Safety Planning Training Program with Clinicians and Mental Health Staff. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Skills to Enhance Positivity in Suicidal Adolescents: Results from a Pilot Randomized Clinical Trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Saving Lives: Recognizing and Intervening with Youth at Risk for Suicide. [2022]