Clinical trial NCT04994873: Skills to Enhance Positivity in Suicidal Youth
Official title: Skills to Enhance Positivity in Adolescents at Risk for Suicide
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide, Attempted
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 216
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 condition randomized clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 216 participants and their families (across two sites) will be randomized to either STEP or ETAU (as described in the research strategy). Aims and hypotheses are below:

Aim 1: Examine the effectiveness of STEP in reducing suicidal events (attempt or emergency intervention to intercede attempt), active SI (with intent or plan), and depression at 6-month f/u (primary) and suicidal events at 12-month follow-up (f/u). H1: It is hypothesized that those randomized to STEP, compared to ETAU, will have lower rates of suicide events (H1A), active SI (H1B), and depression (H1C) over the 6-month follow-up period; H1D: It is hypothesized that those randomized to STEP, compared to ETAU, will have lower rates of suicidal events at the 12-month, long term f/u.

Aim 2: Examine engagement of the hypothesized mechanisms at the 3- and 6-month f/u. It is hypothesized that those randomized to STEP, compared to ETAU, will have: H2A: higher attention to positive affect, assessed by implicit tasks; H2B: higher gratitude and satisfaction with life, assessed by self-report; H2C: lower negative affect, assessed by implicit tasks and self-report.

Aim 3: Examine whether hypothesized mechanisms mediate reduction of suicidal events and ideation. H3: Changes in attention to positive affect, gratitude, satisfaction with life, and negative affect at 3-month f/u will be related to improvements in suicidal ideation and suicidal events at the 6-month f/u.

Secondary Aim Examine elements supporting external validity. Acceptability, appropriateness, and feasibility of STEP to patients, parents, clinicians, and administrators will be assessed by: 1) a survey consisting of brief, standardized measures of these items, and 2) qualitative interviews to further explore these perceptions. These findings will be used to: 1) modify STEP to address potential barriers, and 2) develop implementation strategies designed to overcome these challenges, for testing in a future Hybrid Type III effectiveness-implementation trial.

Eligibility criteria: Inclusion Criteria: Patients

* Ages 12- 60 years
* hospitalized on an inpatient psychiatric unit due to suicide risk
* past month suicide attempts or suicidal ideation
* proficient in English (parent either English or Spanish
* access to a smart phone.

Inclusion Criteria: Stakeholders

Ages 22 - 60 years

* work with adolescents hospitalized on an inpatient psychiatric unit due to suicide risk
* proficient in English or Spanish

Exclusion Criteria:

* active psychotic disorder
* significant cognitive impairment or deficits
* ward of the State
* discharge to residential facility.

Primary outcomes:
measure: Suicidal events
timeFrame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
measure: Suicidal ideation
timeFrame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
measure: Proportion of Weeks with Suicidal ideation
timeFrame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
measure: Depression
timeFrame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Secondary outcomes:
measure: Attention to positive affect
timeFrame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
measure: Implicit positive and negative affect
timeFrame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
measure: Explicit positive and negative affect
timeFrame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
measure: Gratitude
timeFrame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
measure: Satisfaction with life scale
timeFrame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital
state: Massachusetts
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Riverside
country: United States
facility: Bradley Hospital
state: Rhode Island
Study officials:
References: