Skills to Enhance Positivity in Suicidal Youth
ConditionSuicide, Attempted
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-60
SponsorBrown University
About 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 does not accept healthy volunteersQualifiers
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
Disqualifiers
active psychotic disorder
significant cognitive impairment or deficits
ward of the State
discharge to residential facility.
Trial design
Design model
Parallel
Treatments tested in this trial
STEP
BehavioralBehavioral intervention to increase positive affect
Enhanced TAU
BehavioralStandard care plus a phone app with a personalized safety plan
Treatment groups
216 Participants
are divided into 2 treatment groupsGroup A: STEP: Positivity skill enhancementExperimental treatment 1 intervention
Group B: Enhanced TAUActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Suicidal events
Composite variable of either a suicide attempt or emergency intervention to intercede when suicidal behavior may be imminent; Will be obtained from clinical interviews (C-SSRS; CASA) with the participant and parent(s).
Time frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up2
Suicidal ideation
Suicide Ideation (SI) will be operationalized as proportion of participants with active SI as assessed by the Columbia Suicide Severity Rating Scale interview: 5 items on suicidal ideation rated yes or no
Time frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up3
Proportion of Weeks with Suicidal ideation
The proportion of weeks during follow-up with active suicidal ideation as assessed by the Adolescent version of the Longitudinal Interview for Follow-Up Events (A-LIFE) scale (interview based assessment), with the participant.
Time frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up4
Depression
Depressive symptom severity will be assessed using the Beck Depression Inventory II (BDI-II). The BDI-II will be administered to the adolescent participant and their parent (reporting on the adolescent participant) with scores ranging from 0 to 63 with higher scores reflecting greater depression.
Time frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-upSecondary outcomes
1
Attention to positive affect
Using eye tracking we will measure fixation and overall gaze duration during a dot probe task using emotional and neutral words to determine whether there is a change in attention to positive affect (participant only).
Time frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up2
Implicit positive and negative affect
Implicit positive affect will be assessed using the Implicit Positive and Negative Affect Test (IPANAT), which is an indirect assessment of automatic activation of affective representations that utilizes artificial words paired with positive and negative words (participant only).
Time frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up3
Explicit positive and negative affect
Explicit positive affect will be assessed using the Modified Differential Emotions Scale (mDES) which is a 20 item short term self-report of positive and negative emotions administered to the participant only. There are 10 items in the positive affect and 10 items in the negative affect subscales with scores ranging from 0 to 30 for each subscale with higher scores reflecting higher affect.
Time frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up4
Gratitude
Gratitude will be assessed with the 6 item Gratitude Scale, administered to the participant only. Scores range from 6 to 42 with higher scores indicating greater gratitude.
Time frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-upSponsors and contacts
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Source ClinicalTrials.gov