Suicidal IdeationSTEPNCT02130583
Skills to Enhance Positive Affect in Suicidal Adolescents
A study testing Positive Affect Skills Training and Treatment as Usual in people with Suicidal Ideation and Suicide, Attempted, run by Brown University at 1 site in United States.
Trial summary
The prevalence of suicidal behaviors in adolescents remains unacceptably high and is a significant public health concern. The investigators propose a new treatment approach in which skills to increase positive emotions are taught to the most vulnerable at-risk adolescents, those admitted to an inpatient psychiatric… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Suicidal Ideation, Suicide, Attempted
- What is being tested?
- Positive Affect Skills Training and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 2 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- current hospital admission due to concern of suicide risk
- ability of patient to speak, read, and understand English sufficiently well to complete the procedures of the study
- living at home
Who cannot join
- active psychotic disorder
- cognitive deficits that preclude full understanding of study materials
- adolescents who have become wards of the state and do not intend to return to the home of their biological or adoptive parents
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of suicidal behaviors in adolescents remains unacceptably high and is a significant public health concern. The investigators propose a new treatment approach in which skills to increase positive emotions are taught to the most vulnerable at-risk adolescents, those admitted to an inpatient psychiatric unit due to suicide risk. The investigators believe that teaching skills to increase positive emotions will lead to better problem-solving, increased social support, and other benefits which will serve as protective factors and decrease suicide risk.
Read the detailed description
The prevalence of suicidal behaviors in adolescents remains unacceptably high. Reviews of published randomized controlled trials (RCTs) for adolescent suicidality conclude that treatments to date have been minimally efficacious. The preponderance of interventions focus on crisis intervention, underlying psychiatric disorders, regulating negative affect and reducing cognitive distortions. However, our pilot work and other recent data suggest the importance of considering how low positive affectivity contributes to suicide risk independent of other risk factors and may be another mechanism that leads to suicidal behaviors. Our model is based on Fredrickson's empirically-supported Broaden and Build model which asserts that the function of positive affect (PA) includes helping individuals thrive by improving social supports, problem-solving, and personal resilience. Each of these areas is instrumental in decreasing suicidal behavior. We propose that PA increases survival directly by decreasing suicidal ideation and indirectly by increasing social support and problem-solving. In this R34 treatment development grant we seek to develop a novel, individual skills-based, PA intervention, delivered adjunctively to treatment as usual (TAU), targeting the highest risk adolescents - those hospitalized due to suicide risk. We focus on three strategies that have been demonstrated to increase sustainable (vs. transient) PA in community and depressed adults: meditation, gratitude, and savoring. There are several ways to practice each strategy; we take into account patient preferences in a personalized approach in which patients select the practice(s) that fits best with their needs and circumstances. We propose using multiple means of intervention delivery that includes text messaging, to reinforce in-vivo practice. Our intervention, Skills To Enhance Positivity Program (STEP) includes two phases: a) in-person phase consisting of 3 individual in-person sessions and 1 joint parent session during the inpatient hospital stay to teach positive affect skills and develop a personalized intervention; b) remote delivery phase which consists of weekly telephone booster calls and daily text messages over 4 weeks post-discharge. The phone calls will be used to review or adjust personalized intervention components and reinforce use of skills. The text messages will include self-scripted reminders to practice skills and links to online resources. STEP will be tested in an open trial with 20 participants, and after further revision, in a pilot RCT, compared to TAU in a sample of 50 adolescents. The primary goal of this intervention is for patients to increase positive affect by incorporating skills and practices into their normal home-based routines, which we believe will lead to increases in problem-solving and social support and decreases in suicidal ideation. This is a novel intervention for a high-risk acute population via a different mechanism (i.e. PA), and conceptually distinct from other empirically examined theoretical approaches.
- Conditions
- Suicidal Ideation, Suicide, Attempted
- Being tested
- Positive Affect Skills Training, Treatment as Usual
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Affect Skills TrainingBehavioural
Individual sessions (3-4) delivered on the inpatient unit, focused on psycho-education regarding positive affect and mood monitoring and teaching of skills to attend to positive affect such as mindfulness, gratitude, and savoring. In-person sessions are followed by weekly phone calls and daily text messages for one month, with option to extend.
Treatment as UsualBehavioural
Participants will follow the intervention plan laid out in their discharge summary, but do not receive any individual sessions regarding positive affect. Upon discharge, they will receive generic text messages regarding healthy habits for one month, with option to extend.
| Study group | Role | What they receive |
|---|---|---|
| Positive Affect Skills Training | Experimental | Individual sessions (3-4) delivered on the inpatient unit, focused on psycho-education regarding positive affect and mood monitoring and teaching of skills to attend to positive affect such as mindfulness, gratitude, and savoring. In-person sessions are followed by weekly phone calls and daily text messages for one month, with option to extend. Receives: Behavioral: Positive Affect Skills Training |
| Treatment as Usual | Active comparator | Participants will follow the intervention plan laid out in their discharge summary, but do not receive any individual sessions regarding positive affect. Upon discharge, they will receive generic text messages regarding healthy habits for one month, with option to extend. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dot Probe Task
Dot probe tasks are administered to assess for attentional biases. The task is a computer task in which participants are presented with stimuli (e.g., words) of different valences (positive/negative/neutral) at the same time (e.g., smiling face and a neutral face), followed by a probe (*) on one side. Participants are asked to hit a key that corresponds to the correct side in which the probe appeared. The reaction time of their response is indicative of their attention to the valenced image/word. Trials are counterbalanced so that valences appear equally on each side. Faster reaction time (less milliseconds) to positive images/words indicates an attentional bias for positive stimuli. The scores reported here represent bias scores. Positive scores indicate a bias to positive stimuli, negative scores indicate a bias towards neutral stimuli.
Measured: Baseline, 1 month Post Treatment, 4 month Follow-Up
Modified Differential Emotions Scale (Positive Emotions Sub-scale)
The Modified Differential Emotions Scale is a self-report measure comprised of ratings for positive and negative affect. For example, participants are asked to rate the extent to which they feel "Content, serene, peaceful right now" on a likert scale ranging from 1 (not at all) to 5 (extremely). The scores reported are averages for the positive emotions, and thus can be interpreted as ranging from 1 (not at all) to 5 (extremely). We expected an increase in positive affect ratings following the intervention.
Measured: Base, 1 month Post-Treatment, 4 month Follow-Up
Suicide Events
Number of participants who have attempted suicide or have had emergency intervention to intercede a suicide attempt.
Measured: 1 month, 6 month
Secondary outcomes (3)
Suicide Ideation Questionnaire (SIQ)
The Suicidal Ideation Questionnaire is a 30 item self-report measure that was administered to the adolescent to ascertain the frequency of thoughts of death and suicide. Respondents are asked how often they have had these thoughts (e.g., "I thought about killing myself") in the past month ranging from "almost every day" = 1 to "I never had this thought" =7. Scores are then reversed and transformed such that higher scores indicate higher suicidal ideation, with a range of 180 (highest suicidal ideation) to 0 (no suicidal ideation).
Measured: Baseline, 1 month Post-Treatment, 4 month Follow-Up
Beck Depression Inventory
The Beck Depression Inventory is a 21 item self-report form of depression but can be and has been administered to the parent to respond about their child. This questionnaire consists of 21 groups of statements. For example, for "Sadness", respondents are asked to select between 0 ("My child does not feel sad."), 1 ("My child feels sad much of the time"), 2 ("My child is sad all the time"), and 3 ("My child is so sad or unhappy that he/she can't stand it."). Higher scores indicate higher depression with a maximum score of 63 and a minimum score of 0.
Measured: Baseline, 1 month Post-Treatment, 4 month Follow-Up
Columbia Impairment Scale Parent Version
The Columbia Impairment Scale (parent version) is a 13-item scale in which parents are asked to respond about their child's impairment in a variety of domains on a scale of 0 (no problem at all) to 4 (very bad problem). Scores are summed such that higher scored indicate higher functional impairment, with a maximum score of 52 and a minimum score of 0.
Measured: Base, 1 month Post-Treatment, 4 month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startAug 2013
- Primary completion2 Sep 2016
- Study completion2 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Yen, Brown University
- Investigators
- Shirley Yen, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130583
- Sponsor's protocol ID
- R34MH101272
- Acronym
- STEP
- Status last verified
- Feb 2019
- First submitted
- 1 May 2014
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data available upon completion of study by request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skills to Enhance Positive Affect in Suicidal Adolescents
- ClinicalTrials.gov ID
- NCT02130583
- Acronym / sponsor ID
- STEP / R34MH101272
- Conditions
- Suicidal Ideation, Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- 2 Sep 2016 (actual)
- Study completion
- 2 Sep 2016 (actual)
- First posted
- 5 May 2014 (estimated)
- Results
- Posted 24 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of suicidal behaviors in adolescents remains unacceptably high and is a significant public health concern. The investigators propose a new treatment approach in which skills to increase positive emotions are taught to the most vulnerable at-risk adolescents, those admitted to an inpatient psychiatric unit due to suicide risk. The investigators believe that teaching skills to increase positive emotions will lead to better problem-solving, increased social support, and other benefits which will serve as protective factors and decrease suicide risk.
Detailed description
The prevalence of suicidal behaviors in adolescents remains unacceptably high. Reviews of published randomized controlled trials (RCTs) for adolescent suicidality conclude that treatments to date have been minimally efficacious. The preponderance of interventions focus on crisis intervention, underlying psychiatric disorders, regulating negative affect and reducing cognitive distortions. However, our pilot work and other recent data suggest the importance of considering how low positive affectivity contributes to suicide risk independent of other risk factors and may be another mechanism that leads to suicidal behaviors. Our model is based on Fredrickson's empirically-supported Broaden and Build model which asserts that the function of positive affect (PA) includes helping individuals thrive by improving social supports, problem-solving, and personal resilience. Each of these areas is instrumental in decreasing suicidal behavior. We propose that PA increases survival directly by decreasing suicidal ideation and indirectly by increasing social support and problem-solving. In this R34 treatment development grant we seek to develop a novel, individual skills-based, PA intervention, delivered adjunctively to treatment as usual (TAU), targeting the highest risk adolescents - those hospitalized due to suicide risk. We focus on three strategies that have been demonstrated to increase sustainable (vs. transient) PA in community and depressed adults: meditation, gratitude, and savoring. There are several ways to practice each strategy; we take into account patient preferences in a personalized approach in which patients select the practice(s) that fits best with their needs and circumstances. We propose using multiple means of intervention delivery that includes text messaging, to reinforce in-vivo practice. Our intervention, Skills To Enhance Positivity Program (STEP) includes two phases: a) in-person phase consisting of 3 individual in-person sessions and 1 joint parent session during the inpatient hospital stay to teach positive affect skills and develop a personalized intervention; b) remote delivery phase which consists of weekly telephone booster calls and daily text messages over 4 weeks post-discharge. The phone calls will be used to review or adjust personalized intervention components and reinforce use of skills. The text messages will include self-scripted reminders to practice skills and links to online resources. STEP will be tested in an open trial with 20 participants, and after further revision, in a pilot RCT, compared to TAU in a sample of 50 adolescents. The primary goal of this intervention is for patients to increase positive affect by incorporating skills and practices into their normal home-based routines, which we believe will lead to increases in problem-solving and social support and decreases in suicidal ideation. This is a novel intervention for a high-risk acute population via a different mechanism (i.e. PA), and conceptually distinct from other empirically examined theoretical approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Affect Skills Training | Experimental | Behavioral: Positive Affect Skills TrainingIndividual sessions (3-4) delivered on the inpatient unit, focused on psycho-education regarding positive affect and mood monitoring and teaching of skills to attend to positive affect such as mindfulness, gratitude, and savoring. In-person sessions are followed by weekly phone calls and daily text messages for one month, with option to extend. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualParticipants will follow the intervention plan laid out in their discharge summary, but do not receive any individual sessions regarding positive affect. Upon discharge, they will receive generic text messages regarding healthy habits for one month, with option to extend. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- current hospital admission due to concern of suicide risk
- ability of patient to speak, read, and understand English sufficiently well to complete the procedures of the study
- living at home
Key exclusion criteria (3 listed)
- active psychotic disorder
- cognitive deficits that preclude full understanding of study materials
- adolescents who have become wards of the state and do not intend to return to the home of their biological or adoptive parents
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 |
|---|---|---|
| Positive Affect Skills TrainingIndividual sessions (3-4) delivered on the inpatient unit, focused on psycho-education regarding positive affect and mood monitoring and teaching of skills to attend to positive affect such as mindfulness, gratitude, and savoring. In-person sessions are followed by weekly phone calls and daily text messages for one month, with option to extend. | Behavioural | Positive Affect Skills Training |
| Treatment as UsualParticipants will follow the intervention plan laid out in their discharge summary, but do not receive any individual sessions regarding positive affect. Upon discharge, they will receive generic text messages regarding healthy habits for one month, with option to extend. | Behavioural | Treatment as Usual |
Primary outcome
Dot Probe Task
Time frame: Baseline, 1 month Post Treatment, 4 month Follow-Up
Dot probe tasks are administered to assess for attentional biases. The task is a computer task in which participants are presented with stimuli (e.g., words) of different valences (positive/negative/neutral) at the same time (e.g., smiling face and a neutral face), followed by a probe (*) on one side. Participants are asked to hit a key that corresponds to the correct side in which the probe appeared. The reaction time of their response is indicative of their attention to the valenced image/word. Trials are counterbalanced so that valences appear equally on each side. Faster reaction time (less milliseconds) to positive images/words indicates an attentional bias for positive stimuli. The scores reported here represent bias scores. Positive scores indicate a bias to positive stimuli, negative scores indicate a bias towards neutral stimuli.
Modified Differential Emotions Scale (Positive Emotions Sub-scale)
Time frame: Base, 1 month Post-Treatment, 4 month Follow-Up
The Modified Differential Emotions Scale is a self-report measure comprised of ratings for positive and negative affect. For example, participants are asked to rate the extent to which they feel "Content, serene, peaceful right now" on a likert scale ranging from 1 (not at all) to 5 (extremely). The scores reported are averages for the positive emotions, and thus can be interpreted as ranging from 1 (not at all) to 5 (extremely). We expected an increase in positive affect ratings following the intervention.
Suicide Events
Time frame: 1 month, 6 month
Number of participants who have attempted suicide or have had emergency intervention to intercede a suicide attempt.
3 secondary outcomes
Suicide Ideation Questionnaire (SIQ)
Time frame: Baseline, 1 month Post-Treatment, 4 month Follow-Up
Beck Depression Inventory
Time frame: Baseline, 1 month Post-Treatment, 4 month Follow-Up
Columbia Impairment Scale Parent Version
Time frame: Base, 1 month Post-Treatment, 4 month Follow-Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data available upon completion of study by request.
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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. This study is not recruiting at the moment.
Shirley Yen, Ph.D. principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Affect Skills Training and Treatment as Usual in people with Suicidal Ideation and Suicide, Attempted, run by Brown University 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 3 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: finished, as of the sponsor's last update on 5 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 24 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dot Probe Task (time frame: Baseline, 1 month Post Treatment, 4 month Follow-Up). The study lists 3 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 5 Mar 2019.