Skills to Enhance Positive Affect in Suicidal Adolescents (STEP)

February 9, 2019 updated by: Shirley Yen, Brown University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Positive Affect Skills Training
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.
Behavioral: Positive Affect Skills Training
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.
ACTIVE_COMPARATOR: Treatment as Usual
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.
Behavioral: Treatment as Usual
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month Post Treatment, 4 month Follow-Up
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.
Base, 1 month Post-Treatment, 4 month Follow-Up
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.
1 month, 6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Suicide Ideation Questionnaire (SIQ)
Time Frame: Baseline, 1 month Post-Treatment, 4 month Follow-Up
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).
Baseline, 1 month Post-Treatment, 4 month Follow-Up
Beck Depression Inventory
Time Frame: Baseline, 1 month Post-Treatment, 4 month Follow-Up
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.
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
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.
Base, 1 month Post-Treatment, 4 month Follow-Up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hopelessness Scale for Children
Time Frame: Baseline, 1 month Post-Treatment, 4 month Follow-Up
The Hopelessness Scale for Children is a 17 item self-report scale with statements (e.g., I want to grow up because I think things will be better) that are rated as either True or False. Some statements are reverse coded. Higher scores indicate higher hopelessness, with a maximum score of 17 and a minimum score of 0.
Baseline, 1 month Post-Treatment, 4 month Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34MH101272 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data available upon completion of study by request.

IPD Sharing Time Frame

9/1/17

IPD Sharing Access Criteria

Please contact PI at 401-444-1915

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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