Skills to Enhance Positive Affect in Suicidal Adolescents (STEP)

• ClinicalTrials.gov Identifier: NCT02130583
• Recruitment Status: Completed
• First Posted: May 5, 2014
• Results First Posted: January 24, 2019
• Last Update Posted: March 5, 2019
• Sponsor: Brown University
• Information provided by (Responsible Party): Shirley Yen, Brown University

Tracking Information

• First Submitted Date: May 1, 2014
• First Posted Date: May 5, 2014
• Results First Submitted Date: May 25, 2018
• Results First Posted Date: January 24, 2019
• Last Update Posted Date: March 5, 2019
• Study Start Date: August 2013
• Actual Primary Completion Date: September 2, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 15, 2019)

• 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.

Original Primary Outcome Measures (submitted: May 2, 2014)

• Dot Probe Task [ Time Frame: Baseline, 1 month, 4 month ]
  Facial and word dot probe tasks are administered to assess for attentional biases. We expect a change in the bias scores, favoring positive affect, after the intervention.
• Affect Intensity Measure [ Time Frame: Baseline, 1 month, 4 month ]
  We expect a change in the positive affect subscale of the Affect Intensity Measure (AIM).
• Modified Differential Emotions Scale [ Time Frame: Base, 1 month, 4 month ]
  This scale is comprised of ratings for positive and negative affect. We expect an increase in positive affect ratings following the intervention.

Current Secondary Outcome Measures (submitted: January 15, 2019)

• 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).
• 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.
• 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.

Original Secondary Outcome Measures (submitted: May 2, 2014)

• Suicide Ideation Questionnaire (SIQ) [ Time Frame: Baseline, 1 month, 3 month ]
• Beck Depression Inventory [ Time Frame: Baseline, 1 month, 3 month ]
• Beck Hopelessness Scale [ Time Frame: Baseline, 1 month, 3 month ]

Current Other Pre-specified Outcome Measures (submitted: January 15, 2019)

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.

Original Other Pre-specified Outcome Measures (submitted: May 2, 2014)

• Problem Solving Inventory [ Time Frame: Baseline, 1 month, 4 month ]
• Multidimensional Scale of Perceived Social Support [ Time Frame: Baseline, 1 month, 4 month ]
• Social Support Questionnaire - Short Form [ Time Frame: Baseline, 1 month, 4 month ]

Descriptive Information

• Brief Title: Skills to Enhance Positive Affect in Suicidal Adolescents
• Official Title: Skills to Enhance Positive Affect in Suicidal Adolescents
• Brief 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 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Suicidal Ideation
• Suicide, Attempted

Intervention

• 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.
• 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.

Study Arms

• 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.
  Intervention: Behavioral: Positive Affect Skills Training
• 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.
  Intervention: Behavioral: Treatment as Usual

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 29, 2016): 52
• Original Estimated Enrollment (submitted: May 2, 2014): 70
• Actual Study Completion Date: September 2, 2016
• Actual Primary Completion Date: September 2, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02130583
• Other Study ID Numbers: R34MH101272( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Data available upon completion of study by request.
• Supporting Materials: Study Protocol
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: 9/1/17
• Access Criteria: Please contact PI at 401-444-1915

• Responsible Party: Shirley Yen, Brown University
• Study Sponsor: Brown University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Shirley Yen, Ph.D.; Brown University

• PRS Account: Brown University
• Verification Date: February 2019