Overview

This trial is active, not recruiting.

Conditions suicidal ideation, suicide, attempted
Treatments positive affect skills training, treatment as usual
Sponsor Brown University
Start date August 2013
End date November 2016
Trial size 52 participants
Trial identifier NCT02130583, R34MH101272

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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.
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)
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.
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.

Primary Outcomes

Measure
Dot probe task
time frame: Baseline, 1 month, 4 month
Affect Intensity Measure
time frame: Baseline, 1 month, 4 month
Modified Differential Emotions Scale
time frame: Base, 1 month, 4 month

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 12 years up to 18 years old.

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

Additional Information

Official title Skills to Enhance Positive Affect in Suicidal Adolescents
Principal investigator Shirley Yen, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Brown University.