Skills to Enhance Positive Affect in Suicidal Adolescents

NCT02130583 | Completed Results DMC

• 1 other identifier: R34MH101272
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Suicide, Attempted

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 month, 6 month

Secondary Outcomes (3)

• Suicide Ideation Questionnaire (SIQ)

  Baseline, 1 month Post-Treatment, 4 month Follow-Up

• Beck Depression Inventory

  Baseline, 1 month Post-Treatment, 4 month Follow-Up

• Columbia Impairment Scale Parent Version

  Base, 1 month Post-Treatment, 4 month Follow-Up

Other Outcomes (1)

• Hopelessness Scale for Children

  Baseline, 1 month Post-Treatment, 4 month Follow-Up

Study Arms (2)

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.

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.

Behavioral: Treatment as Usual

Interventions

Positive Affect Skills Training BEHAVIORAL

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

Treatment as Usual BEHAVIORAL

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

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Limitations and Caveats

This study is not powered to observe between group differences or to examine mediators (e.g., increased social support or resources, improved problem-solving). Based on the encouraging preliminary data we are planning a larger trial.

Results Point of Contact

• Title: Shirley Yen, Ph.D., Principal Investigator
• Organization: Alpert Brown Medical School

Shirley_Yen_PhD@Brown.edu

4014441915

Study Officials

• Shirley Yen, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research)

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 5, 2014
• Study Start: August 1, 2013
• Primary Completion: September 2, 2016
• Study Completion: September 2, 2016
• Last Updated: March 5, 2019
• Results First Posted: January 24, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 9/1/17
• Access Criteria: Please contact PI at 401-444-1915

Locations

US (1)