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Skills to Enhance Positive Affect in Suicidal Adolescents (STEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Shirley Yen, Brown University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Suicidal Ideation
Suicide, Attempted
Interventions Behavioral: Positive Affect Skills Training
Behavioral: Treatment as Usual
Enrollment 52
Recruitment Details Participants in this study were adolescents who were hospitalized at a psychiatric hospital in Rhode Island due to concern of suicide risk. The last participant completed the study procedures in September 2016.
Pre-assignment Details  
Arm/Group Title Positive Affect Skills Training Treatment as Usual
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 26 26
Completed 17 19
Not Completed 9 7
Arm/Group Title Positive Affect Skills Training Treatment as Usual Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 26 26 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 26 participants 52 participants
15.69  (1.1715) 15.58  (1.206) 15.63  (1.469)
Sex/Gender, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Female
15
  57.7%
17
  65.4%
32
  61.5%
Male
10
  38.5%
9
  34.6%
19
  36.5%
Other
1
   3.8%
0
   0.0%
1
   1.9%
[1]
Measure Description: Self-identified gender
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Female
18
  69.2%
18
  69.2%
36
  69.2%
Male
8
  30.8%
8
  30.8%
16
  30.8%
[1]
Measure Description: Biological Sex
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Hispanic or Latino
6
  23.1%
7
  26.9%
13
  25.0%
Not Hispanic or Latino
20
  76.9%
19
  73.1%
39
  75.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Dot Probe Task
Hide Description 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.
Time Frame Baseline, 1 month Post Treatment, 4 month Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Numbers may differ due to participant attrition and invalid profiles.
Arm/Group Title STEP ETAU
Hide Arm/Group Description:
Study Intervention: Skills to Enhance Positivity
Enhanced Treatment as Usual: Healthy Habits Text Messages
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: milliseconds
Baseline Number Analyzed 26 participants 25 participants
1.56  (18.12) -1.65  (17.43)
Post-Treatment Number Analyzed 20 participants 22 participants
-1.48  (13.85) 1.23  (18.75)
Follow-up Number Analyzed 16 participants 20 participants
6.88  (34.12) -19.8  (40.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STEP, ETAU
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .034
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.06
Estimation Comments [Not Specified]
2.Primary Outcome
Title Modified Differential Emotions Scale (Positive Emotions Sub-scale)
Hide Description 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.
Time Frame Base, 1 month Post-Treatment, 4 month Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were lost to follow-up.
Arm/Group Title STEP ETAU
Hide Arm/Group Description:
Study Intervention: Skills to Enhance Positivity
Enhanced Treatment as Usual: Healthy Habits Text Messages
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 26 participants 26 participants
1.97  (0.71) 2.09  (0.71)
Post-Treatment Number Analyzed 21 participants 24 participants
1.95  (0.62) 2.26  (0.97)
Follow-up Number Analyzed 21 participants 21 participants
1.98  (0.82) 2.06  (0.87)
3.Primary Outcome
Title Suicide Events
Hide Description Number of participants who have attempted suicide or have had emergency intervention to intercede a suicide attempt.
Time Frame 1 month, 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were lost to follow-up
Arm/Group Title STEP ETAU
Hide Arm/Group Description:
Study Intervention: Skills to Enhance Positivity
Enhanced Treatment as Usual: Healthy Habits Text Messages
Overall Number of Participants Analyzed 26 26
Measure Type: Count of Participants
Unit of Measure: Participants
Post-Treatment Number Analyzed 21 participants 24 participants
2
   9.5%
7
  29.2%
6 Month Follow Up Number Analyzed 17 participants 12 participants
5
  29.4%
10
  83.3%
4.Secondary Outcome
Title Suicide Ideation Questionnaire (SIQ)
Hide Description 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).
Time Frame Baseline, 1 month Post-Treatment, 4 month Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were lost to follow up.
Arm/Group Title STEP ETAU
Hide Arm/Group Description:
Study Intervention: Skills to Enhance Positivity
Enhanced Treatment as Usual: Healthy Habits Text Messages
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 26 participants 26 participants
100.04  (44.42) 106.00  (40.28)
Post-Treatment Number Analyzed 21 participants 24 participants
51.71  (55.24) 70.96  (42.72)
Follow-up Number Analyzed 21 participants 21 participants
47.81  (52.96) 43.24  (45.66)
5.Secondary Outcome
Title Beck Depression Inventory
Hide Description 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.
Time Frame Baseline, 1 month Post-Treatment, 4 month Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants' parents did not participate (e.g. if teen was = 18 y/o); Also, some parents were lost to follow-up.
Arm/Group Title STEP ETAU
Hide Arm/Group Description:
Study Intervention: Skills to Enhance Positivity
Enhanced Treatment as Usual: Healthy Habits Text Messages
Overall Number of Participants Analyzed 24 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 24 participants 22 participants
27.88  (25.79) 29.77  (8.18)
Post-treatment Number Analyzed 21 participants 23 participants
11.56  (11.35) 20.70  (11.73)
Follow-Up Number Analyzed 17 participants 18 participants
11.88  (10.90) 16.83  (12.66)
6.Secondary Outcome
Title Columbia Impairment Scale Parent Version
Hide Description 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.
Time Frame Base, 1 month Post-Treatment, 4 month Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants' parents did not participate (e.g. if teen was = 18 y/o); Also, some parents were lost to follow-up.
Arm/Group Title STEP ETAU
Hide Arm/Group Description:
Study Intervention: Skills to Enhance Positivity
Enhanced Treatment as Usual: Healthy Habits Text Messages
Overall Number of Participants Analyzed 24 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 24 participants 22 participants
25.79  (10.14) 26.68  (9.17)
Post-treatment Number Analyzed 21 participants 23 participants
17.33  (10.21) 21.43  (10.59)
Follow-Up Number Analyzed 17 participants 18 participants
13.82  (7.23) 19.78  (8.91)
7.Other Pre-specified Outcome
Title Hopelessness Scale for Children
Hide Description 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.
Time Frame Baseline, 1 month Post-Treatment, 4 month Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were lost to follow up.
Arm/Group Title STEP ETAU
Hide Arm/Group Description:
Study Intervention: Skills to Enhance Positivity
Enhanced Treatment as Usual: Healthy Habits Text Messages
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 26 participants 26 participants
7.35  (5.26) 7.77  (5.00)
Post-Treatment Number Analyzed 21 participants 24 participants
9.24  (5.96) 10.58  (4.67)
Follow-up Number Analyzed 21 participants 21 participants
9.71  (5.98) 11.67  (5.69)
Time Frame 1 month, 3 month, 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Positive Affect Skills Training Treatment as Usual
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Positive Affect Skills Training Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)      0/26 (0.00%)    
Hide Serious Adverse Events
Positive Affect Skills Training Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/26 (19.23%)      12/26 (46.15%)    
Psychiatric disorders     
Hospitalized for suicidal thoughts and/or behaviors   5/26 (19.23%)  6 9/26 (34.62%)  13
Hospitalized for aggressive/assaultive behaviors   0/26 (0.00%)  0 2/26 (7.69%)  2
Ran away from home   0/26 (0.00%)  0 1/26 (3.85%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Positive Affect Skills Training Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/26 (0.00%)    
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shirley Yen, Ph.D., Principal Investigator
Organization: Alpert Brown Medical School
Phone: 4014441915
EMail: Shirley_Yen_PhD@Brown.edu
Layout table for additonal information
Responsible Party: Shirley Yen, Brown University
ClinicalTrials.gov Identifier: NCT02130583    
Other Study ID Numbers: R34MH101272 ( U.S. NIH Grant/Contract )
First Submitted: May 1, 2014
First Posted: May 5, 2014
Results First Submitted: May 25, 2018
Results First Posted: January 24, 2019
Last Update Posted: March 5, 2019