Trial Outcomes & Findings for Skills to Enhance Positive Affect in Suicidal Adolescents (NCT NCT02130583)
NCT ID: NCT02130583
Last Updated: 2019-03-05
Results Overview
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.
COMPLETED
NA
52 participants
Baseline, 1 month Post Treatment, 4 month Follow-Up
2019-03-05
Participant Flow
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.
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Skills to Enhance Positive Affect in Suicidal Adolescents
Baseline characteristics by cohort
| Measure |
Positive Affect Skills Training
n=26 Participants
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.
|
Treatment as Usual
n=26 Participants
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
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.69 years
STANDARD_DEVIATION 1.1715 • n=5 Participants
|
15.58 years
STANDARD_DEVIATION 1.206 • n=7 Participants
|
15.63 years
STANDARD_DEVIATION 1.469 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month Post Treatment, 4 month Follow-UpPopulation: Numbers may differ due to participant attrition and invalid profiles.
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.
Outcome measures
| Measure |
STEP
n=26 Participants
Study Intervention: Skills to Enhance Positivity
|
ETAU
n=26 Participants
Enhanced Treatment as Usual: Healthy Habits Text Messages
|
|---|---|---|
|
Dot Probe Task
Baseline
|
1.56 milliseconds
Standard Deviation 18.12
|
-1.65 milliseconds
Standard Deviation 17.43
|
|
Dot Probe Task
Post-Treatment
|
-1.48 milliseconds
Standard Deviation 13.85
|
1.23 milliseconds
Standard Deviation 18.75
|
|
Dot Probe Task
Follow-up
|
6.88 milliseconds
Standard Deviation 34.12
|
-19.8 milliseconds
Standard Deviation 40.36
|
PRIMARY outcome
Timeframe: Base, 1 month Post-Treatment, 4 month Follow-UpPopulation: Some participants were lost to 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.
Outcome measures
| Measure |
STEP
n=26 Participants
Study Intervention: Skills to Enhance Positivity
|
ETAU
n=26 Participants
Enhanced Treatment as Usual: Healthy Habits Text Messages
|
|---|---|---|
|
Modified Differential Emotions Scale (Positive Emotions Sub-scale)
Baseline
|
1.97 units on a scale
Standard Deviation 0.71
|
2.09 units on a scale
Standard Deviation 0.71
|
|
Modified Differential Emotions Scale (Positive Emotions Sub-scale)
Post-Treatment
|
1.95 units on a scale
Standard Deviation 0.62
|
2.26 units on a scale
Standard Deviation 0.97
|
|
Modified Differential Emotions Scale (Positive Emotions Sub-scale)
Follow-up
|
1.98 units on a scale
Standard Deviation 0.82
|
2.06 units on a scale
Standard Deviation 0.87
|
PRIMARY outcome
Timeframe: 1 month, 6 monthPopulation: Some participants were lost to follow-up
Number of participants who have attempted suicide or have had emergency intervention to intercede a suicide attempt.
Outcome measures
| Measure |
STEP
n=26 Participants
Study Intervention: Skills to Enhance Positivity
|
ETAU
n=26 Participants
Enhanced Treatment as Usual: Healthy Habits Text Messages
|
|---|---|---|
|
Suicide Events
6 Month Follow Up
|
5 Participants
|
10 Participants
|
|
Suicide Events
Post-Treatment
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1 month Post-Treatment, 4 month Follow-UpPopulation: Some participants were lost to 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).
Outcome measures
| Measure |
STEP
n=26 Participants
Study Intervention: Skills to Enhance Positivity
|
ETAU
n=26 Participants
Enhanced Treatment as Usual: Healthy Habits Text Messages
|
|---|---|---|
|
Suicide Ideation Questionnaire (SIQ)
Baseline
|
100.04 units on a scale
Standard Deviation 44.42
|
106.00 units on a scale
Standard Deviation 40.28
|
|
Suicide Ideation Questionnaire (SIQ)
Post-Treatment
|
51.71 units on a scale
Standard Deviation 55.24
|
70.96 units on a scale
Standard Deviation 42.72
|
|
Suicide Ideation Questionnaire (SIQ)
Follow-up
|
47.81 units on a scale
Standard Deviation 52.96
|
43.24 units on a scale
Standard Deviation 45.66
|
SECONDARY outcome
Timeframe: Baseline, 1 month Post-Treatment, 4 month Follow-UpPopulation: Some participants' parents did not participate (e.g. if teen was = 18 y/o); Also, some parents were lost to 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.
Outcome measures
| Measure |
STEP
n=24 Participants
Study Intervention: Skills to Enhance Positivity
|
ETAU
n=23 Participants
Enhanced Treatment as Usual: Healthy Habits Text Messages
|
|---|---|---|
|
Beck Depression Inventory
Baseline
|
27.88 units on a scale
Standard Deviation 25.79
|
29.77 units on a scale
Standard Deviation 8.18
|
|
Beck Depression Inventory
Post-treatment
|
11.56 units on a scale
Standard Deviation 11.35
|
20.70 units on a scale
Standard Deviation 11.73
|
|
Beck Depression Inventory
Follow-Up
|
11.88 units on a scale
Standard Deviation 10.90
|
16.83 units on a scale
Standard Deviation 12.66
|
SECONDARY outcome
Timeframe: Base, 1 month Post-Treatment, 4 month Follow-UpPopulation: Some participants' parents did not participate (e.g. if teen was = 18 y/o); Also, some parents were lost to 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.
Outcome measures
| Measure |
STEP
n=24 Participants
Study Intervention: Skills to Enhance Positivity
|
ETAU
n=23 Participants
Enhanced Treatment as Usual: Healthy Habits Text Messages
|
|---|---|---|
|
Columbia Impairment Scale Parent Version
Baseline
|
25.79 units on a scale
Standard Deviation 10.14
|
26.68 units on a scale
Standard Deviation 9.17
|
|
Columbia Impairment Scale Parent Version
Post-treatment
|
17.33 units on a scale
Standard Deviation 10.21
|
21.43 units on a scale
Standard Deviation 10.59
|
|
Columbia Impairment Scale Parent Version
Follow-Up
|
13.82 units on a scale
Standard Deviation 7.23
|
19.78 units on a scale
Standard Deviation 8.91
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 month Post-Treatment, 4 month Follow-UpPopulation: Some participants were lost to 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.
Outcome measures
| Measure |
STEP
n=26 Participants
Study Intervention: Skills to Enhance Positivity
|
ETAU
n=26 Participants
Enhanced Treatment as Usual: Healthy Habits Text Messages
|
|---|---|---|
|
Hopelessness Scale for Children
Baseline
|
7.35 units on a scale
Standard Deviation 5.26
|
7.77 units on a scale
Standard Deviation 5.00
|
|
Hopelessness Scale for Children
Post-Treatment
|
9.24 units on a scale
Standard Deviation 5.96
|
10.58 units on a scale
Standard Deviation 4.67
|
|
Hopelessness Scale for Children
Follow-up
|
9.71 units on a scale
Standard Deviation 5.98
|
11.67 units on a scale
Standard Deviation 5.69
|
Adverse Events
Positive Affect Skills Training
Treatment as Usual
Serious adverse events
| Measure |
Positive Affect Skills Training
n=26 participants at risk
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.
|
Treatment as Usual
n=26 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Hospitalized for suicidal thoughts and/or behaviors
|
19.2%
5/26 • Number of events 6 • 1 month, 3 month, 6 months
|
34.6%
9/26 • Number of events 13 • 1 month, 3 month, 6 months
|
|
Psychiatric disorders
Hospitalized for aggressive/assaultive behaviors
|
0.00%
0/26 • 1 month, 3 month, 6 months
|
7.7%
2/26 • Number of events 2 • 1 month, 3 month, 6 months
|
|
Psychiatric disorders
Ran away from home
|
0.00%
0/26 • 1 month, 3 month, 6 months
|
3.8%
1/26 • Number of events 1 • 1 month, 3 month, 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Shirley Yen, Ph.D., Principal Investigator
Alpert Brown Medical School
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place