STEP: Skills to Enhance Positive Affect in Suicidal Adolescents

• Sponsor: Brown University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02130583
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Duration (Months): 37.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Suicidal Ideation; Suicide, Attempted	Behavioral: Positive Affect Skills Training; Behavioral: Treatment as Usual	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Skills to Enhance Positive Affect in Suicidal Adolescents
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Sep 2, 2016
• Actual Study Completion Date: Sep 2, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.	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.

Outcome Measures

Primary Outcome Measures

1. Dot Probe Task [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.

2. Modified Differential Emotions Scale (Positive Emotions Sub-scale) [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.

3. Suicide Events [1 month, 6 month]

   Number of participants who have attempted suicide or have had emergency intervention to intercede a suicide attempt.

Secondary Outcome Measures

1. Suicide Ideation Questionnaire (SIQ) [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).

2. Beck Depression Inventory [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.

3. Columbia Impairment Scale Parent Version [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.

Other Outcome Measures

1. Hopelessness Scale for Children [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Butler Hospital	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

• Brown University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shirley Yen, Associate Professor (Research), Brown University
• ClinicalTrials.gov Identifier: NCT02130583
• Other Study ID Numbers: R34MH101272
• First Posted: May 5, 2014
• Last Update Posted: Mar 5, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Suicide; Suicidal Ideation; Suicide, Attempted

Study Results

Participant Flow

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.

Arm/Group Title	Positive Affect Skills Training	Treatment as Usual
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

Baseline Characteristics

Arm/Group Title	Positive Affect Skills Training	Treatment as Usual	Total
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 Participants	26	26	52
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.69 (1.1715)	15.58 (1.206)	15.63 (1.469)
Sex/Gender, Customized (Count of 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%	1 1.9%
Sex: Female, Male (Count of Participants)
Female	18 69.2%	18 69.2%	36 69.2%
Male	8 30.8%	8 30.8%	16 30.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 23.1%	7 26.9%	13 25%
Not Hispanic or Latino	20 76.9%	19 73.1%	39 75%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Dot Probe Task
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

Outcome Measure Data

Analysis Population Description

Numbers may differ due to participant attrition and invalid profiles.

Arm/Group Title	STEP	ETAU
Arm/Group Description	Study Intervention: Skills to Enhance Positivity	Enhanced Treatment as Usual: Healthy Habits Text Messages
Measure Participants	26	26
Baseline	1.56 (18.12)	-1.65 (17.43)
Post-Treatment	-1.48 (13.85)	1.23 (18.75)
Follow-up	6.88 (34.12)	-19.8 (40.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	STEP, ETAU
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.034
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.06
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Modified Differential Emotions Scale (Positive Emotions Sub-scale)
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

Outcome Measure Data

Analysis Population Description

Some participants were lost to follow-up.

Arm/Group Title	STEP	ETAU
Arm/Group Description	Study Intervention: Skills to Enhance Positivity	Enhanced Treatment as Usual: Healthy Habits Text Messages
Measure Participants	26	26
Baseline	1.97 (0.71)	2.09 (0.71)
Post-Treatment	1.95 (0.62)	2.26 (0.97)
Follow-up	1.98 (0.82)	2.06 (0.87)

3. Primary Outcome

Title	Suicide Events
Description	Number of participants who have attempted suicide or have had emergency intervention to intercede a suicide attempt.
Time Frame	1 month, 6 month

Outcome Measure Data

Analysis Population Description

Some participants were lost to follow-up

Arm/Group Title	STEP	ETAU
Arm/Group Description	Study Intervention: Skills to Enhance Positivity	Enhanced Treatment as Usual: Healthy Habits Text Messages
Measure Participants	26	26
Post-Treatment	2 7.7%	7 26.9%
6 Month Follow Up	5 19.2%	10 38.5%

4. Secondary Outcome

Title	Suicide Ideation Questionnaire (SIQ)
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

Outcome Measure Data

Analysis Population Description

Some participants were lost to follow up.

Arm/Group Title	STEP	ETAU
Arm/Group Description	Study Intervention: Skills to Enhance Positivity	Enhanced Treatment as Usual: Healthy Habits Text Messages
Measure Participants	26	26
Baseline	100.04 (44.42)	106.00 (40.28)
Post-Treatment	51.71 (55.24)	70.96 (42.72)
Follow-up	47.81 (52.96)	43.24 (45.66)

5. Secondary Outcome

Title	Beck Depression Inventory
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

Outcome Measure Data

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
Arm/Group Description	Study Intervention: Skills to Enhance Positivity	Enhanced Treatment as Usual: Healthy Habits Text Messages
Measure Participants	24	23
Baseline	27.88 (25.79)	29.77 (8.18)
Post-treatment	11.56 (11.35)	20.70 (11.73)
Follow-Up	11.88 (10.90)	16.83 (12.66)

6. Secondary Outcome

Title	Columbia Impairment Scale Parent Version
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

Outcome Measure Data

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
Arm/Group Description	Study Intervention: Skills to Enhance Positivity	Enhanced Treatment as Usual: Healthy Habits Text Messages
Measure Participants	24	23
Baseline	25.79 (10.14)	26.68 (9.17)
Post-treatment	17.33 (10.21)	21.43 (10.59)
Follow-Up	13.82 (7.23)	19.78 (8.91)

7. Other Pre-specified Outcome

Title	Hopelessness Scale for Children
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

Outcome Measure Data

Analysis Population Description

Some participants were lost to follow up.

Arm/Group Title	STEP	ETAU
Arm/Group Description	Study Intervention: Skills to Enhance Positivity	Enhanced Treatment as Usual: Healthy Habits Text Messages
Measure Participants	26	26
Baseline	7.35 (5.26)	7.77 (5.00)
Post-Treatment	9.24 (5.96)	10.58 (4.67)
Follow-up	9.71 (5.98)	11.67 (5.69)

Adverse Events

Time Frame	1 month, 3 month, 6 months
Arm/Group Title	Positive Affect Skills Training		Treatment as Usual
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)
Serious Adverse Events
	Positive Affect Skills Training		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/26 (19.2%)		12/26 (46.2%)
Psychiatric disorders
Hospitalized for suicidal thoughts and/or behaviors	5/26 (19.2%)	6	9/26 (34.6%)	13
Hospitalized for aggressive/assaultive behaviors	0/26 (0%)	0	2/26 (7.7%)	2
Ran away from home	0/26 (0%)	0	1/26 (3.8%)	1
Other (Not Including Serious) Adverse Events
	Positive Affect Skills Training		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)

Limitations/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.

More Information

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.