As Safe As Possible (ASAP): A Balanced, Two-by-Two Design To Test Conjoint and Unique Efficacy of an Inpatient Intervention and an Emotion Regulation/Safety Planning App in Preventing Suicide Attempts Post-Discharge
Phase: NA
Conditions: Suicidal Ideation, Suicide, Attempted
Sponsor: University of Texas Southwestern Medical Center

STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
 
Official title: As Safe As Possible (ASAP): A BALANCED, 2X2 DESIGN 
TO TEST CONJOINT AND UNIQUE EFFICACY OF AN INPATIENT 
INTERVENTION AND AN EMOTION REGULATION/SAFETY PLANNING 
APP IN PREVENTING SUICIDE ATTEMPTS POST-DISCHARGE. 
 
NCT number: NCT03825588 
IRB approved date: 10-01-21 

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As Safe As Possible (ASAP): A BALANCED, 2X2 DESIGN TO TEST CONJOINT AND UNIQUE 
EFFICACY OF AN INPATIENT INTERVENTION AND AN EMOTION REGULATION/SAFETY 
PLANNING APP IN PREVENTING SUICIDE ATTEMPTS POST-DISCHARGE. 
 
Abstract 
Aims: One of the highest risk periods for suicidal behavior is in the first 6 months after discharge from 
psychiatric hospital. In this 2-site study (University of Texas Southwestern Medical Center; UTSW and 
Western Psychiatric Institute and Clinic; WPIC), we propose to conduct a randomized clinical trial 
(RCT) in  250 hospitalized suicidal adolescents, examining the single and additive effects of two 
components of an inpatient unit intervention for suicidal adolescents, As Safe As Possible (ASAP), 
which focuses on emotion regulation and safety planning, and an emotion regulation/safety plan phone 
app (BRITE).   In a recently completed pilot RCT of 65 suicidal adolescent inpatients, ASAP + BRITE 
reduced the hazard of suicide attempts over the subsequent 6 months compared to treatment as usual 
(AU) substantially (adjusted HR=0.22, p=0.03), especially in youth with a previous history of a suicide 
attempt (HR=0.12, p<.05). Methods:  We will randomize 250 hospitalized suicidal adolescents with a 
history of a suicide attempt or ideation with plan to one of 4 conditions in a 2 by 2 design: (1) ASAP + 
BRITE + TAU; (2) BRITE + TAU; (3) ASAP + TAU; or (4) TAU alone to determine the single and 
additive effects of ASAP and BRITE on suicide attempts in the subsequent six months. Expected 
Outcomes:  We hypothesize that ASAP and BRITE will each effectively reduce suicide risk post-
discharge compared to TAU and that the combination will be superior and more cost effective relative 
to each individual intervention as well as to TAU.  
Project Description 
I. SPECIFIC AIMS/HYPOTHESES  
The transition from inpatient to outpatient care is a time of extremely high risk for suicidal behavior and 
suicide and accounts for a significant proportion of suicides that occur while patients are in mental 
health care (Appleby, Dennehy, Thomas, Faragher, & Lewis, 1999; Appleby, Shaw, et al., 1999). There 
are currently no established interventions for suicidal teens transitioning from inpatient to outpatient 
care. By implementing a treatment that can be delivered on an inpatient unit prior to the transition to 
outpatient treatment, we anticipate being able to lower suicidal risk during this critical high-risk period, 
which can contribute to reversing the more than decade-long increase in adolescent suicide (Curtin, 
Warner, & Hedegaard, 2016). To address this issue, we developed brief, 3-hour intervention for 
adolescents who were psychiatrically hospitalized for suicide risk, termed ASAP (As Safe As Possible). 
ASAP focuses on the development of a safety plan, teaching emotion regulation and distress tolerance 
skills, along with 1-2 post-discharge follow-up calls to encourage adherence to use of the safety plan 
and to outpatient treatment. ASAP was supplemented by a smartphone app (BRITE) that supported 
daily emotion regulation and a safety plan that was personalized to the needs and preferences of each 
adolescent.  We conducted a two-site clinical trial in 65 psychiatrically hospitalized suicidal adolescents, 
randomized to ASAP + BRITE + TAU or treatment as usual (TAU) alone. ASAP showed a reduced 
hazard for post-discharge suicide attempt over the subsequent six months (adjusted hazard ratio (HR) 
= 0.22, p=0.03), and ASAP effects were even stronger in those participants (n=52, 80%) who had a 
history of a suicide attempt (HR=0.12; p=0.04). BRITE appears to contribute to this effect, insofar as 
declines in suicidal ideation and emotion dysregulation, and, increases in reasons for living, were 
proportional to the frequency of use of the app(r’s=0.37). We believe that ASAP and BRITE have the 
potential to be widely disseminated because: (1) 64% of eligible participants enrolled in the study; (2) 
the interventions are brief and inexpensive; and (3) patients and families gave very positive feedback 
with regard to both ASAP and BRITE.   

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In order to identify the most cost-effective component of this intervention, we propose to build on our 
pilot work by: (1) recruiting a larger, more demographically diverse sample to replicate these findings; 
(2) disaggregating the effects of ASAP and BRITE through the use of a 2 by 2 design; (3) testing for 
mediators of treatment outcome; and (4) determining which treatment arm is most cost-effective, and 
therefore most likely to be acceptable to payers and providers.  
Therefore, we aim to randomize 250 adolescents hospitalized, either in a psychiatric unit or a medical 
unit for a suicide attempt, to one of four treatment arms: (1) ASAP + BRITE + TAU; (2) BRITE + TAU; 
(3) ASAP + TAU; and (4) TAU alone and assess suicidal ideation and behavior at 1, 3, and 6 months 
post-intake, in order to: 
1. Assess the relative efficacy of ASAP, BRITE and the combination on suicidal ideation, non-suicidal 
self-injury (NSSI), and suicide attempts, and re-hospitalizations. 
H1: Both ASAP and BRITE will be superior to TAU alone, and ASAP + BRITE + TAU will be superior to 
BRITE or ASAP alone. 
2. Examine mediators and moderators of treatment outcome 
H2: The effects of ASAP and BRITE will be mediated by increases in reasons for living, decreases in 
dysfunctional emotional regulation, increases in functional emotional regulation, and decreases in 
implicit associations with death, and will be moderated by previous history of an attempt, and family 
engagement in treatment. In addition, the impact of BRITE will be proportional to the frequency of use. 
3. To examine the costs and cost efficacy of ASAP and BRITE and the combination. 
H3: Both ASAP and BRITE will be more cost-effective than TAU, and the combination of ASAP and 
BRITE will be more cost-effective than either individual component alone. 
 
II. BACKGROUND AND SIGNIFICANCE 
Background. Adolescent suicidal behavior is common, with more than 2,000,000 adolescents 
presenting to emergency departments (EDs) each year with suicidal behavior. Nearly 7% of 
adolescents in any one year make a suicide attempt, and an equal number have clinically significant 
suicidal ideation with a plan (Lewinsohn, Rohde, & Seeley, 1996). Suicide is the 2nd leading cause of 
death among 12-17 year olds, and suicidal behavior is associated with functional impairment and 
significant costs to the health care system, other service systems, and families (Centers for Disease 
Control and Prevention, 2010; Curtin et al., 2016; Florence, Haegerich, Simon, Zhou, & Luo, 2015; 
Shepard, Gurewich, Lwin, Reed, & Silverman, 2015). Short-term costs include costs of medical care for 
youth with suicide attempts, lost productivity for youth who die, and costs to families such as lost 
productivity for family members caring for youth in crisis.  While Healthy People 2020 has as its 
objective to reduce suicide and suicide attempts in adolescents, trends for more than a decade have 
shown an increase in teen suicide (Curtin et al., 2016). 
Focus early in treatment. In clinical populations, one of  the times of greatest risk for recurrent suicidal 
behavior and completed suicide is during transition of care (transition between inpatient and outpatient 
care; prior to or at the onset of outpatient care), and quality improvements in this window of time have 
been shown to decrease the suicide rate in adults (Appleby, Dennehy, et al., 1999; Appleby, Shaw, et 
al., 1999; While, et al., 2012). The window of greatest risk is in the 1-4 weeks after the initial suicide 
attempt, with 25-50% of all suicidal events (defined as a suicide attempt or an increase in suicidal 
ideation) occurred within the first 4 weeks of treatment (Brent, Greenhill, et al., 2009; Vitiello, Silva et 
al., 2009; Wilkinson, Kelvin, Roberts, Dubicka, & Goodyer, 2011). Thus, providing a brief, targeted 
intervention prior to discharge that protects against acting on suicidal urges in early outpatient 

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treatment could make a substantial contribution towards reducing the incidence of youth suicidal 
behavior.  
Early-onset of suicide event, even in high-quality treatment of suicidal ideation.  In clinical studies 
of adolescents with treatment resistant depression, in which participants received close monitoring and 
either medication management alone, or in combination with CBT, the rate of suicidal events was 28% 
in the first 12 weeks of treatment, with a median time to event of 3 weeks (Brent, Emslie, et al., 2009). 
In an open trial of a CBT intervention especially designed to reduce suicide attempts in depressed 
adolescent suicide attempters, 40% of all suicidal events took place within the first 3 weeks of treatment 
(Brent, Greenhill, et al., 2009).  Moreover, one of the most potent predictors of an eventual attempt or 
suicidal event is high baseline suicidal ideation (Brent, Emslie, et al., 2009; Brent, Greenhill, et al., 
2009; Vitiello, Silva, et al., 2009; Wilkinson et al., 2011). In community samples, 56% and 29% of 
adolescents with suicidal ideation with or without a plan, respectively, will make a suicide attempt within 
a year of assessment (Nock et al., 2013).  
Safety Planning. The safety plan, a structured set of coping strategies that a suicidal individual can 
deploy to de-escalate suicidal risk in the face of suicidal urges or identified precursors thereof (e.g., 
anger, sadness) is considered best practice for the management of high risk patients. The plan, 
developed with a mental health clinician, consists of: (1) activities the suicidal individual can do 
independently or alone (e.g. distraction, deep breathing); (2) reaching out to supportive individuals; and 
(3) finally, seeking clinical attention (Samra & Bilsker, 2007; Stanley et al., 2009). A safety plan is 
developed in the context of treatment, in which a chain analysis of the events leading up to the suicidal 
episode is conducted, a more comprehensive treatment plan to reduce suicidal risk is developed, and 
motivational techniques are deployed to enhance use of the safety plan and follow-up with treatment.  
While safety plans have become a mainstay of clinical care, methods to facilitate their implementation 
have not yet been critically evaluated, nor has the efficacy of safety plans in preventing future suicidal 
acts been carefully evaluated (Knox et al., 2012). In order for a youth in crisis to deploy his or her safety 
plan, the plan has to be accessible. Youth at high risk for suicide who are being treated for suicidality 
may have a written safety plan as part of their treatment; however, this plan may not always be 
accessible when they experience suicidal urges. Therefore, identifying an alternative mechanism to 
increase accessibility and utility of safety plans could be quite helpful. 
A precursor of the modern safety plan was developed by Rotheram-Borus and Bradley (1991), in which 
youth in a shelter for homeless runaways were taught a 5-step program for coping with suicidal 
ideation: 1. Identify 3 positive compliments about self; 2. Identify 3 people to go to for support; 3. Learn 
how to monitor and regulate emotion using an “emotion thermometer” in order to cope with suicidal 
urges; 4. Develop a concrete alternative to acting on suicidal impulses; and 5. Make a commitment to 
refrain from engaging in suicidal behavior.  The number of suicide attempts in these shelters prior to 
implementation of the program was 9 in the previous 3 months, compared to 2 in the subsequent 18 
months, which, when corrected for the period of observation, is a 27-fold decrease in the incidence of 
suicide attempts (assuming a similar number of youth in both conditions). This suggests that a brief 
intervention using emotion regulation techniques and mobilization of social support to cope with suicidal 
urges can be effective in reducing the probability that an adolescent will act on his or her suicidal 
ideation. However, to our knowledge, other than this study, the efficacy of safety planning has never 
been critically evaluated, particularly in adolescents. 
ASAP is designed to target known protective and risk factors for suicidal behavior, namely reasons for 
living (Bagge, Lamis, Nardoff, & Osman, 2013; Bakhiyi, Calati, Guillaume, & Courtet, 2016) and 
adaptive emotion regulation (Zlotnick, Donaldson, Spirito, & Pearlstein,1997; Polanco-Roman, Jurska, 
Quinones, & Miranda, 2014), and to decrease the frequency of maladaptive emotion regulation. We 

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found that ASAP + BRITE + TAU, compared to TAU, increased reasons for living and adaptive emotion 
regulation, and decreased dysfunctional emotion regulation, as described in more detail below. 
Utilizing technology for improving distress tolerance and safety planning. Approximately 73% of 
American youth have or have access to smart phones (Lenhart, 2015). Close to 80% of homes have 
internet access, and for 21% of teens (up to 44% of minority teens), a cell phone is the teen’s sole 
means of access to the Internet (Lenhart, 2010). Consequently, use of technology in this population to 
extend treatment is logical and timely.  There are no empirically tested phone apps for safety planning, 
especially for teens, but there is a randomized trial to evaluate a safety planning app in adults currently 
underway (Andreasson et al., 2017). While there are cell phone applications related to safety planning 
in adults with suicidal behavior (Emory News, 2013; De la Torre, Castillo, Arambarri, Lopez-Coronado, 
& Franco, 2017; Larsen, Nicholas, & Christensen, 2016; Stanley & Brown, 2012;). We propose to 
supplement standard care by evaluating a safety plan smartphone application (which has been 
developed with promising outcomes; Kennard et al., 2015) that teens can easily access to provide tools 
to cope with suicidal urges and preserve safety. 
Significance.  Adolescent suicide is the second-leading cause of mortality in adolescents, and adolescent 
suicidal behavior is a common cause of morbidity associated with significant functional impairment. The 
rates of both adolescent suicide and suicidal behavior has been increasing. This proposal aims to reduce 
the likelihood of a suicide attempt during a very high-risk period of time, which is the transition from inpatient 
to outpatient care. Currently, even with high quality treatment, there is a high incidence of early suicidal 
events in outpatient care. 
 
Innovation: In our previous pilot RCT, we found that the combination of BRITE and ASAP with TAU resulted 
in a significant reduction in the hazard for suicide attempts.  This is novel, as there are no established 
interventions to prevent suicidal behavior during the transition from inpatient to outpatient care for 
hospitalized suicidal adolescents. . This study would provide a replication of these findings in a larger, and 
more demographically diverse sample (larger minority recruitment and higher proportion of males). This is 
important, as ethnicity may moderate the impact of psychosocial interventions (Weersing et al., 2017) and 
risk factors for suicidal behavior differ between adolescent males and females (Brent, Baugher, Bridge, 
Chen, & Chiappetta, 1999; King, Jiang, Czyz, & Kerr, 2014). Moreover, this new study will disaggregate the 
effects of ASAP and BRITE. With respect to BRITE, this would be one of the first studies to evaluate the 
added value of a structured safety plan. Finally, we will evaluate the cost-efficacy of BRITE, ASAP, and the 
combination. While there are an increasing number of suicide prevention apps, almost none are geared to 
adolescents, and none have been critically evaluated.  Moreover, this study also aims to assess the 
incremental costs and benefits of these brief interventions, which is critical to widespread dissemination of 
these interventions.  Moreover, the cost analysis will include costs to the families of youth who attempt 
suicide, and these costs have rarely been studied. 
 
Impact: This study will identify the most cost-effective components of ASAP + BRITE + TAU (i.e. BRITE, 
ASAP, or BRITE + ASAP) to prevent suicidal behavior in adolescents after discharge from the hospital, 
which can lead to larger scale dissemination studies. In our initial pilot studies, ASAP + BRITE + TAU cut 
the suicide attempt rate 2.5 fold and reduced re-hospitalizations as well. Hence, this intervention has the 
potential to reduce suicidal behavior and to prevent rehospitalization, which could in turn prevent future 
pain and suffering and save costs to health systems and families as well. 
 
 There are no established interventions to prevent the recurrence of adolescent suicidal behavior after 
discharge from psychiatric hospital. This proposal has the potential to assess and improve upon a major 
component of best clinical care for suicidal teens, which is the transition from inpatient to outpatient care. 
By focusing on the time-period of greatest risk for recurrence—the transition from a higher level of care to 
outpatient treatment, this project directly aligns with the mission of the recently convened National Action 

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Alliance for Suicide Prevention Research Prioritization Task Force that calls for the development and testing 
of interventions that will reduce the rate of suicide and suicide attempts, particularly among high-risk groups 
(National Action Alliance for Suicide Prevention Research Prioritization Task Force, 2014). 
The addition of the BRITE app could potentially improve suicidal adolescents’ ability to resist acting 
upon suicidal urges, be easily and widely deployed, and save lives. Since many suicides in this 
population are impulsive, the BRITE app could be an easily accessible tool to manage suicidal urges 
that could foster greater resiliency among youth at high risk for suicide. As such, the proposed work is 
expected to have a significant impact on high risk children, their families, and clinicians.   
Feasibility: The investigators have worked productively together in the past through collaborations on 
2 multisite trials (the Treatment of SSRI-Resistant Depression in Adolescents (TORDIA) and the 
Treatment of Adolescent Suicidal Adolescents TASA), resulting in several publications that inform this 
proposal (Brent et al., 2008; Brent, Emslie, et al., 2009; Brent, Greenhill, et al,. 2009; Emslie et al., 
2010; Kennard et al., 2009; Lynch, Dickerson, Clarke, et al., 2011; McMakin et al., 2012; Stanley et al., 
2009; Vitiello, Brent, et al., 2009; Vitiello et al., 2011).  
Additionally, the investigators worked together to successfully complete a two-site NIMH funded 
treatment development trial for the ASAP intervention (Kennard et al., 2017). Both sites are very 
familiar with the management of suicidal adolescents and proper rescue procedures in the contexts of 
both research and clinical care. Both groups also have experience in treatment development, with 
Kennard (2014) developing a wellness-oriented cognitive behavior therapy (CBT) that effectively 
prevents depressive relapse (HR = 0.31, p = .01). Both groups have met or exceeded recruitment 
targets for multiple adolescent treatment trials. Both sites see at least 200 new suicidal adolescent 
inpatients per year, with an average length of stay of 5 to 7 days. Retention in previous studies of 
similar populations has been in excess of 85% for the year. 
Previous work informing this study: The motivation for this study is that, despite delivering “state of 
the art” psychosocial interventions in TORDIA and TASA, a high proportion of the suicidal events that 
occurred in these studies happened within 3-4 weeks of intake (Brent, Emslie, et al., 2009; Brent, 
Greenhill, et al., 2009). Hence, some additional intervention is needed early in treatment to protect 
against suicidal urges. The investigators conducted focus groups with patients, parents, and clinicians, 
which informed the development of the ASAP intervention and BRITE phone application for this 
proposal (Kennard et al., 2015). The phone app has been developed and piloted with good preliminary 
outcomes (see below).  
Preliminary Data: The pilot study (N=65) for ASAP/BRITE was conducted by these two sites. 
Adolescents (ages 12 to 17) who were hospitalized with recent ideation with plan or intent and/or a 
recent suicide attempt were randomized to receive ASAP + BRITE + TAU or TAU alone. Participants 
were balanced both within and across sites on age (12-15 vs. 16-17.11), gender, and past attempt.  
Suicidal ideation (Suicidal Ideation Questionnaire – Junior) and behavior (Columbia Suicide Severity 
Rating Scale, C-SSRS) were assessed at weeks 4, 12, and 24 by independent evaluators. The 
intervention was accepted by a high proportion of those patients who were eligible (65%).  Those in the 
ASAP group, compared to those in TAU had fewer attempts over time (13.3% vs. 31.0%, p=.10, 
Hedge’s g = .44), and a longer time from baseline to attempt than TAU (adjusted HR=0.22, 95% CI: 
0.05, 0.85, z=-2.19, p = 0.03).  Prior attempts moderated treatment, such that those who had a prior 
attempt (2/3 of the sample) and received ASAP had a much lower hazard of time to reattempt 
(HR=0.12, 95% CI: 0.01, 0.94, z=-2.02, p=0.04). There was a non-significant trend for those assigned 
to ASAP to be less likely to be re-hospitalized (10.0% vs. 24.1%, χ21=2.09, p=0.15, g=-0.38). Also, 
ASAP + BRITE + TAU, in moderator analyses, reduced suicidal ideation in those with lower reasons for 
living and more dysfunction emotion regulation., Participants whose families participated in the 
intervention showed slightly lower rates of attempt during the study (11.1% vs. 14.3%, p>0.99), lower 

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hazard of attempt (HR=0.72, 95%CI: 0.07, 6.88, p=0.77) and more decreasing SIQ scores over time 
(β=-0.61, 95%CI: -1.12, -0.11, p=0.02). Of those participants who received the phone app, 72.7% 
viewed the app, and of these 75% added content with an average use of almost 30 times. More 
frequent response to prompts from the app for mood check-in, was associated with improvement on 
reasons for living (ρ=0.37, p=0.08) and declines in suicidal ideation (rho=-0.37) over the 24- week 
follow-up period (see figure below).
 
Using the Client Satisfaction Questionnaire, CSQ, where higher scores indicate more satisfaction with 
their treatment (range 8 to 32), the ASAP group showed greater satisfaction than the TAU group 
([N=26], M=26.6, SD=3.8 vs. [N=20], M=24.1, SD=5.2, z = 1.57, p =0.12, g = 0.56). The satisfaction 
scores on the app using the Post-Study Satisfaction and Usability Questionnaire (PSSUQ; where lower 
scores indicate more satisfaction, range 10 to 70) were as follows: week 4: M = 17.6, SD = 7.1, N=21; 
week 12: M = 18.6, SD = 10.4, N=24; week 24: M = 18.4, SD = 8.0, N=25.  
 
Our data demonstrate that the intervention is feasible, acceptable, and effective. We propose to build on 
the pilot RCT to include a larger sample. This will allow us to test each aspect of the intervention 
separately, as well to test the additive effects of the combined intervention, against treatment as usual 
(TAU).  
Previous studies related to cost-effectiveness analysis. The long-term goal of this study is to 
develop and implement evidence based care for youth with suicidal behavior and ideation into health 
systems that serve such youth.  To this end, it is critical that we provide practical information about the 
cost of running the interventions, and the longer-term impact of the interventions on health care and 
other costs.  This type of information could be critical to the future adoption of these interventions into 
routine practice.  In order to achieve this aim, we have added Frances Lynch, a health economist to our 
-100
-50
0
50
100
Change in Score
0
20
40
60
80
100
120
# Mood Ratings Added
SIQ
Reasons for Living

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study team.  Dr. Lynch has extensive experience in designing and leading cost-effectiveness analyses 
in the context of randomized controlled trials (Lynch, Dickerson, Pears, & Fisher, 2017; Lynch, 
Dickerson, Clarke, et al., 2011; Lynch, Dickerson, Garber, et al., 2011; Beardslee et al., 2013), and she 
has previously worked with the lead investigators in the proposed study (Kennard, Brent) in examining 
the cost effectiveness of interventions for youth with treatment resistant depression (Lynch, Dickerson, 
Clarke, et al., 2011; Lynch, Dickerson, Garber, et al., 2011). Dr. Lynch has particular expertise in the 
economics of youth mental health conditions (Lynch & Dickerson, 2017), and suicide prevention 
(Lynch, 2014).   
 
III. RESEARCH METHODS  
Overview of Study Design.  
Participants 
 
Participants will include adolescents 12-17.11 years of age (N=250) who either 1) present to the 
inpatient psychiatry unit with recent suicidal ideation with plan or intent and/or a recent suicide attempt, 
or 2) are hospitalized on a medical floor for a suicide attempt.  Participants must be English speaking 
because the treatment is not validated in any language other than English. Additionally, adolescents 
must own a smartphone, tablet, or device on which the Brite app can be utilized. Exclusion criteria 
include current (i.e., within the past two weeks) psychosis, mania, <85% of ideal body weight, and any 
cognitive disabilities necessitating additional testing (e.g., IQ <70, recent concussions with ongoing 
symptoms, etc.), as these conditions may require more intensive interventions or limit comprehension 
of the intervention components. Additionally, we will exclude participants being discharged to a 
residential treatment facility due to the level of supervision by professional adults in those facilities. The 
idea of the study is that the youth will return to his/her environment and will have the ability/need to use 
her/her safety plan while facing her/her real life problems. Residential treatment is very similar to the 
inpatient setting in that it is very treatment oriented and there are numerous restrictions about 
electronics. Lastly, youth who does not have a responsible adult who has the ability/authority to consent 
for research participation (e.g., youth in the custody of child protective services) will be excluded. We 
will oversample males and ethnic minorities so that each group constitutes at least 25% and 35% of the 
total sample, respectively. 
 
Treatment Intervention (ASAP) 
 
The ASAP intervention model is designed to increase protection against adolescents acting on their 
suicidal urges and attempting suicide. We use a motivational interviewing (MI) framework for the 
intervention. The four modules are as follows: 1. treatment overview and psychoeducation about suicidal 
behavior, chain analysis, reasons for living, and safety planning; 2. distress tolerance techniques 3. 
savoring techniques for the maintenance of positive mood by reminiscing on recent positive events are 
taught, along with the practice of “switching” strategies designed to build resilience to stressors that may 
destabilize mood (29); and 4. review of the ASAP skills and safety plan with the teens and their family 
members (as available).  Quality assurance ratings will be obtained on a random sample of 20% of ASAP 
sessions.  Up to two bridging calls (2) to the participant will be made at 1 and 2 weeks after discharge to 
review use of safety plan and ASAP components, and assess adherence to follow-up care.  
 
Phone App/BRITE (See also description about how app is personalized below) 
A HIPAA-compliant web-based phone application (Fig 1) provides the participants with guidance, social 
support, and convenient access to distress tolerance strategies and their safety plan via the patients’ 

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phone. The app is compatible with both IOS and Android platforms.  The study therapist will have access 
to a setup interface and web interface in order to customize the content of the participant’s view usage.  
Participants get daily text reminders to rate their level of emotional distress (1-5, 5 the most upsetting) 
and on the basis of their level of distress, they are offered distress tolerance and emotion regulation skills, 
and support material that they have chosen. For participants at a high level of distress, the app offers the 
safety plan, including individual, interpersonal, and clinical contact options. The therapist, with the patient, 
will have the capacity to input hypertext links to offsite techniques such as videos, images, sound memos, 
and support systems. For example, if a standard safety plan might recommend distraction or review of 
reasons for staying alive, we can link these recommendations to a video or text that might outline reasons 
for living, reasons to be hopeful, or an image that would serve as a distraction or a cue to savoring that is 
personalized for that individual. If initial “personal strategies” do not work, and the patient wanted to 
contact a parent, friend, or professional, the app provides a direct link (call or text) to the supportive or 
professional contacts developed as per the safety plan. Up to two bridging calls (2) to the participant will 
be made at 1 and 2 weeks after discharge to review use of safety plan and ASAP components, and 
assess adherence to follow-up care. 
 
Figure 1. 
 
 
 
 
BRITE ALONE 
The BRITE only condition will consist of a one session (1 hour) visit with a study therapist who will 
conduct safety planning, specifically identifying the triggers of the suicide attempt/event using a chain 
analysis approach. In addition, the therapist will assist the patient in recognizing existing coping skills. 
The BRITE ALONE intervention will also include up to two bridging calls (2) to the participant that will be 
made at 1 and 2 weeks after discharge to review use of BRITE, and assess adherence to follow-up care.  
 
The BRITE app intervention will include using an emotional thermometer to identify markers of “point of 
no return" and ask the participant to identify strategies that could be used to de-escalate (avoid triggers, 
distraction, calling family support/ professionals, reasons for living, deep breathing, mindfulness, 
emergency contacts). Information from the chain analysis, coping skills assessment, and emotional 
thermometer discussion will assist the therapist and patient in populating the BRITE app. Finally the 
therapist and patient will identify barriers that might interfere with the patient’s ability to use their plan. 
The Safety Plan will include: (1) a family component that includes the following: asking the patient to 
explain the safety plan to the parents, getting parental feedback, asking both parents and patient what 
might get in the way of implementing the plan, considering either ways to overcome those barriers or 
revising the plan, and (2) removing/securing lethal agents. The patient should be referred for 
emergency evaluation if they clearly express suicidal intent and are unwilling to commit to the safety 
plan. Clinical conditions that would impede ability to adhere to a safety plan include: psychosis, bipolar 
disorder (rapid cycling or mixed state), alcohol and drug abuse, and a traumatic brain injury.  

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ASAP + BRITE + TAU:  
 
In this treatment condition, we will combine treatment as usual with ASAP and the phone app as we did in 
the pilot study (N = 65). The study therapist will provide the ASAP components that are described above, 
and assist the patient in populating the app with the ASAP strategies (safety plan, reasons for living, 
distress tolerance, savoring, supportive and professional contacts). The family will be included in the 
treatment to review ASAP skills and the phone app. 
 
Treatment as Usual. The focus of inpatient care across sites is on diagnosis, safety assessment, 
development of a safety plan, stabilization, initiation or adjustment of pharmacotherapy, psychoeducation 
for patients and families, and disposition. Clinical referrals for outpatient treatment will be provided prior to 
discharge. Unit therapists develop a safety plan with the patient and family, although there is no standard 
protocol for doing so.  For participants in the ASAP only group, BRITE only group, and ASAP + BRITE + 
TAU, therapists will expand on the inpatient safety plan to include emotion regulation and distress 
tolerance strategies. 
 
The ASAP + TAU, BRITE + TAU, and ASAP + BRITE + TAU treatment will be front-loaded, meaning that 
each will either precede discharge or commence within one week of discharge to recommended 
outpatient psychiatric treatment. Study therapists will be trained to deliver all three active treatment arms. 
TAU will be provided by inpatient staff. Researchers will also send a letter regarding participation in the 
study to the subject’s outpatient therapist.  
 
 
Randomization. Participants will be randomized centrally at WPIC by a web-based computer program 
that has been used successfully in other studies (Brent et al., 2008; Garber et al., 2009).The study 
coordinator at each site will complete a Randomization Request form on the secure website. Once the 
form is completed, a database trigger will run the randomization program to determine the group 
assignment. The program will automatically generate and send an email to the study coordinator and 
the data coordinating center to notify them of the assignment. Participants will be balanced both within 
and across sites on age (12-15 vs. 16-17.11), and past attempt vs. high ideation. To increase the 
gender and ethnic diversity in the overall sample, we will oversample males and individuals from 
minority groups to include 25% males and 35% minority groups.  
 
 
Assessments (see Table 1): 
 
Follow-up assessments using independent evaluators blind to treatment condition will be conducted at 
Weeks 4, 12, and 24. TAU or standard care on the inpatient unit includes diagnosis, safety assessment 
and stabilization, initiation or adjustment of pharmacotherapy, psychoeducation of patients and families, 
and disposition. It is standard care for the inpatient units to provide clinical referrals for outpatient 
treatment and typically a follow-up appointment occurs about 1 week after discharge.  We will also directly 
measure TAU services post hospitalization using a service use assessment instrument (CASA – see 
measures section).   
 
Demographics, including gender identity and sexual orientation (as per requirements by AFSP research 
grants) will be collected at baseline. We will compare the four treatment conditions with respect to three 
main sets of outcomes: (1) efficacy at reducing suicidal ideation, and increasing time to suicidal attempt 
and (2) moderators and mediators related to suicidal outcomes, (3) cost effectiveness of each 
intervention alone and combined compared to TAU.  
 

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10 
To shorten the diagnostic assessment, dimensional measures of psychopathology will be obtained from 
the parent, using the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) and the 
corresponding Youth Self Report (YSR) from the participant (Achenbach, 1991) at intake. Diagnostic 
assessment will include dimensional measures of anxiety (the Screen for Anxiety Related Disorders 
[SCARED, 5 item scale]) (Birmaher et al., 1999), depression (Patient Health Questionnaire [PHQ-9]) 
(Johnson, Harris, Spitzer, & Williams,  2002; Richardson et al., 2010), alcohol and drug use (CRAFFT- 
self report substance use screening tool) (Knight et al., 1999), and sleep disturbance (Pittsburgh Sleep 
Quality Index [PSQ]; Buysse, Reynolds, Monk, Berman, & Kupfer, 1989). These measures will be 
obtained at each follow up, since these are often targets of group and individual treatment and because 
these may be potential moderators of use of the safety plan and of suicidal ideation change.  
Outcome measures: 
 
Suicidal ideation and behavior.  Information about past and current suicidal behavior and non-suicidal 
self-injury will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) (Posner et al., 
2011).  NSSI, while not a primary outcome of this study, is important because of recent findings that 
NSSI is an even stronger predictor of eventual suicidal behavior than past suicidal behavior (Asarnow 
et al., 2011; Wilkinson et al., 2011; Cox, Stanley, et al., 2012). Factors related to the risk of suicide 
attempt or completion will also be measured using the Concise Health Risk Tracking scale (CHRT; 
Trivedi et al., 2011). As a secondary outcome, we will track reasons for living, using the Reasons for 
Living Inventory questionnaire, with the expectation that over time, as a result of treatment and the 
safety plan, that adolescents will show an increased score on this scale, which has been shown to be 
protective against future suicidal behavior (Osman et al., 1998). 
Assessment of Moderators and Mediators. We will be comparing the efficacy of ASAP, BRITE, and the 
combination of both on change in suicidal ideation, suicidal behavior free days, and time to suicide 
attempts. It is important to assess those variables most likely to contribute to differences in outcome, or 
that may moderate the effects of the intervention. Based on our preliminary results, we anticipate that 
the effects of ASAP and BRITE will be mediated by changes in emotion regulation (Difficulties in 
Emotion Regulation Scale [DERS]; Gratz & Roemer, 2004), distress tolerance (Distress Tolerance Scale; 
Simons & Gaher, 2005), reasons for living (RFL-A; Osman et al., 1998), and motivation (Readiness, 
Importance, & Confidence Ruler [RICTC]; Moyers et al., 2009). 
Possible moderators of outcome include history of child maltreatment (Childhood Trauma 
Questionnaire [CTQ]; Bernstein, Fink, Handelsman, & Foote, 1997), social support (Multidimensional 
Scale of Perceived Social Support [MSPSS]; Zimet, Dahlem, Zimet, & Farley, 1988), and family climate 
(Family Adaptability and Cohesion Evaluation Scale [FACES-IV]; Marsac & Alderfer, 2011). As noted 
above, we will also test whether history of a suicidal attempt moderates treatment response, as it did in 
our pilot study. 
Client Satisfaction. Client satisfaction will be obtained from the patient and caretaking parent using an 
adaptation of the Computer System Usability Questionnaire (CSUQ) to assess satisfaction with the 
phone app. The PSSUQ will be filled out by the participant, and is based on earlier measures designed 
to predict the adoption of technology, based on two main factors: ease of use (easy to learn, access, 
flexibility, quality of sound, quality of visual display) and usefulness (able to access when needed, 
helpful when used), which are scored along a 7-point Likert Scales with good psychometric properties 
(Davis, 1989; Lucas & Spitler, 1999). Exit interviews will also take place to measure satisfaction. 
Participants who are randomly selected to complete an Exit interview assessment will be given an 
additional $25 payment. Participants will only be paid after completion of the assessment.  

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11 
Treatment Utilization. Treatment history will be obtained at baseline, including services received for 
psychiatric complaints and medications taken. History will also be obtained at baseline and recent use 
during all follow-up assessment calls using the Child and Adolescent Services Assessment [CASA] 
(Ascher & Farmer, 1996). 
 
Suicide Free Days. The adolescent version of the Longitudinal Interval Follow-Up Evaluation (A-LIFE): 
Psychiatric Status Ratings (PSR) score sheet (Keller et al,, 1987) will be used to evaluate suicide free 
days. This measure is used to record symptom variations that have occurred since the last 
assessment. The extent of the subject’s recovery from previous episodes of DSM-IV disorders as well 
as the occurrence and degree of severity of any new disorders is recorded using a 4-point rating over 
monthly intervals on the PSR score sheet. 
 
 
Rescue procedures and disclosure of suicidal ideation on interview. Upon entry into the study, we 
obtain permission to discuss the patient’s care with one of three supportive individuals nominated by 
the participant who can help the participant to obtain emergency treatment, if he or she is judged to be 
Table 1. Assessments 
 
Completed By: 
Assessment Of: 
Baseline 
Wk 
4 
Wk 
12 
Wk 
24 
SDQ 
P 
Symptoms 
X 
 
 
 
YSR 
SR 
Symptoms 
X 
 
 
 
C-SSRS 
C, IE 
Suicidal behavior 
X 
X 
X 
X 
CASA 
C, IE 
Service Use 
X 
X 
X 
X 
Trauma (2-items) SR 
Trauma 
X 
 
 
 
PHQ-9 
SR 
Depression 
X 
X 
X 
X 
SCARED (5 
item) 
SR 
Anxiety 
X 
X 
X 
X 
DERS 
SR 
Emotional Regulation 
X 
X 
X 
X 
DTS 
SR 
Distress Tolerance 
X 
X 
X 
X 
RICTC 
C, IE 
Motivation 
X 
X 
X 
X 
MSPSS 
SR 
Social Support 
X 
X 
X 
X 
FACES-IV 
SR 
Family Support 
X 
 
 
 
CRAFFT 
SR 
Substance 
X 
X 
X 
X 
PSQI 
SR 
Sleep 
X 
X 
X 
X 
RFL-A 
SR 
Reasons for Living 
X 
X 
X 
X 
CSUQ 
SR (app users) 
Satisfaction with app 
 
X 
 
 
PedsQL 
SR, P 
Quality of Life 
X 
X 
X 
X 
FEII-E 
P 
Parent missed time from 
work 
X 
X 
X 
X 
ALIFE 
IE 
Suicide free days 
 
X 
X 
X 
CHRT 
SR 
Suicide Risk 
X 
X 
X 
X 
Exit interview 
SR 
Satisfaction 
 
X 
 
 
GENINFO 
C 
Demographics 
X 
 
 
 
IE: Independent Evaluator; C: Clinician/Therapist; SR: Self-Report; P: Parent; B: 
Behavioral Marker completed by patient 

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12 
a high suicidal risk during the follow-up period, after discharge from inpatient care.  If the patient 
endorses suicidal ideation on a clinical assessment, we ask if the participant can keep him- or herself 
safe, and assess the degree of intent and planning related to suicidal ideation. Participants judged to be 
at high risk will be discussed with either Drs. Kennard or Brent.  If upon discharge, during the follow-up 
period, the patient is judged to be at high risk, participants and/or their parents will be referred for 
emergency care. Both sites have access to 24-hour psychiatric emergency care.  
 
Removal from the study. The main reason to be removed from the intervention is if the participant 
develops a condition that makes it impossible to cooperate with case management (e.g., acute 
psychosis, mania). However, we will follow-up all participants at their scheduled assessments. 
 
Personalization of the App: A HIPAA-compliant web-based application has been designed to provide 
the participants with guidance, social support, and convenient access to their safety plan via the 
patients’ phone. If a participant does not have a cell phone or a device that can access the application, 
the study will supply the participant with one for the duration of the study (24 weeks). Phones that are 
provided to the participants will have all data removed prior to reassigning to a new participant. All 
phones will be password protected in case it is lost or stolen. The research coordinator and PIs will 
have access to a setup interface and web interface in order to customize the content of the participant’s 
app and view usage. The app goes beyond the current practice of writing a safety plan that the patient 
can carry with them.  Instead, the app will not only list the steps in the plan, but has the capacity to 
support these steps through hypertext links to offsite techniques such as videos, images, sound 
memos, and support systems. 
The BRITE App includes the following components, which are in accordance with accepted best 
practice for developing and implementing such plans: Personal Strategies: Distraction (take a walk), 
listen to music (link to audio), think about a favorite spot (beach picture), reasons for living (link to family 
picture, picture of pet, image of a college s/he wants to attend, friend talking about how important the 
patient is to them), or other techniques (exercise, self-talk, savoring). Reaching out: Talking with friends, 
family and other supports; (participant clicks on one and autodials or autotexts). Professional help: 
therapist, guidance counselor, family physician, psychiatrist, emergency numbers; (list of contacts, the 
patient clicks on one, and autodials). 
Clinical studies and real-time analyses of contributors to suicidal behavior find that the following are 
contributors to the decision to make a suicide attempt in the face of suicidal urges: (1) inability to 
generate alternative solutions; (2) inability to manage or cope with negative affect; (3) hopelessness 
and inability to consider reasons for living; and (4) perception of being a burden, and hence not 
reaching out for support (Joiner, Pfaff, & Acres, 2002). The app provides technological aids to combat 
these common characteristics of suicidal adolescents. The application has a list of alternative solutions 
to suicide which the adolescent has generated when calm. By having such a list handy and stored on 
the phone, the teen does not have to re-generate this list when under duress. In addition to poor 
problem-solving, youth who are at risk for suicidal behavior show difficulty with emotion regulation: they 
experience more subjectively distress, and are less adept at coping and attenuating negative emotion 
(Nock et al., 2013). The first step in the safety plan is to review techniques, chosen by the teen that can 
be effective in achieving emotional de-escalation. Joiner has articulated a model of suicidal behavior 
that includes perceived burdensomeness (Joiner et al., 2002). The dangerous part of this perception is 
that support can be protective against suicidal risk, but a person who perceives her/himself to be a 
burden will not reach out. Thus, we have the capacity to include, when appropriate, short videos of a 
person in the patient’s social network who says how important s/he is to them. The second and third tier 
of interventions are to reach out to other people in his/her social network, and to seek clinical 
attention—either from the therapist, ED, or 24-hour hotline that is programmed into the app.  All these 
techniques serve to help the participant cope with suicidal urges and defuse the suicidal crisis.  Since 

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13 
the phone will record the patient’s response to, and use of, the different techniques of the safety plan, 
this provides a framework for the therapist to evaluate the efficacy of the plan and to make changes 
accordingly.  
Treatment blinding. During the RCT, the independent evaluator (IE) will be blinded to the assigned 
condition and will take the following steps to preserve the blind: participants and families are asked not 
to share with the IE which condition they are assigned to; at staff meetings when cases are reviewed, 
IEs are not present; IEs are asked to guess what the treatment assignment is at the end of each 
interview, and they will notify the project coordinator if they become unblinded. Also, we obtain 
complementary self-report forms that will not be influenced by interviewer bias.  
Research Clinician dashboard:  The study therapist whose patient is assigned to BRITE and ASAP + 
BRITE + TAU will have a dashboard for that patient set up that will display information gathered from 
use of the app, namely frequency of use. The BRITE clinician dashboard contains information about 
each individual participant’s activity on the app. From the dashboard, research and clinical staff are 
able to view the date and time participants downloaded and registered the app onto their phone.  Study 
staff are also able to view other app activities including how many times they log in, how they rate their 
mood at each login (on a 1-5 scale) and which activities they viewed, modified to make more personal, 
or deleted.  The duration of time in which the app remains open and any navigation the participant does 
within the app is logged and time stamped. After completing an activity, participants are also prompted 
to submit if they feel better, worse, or the same after the activity and are offered a chance to re-rate 
their mood post activity. We will, with the permission of the participant and family, provide their 
outpatient clinician with regular updates about app use and efficacy of different strategies. 
Quality Assurance.  
Assessments. IEs will be supervised by trained and experienced evaluators on the C-SSRS. All 
assessments will be taped, and 20% will be reviewed by the supervisors at each site.  IEs must 
maintain at least 80% agreement with the supervisors in order to continue in this role.  
 
Safety planning. There are three aspects to quality assurance for case management. First, each 
assessment will be staffed at each site by the PIs or co-Is (Drs. Brent, Goldstein, or Douaihy or Drs. 
Kennard, Foxwell, Stone). Second, after the chain analysis, assigned site investigators will review the 
chain analysis and subsequent safety plan that is developed at their respective sites.  Third, the quality 
of the safety planning will be reviewed using the Safety Plan Rating Scale (SPRS) (Kennard et al., 
submitted). 
Treatment. Therapists will have at least a master’s level training or will be currently enrolled in a doctoral 
program with experience and expertise in treating suicidal youth. ASAP therapists will have a 2-day 
training (by Skype or ooVoo) on the components of treatment prior to beginning formal intervention and 
will also attend a day-long training in MI principles, skills and strategies with study with Co-I Dr. Douaihy, 
an experienced member of the MI Network of Trainers (MINT) and Dr. Tina Goldstein, who has expertise 
in the application of MI principles. Dr. Dana McMakin (Co-I) will provide training in savoring, switching 
strategies for improving access to positive mood. Therapists will record all of their sessions; all sessions 
will be reviewed for the open trial, and then a random 20% of sessions will be reviewed in the RCT for 
adherence and competence. Therapists will also receive training on BRITE during the 2 day training. 
Study therapists will be able to provide ASAP only, BRITE only, and ASAP + BRITE + TAU.  
Statistical analysis.  
We will begin with a preliminary analysis of data, for example to examine missingness patterns, 
outliers, and consider transformations and dimension reduction methods. Next, we will compare the 
four groups on demographic and clinical variables to identify any differences between groups. In the 
regression analyses below, we will include those variables that are related to the main outcomes of the 

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14 
study. We will also assess site effects and control for them if indicated. Our initial analysis for each 
hypothesis will be a test of equality of the two or four cells without covariates, using the appropriate (t or 
F, chi-square, Kaplan-Meier) test for continuous, discrete, and time-to-event data. We will then use 
appropriate (GLM) regression methods developed by Hedeker and colleagues (Hedeker, Mermelstein, 
& Demirtas, 2008; Hedeker, Mermelstein, & Demirtas, 2009) for both continuous and discrete data. We 
will also use the Cox models to study the time to suicidal event, with appropriate modifications if the 
proportional hazards assumption is in doubt. We will try to ascertain the reason(s) for any missing data 
in order to decide on how to deal with missingness. We adopt the general approach of Little and Rubin 
(2002): we will do sensitivity analyses, comparing the results of completers only, last value carried 
forward, and multiple imputation by chained equations (MICE) and report inferences that are well 
supported by those analyses. Next, we will address the three secondary aims: our approach to 
mediation and moderation analysis, and cost-effectiveness analysis are described below. We will also 
do extensive exploratory analyses to assess the potential effects of other covariates we measure, such 
as adherence, gender identity, emotion regulation, and sexual orientation. Finally, for all regression 
analyses, we will use standard regression diagnostics (residual plots, influence measures) to assess 
the fits of our models, and refine them if indicated by the data. 
 
Primary aims. 
Hypothesis 1. Both ASAP and BRITE will be superior to TAU alone, and ASAP + BRITE + TAU will be 
superior to BRITE or ASAP alone. 
Our main analysis will be the use of two-way ANOVA with an interaction term. We will use the 
assessments from the instruments listed in Table 1 to study the three main outcomes. For SI severity, 
we will use a linear model; for NSSI and suicide attempts, we will use a Poisson model; and for the time 
to attempt, we will use the Cox model. We will include as covariates the following: site, the three 
covariates we balanced on in our randomization, and any covariates we find in our preliminary analyses 
to be associated with the outcome; we will consider mixed effects models if they provide a better fit. We 
do not expect a strong interaction term; if so, our inferences will be based on the main effects. As 
additional analyses, we will use post-hoc tests for the four main comparisons: the combination vs. each 
component, and each component vs. TAU.  
 
H2: The effects of ASAP and BRITE will be mediated by increases in reasons for living, decreases in 
dysfunctional emotional regulation, increases in functional emotional regulation, and decreases in 
implicit associations with death, and will be moderated by previous history of an attempt, and family 
engagement in treatment. In addition, the impact of BRITE will be proportional to the frequency of use. 
For moderator and mediator analyses, we use the standard approach of Baron and Kenney (1986) and 
later explicated by Kraemer and colleagues (2002) and Kraemer (2008) for moderators. The search for 
moderators is typically an exploratory analysis because it involves the testing of interaction terms, for 
which power is usually limited. Thus, we will use the recent optimal weighted moderator profiles 
developed by Wallace, Frank, and Kraemer (2013) that combine potential (weaker) moderators. For 
mediator analyses, we will follow the approach of Preacher and Hayes (2008) for handling multiple 
mediators. In particular, we will begin by including the candidate mediators listed above in a single 
model and test their significance using both standard errors using the Gaussian model or the bootstrap 
if the Gaussian model is not a good fit. 
 
H3: Cost per outcome achieved will by will be lower for each of the interventions (ASAP + BRITE + 
TAU; ASAP alone; BRITE alone) compared to TAU at Week 24 Weeks follow-up. Cost per outcome 
achieved will be most advantageous for ASAP + BRITE + TAU.  We will adopt a societal perspective on 
costs, assessing the cost of all usual health services, costs of services in other sectors (e.g., school), 

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15 
and costs to the families (e.g., out-of-pocket costs, missed time from work).  This perspective will 
provide the type of data relevant to health care managers and health policy makers who would make 
decisions about whether or not to adopt these interventions.  We will conduct a series of incremental 
cost-effectiveness analyses (CEA) comparing ASAP + BRITE + TAU, ASAP, BRITE, and TAU. 
Cost effectiveness ratio (CE ratio).  Below, we provide a sample computation of a CE ratio, comparing 
ASAP to TAU and using change in quality-adjusted life years (QALYs) as the clinical outcome metric.  
 
Experts have noted that there are numerous empirical challenges to accurately estimating incremental 
cost-effectiveness ratios (Gold et al., 1996).  We next describe our procedures for assessing each 
component of the CE ratio, namely, the CE clinical metric and the costs of the ASAP and BRITE 
interventions, other services and family costs.   
Clinical metrics.  We will conduct cost-effectiveness analyses using several clinical metrics that may 
be useful to decision-makers.  First, we will calculate CE ratios using QALYs, this is the recommended 
metric by experts (Gold, Siegel, Russell, & Weinstein, 1996).  Specifically, we will calculate QALYs 
using the PEDSQL (Varni, Seid, & Rode, 1999).  However, this may not be the most meaningful 
outcome to clinical decision-makers.  For this reason, we will also calculate CE ratios using an 
additional clinical metric, number of days free from suicide attempt and/or ideation (SFD).  We will 
follow methods used in studies of the cost-effectiveness of depression treatment (Lave, Frank, 
Schulberg, & Kamlet, 1998; Lynch et al., 2017; Lynch, Dickerson, Clarke, et al., 2011). We will calculate 
SFDs using data from our suicide attempt and ideation outcome measures. Total SFDs will be 
calculated by summing estimated daily SFD values over the 6-month study period.  
Overall approach to measurement of cost. In our analysis, costs will be assessed with the following 
general strategy: (a) calculate direct costs of ASAP and BRITE, including intervention (labor, 
equipment, supplies, facilities, management); (b) calculate total other service use and expense for each 
participant, in each arm of the study (ASAP, BRITE, ASAP+BRITE+TAU, TAU) using the CASA; and 
(c) family costs (out-of-pocket expenses, parent missed time from work).  Note that this approach 
includes all services as “costs” for youths in each arm, not simply the cost of the new intervention 
programs.  This methodology will allow us to capture any cost-offset of participation in the ASAP, 
BRITE, or ASAP + BRITE + TAU programs or, conversely, any increase in costs associated with 
additional service utilization by youths in these arms.  This same strategy will be used for determining 
costs of the TAU arm (counting all service utilization as a cost associated TAU). 
Measurement of direct intervention costs. An intervention “input” will be defined as any service 
provided to the intervention groups that is not provided to the TAU control group by the research team. 
We will not include research-specific inputs on either side of this calculation, such as time spent 
conducting baseline assessments.  The direct costs of the intervention programs are the salary and 
fringe benefits for labor inputs (e.g., therapists, appointments clerks); costs of medical office space to 
Incremental Cost-Effectiveness = 
(Direct ASAP Intervention Costs) + (Total Service & Family CostASAP - Total Service & Family Costs TAU) 
[∆Mean QALYASAP - ∆Mean QALYTAUl] 

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16 
conduct the intervention meetings; costs of treatment manuals and materials and therapy supplies; and 
general administration and overhead. Purchased inputs (e.g., manual printing) will be valued at their 
invoiced cost.  Professional labor inputs will be valued using unit cost estimates developed from a 
national database (see costing algorithm).  
Measurement of utilization of services (Total Service Costs). Comprehensive service use profiles 
will be developed on every participant.  We will obtain data on utilization with the CASA, Child Health 
Services Screen. The CASA collects comprehensive data on all types of health services received by 
the participant in any health care setting, associated with treatment for the target conditions of the study 
(i.e., internalizing symptoms). We will also collect family out-of-pocket expenses from the CASA.  
Parent time missed from work will be assessed using the Family Economic Impact Interview, 
Employment module (FEII-E) (Lynch & Dickerson, 2012).   
Costing algorithm. To assign costs to the utilization data and the mental health professional services 
used in the interventions, we will develop a set of unit cost coefficients using the Medical Expenditure 
Panel Study (MEPS), a nationally representative survey of health care utilization and cost that includes 
comprehensive assessment of health care services including mental health services (Agency for 
Healthcare Research and Quality, 2004).  Similar approaches have been used by other investigators 
conducting CEA of mental health interventions (Schoenbaum et al., 2001). Health care costs will be 
converted to constant dollars by using the cost conversion coefficients for a year in the middle of the 
study period. This approach eliminates the effects of inflation on expenses and removes the burden of 
adjusting for inflation from the cost and cost-effectiveness models. 
Model fitting.  We will collect detailed data to minimize the need to estimate resource consumption. 
This will not alleviate all uncertainty in measurement of the CEA, however.  To address the remaining 
uncertainty, we will conduct sensitivity analyses to ascertain the effects of variations in the key 
parameters.  If these analyses indicate considerable uncertainty, we will use simulation modeling such 
as bootstrapped estimates to reduce uncertainty.  We have used these methods successfully in 
previous studies (Lynch et al., 2017; Lynch, Dickerson, Clarke, et al., 2011; Lynch et al., 2005). The 
CEA will be conducted by Dr. Lynch in coordination with the lead investigators (Kennard, Brent).   
Power Analyses  
All power calculations assume size alpha= 0.05 two-sided tests and requiring power 0.80, and 
assuming 85% retention (we had 92% retention in our pilot study), so we have 51 subjects per cell. For 
Hypothesis 1, with a total of 204 patients, we can detect a small effect size of approximately f2 = 0.06 
for the two-way models with an interaction term. For post-hoc direct comparisons involving only the 
cells of size 51 we have power to detect medium effects of size approximately d=0.55. For Hypothesis 
2, the results of Hedges and Pigott (2004) show that we have power to detect large effects for individual 
cells. It is well known that tests for moderation can have low power; however, we do expect that our use 
of optimally combined moderators will enhance our ability to identify key moderators. Finally, for testing 
potential mediators, previous simulation studies indicate that we have power to detect medium to large 
effects sizes for the individual cells (MacKinnon, Lockwood, Hoffman, West, & Sheets, 2002). 
Strengths, Limitations, and Future Plans.  
To our knowledge, this is the first attempt to establish the efficacy of brief interventions to prevent post-
discharge suicide attempts in psychiatrically hospitalized suicidal adolescents, the first to establish the 

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17 
efficacy of safety planning as an intervention, and the first to test the efficacy of a smartphone 
intervention to reduce suicidal behavior. However, we cannot control the duration and types of 
treatments that the participants experience while on the inpatient unit and thereafter, although we can 
document and adjust for the effects of differences to pre- and post-discharge intervention. For example, 
we can conduct analyses stratified by length of hospitalization as a sensitivity check. In addition, there 
may be differences with respect the type, intensity, and duration of outpatient care, although we will 
gather this information and covary its impact on outcome.   
Based on our cost-effectiveness analyses, we will identify the most cost-effective component of our 
intervention for future dissemination studies, by training inpatient staff on the intervention, and 
evaluating the effectiveness of this intervention as delivered by inpatient clinicians.  
 
HUMAN SUBJECTS RESEARCH 
Human Subjects Issues. A full IRB application has been submitted and will be modified to include this 
increased sample size. We are aware that any study of suicidal patients requires special attention to 
issues of participant safety and confidentiality.  All participants will be in inpatient treatment with close 
monitoring by the treatment staff. However, we will take several steps to ensure participant safety. We 
will include provision of rescue procedures for patients at high suicidal risk, including involvement of 
significant others and involvement of emergency mental health services if necessary.  
 
Protection Against Risk. The risks due to interview are three-fold: discussion of potentially upsetting 
information, loss of confidentiality, and assessment burden. The interviewers will all be trained and skilled 
interviewers who can assess and monitor the reaction to questioning about sensitive topics; interviewees 
will be given the option of not responding or ending the interview. We will provide the patient and family 
with emergency contact numbers regardless of treatment assignment. If upon follow-up, participants are 
not in treatment and we identify serious psychopathology and/or suicidal risk, we will provide referral 
information to the participant and parents. If at any of these points, we perceive that the patient is in 
imminent suicidal risk and the parent/patient is not willing to address this issue, then we will contact 
emergency mental health services to initiate an emergency assessment. To protect against violations of 
privacy, we try to have the respondent take the phone call in a private place. To protect the adolescent 
who may be suicidal, we only conduct phone interviews when know we will be able to reach the 
participant’s parent. In particular, teens will be evaluated at weeks 4, 12, and 24 to assess suicidal 
ideation and behaviors, as well as specific psychiatric illnesses, and may be given recommendations for 
additional treatment options should concerns arise during the evaluation. The risk of lack of improvement 
or worsening of psychiatric illness will be addressed by monitoring subjects closely during assessments. 
For all groups at 4, 12, and 24 weeks, if we detect untreated psychiatric disorder, or non-adherence, and 
there is not imminent risk, then we will pass this information to the parent and provide recommendations.  
 
Because of the sensitive nature of the phone app, the phone application will follow HIPAA compliance 
best practices to ensure the privacy of the users’ information at all times. Security will be integrated 
throughout the app, and accomplished with device login timeouts; ensuring all sensitive information is 
encrypted when stored and transmitted; two-factor authentication, which is an approach to 
authentication that requires the presentation of “two or more” factors (e.g., phone UID and login 
password); and ensuring that no sensitive data is stored on the device itself. Most of these features will 
prevent loss of confidentiality in the event that the phone is lost; however, we will also ensure that the 
app can be remotely deactivated to make sure all information remains confidential.  
 

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18 
 
We will convene an independent Data Safety Monitoring Board (DSMB) to review adverse events across 
the study and within each intervention arm. Prior to any clinical interview confidentiality is discussed with 
the patient and family during the consent process. This includes state guidelines for reporting abuse. All 
research personnel are trained and certified in ethical conduct of research, all information stored securely 
and separately from identifying information, phones will contain no identifying data and the phone app 
will be password protected, and communication between participant and research staff will be encrypted. 
Because its sensitive nature, the phone application will follow HIPAA compliance best practices to ensure 
the privacy of the users’ information at all times.  
 
Project Timeline 
 
 
 
 
Year 1 
Year 2 
Year 3 
Year 4 
 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
Technical support, app training   
 
Training 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment, consent, and enroll patients to RCT 
 
 
 
Data entry and cleaning > 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outcome 
papers 
 
Months 1 – 3 (June 1, 2018 – August 31, 2018) 
Study implementation preparations 
− 
Training in ASAP intervention and BRITE 
− 
Meet with inpatient staff 
 
Months 3-43 (September 1, 2018 – December 1, 2021) 
− 
Recruitment of participants for RCT 
− 
Data entry 
 
Months 44 – 48 (December 1, 2022 – May 31, 2021) 
 
− 
Data entry continued 
− 
Data cleaning on completed participants 
− 
Write primary outcome paper  
 
MULTIPLE PI LEADERSHIP PLAN 
Drs.  Kennard and Brent will jointly provide oversight of the entire project and development and 
implementation of all policies, procedures, and processes, including the scientific agenda, specific 
aims, study design, and training of personnel. In addition, both will oversee the study procedures to 

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19 
ensure that systems are in place and function in a way so as to remain in compliance with local IRB 
policies, US laws, DHHS and AFSP policies including human research, data and facilities. 
Governance: We will operate on consensus whenever possible. The process will be to encourage 
all to have a voice in decisions and to move the group toward consensus. In the multi-site TORDIA 
project, for which WPIC and UTSW were the two largest sites, we were always able to achieve 
consensus. If we cannot come to consensus,   will consult with other senior colleagues and reconvene.  
Executive Committee (EC): The EC will have a weekly conference call to discuss the status of the 
study, recruitment, intervention, adherence, and adverse events. The EC will consist of each of the PIs 
and 1 Co-I from each site (Brent, Kennard, Goldstein, Foxwell), and Dr. Kennard will serve as the chair. 
The EC will make all decisions regarding the protocol, budget, and publication policy. 
Publication Policy: The EC will establish a publication policy at the start of the study. The core 
papers are listed under the products at the end of the application will include papers on the description 
of the model and feasibility, the utility of the phone app, and the results of the RCT with respect to 
proximal (e.g., positive affect) and more distal (suicidal events) outcomes. Additional papers will be 
proposed by individual authors at the sites, and the EC will review and approve all papers. Each site 
will be represented on all outcome papers. 
Study Coordinator Conference Calls: The study coordinators, research assistants, and data 
manager (WPIC) from each site will have a biweekly conference call to discuss day-to-day study 
procedures, patient management, reliability of assessments, and review for data completeness and 
data management.  
Dispute resolution. As noted above, we strive to make all decisions by consensus, and in the past 
decade of working together, always have been able to do that. However, should we not be able to 
reach consensus, we will turn to our respective chairpersons who will confer and decide. 
 
 
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