Developing an Adaptive Intervention for Suicidal Adolescents Following Inpatient Hospitalization: A Pilot SMART
Phase: NA
Conditions: Suicide, Self Harm
Sponsor: University of Michigan

 
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Developing an adaptive intervention for suicidal adolescents following inpatient hospitalization: A pilot 
SMART 
 
NCT03838198 
 
3/21/2021 
 

 
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Study Title: Developing an adaptive intervention for suicidal adolescents following inpatient hospitalization: A 
pilot SMART 
 
 
STUDY AIMS 
Youth suicide, one of the leading causes of death among adolescents,1 has tragically increased in recent 
years2 and is a national priority.3 However, there is a paucity of effective interventions for adolescent suicidal 
behavior.4-6 In particular, there is a critical need for developing interventions for psychiatrically hospitalized 
suicidal teens, many of whom are at a high risk for repeated suicide attempts, persisting suicidal ideation, 
emergency department (ED) visits, and rehospitalizations.7-9 These events are associated with long-term 
psychosocial impairment10,11 and increased healthcare system costs.12 Intervening with suicidal teens during 
and shortly after hospitalization offers a promising window of opportunity to prevent relapse of suicide-related 
events. Because suicidal youth are at varying levels of risk after discharge7,13 and vary in their response to 
interventions,14-16 interventions should ideally be adapted to their heterogeneous treatment needs. Concerned 
with optimizing outcomes while reducing burden and cost, an adaptive intervention (AI) is a treatment design 
that individualizes the type, intensity, and timing of treatment.17-20 However, there currently are no AIs for youth 
suicide prevention. Moreover, despite the ubiquity and youths’ preference for mobile communication,21,22 using 
mobile technology to augment interventions for suicidal youth is understudied. The significant need to address 
heterogeneity in suicidal youth transitioning from inpatient care, and the potential of mobile technology to 
facilitate engagement and increase intervention impact, calls for adaptive technology-enhanced interventions 
to reduce suicide-related outcomes. We propose to conduct a Sequential Multiple Assignment Randomized 
Trial (SMART) pilot to inform the development of a technology-augmented AI for suicidal youth. The AI will 
focus on strengthening adolescents’ motivation and self-efficacy to use their safety plans and adaptive coping 
post-discharge. The proposed intervention (MI-SafeCope) will include three components: (1) a Motivational 
Interview (MI)-enhanced safety plan delivered during hospitalization, which incorporates an individual and a 
family meeting; (2) post-discharge MI-enhanced booster calls; and (3) personalized daily text messages 
delivered to adolescents for one month after discharge. Specific aims are: 
 
Aim 1. To finalize intervention components, study implementation protocol, and fidelity assessment tools in 
preparation for the pilot SMAR. Specifically, we will develop and refine the text message boosters. The 
message content will be iteratively refined based on consultation with experts and feedback from adolescent. 
 
Aim 2. To conduct the pilot SMART with adolescent inpatients to demonstrate acceptability and feasibility of 
study procedures, including the sequencing of intervention components. Participants will be randomized to MI-
enhanced safety plan with and without text boosters (Phase 1 intervention) and then re-randomized to an 
added telephone booster call or no call (Phase 2 intervention). We will:  
 
2a) Evaluate feasibility of study procedures and implementation of intervention components and sequencing;  
 
2b) Assess intervention acceptability (i..e. participant satisfaction; rates of attrition and adherence);  
 
2c) Define indicators of response to Phase 1 intervention by exploring candidate tailoring variables. 
 
2d) Conduct exploratory analyses of intervention effects on proximal /mechanisms (e.g., coping, safety plan 
use, self-efficacy) and distal (suicidal ideation/behavior) outcomes.  
 
INTERVENTION COMPONENTS 
MI-Enhanced Safety Plan Developed at Hospitalization (all teens receive this component).  
Individual Meeting: An individualized safety plan, incorporating common elements of safety planning,23 27 will be 
developed with the teen to use during a suicidal crisis. This “best practices” approach for treating suicidal 
individuals23-41 is augmented with MI28 as a core strategy to explicitly elicit adolescents’ motivation and 
commitment to behavior change (i.e. use safety plan; adaptive coping), address barriers or ambivalence, and 
strengthen self-efficacy. A 4-phase MI framework28 will be used, which includes engaging, focusing, evoking, 
and planning to guide the session.  

 
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Family Meeting: Similarly guided by MI, the family meeting includes a focus on preparing parents, with input 
from the adolescent, for how they may support the adolescent in implementing the individualized safety plan 
after discharge and on strengthening parents’ commitment and self-efficacy to follow through with these 
recommendations. Parents’ roles are also crucial in maintaining adequate monitoring, securing lethal means, 
and providing general support to their adolescents. Involving parents in safety planning is thus essential. 
 
 
Post-Discharge Components (teens receive none, one, or both components; see Figure). Because 
heterogeneity in post-discharge functioning (e.g. suicidal ideation severity) and response to the  
MI-enhanced safety plan (e.g. coping behavior) is expected, the safety plan may or may not need to be 
supplemented with additional follow-up components to further strengthen adolescents’ motivation and self-
efficacy for healthy coping. Because the highest risk for the relapse of suicide-related events is during the first 
month after discharge,5 we propose to deliver these follow-up components within this most critical risk period. 
 
Text Message Boosters: The safety plan component may be followed with daily text message boosters for a 
month after discharge to further enhance adolescents’ self-efficacy and motivation to use adaptive coping in 
their natural environment, which has the potential to increase the impact of the intervention. For example, the 
messages will be tailored to encourage use of individualized coping strategies identified as part of safety 
planning at hospitalization. Messages will also encourage accessing different types of support and introduce 
additional coping tools (e.g. coping tips and skills) and resources (e.g. crisis lines, websites). The text message 
content and tone will be consistent with principles of MI (e.g. affirming statements; open-ended questions 
encouraging reflection and generating solutions; MI-consistent language to provide coping tips).  
 
Booster Calls: The safety plan component may be followed with a booster call with the adolescent and the 
parent in week 3 after discharge to further adjust the safety plan to better meet post-discharge needs, to further 
enhance adolescents’ motivation and commitment to use coping strategies, and to further support adolescents’ 
and parents’ self-efficacy to manage suicidal crises.  
 
METHODS 
Eligibility and Enrollment of Participant Recruitment. Participants will include 80 adolescents (ages 13 to 
17) recruited from the Child and Adolescent Psychiatry Inpatient Program at the University of Michigan. Charts 
will be screened for eligibility based on either (1) past-month suicide attempt or (2) past-week suicidal ideation 
with method, intent, or plan (based on Columbia-Suicide Severity Rating Scale29). Exclusion criteria will include 
(1) severe cognitive impairment or altered mental status (psychosis, manic state), (2) transfer to medical unit or 
residential placement, (3) no availability of a legal guardian, or (4) no cell phone with text messaging capability. 
Adolescents and parents will be approached during admission or visiting hours. Those who provide 
consent/assent will participate in Aim 1(text component development) or Aim 2 (pilot SMART).  
 
Aim 2 activities are described below. 
 
Pilot Design. Eighty adolescents (ages 13-17) meeting inclusion/exclusion criteria and their parents will 
participate in the SMART pilot. All participants who complete the baseline assessment will receive the in-
person intervention components (individua and family meeting) on the inpatient unit and will subsequently be 
randomized as outlined below. 
The in-person MI-SafeCope intervention will be delivered during the inpatient stay and the adolescent’s 
condition (stabilization; e.g. likely not on the first day of being admitted) will be considered for the timing of 
intervention delivery. The meeting with the adolescent will take approximately 60 minutes, the family meeting 
approximately 30 minutes. The in-person intervention component will be guided by the goal to develop 
personalized coping strategies that the adolescent has self-efficacy and motivation to use after discharge (a 
safety plan template will be used in the session) and by empowering the adolescent’s parent/guardian to 
supporting the adolescent’s coping (Parent Crisis Card will be used in the session). Sessions will be tape 
recorded for clinician supervision purposes, and participants will be asked to provide a brief feedback survey.  
As shown in the Figure, adolescents will be randomized twice. The first randomization will be to either MI-
enhanced safety plan at hospitalization alone (the in-person intervention component described above) or MI-
enhanced safety plan at hospitalization in combination with text boosters for two weeks after discharge (Phase 

 
4
+ 
1). At the end of week 2, all participants will be re-randomized to two additional weeks of either: (a) 
continuation of Phase 1 intervention or (b) continuation of Phase 1 intervention with the addition of the MI-
enhanced booster call in week 3 (Phase 2). Thus, participants will receive one of four treatment sequences (A-
D; see Figure).  
For those randomized to receive the MI-enhanced booster call, the study therapist will call the adolescent 
and parent approximately three weeks of discharge. The booster phone call with adolescent and with parent, 
each conducted separately, will take approximately 15 minutes. In the even that a teen is rehospitalized prior to 
the booster call being completed, we will try to complete the follow-up call during the teen’s hospitalization stay 
(if appropriate, e.g. the teen has been stabilized) or approximately within one or two weeks following the new 
discharge. For participants randomized to receive text boosters, messages will be sent once a day (“pushes”) 
for a total of 4 weeks, and teens will receive a second text message enabling them to request additional 
support messages by texting a pre-specified keyword (“pulls”). Thus, teens will receive two supportive text 
messages per day. The “bank” of these messages is based on feedback from teens obtained in Aim 1. 
Participants will receive the messages at a time that is identified by participants. Messages will be sent to 
participants’ phone using an automated and secure text message delivery system. 
 
 
k 
Figure. Pilot Design 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Measures and Assessment Protocol. 
 
Primary Outcome Measures: 
1. Percentage of eligible participants recruited will be used to assess feasibility and acceptability.  
2. Percentage of randomized participants and who complete intervention components will be used to 
assess feasibility and acceptability.  
3. Percentage of participants who complete study assessments will be used to assess feasibility and 
acceptability.  
4. Satisfaction ratings will be used to assess acceptability.  
 
All other measures are considered exploratory. 
 
Assessments:  
 
a. Baseline Assessments (adolescents and guardians/parents) 
Participants will be asked to complete baseline measures using Qualtrics on Tablet computers. Participants 
will be provided the option of filling out the baseline measures using a paper and pencil format if they prefer or 
if any technological difficulties are encountered that would prevent the completion of the surveys on a Tablet 
computer. In addition, parents who are not able to fill out baseline surveys in person, will have the option to 
complete these by phone or via internet (Qualtrics) survey link sent to their email or by text message. 
Participating adolescents and parents will be compensated $20 and $10, respectively, for completing the 
baseline assessment.  
 
b.  1- and 3-month Follow-ups (adolescents and guardians/parents) 
MI-Enhanced 
Safety Plan 
 
R 
N= 80 
R 
A 
B 
Ecological Momentary Assessment (once a day; weeks 1-4) 
1-mo. 
Asses. 
Discharge  
Hospitalization 
Weeks 1—2 
Weeks 3—4 
 
 
MI-Enhanced  
Text Boosters  
 
 
Monitoring 
+ 
MI-Enhanced 
Safety Plan  
 
Monitoring 
3-mo. 
Asses. 
Continue MI Text Boosters  
 
+ Monitoring 
N = 20 
N = 20 
MI-Enhanced Booster Call (week 3) 
 
+ Monitoring 
N = 20 
N = 20 
R 
D 
C 
Monitoring 
+ 
N = 40 
N = 40 
MI-Enhanced Booster Call (week 3)  
 
+ Continue MI Text Boosters 
 
+ Monitoring 
Baseline 
Assessme

 
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These assessments will be completed over the phone, however, participants will have the option of 
completing all or some of these follow-up measures online; they may also have the option to receive these 
measures online but provide their answers to a research staff member over the phone to facilitate the phone 
assessment. For each of the 1- and 3-month follow-up assessment, adolescents will receive $30 and parents 
will receive $20 as a thank you for their time. The compensation will be provided as a gift card in person and 
follow-up compensation will be loaded after completing the follow-up assessments.  
 
c.  Daily Surveys) (adolescents) 
Participating adolescents will be asked to complete daily surveys for 4 weeks after discharge. Participants 
will be compensated up to $142 for completing daily surveys ($4 x 28 days and an additional $30 if they 
complete 75% daily surveys). Online survey links will be sent via text message to participants’ phones once a 
day in the evening for a month. The Qualtrics survey links (using the University of Michigan Qualtrics system) 
will be sent to participants by a text message. Participants will be able to complete these 2-5 minute surveys 
on their phone or by copying the link into a computer browser (if they do not have a smartphone). Participants 
may be contacted by phone if they miss three consecutive surveys to inquire if they are experiencing technical 
difficulties. We will assess suicidal ideation/behavior, coping behavior, self-efficacy, and other factors (affect, 
connectedness, hopelessness, etc.). Of note, the automated text message delivery system will not store 
identifiable information, including names, demographic information, any other sensitive information, or data. 
The survey links themselves received by participants will link to the University of Michigan Qualtrics data 
collection tool. No identifying information will be collected via daily diaries using Qualtrics.  
 
Risk Management. 
a. Daily Diaries: 
Participant daily responses (particularly suicidal ideation questions) will be monitored very closely to 
determine if there is an increase in level of suicide risk. This will be achieved in several ways.  
 
(1) An endorsement of an acute/high level of risk (defined as an endorsement of current suicidal ideation 
together with current suicidal intent or plan OR an endorsement of a suicide attempt in the last 24 hours) on 
the daily questionnaire will result in an automated message displayed as part of the survey urging that the 
participant seeks support and providing phone numbers to the crisis line and emergency contacts. The PI, or 
the backup clinician on call, will also receive an automated message from Qualtrics that a participant with a 
specific ID number endorsed acute risk. To protect confidentiality, this notification will only indicate a specific ID 
number associated with a participant endorsing this response. As the primary on-call psychologist, the PI, or 
backup on-call clinician, will initiate the Action Plan, which will involve calling the adolescent and 
parent/guardian as soon as possible on the same day. Once a participant is contacted, an Action Plan will be 
filled out and recommendations will be made. If the adolescent and/or parent are not reachable after several 
tries to reach them, the PI, or backup clinician on-call, may contact appropriate emergency services or 
authorities to seek assistance. This will be described in the consent form and discussed with participants 
during the consent process. It is important to also note that participant responses will be reviewed daily to 
safeguard against the unlikely possibility that acute/high risk participants were missed via the automated alert 
process. 
 
(2) An endorsement of a moderate level of risk (defined as an endorsement of suicidal ideation within the 
last 24 hours but no current suicidal intent or plan) on the daily questionnaire will result in an automated 
message displayed as part of the survey urging that the participant seems support and providing phone 
numbers to the crisis line and emergency contacts. 
 
 
b. Follow-up Assessments and Follow-up Phone Call: 
 
Participants who disclose either a) current active suicidal thoughts (within the last week) or b) who disclose 
suicidal action (actual attempt, aborted, or interrupted suicide attempt) since last assessment will be asked 
follow-up questions, as per Action Plan, and appropriate recommendations – in consultation with an on-call 
clinician— will be provided. Risk management procedures will be reviewed regularly to ensure compliance with 
the protocol. 
 
 

 
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Therapist Training and Fidelity. Training and fidelity protocols/tools will be developed in Aim 1. Therapists 
will participate in a MI training workshop and will complete intervention-specific training that will be developed 
and provided by the PI. Therapists will demonstrate proficiency by completing a series of role-plays prior to 
delivering the intervention. To monitor fidelity, therapists will audiotape all sessions. Audiotapes will be 
reviewed by the PI, and a randomly selected subset (25%) will be coded using the fidelity assessment tool. 
Regular supervision and booster trainings to reduce therapist drift will be provided by the PI. Therapists will 
also be trained in crisis management and the study’s risk management protocol. 
. 
 
Data Analysis. We will obtain data related to intervention feasibility and acceptability, including retention and 
adherence rates, participant satisfaction with intervention, and intervention fidelity/adherence. We will also 
explore candidate primary tailoring variables for Phase 2 re-randomization and estimate rates of 
respondents/non-respondents to Phase 1 intervention. Receiver Operating Characteristic (ROC) analyses will 
be used to explore predictive validity and utility (sensitivity/specificity) of candidate primary tailoring variables 
collected via daily surveys within 2 weeks post discharge in predicting 1- and 3-month outcomes (e.g., suicidal 
ideation/behavior). Using multi-level analyses for continuous (SAS PROC MIXED) and non-normally distributed 
(SAS PROC GLIMMIX) variables, exploratory analyses of the effect of the Phase 1 and 2 interventions on 
daily-level mechanisms (e.g., coping behavior, self-efficacy to refrain from suicidal action, safety plan use) as 
well as the 1- and 3-month proximal (e.g., self-efficacy to cope with suicidal urges, parent self-efficacy) and 
distal (e.g., suicidal ideation/behavior) outcomes will be conducted. Using multi-level analyses, exploratory 
analyses of potential baseline moderators (e.g., attempt history) will be conducted to determine who might 
benefit more from Phase 1 and 2 interventions. Because pilot studies are not powered for efficacy,30 we will 
examine if the pattern of change is in the desired direction (e.g. increase in self-efficacy; decrease in suicidal 
ideation).  
 
 
 
 
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