Self Harm, Suicide
Conditions
Keywords
Adaptive Intervention, Sequential, Multiple Assignment, Randomized Trial (SMART), Adolescent, Motivational Interviewing, Suicide attempt, Safety planning, mobile technology
Brief summary
To inform the development of a technology-augmented adaptive intervention for adolescents at risk for suicide, the goal of this study is to conduct a Sequential, Multiple Assignment, Randomized Trial (SMART) pilot of a Motivational Interview (MI)-enhanced safety planning intervention (MI-SafeCope). Findings from this study will provide the groundwork for the construction of a technology-augmented adaptive intervention that could lead to a reduction in suicidal behaviors and related events during the high-risk post-discharge period-an important suicide prevention target.
Interventions
BEHAVIORALMI-Enhanced Safety Plan at Hospitalization (1st Component)
The MI-enhanced safety plan intervention component is delivered during hospitalization and includes an individual and family meetings. The goal of the individual meeting with the adolescent is to develop an individualized safety plan for use during a suicidal crisis. This best practices approach of safety planning is augmented with Motivational Interviewing (MI) 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. The focus of the family meeting, which is similarly guided by MI, is to prepare parents/guardians, 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.
BEHAVIORALMI-Enhanced Text Boosters (2nd Component)
For participants randomized to receive text boosters, booster text messages will be sent daily for 4 weeks. The messages will be tailored to encourage use of individualized coping strategies identified as part of safety planning at hospitalization and will include additional adaptive coping tools and resources. The text message content and tone will be consistent with principles of MI.
BEHAVIORALMI-Enhanced Booster Call (3rd Component)
The focus of the post-discharge booster phone call with adolescent and with parent, each conducted separately, will be to 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.
Sponsors
National Institute of Mental Health (NIMH)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This Sequential, Multiple Assignment, Randomized Trial (SMART) pilot of a Motivational Interview (MI)-enhanced safety planning intervention is designed to inform the development of a technology-augmented adaptive intervention for youth at risk for suicide. The MI-SafeCope intervention includes three components: (1) MI-enhanced safety plan delivered during hospitalization (encompassing individual and family meetings); (2) post-discharge booster call; and (3) post-discharge daily text message boosters. In this SMART pilot, adolescents will be randomized to either MI-enhanced safety plan alone or in combination with text boosters for two weeks after discharge (Phase 1 intervention). At the end of week 2, adolescents will be re-randomized to two additional weeks of either: continuation of Phase 1 intervention or continuation of Phase 1 intervention with the addition of post-discharge booster call. Thus, participants will receive one of four treatment sequences (Groups A-D).
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Suicide attempt (previous month), and/or * Suicidal ideation (previous week)
Exclusion criteria
* Severe cognitive impairment or altered mental status (psychosis, manic state) * Transfer to medical unit or residential placement * No availability of a legal guardian * No cell phone with text messaging capability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eligible Participants Recruited to the Study | At time of study enrollment, measured following study consent/assent | Eligible participants were candidates for participation based on medical record review who were approached for consent/assent. The percentage of eligible participants who consented to the study is presented below. |
| Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability | Following intervention, measured up to 1 month | Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability |
| Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability | Following intervention and follow-up assessment, measured up to 3 months | Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability |
| Satisfaction Ratings Will be Used to Assess Acceptability | Following intervention and follow-up assessment, measured up to 3 months | Satisfaction was scored by responses to two questions: How satisfied were you? on a 4 point scale, where 1 means very dissatisfied and 4 means very satisfied and how likely would you be to recommend this program to a friend in similar circumstances, on the same point scale, where 1 means definitely not and 4 means definitely yes |
Countries
United States
Participant flow
Pre-assignment details
Of a larger number of hospital admissions records reviewed, 94 persons were deemed eligible and were approached. 82 consented to participate in the trial, of whom, two participants were consented but excluded prior to randomization because they were discharged early.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1 - Safety Plan Participants who received the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies | 41 |
| Phase 1 - Safety Plan & Text Messages Participants who received the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge. | 42 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Phase 2: Added Booster Call or Not | In this SMART trial design, this group was randomized to no booster call. | 0 | 22 | 0 | 22 |
| Phase 2: Added Booster Call or Not | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Phase 1 - Safety Plan & Text Messages | Phase 1 - Safety Plan |
|---|---|---|---|
| Age, Continuous | 15.16 years STANDARD_DEVIATION 1.35 | 15.25 years STANDARD_DEVIATION 1.32 | 15.08 years STANDARD_DEVIATION 1.4 |
| Common Diagnoses Anxiety disorder | 43 Participants | 23 Participants | 20 Participants |
| Common Diagnoses Depressive disorder | 69 Participants | 37 Participants | 32 Participants |
| Count of participants with at least one suicide attempt during their lifetime | 40 Participants | 19 Participants | 21 Participants |
| Last-month suicide attempt | 30 Participants | 12 Participants | 18 Participants |
| Lifetime nonsuicidal self-injury | 62 Participants | 31 Participants | 31 Participants |
| Multiple attempt history | 28 Participants | 14 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 67 Participants | 35 Participants | 32 Participants |
| Sex: Female, Male Female | 54 Participants | 27 Participants | 27 Participants |
| Sex: Female, Male Male | 26 Participants | 13 Participants | 13 Participants |
| Suicidal ideation mean | 3.91 units on a scale STANDARD_DEVIATION 0.9 | 3.93 units on a scale STANDARD_DEVIATION 0.92 | 3.90 units on a scale STANDARD_DEVIATION 0.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 22 | 0 / 18 | 0 / 22 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 15 | 2 / 19 | 3 / 14 | 3 / 20 |
Outcome results
Primary
Percentage of Eligible Participants Recruited to the Study
Eligible participants were candidates for participation based on medical record review who were approached for consent/assent. The percentage of eligible participants who consented to the study is presented below.
Time frame: At time of study enrollment, measured following study consent/assent
Population: Eligible youth whether consent was provided or not
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Youth | Percentage of Eligible Participants Recruited to the Study | 87.2 Percentage of eligible participants |
Primary
Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability
Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability
Time frame: Following intervention and follow-up assessment, measured up to 3 months
Population: Intent to treat analysis includes all participants assigned
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Youth | Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability | 100 percent of participants |
| Safety Plan + Booster Text Messages (Group B) | Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability | 100 percent of participants |
| Safety Plan + Booster Call (Group C) | Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability | 94.4 percent of participants |
| Safety Plan (Group D) | Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability | 100 percent of participants |
Primary
Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability
Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability
Time frame: Following intervention, measured up to 1 month
Population: No texts and boosters were planned for the associated data fields
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Eligible Youth | Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability | Safety Plan (Phase 1) | 100 percent of participants |
| All Eligible Youth | Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability | Booster Texts | 100 percent of participants |
| All Eligible Youth | Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability | Booster Call (Phase 2) | 88.9 percent of participants |
| Safety Plan + Booster Text Messages (Group B) | Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability | Booster Texts | 100 percent of participants |
| Safety Plan + Booster Text Messages (Group B) | Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability | Safety Plan (Phase 1) | 100 percent of participants |
| Safety Plan + Booster Call (Group C) | Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability | Booster Call (Phase 2) | 88.9 percent of participants |
| Safety Plan + Booster Call (Group C) | Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability | Safety Plan (Phase 1) | 100 percent of participants |
| Safety Plan (Group D) | Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability | Safety Plan (Phase 1) | 100 percent of participants |
Primary
Satisfaction Ratings Will be Used to Assess Acceptability
Satisfaction was scored by responses to two questions: How satisfied were you? on a 4 point scale, where 1 means very dissatisfied and 4 means very satisfied and how likely would you be to recommend this program to a friend in similar circumstances, on the same point scale, where 1 means definitely not and 4 means definitely yes
Time frame: Following intervention and follow-up assessment, measured up to 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Eligible Youth | Satisfaction Ratings Will be Used to Assess Acceptability | Satisfaction score | 3.59 units on a scale | Standard Deviation 0.51 |
| All Eligible Youth | Satisfaction Ratings Will be Used to Assess Acceptability | Likelihood of recommending plan to a friend score | 3.82 units on a scale | Standard Deviation 0.39 |
| Safety Plan + Booster Text Messages (Group B) | Satisfaction Ratings Will be Used to Assess Acceptability | Likelihood of recommending plan to a friend score | 3.77 units on a scale | Standard Deviation 0.43 |
| Safety Plan + Booster Text Messages (Group B) | Satisfaction Ratings Will be Used to Assess Acceptability | Satisfaction score | 3.55 units on a scale | Standard Deviation 0.51 |
| Safety Plan + Booster Call (Group C) | Satisfaction Ratings Will be Used to Assess Acceptability | Satisfaction score | 3.31 units on a scale | Standard Deviation 0.79 |
| Safety Plan + Booster Call (Group C) | Satisfaction Ratings Will be Used to Assess Acceptability | Likelihood of recommending plan to a friend score | 3.38 units on a scale | Standard Deviation 0.81 |
| Safety Plan (Group D) | Satisfaction Ratings Will be Used to Assess Acceptability | Satisfaction score | 3.55 units on a scale | Standard Deviation 0.6 |
| Safety Plan (Group D) | Satisfaction Ratings Will be Used to Assess Acceptability | Likelihood of recommending plan to a friend score | 3.64 units on a scale | Standard Deviation 0.49 |