An Adaptive Intervention for Adolescents at Risk for Suicide: A Pilot SMART
Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT03838198
Collaborator
National Institute of Mental Health (NIMH) (NIH)
82
1
4
12.8
6.4
Study Details
Study Description
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
82 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
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).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).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Developing an Adaptive Intervention for Suicidal Adolescents Following Inpatient Hospitalization: A Pilot SMART
Actual Study Start Date
:
Mar 14, 2019
Actual Primary Completion Date
:
Apr 7, 2020
Actual Study Completion Date
:
Apr 7, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Safety plan + booster text messages + booster call (Group A) Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive 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-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call. |
Behavioral: MI-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.
Behavioral: MI-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.
Behavioral: MI-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.
|
| Other: Safety plan + booster text messages (Group B) Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge. |
Behavioral: MI-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.
Behavioral: MI-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.
|
| Other: Safety plan + booster call (Group C) Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call. |
Behavioral: MI-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.
Behavioral: MI-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.
|
| Other: Safety plan (Group D) Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization. |
Behavioral: MI-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.
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
13 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Ewa Czyz, University of Michigan
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Ewa Czyz,
Assistant Professor,
University of Michigan
ClinicalTrials.gov Identifier:
NCT03838198
Other Study ID Numbers:
- HUM00129173
- 1K23MH113776-01
First Posted:
Feb 12, 2019
Last Update Posted:
May 28, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ewa Czyz,
Assistant Professor,
University of Michigan
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Safety Plan + Booster Text Messages + Booster Call | Safety Plan + Booster Text Messages | Safety Plan + Booster Call | Safety Plan |
|---|---|---|---|---|
| Arm/Group Description | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive 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 -- which will be followed by 4 weeks of daily post-discharge booster text messages and in Period/Phase 2 a phone booster call. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge without booster phone call. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization with neither follow-up text messages nor booster phone call. |
| Period Title: Phase 1: Safety Plan (SP) vs. SP w/Texts | ||||
| STARTED | 0 | 40 | 0 | 40 |
| COMPLETED | 0 | 40 | 0 | 40 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: Phase 1: Safety Plan (SP) vs. SP w/Texts | ||||
| STARTED | 18 | 22 | 18 | 22 |
| COMPLETED | 18 | 0 | 17 | 0 |
| NOT COMPLETED | 0 | 22 | 1 | 22 |
| Period Title: Phase 1: Safety Plan (SP) vs. SP w/Texts | ||||
| STARTED | 18 | 22 | 17 | 22 |
| Adolescent Surveys Completed | 16 | 22 | 16 | 22 |
| COMPLETED | 16 | 22 | 16 | 21 |
| NOT COMPLETED | 2 | 0 | 1 | 1 |
| Period Title: Phase 1: Safety Plan (SP) vs. SP w/Texts | ||||
| STARTED | 18 | 22 | 17 | 22 |
| Adolescent Survey Completed | 16 | 21 | 15 | 21 |
| COMPLETED | 15 | 19 | 14 | 18 |
| NOT COMPLETED | 3 | 3 | 3 | 4 |
Baseline Characteristics
| Arm/Group Title | Phase 1 - Safety Plan | Phase 1 - Safety Plan & Text Messages | Total |
|---|---|---|---|
| Arm/Group Description | 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 | Participants who received the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge. | Total of all reporting groups |
| Overall Participants | 41 | 42 | 83 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
15.08
(1.4)
|
15.25
(1.32)
|
15.16
(1.35)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
27
65.9%
|
27
64.3%
|
54
65.1%
|
| Male |
13
31.7%
|
13
31%
|
26
31.3%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
3
7.3%
|
1
2.4%
|
4
4.8%
|
| Asian |
2
4.9%
|
2
4.8%
|
4
4.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
2.4%
|
1
1.2%
|
| Black or African American |
3
7.3%
|
2
4.8%
|
5
6%
|
| White |
32
78%
|
35
83.3%
|
67
80.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
2.4%
|
1
2.4%
|
2
2.4%
|
| Count of participants with at least one suicide attempt during their lifetime (Count of Participants) | |||
| Count of Participants [Participants] |
21
51.2%
|
19
45.2%
|
40
48.2%
|
| Last-month suicide attempt (Count of Participants) | |||
| Count of Participants [Participants] |
18
43.9%
|
12
28.6%
|
30
36.1%
|
| Multiple attempt history (Count of Participants) | |||
| Count of Participants [Participants] |
14
34.1%
|
14
33.3%
|
28
33.7%
|
| Lifetime nonsuicidal self-injury (Count of Participants) | |||
| Count of Participants [Participants] |
31
75.6%
|
31
73.8%
|
62
74.7%
|
| Suicidal ideation mean (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
3.90
(.90)
|
3.93
(0.92)
|
3.91
(0.90)
|
| Common Diagnoses (Count of Participants) | |||
| Depressive disorder |
32
78%
|
37
88.1%
|
69
83.1%
|
| Anxiety disorder |
20
48.8%
|
23
54.8%
|
43
51.8%
|
Outcome Measures
| Title | Percentage of Eligible Participants Recruited to the Study |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible youth whether consent was provided or not |
| Arm/Group Title | All Eligible Youth |
|---|---|
| Arm/Group Description | Potential participants prior to randomization |
| Measure Participants | 94 |
| Number [Percentage of eligible participants] |
87.2
212.7%
|
| Title | Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| No texts and boosters were planned for the associated data fields |
| Arm/Group Title | Safety Plan + Booster Text Messages + Booster Call (Group A) | Safety Plan + Booster Text Messages (Group B) | Safety Plan + Booster Call (Group C) | Safety Plan (Group D) |
|---|---|---|---|---|
| Arm/Group Description | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive 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-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization. |
| Measure Participants | 18 | 22 | 18 | 22 |
| Safety Plan (Phase 1) |
100
243.9%
|
100
238.1%
|
100
120.5%
|
100
NaN
|
| Booster Texts |
100
243.9%
|
100
238.1%
|
||
| Booster Call (Phase 2) |
88.9
216.8%
|
88.9
211.7%
|
| Title | Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat analysis includes all participants assigned |
| Arm/Group Title | Safety Plan + Booster Text Messages + Booster Call (Group A) | Safety Plan + Booster Text Messages (Group B) | Safety Plan + Booster Call (Group C) | Safety Plan (Group D) |
|---|---|---|---|---|
| Arm/Group Description | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive 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-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization. |
| Measure Participants | 18 | 22 | 18 | 22 |
| Number [percent of participants] |
100
243.9%
|
100
238.1%
|
94.4
113.7%
|
100
NaN
|
| Title | Satisfaction Ratings Will be Used to Assess Acceptability |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Safety Plan + Booster Text Messages + Booster Call (Group A) | Safety Plan + Booster Text Messages (Group B) | Safety Plan + Booster Call (Group C) | Safety Plan (Group D) |
|---|---|---|---|---|
| Arm/Group Description | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive 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-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization. |
| Measure Participants | 17 | 22 | 16 | 22 |
| Satisfaction score |
3.59
(0.51)
|
3.55
(0.51)
|
3.31
(0.79)
|
3.55
(0.6)
|
| Likelihood of recommending plan to a friend score |
3.82
(0.39)
|
3.77
(0.43)
|
3.38
(0.81)
|
3.64
(0.49)
|
Adverse Events
| Time Frame | Data on suicide attempts was collected over a 3 month period. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Since all participants were hospitalized for suicide risk (ideation or attempts) to be eligible, those who were unreachable at follow-up weren't included in denominators of suicide attempt data, as they couldn't be presumed to have attempted suicide nor could they be presumed with certainty not to have attempted suicide. Thus it is most accurate to report only known data that is based on collected AEs. Non-serious Adverse Events were not collected. | |||||||
| Arm/Group Title | Safety Plan + Booster Text Messages + Booster Call (Group A) | Safety Plan + Booster Text Messages (Group B) | Safety Plan + Booster Call (Group C) | Safety Plan (Group D) | ||||
| Arm/Group Description | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive 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-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call. | Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization. | ||||
All Cause Mortality |
||||||||
| Safety Plan + Booster Text Messages + Booster Call (Group A) | Safety Plan + Booster Text Messages (Group B) | Safety Plan + Booster Call (Group C) | Safety Plan (Group D) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | 0/22 (0%) | 0/18 (0%) | 0/22 (0%) | ||||
Serious Adverse Events |
||||||||
| Safety Plan + Booster Text Messages + Booster Call (Group A) | Safety Plan + Booster Text Messages (Group B) | Safety Plan + Booster Call (Group C) | Safety Plan (Group D) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 2/19 (10.5%) | 3/14 (21.4%) | 3/20 (15%) | ||||
| Psychiatric disorders | ||||||||
| Suicide Attempt | 0/15 (0%) | 2/19 (10.5%) | 3/14 (21.4%) | 3/20 (15%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Safety Plan + Booster Text Messages + Booster Call (Group A) | Safety Plan + Booster Text Messages (Group B) | Safety Plan + Booster Call (Group C) | Safety Plan (Group D) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Ewa Czyz |
|---|---|
| Organization | University of Michigan |
| Phone | 734-764-9466 |
| ewac@umich.edu |
Responsible Party:
Ewa Czyz,
Assistant Professor,
University of Michigan
ClinicalTrials.gov Identifier:
NCT03838198
Other Study ID Numbers:
- HUM00129173
- 1K23MH113776-01
First Posted:
Feb 12, 2019
Last Update Posted:
May 28, 2021
Last Verified:
May 1, 2021