Trial Outcomes & Findings for An Adaptive Intervention for Adolescents at Risk for Suicide: A Pilot SMART (NCT NCT03838198)

Last Updated: 2021-05-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

82 participants

Primary outcome timeframe

At time of study enrollment, measured following study consent/assent

Results posted on

2021-05-28

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Safety Plan + Booster Text Messages + Booster Call 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.	Safety Plan + Booster Text Messages 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.	Safety Plan + Booster 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.	Safety Plan 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.
Phase 1: Safety Plan (SP) vs. SP w/Texts STARTED	0	40	0	40
Phase 1: Safety Plan (SP) vs. SP w/Texts COMPLETED	0	40	0	40
Phase 1: Safety Plan (SP) vs. SP w/Texts NOT COMPLETED	0	0	0	0
Phase 2: Added Booster Call or Not STARTED	18	22	18	22
Phase 2: Added Booster Call or Not COMPLETED	18	0	17	0
Phase 2: Added Booster Call or Not NOT COMPLETED	0	22	1	22
1 Month Follow up Period STARTED	18	22	17	22
1 Month Follow up Period Adolescent Surveys Completed	16	22	16	22
1 Month Follow up Period COMPLETED	16	22	16	21
1 Month Follow up Period NOT COMPLETED	2	0	1	1
3 Month Follow up Period STARTED	18	22	17	22
3 Month Follow up Period Adolescent Survey Completed	16	21	15	21
3 Month Follow up Period COMPLETED	15	19	14	18
3 Month Follow up Period NOT COMPLETED	3	3	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Safety Plan + Booster Text Messages + Booster Call 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.	Safety Plan + Booster Text Messages 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.	Safety Plan + Booster 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.	Safety Plan 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.
Phase 2: Added Booster Call or Not Withdrawal by Subject	0	0	1	0
Phase 2: Added Booster Call or Not In this SMART trial design, this group was randomized to "no booster call.	0	22	0	22

Baseline Characteristics

For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: At time of study enrollment, measured following study consent/assent

Population: Eligible youth whether consent was provided or not

Outcome measures

Outcome measures
Measure	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.	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.	Safety Plan + Booster Text Messages + Booster Call (Group A) n=94 Participants 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.	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.
Percentage of Eligible Participants Recruited to the Study	—	—	87.2 Percentage of eligible participants	—

PRIMARY outcome

Timeframe: Following intervention, measured up to 1 month

Population: No texts and boosters were planned for the associated data fields

Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability

Outcome measures

Outcome measures
Measure	Safety Plan + Booster Call (Group C) n=18 Participants 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.	Safety Plan (Group D) n=22 Participants 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.	Safety Plan + Booster Text Messages + Booster Call (Group A) n=18 Participants 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.	Safety Plan + Booster Text Messages (Group B) n=22 Participants 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.
Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability Safety Plan (Phase 1)	100 percent of participants	100 percent of participants	100 percent of participants	100 percent of participants
Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability Booster Texts	—	—	100 percent of participants	100 percent of participants
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	—	88.9 percent of participants	—

PRIMARY outcome

Timeframe: Following intervention and follow-up assessment, measured up to 3 months

Population: Intent to treat analysis includes all participants assigned

Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability

Outcome measures

Outcome measures
Measure	Safety Plan + Booster Call (Group C) n=18 Participants 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.	Safety Plan (Group D) n=22 Participants 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.	Safety Plan + Booster Text Messages + Booster Call (Group A) n=18 Participants 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.	Safety Plan + Booster Text Messages (Group B) n=22 Participants 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.
Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability	94.4 percent of participants	100 percent of participants	100 percent of participants	100 percent of participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Safety Plan + Booster Call (Group C) n=16 Participants 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.	Safety Plan (Group D) n=22 Participants 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.	Safety Plan + Booster Text Messages + Booster Call (Group A) n=17 Participants 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.	Safety Plan + Booster Text Messages (Group B) n=22 Participants 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.
Satisfaction Ratings Will be Used to Assess Acceptability Satisfaction score	3.31 units on a scale Standard Deviation 0.79	3.55 units on a scale Standard Deviation 0.6	3.59 units on a scale Standard Deviation 0.51	3.55 units on a scale Standard Deviation 0.51
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	3.64 units on a scale Standard Deviation 0.49	3.82 units on a scale Standard Deviation 0.39	3.77 units on a scale Standard Deviation 0.43

Adverse Events

Safety Plan + Booster Text Messages + Booster Call (Group A)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Safety Plan + Booster Text Messages (Group B)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Safety Plan + Booster Call (Group C)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Safety Plan (Group D)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Safety Plan + Booster Text Messages + Booster Call (Group A) n=15 participants at risk 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.	Safety Plan + Booster Text Messages (Group B) n=19 participants at risk 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.	Safety Plan + Booster Call (Group C) n=14 participants at risk 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.	Safety Plan (Group D) n=20 participants at risk 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.
Psychiatric disorders Suicide Attempt	0.00% 0/15 • Data on suicide attempts was collected over a 3 month period. 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.	10.5% 2/19 • Data on suicide attempts was collected over a 3 month period. 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.	21.4% 3/14 • Data on suicide attempts was collected over a 3 month period. 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.	15.0% 3/20 • Data on suicide attempts was collected over a 3 month period. 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.

Other adverse events

Adverse event data not reported

Additional Information

Ewa Czyz

University of Michigan

Phone: 734-764-9466

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase 1 - Safety Plan n=41 Participants 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	Phase 1 - Safety Plan & Text Messages n=42 Participants Participants who received the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.	Total n=83 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=41 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	1 Participants n=42 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	2 Participants n=83 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.
Count of participants with at least one suicide attempt during their lifetime	21 Participants n=40 Participants • This is the actual number of participants assigned to this group	19 Participants n=40 Participants • This is the actual number of participants assigned to this group	40 Participants n=80 Participants • This is the actual number of participants assigned to this group
Age, Continuous	15.08 years STANDARD_DEVIATION 1.4 • n=40 Participants • This is the actual number of participants assigned to this group	15.25 years STANDARD_DEVIATION 1.32 • n=40 Participants • This is the actual number of participants assigned to this group	15.16 years STANDARD_DEVIATION 1.35 • n=80 Participants • This is the actual number of participants assigned to this group
Sex: Female, Male Female	27 Participants n=40 Participants • This is the actual number of participants assigned to this group	27 Participants n=40 Participants • This is the actual number of participants assigned to this group	54 Participants n=80 Participants • This is the actual number of participants assigned to this group
Sex: Female, Male Male	13 Participants n=40 Participants • This is the actual number of participants assigned to this group	13 Participants n=40 Participants • This is the actual number of participants assigned to this group	26 Participants n=80 Participants • This is the actual number of participants assigned to this group
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=41 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	1 Participants n=42 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	4 Participants n=83 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.
Race (NIH/OMB) Asian	2 Participants n=41 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	2 Participants n=42 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	4 Participants n=83 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	1 Participants n=42 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	1 Participants n=83 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.
Race (NIH/OMB) Black or African American	3 Participants n=41 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	2 Participants n=42 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	5 Participants n=83 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.
Race (NIH/OMB) White	32 Participants n=41 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	35 Participants n=42 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	67 Participants n=83 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.
Race (NIH/OMB) More than one race	0 Participants n=41 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	0 Participants n=42 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.	0 Participants n=83 Participants • For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.
Last-month suicide attempt	18 Participants n=40 Participants • This is the actual number of participants assigned to this group	12 Participants n=40 Participants • This is the actual number of participants assigned to this group	30 Participants n=80 Participants • This is the actual number of participants assigned to this group
Multiple attempt history	14 Participants n=40 Participants • This is the actual number of participants assigned to this group	14 Participants n=40 Participants • This is the actual number of participants assigned to this group	28 Participants n=80 Participants • This is the actual number of participants assigned to this group
Lifetime nonsuicidal self-injury	31 Participants n=40 Participants • This is the actual number of participants assigned to this group	31 Participants n=40 Participants • This is the actual number of participants assigned to this group	62 Participants n=80 Participants • This is the actual number of participants assigned to this group
Suicidal ideation mean	3.90 units on a scale STANDARD_DEVIATION .90 • n=40 Participants • This is the actual number of participants assigned to this group	3.93 units on a scale STANDARD_DEVIATION 0.92 • n=40 Participants • This is the actual number of participants assigned to this group	3.91 units on a scale STANDARD_DEVIATION 0.90 • n=80 Participants • This is the actual number of participants assigned to this group
Common Diagnoses Depressive disorder	32 Participants n=40 Participants • This is the actual number of participants assigned to this group	37 Participants n=40 Participants • This is the actual number of participants assigned to this group	69 Participants n=80 Participants • This is the actual number of participants assigned to this group
Common Diagnoses Anxiety disorder	20 Participants n=40 Participants • This is the actual number of participants assigned to this group	23 Participants n=40 Participants • This is the actual number of participants assigned to this group	43 Participants n=80 Participants • This is the actual number of participants assigned to this group