Trial Outcomes & Findings for Southwest Hub for American Indian Youth Suicide Prevention Research (NCT NCT03543865)
NCT ID: NCT03543865
Last Updated: 2026-01-23
Results Overview
The SIQ for adults (ages \>14; 27 items) and SIQ-Junior for youth (ages ≤14; 13 items). Both measure frequency of suicidal thoughts on a 7-point Likert scale (0=Never to 6=Almost Every Day). Raw scores range from 0-162 (SIQ) and 0-78 (SIQ-JR); higher raw scores indicate greater suicidal ideation. Raw scores of ≥30 on the SIQ and ≥23 on the SIQ-JR indicate clinically severe suicidal ideation. To create comparable scores across age groups, raw scores were converted to z-scores based on the study sample's baseline distribution, calculated separately for adults and youth using their respective scale versions. A constant of 10 was added to all z-scores to facilitate interpretation. Interpretation of Z-scores: * Each unit change represents one standard deviation from the sample * Z-scores \>10 indicate above-average suicidal ideation (worse outcome) * Z-scores \<10 indicate below-average suicidal ideation (better outcome) A Z-score of 0 represents the population mean
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
304 participants
Primary outcome timeframe
Baseline, 30 days, 60 days, 90 days, 180 days
Results posted on
2026-01-23
Participant Flow
N=304 participants were consented, N=284 completed baseline
N=284 participants completed baseline data and were randomized to the study arms. The participants who were not randomized were marked lost to follow-up if staff could not contact them further, or withdrawn if they requested to withdraw from the study.
Participant milestones
| Measure |
New Hope (NH)
Participants Receive New Hope and Case Management
|
Elders' Resilience (ER)
Participants Receive Elders' Resilience Curriculum and Case Management
|
New Hope (NH) + Elders' Resilience (ER) + Case Management
Participants Receive New Hope, Elders' Resilience Curriculum and Case Management
|
Case Management (CM)
Case Management alone
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
71
|
68
|
65
|
80
|
|
Overall Study
COMPLETED
|
71
|
68
|
65
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Southwest Hub for American Indian Youth Suicide Prevention Research
Baseline characteristics by cohort
| Measure |
New Hope (NH)
n=71 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
Elders' Resiliency (ER)
n=68 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).
|
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
n=65 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
|
Control Condition
n=80 Participants
The control condition will only receive Case Management (CM) (n=76).
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age · 14 and younger
|
33 Participants
n=270 Participants
|
30 Participants
n=4 Participants
|
33 Participants
n=9 Participants
|
36 Participants
n=220 Participants
|
132 Participants
n=3 Participants
|
|
Age, Customized
Age · 15-19
|
19 Participants
n=270 Participants
|
17 Participants
n=4 Participants
|
20 Participants
n=9 Participants
|
28 Participants
n=220 Participants
|
84 Participants
n=3 Participants
|
|
Age, Customized
Age · 20-24
|
12 Participants
n=270 Participants
|
18 Participants
n=4 Participants
|
10 Participants
n=9 Participants
|
12 Participants
n=220 Participants
|
52 Participants
n=3 Participants
|
|
Age, Customized
Age · 25-29
|
7 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=220 Participants
|
16 Participants
n=3 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
19 Participants
n=270 Participants
|
20 Participants
n=4 Participants
|
12 Participants
n=9 Participants
|
21 Participants
n=220 Participants
|
72 Participants
n=3 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
51 Participants
n=270 Participants
|
48 Participants
n=4 Participants
|
51 Participants
n=9 Participants
|
59 Participants
n=220 Participants
|
209 Participants
n=3 Participants
|
|
Sex/Gender, Customized
Sex · Do not wish to disclose
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
|
Sex/Gender, Customized
Sex · Missing
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
71 Participants
n=270 Participants
|
68 Participants
n=4 Participants
|
65 Participants
n=9 Participants
|
80 Participants
n=220 Participants
|
284 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 days, 180 daysPopulation: Participants with data collected
The SIQ for adults (ages \>14; 27 items) and SIQ-Junior for youth (ages ≤14; 13 items). Both measure frequency of suicidal thoughts on a 7-point Likert scale (0=Never to 6=Almost Every Day). Raw scores range from 0-162 (SIQ) and 0-78 (SIQ-JR); higher raw scores indicate greater suicidal ideation. Raw scores of ≥30 on the SIQ and ≥23 on the SIQ-JR indicate clinically severe suicidal ideation. To create comparable scores across age groups, raw scores were converted to z-scores based on the study sample's baseline distribution, calculated separately for adults and youth using their respective scale versions. A constant of 10 was added to all z-scores to facilitate interpretation. Interpretation of Z-scores: * Each unit change represents one standard deviation from the sample * Z-scores \>10 indicate above-average suicidal ideation (worse outcome) * Z-scores \<10 indicate below-average suicidal ideation (better outcome) A Z-score of 0 represents the population mean
Outcome measures
| Measure |
New Hope (NH)
n=71 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
Elders' Resiliency (ER)
n=68 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).
|
Control Condition
n=80 Participants
The control condition will only receive Case Management (CM) (n=76).
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
n=65 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
|
|---|---|---|---|---|
|
Suicide Ideation Questionnaire (SIQ)
Baseline
|
10.2 Z-score
Interval 9.5 to 11.7
|
10 Z-score
Interval 9.3 to 10.7
|
10.1 Z-score
Interval 9.7 to 11.1
|
10.1 Z-score
Interval 9.4 to 11.4
|
|
Suicide Ideation Questionnaire (SIQ)
30 Days
|
9.9 Z-score
Interval 9.2 to 10.3
|
9.8 Z-score
Interval 9.2 to 10.2
|
9.9 Z-score
Interval 9.4 to 10.8
|
9.5 Z-score
Interval 9.2 to 10.1
|
|
Suicide Ideation Questionnaire (SIQ)
60 Days
|
9.6 Z-score
Interval 9.2 to 10.2
|
9.5 Z-score
Interval 9.2 to 10.1
|
9.7 Z-score
Interval 9.3 to 10.1
|
9.3 Z-score
Interval 9.2 to 10.1
|
|
Suicide Ideation Questionnaire (SIQ)
90 Days
|
9.5 Z-score
Interval 9.2 to 10.1
|
9.5 Z-score
Interval 9.2 to 9.7
|
9.8 Z-score
Interval 9.2 to 10.1
|
9.5 Z-score
Interval 9.2 to 10.0
|
|
Suicide Ideation Questionnaire (SIQ)
180 Days
|
9.4 Z-score
Interval 9.2 to 10.0
|
9.9 Z-score
Interval 9.3 to 10.3
|
9.3 Z-score
Interval 9.2 to 9.7
|
9.4 Z-score
Interval 9.2 to 10.1
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 days, 180 daysPopulation: Participants with data collected
Resilience Scales for Children and Adolescents (RSCA), adapted and validated with community input. The RSCA measures 3 domains of resilience using a 4-point Likert scale (0=Not at All, 1=A little bit, 2=A medium amount, 3=A lot): * Sense of Mastery: 20 items assessing self-efficacy and control (range: 0-60; higher better) * Sense of Relatedness: 18 items assessing trust and support from relationships (range: 0-54; higher better) * Emotional Reactivity: 24 items assessing vulnerability to stress and negative emotions (range: 0-72; lower better) 1. Items are summed within each subscale 2. Mastery and Relatedness subscales are summed to create a Resource Index (range: 0-114) 3. The Total Resilience Score is calculated as: Resource Index minus Emotional Reactivity Total Resilience Score Range: -72 to 114 Interpretation: * Higher scores indicate greater resilience (better outcome) * Better scores reflect more personal and relational resources combined with lower emotional vulnerab
Outcome measures
| Measure |
New Hope (NH)
n=71 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
Elders' Resiliency (ER)
n=68 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).
|
Control Condition
n=80 Participants
The control condition will only receive Case Management (CM) (n=76).
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
n=65 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
|
|---|---|---|---|---|
|
The Resiliency Scales
Baseline
|
31.7 Units on a scale
Standard Deviation 25.2
|
30.8 Units on a scale
Standard Deviation 21.5
|
33.3 Units on a scale
Standard Deviation 26.3
|
31.7 Units on a scale
Standard Deviation 22.7
|
|
The Resiliency Scales
30 Days
|
43.9 Units on a scale
Standard Deviation 27.7
|
25.6 Units on a scale
Standard Deviation 26.9
|
33.8 Units on a scale
Standard Deviation 28
|
33.9 Units on a scale
Standard Deviation 28.6
|
|
The Resiliency Scales
60 Days
|
46.2 Units on a scale
Standard Deviation 24.1
|
35.2 Units on a scale
Standard Deviation 25.1
|
39.4 Units on a scale
Standard Deviation 23.6
|
36.4 Units on a scale
Standard Deviation 30.8
|
|
The Resiliency Scales
90 Days
|
40.9 Units on a scale
Standard Deviation 28.1
|
27.4 Units on a scale
Standard Deviation 19.7
|
39.8 Units on a scale
Standard Deviation 26
|
41.9 Units on a scale
Standard Deviation 29.8
|
|
The Resiliency Scales
180 Days
|
50.5 Units on a scale
Standard Deviation 24.2
|
30.5 Units on a scale
Standard Deviation 26.7
|
43.4 Units on a scale
Standard Deviation 27.7
|
42.3 Units on a scale
Standard Deviation 29.9
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 days, 180 daysPopulation: Participants with data collected
The Centers for Epidemiologic Studies of Depression (CESDR-10) is a self-report scale used to measure depressive symptoms (Cronbach's alpha ranged from 0.90 to 0.91 in a validation study). Scores on the CESDR-10 range from 0 (minimum) to 40 (maximum) with higher scores representing higher frequency of experiencing depression symptoms. CESDR-10 score is summed to provide an overall total for each participant. The full version has been widely used among adolescent and AI populations, including Apache youth.
Outcome measures
| Measure |
New Hope (NH)
n=71 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
Elders' Resiliency (ER)
n=68 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).
|
Control Condition
n=80 Participants
The control condition will only receive Case Management (CM) (n=76).
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
n=65 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
|
|---|---|---|---|---|
|
Centers for Epidemiologic Studies of Depression (CESDR-10)
60 Days
|
7 score on a scale
Interval 0.0 to 19.0
|
11 score on a scale
Interval 3.0 to 18.0
|
9 score on a scale
Interval 4.0 to 16.0
|
6 score on a scale
Interval 1.0 to 17.5
|
|
Centers for Epidemiologic Studies of Depression (CESDR-10)
90 Days
|
9.5 score on a scale
Interval 1.0 to 19.0
|
11.5 score on a scale
Interval 5.5 to 17.0
|
8 score on a scale
Interval 3.0 to 18.0
|
5.5 score on a scale
Interval 2.0 to 17.0
|
|
Centers for Epidemiologic Studies of Depression (CESDR-10)
Baseline
|
15 score on a scale
Interval 7.0 to 23.0
|
15 score on a scale
Interval 5.5 to 21.0
|
14.5 score on a scale
Interval 8.0 to 20.0
|
11 score on a scale
Interval 5.0 to 24.0
|
|
Centers for Epidemiologic Studies of Depression (CESDR-10)
30 Days
|
8 score on a scale
Interval 0.0 to 18.0
|
12 score on a scale
Interval 4.0 to 18.0
|
13 score on a scale
Interval 6.0 to 20.0
|
8 score on a scale
Interval 2.0 to 19.0
|
|
Centers for Epidemiologic Studies of Depression (CESDR-10)
180 Days
|
4 score on a scale
Interval 2.0 to 14.0
|
8.5 score on a scale
Interval 2.5 to 15.5
|
6 score on a scale
Interval 0.0 to 13.0
|
5.5 score on a scale
Interval 1.0 to 13.5
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 days, 180 daysPopulation: Participants with data collected
Children's Hope Scale, a 6-item measure assessing goal-directed thinking and pathways to achieve goals. Items are rated on a 6-point Likert scale (0=None of the time to 5=All of the time). Scoring Method: The total Hope Score is calculated by summing all 6 items. Score Range: 0 to 30 Interpretation: * Higher scores indicate greater hope (better outcome) * Lower scores indicate lower hope (worse outcome)
Outcome measures
| Measure |
New Hope (NH)
n=71 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
Elders' Resiliency (ER)
n=68 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).
|
Control Condition
n=80 Participants
The control condition will only receive Case Management (CM) (n=76).
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
n=65 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
|
|---|---|---|---|---|
|
The Children's Hope Scale (CHS)
30 Days
|
17.6 units on a scale
Standard Deviation 8.8
|
13.5 units on a scale
Standard Deviation 7.3
|
15.2 units on a scale
Standard Deviation 8.4
|
16.8 units on a scale
Standard Deviation 8.2
|
|
The Children's Hope Scale (CHS)
60 Days
|
16.4 units on a scale
Standard Deviation 8.9
|
15.2 units on a scale
Standard Deviation 8.2
|
17.6 units on a scale
Standard Deviation 7.3
|
15.8 units on a scale
Standard Deviation 8.5
|
|
The Children's Hope Scale (CHS)
Baseline
|
14.4 units on a scale
Standard Deviation 7.9
|
14.2 units on a scale
Standard Deviation 7
|
15.2 units on a scale
Standard Deviation 7.7
|
14.6 units on a scale
Standard Deviation 7.5
|
|
The Children's Hope Scale (CHS)
90 Days
|
17 units on a scale
Standard Deviation 8.4
|
15.8 units on a scale
Standard Deviation 8.2
|
18.7 units on a scale
Standard Deviation 7.9
|
17.2 units on a scale
Standard Deviation 8.7
|
|
The Children's Hope Scale (CHS)
180 Days
|
18.2 units on a scale
Standard Deviation 8
|
18.4 units on a scale
Standard Deviation 7.2
|
18.4 units on a scale
Standard Deviation 8.3
|
18.7 units on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 days, 180 daysPopulation: Participants with data collected
Multicultural Mastery Scale, an adapted version measuring problem-solving through social networks across three domains: Mastery-Friends (4 items), Mastery-Family (4 items), and Mastery-Self (5 items), totaling 13 items. Items were assessed using either a slider scale (0-100) recoded to a 5-point scale, or a 3-point scale (0=Not at all, 1=Somewhat, 2=A lot) rescaled to a 5-point format. The final scoring uses a 5-point scale where each item ranges from 0 to 4. Scoring Method: The total Communal Mastery Score is calculated by summing all 13 items. Score Range: 0 to 52 Interpretation: * Higher scores indicate a stronger sense of mastery and control (better outcome) * Lower scores indicate lower mastery (worse outcome)
Outcome measures
| Measure |
New Hope (NH)
n=71 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
Elders' Resiliency (ER)
n=68 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).
|
Control Condition
n=80 Participants
The control condition will only receive Case Management (CM) (n=76).
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
n=65 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
|
|---|---|---|---|---|
|
Multicultural Mastery Scale
Baseline
|
30.7 units on a scale
Standard Deviation 11.5
|
29.9 units on a scale
Standard Deviation 10
|
30.7 units on a scale
Standard Deviation 11.8
|
30.9 units on a scale
Standard Deviation 10.0
|
|
Multicultural Mastery Scale
30 Days
|
34.2 units on a scale
Standard Deviation 11.2
|
29 units on a scale
Standard Deviation 9.9
|
29 units on a scale
Standard Deviation 13.2
|
33 units on a scale
Standard Deviation 10.5
|
|
Multicultural Mastery Scale
60 Days
|
32.2 units on a scale
Standard Deviation 13.1
|
30.6 units on a scale
Standard Deviation 11.7
|
35.2 units on a scale
Standard Deviation 9.2
|
29.8 units on a scale
Standard Deviation 11
|
|
Multicultural Mastery Scale
90 Days
|
32.7 units on a scale
Standard Deviation 11.4
|
31 units on a scale
Standard Deviation 8.4
|
33.9 units on a scale
Standard Deviation 10.6
|
30.3 units on a scale
Standard Deviation 13.4
|
|
Multicultural Mastery Scale
180 Days
|
31.7 units on a scale
Standard Deviation 9.6
|
32.7 units on a scale
Standard Deviation 11.1
|
33.4 units on a scale
Standard Deviation 11.2
|
35.8 units on a scale
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 days, 180 daysPopulation: Participants with data collected
The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
Outcome measures
| Measure |
New Hope (NH)
n=71 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
Elders' Resiliency (ER)
n=68 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).
|
Control Condition
n=80 Participants
The control condition will only receive Case Management (CM) (n=76).
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
n=65 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
|
|---|---|---|---|---|
|
Rosenberg Self Esteem Scale
30 Days
|
15.8 score on a scale
Standard Deviation 4.1
|
16.5 score on a scale
Standard Deviation 4.2
|
16.5 score on a scale
Standard Deviation 5.3
|
17.2 score on a scale
Standard Deviation 3.1
|
|
Rosenberg Self Esteem Scale
Baseline
|
17.5 score on a scale
Standard Deviation 3.7
|
17.7 score on a scale
Standard Deviation 3.9
|
17.5 score on a scale
Standard Deviation 3.5
|
16.5 score on a scale
Standard Deviation 4.9
|
|
Rosenberg Self Esteem Scale
60 Days
|
15.9 score on a scale
Standard Deviation 5.6
|
17.3 score on a scale
Standard Deviation 3.4
|
18.1 score on a scale
Standard Deviation 4.7
|
17.5 score on a scale
Standard Deviation 4.8
|
|
Rosenberg Self Esteem Scale
90 Days
|
16.6 score on a scale
Standard Deviation 3.8
|
16.5 score on a scale
Standard Deviation 5.8
|
17.8 score on a scale
Standard Deviation 4.5
|
16.5 score on a scale
Standard Deviation 5.8
|
|
Rosenberg Self Esteem Scale
180 Days
|
16.8 score on a scale
Standard Deviation 3.6
|
17.4 score on a scale
Standard Deviation 4.2
|
16.8 score on a scale
Standard Deviation 5.4
|
16.1 score on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 days, 180 daysPopulation: Restricted to participants who reported alcohol use at baseline. This outcome measures reduction in existing alcohol use among current users. Non-users were excluded as the intervention targets harm reduction rather than prevention of initiation.
The World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is a questionnaire that screens for all levels of problem or risky substance use in adults. A risk score can be provided for each substance, and scores are grouped into low risk (0-10 for alcohol), moderate risk (11-26 for alcohol) or high risk (27 or higher for alcohol). The score range is 0-39. Higher score worse risk.
Outcome measures
| Measure |
New Hope (NH)
n=36 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
Elders' Resiliency (ER)
n=46 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).
|
Control Condition
n=40 Participants
The control condition will only receive Case Management (CM) (n=76).
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
n=38 Participants
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
|
|---|---|---|---|---|
|
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Risk Score
Baseline
|
19 score on a scale
Interval 14.5 to 25.5
|
15 score on a scale
Interval 8.0 to 23.0
|
18 score on a scale
Interval 10.0 to 27.0
|
12 score on a scale
Interval 2.0 to 18.0
|
|
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Risk Score
30 Days
|
5 score on a scale
Interval 5.0 to 15.0
|
21 score on a scale
Interval 10.0 to 26.0
|
21.5 score on a scale
Interval 12.0 to 27.0
|
10 score on a scale
Interval 5.0 to 22.0
|
|
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Risk Score
60 Days
|
9 score on a scale
Interval 5.0 to 23.0
|
14 score on a scale
Interval 8.0 to 28.0
|
15 score on a scale
Interval 7.0 to 27.0
|
7.5 score on a scale
Interval 3.5 to 11.0
|
|
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Risk Score
90 Days
|
6.5 score on a scale
Interval 2.0 to 20.0
|
10.5 score on a scale
Interval 5.0 to 17.0
|
20 score on a scale
Interval 9.0 to 22.0
|
11 score on a scale
Interval 3.0 to 21.0
|
|
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Risk Score
180 Days
|
20 score on a scale
Interval 9.0 to 26.0
|
15 score on a scale
Interval 5.0 to 23.0
|
11 score on a scale
Interval 6.0 to 20.0
|
8 score on a scale
Interval 5.0 to 13.0
|
Adverse Events
New Hope (NH)
Serious events: 15 serious events
Other events: 5 other events
Deaths: 0 deaths
Elders' Resiliency (ER)
Serious events: 10 serious events
Other events: 1 other events
Deaths: 0 deaths
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Condition
Serious events: 15 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
New Hope (NH)
n=71 participants at risk
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
Elders' Resiliency (ER)
n=68 participants at risk
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).
|
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
n=65 participants at risk
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
|
Control Condition
n=80 participants at risk
The control condition will only receive Case Management (CM) (n=76).
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
|---|---|---|---|---|
|
Psychiatric disorders
ER Treatment for Suicide Ideation
|
9.9%
7/71 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
8.8%
6/68 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
7.7%
5/65 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
8.8%
7/80 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
|
Psychiatric disorders
In-patient treatment for SI
|
11.3%
8/71 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
5.9%
4/68 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
7.7%
5/65 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
10.0%
8/80 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
Other adverse events
| Measure |
New Hope (NH)
n=71 participants at risk
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
Elders' Resiliency (ER)
n=68 participants at risk
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).
|
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
n=65 participants at risk
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
|
Control Condition
n=80 participants at risk
The control condition will only receive Case Management (CM) (n=76).
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
|
|---|---|---|---|---|
|
General disorders
Incarceration
|
4.2%
3/71 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
0.00%
0/68 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
0.00%
0/65 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
3.8%
3/80 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
|
General disorders
Other hospitalization
|
0.00%
0/71 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
1.5%
1/68 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
0.00%
0/65 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
1.2%
1/80 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
|
General disorders
Expelled from school
|
1.4%
1/71 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
0.00%
0/68 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
0.00%
0/65 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
0.00%
0/80 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
|
General disorders
Sexual abuse
|
1.4%
1/71 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
0.00%
0/68 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
0.00%
0/65 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
0.00%
0/80 • from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place