Trial Outcomes & Findings for Coping Long Term With Attempted Suicide - Adolescents (NCT NCT01748760)
NCT ID: NCT01748760
Last Updated: 2017-01-13
Results Overview
A suicide event is either a suicide attempts (actual, aborted, interrupted), or emergency interventions to intercede an attempt.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
6 months
Results posted on
2017-01-13
Participant Flow
Adolescent Psychiatric Inpatient Unit
Participant milestones
| Measure |
CLASP-A Intervention
Adolescent participants and parents will receive adjunctive psychosocial intervention.
CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan.
|
Treatment as Usual
Adolescent participants and parents will not receive study intervention
Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
19
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
CLASP-A Intervention
Adolescent participants and parents will receive adjunctive psychosocial intervention.
CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan.
|
Treatment as Usual
Adolescent participants and parents will not receive study intervention
Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
Baseline Characteristics
Coping Long Term With Attempted Suicide - Adolescents
Baseline characteristics by cohort
| Measure |
CLASP-A Intervention
n=25 Participants
Adolescent participants and parents will receive adjunctive psychosocial intervention.
CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan.
|
Treatment as Usual
n=25 Participants
Adolescent participants and parents will not receive study intervention
Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.96 years
STANDARD_DEVIATION 1.21 • n=93 Participants
|
15.52 years
STANDARD_DEVIATION 1.42 • n=4 Participants
|
15.74 years
STANDARD_DEVIATION 1.32 • n=27 Participants
|
|
Sex/Gender, Customized
Male
|
3 participants
n=93 Participants
|
6 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Sex/Gender, Customized
Female
|
21 participants
n=93 Participants
|
19 participants
n=4 Participants
|
40 participants
n=27 Participants
|
|
Sex/Gender, Customized
Other
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
25 participants
n=4 Participants
|
50 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsA suicide event is either a suicide attempts (actual, aborted, interrupted), or emergency interventions to intercede an attempt.
Outcome measures
| Measure |
CLASP-A Intervention
n=19 Participants
Adolescent participants and parents will receive adjunctive psychosocial intervention.
CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan.
|
Treatment as Usual
n=23 Participants
Adolescent participants and parents will not receive study intervention
Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning.
|
|---|---|---|
|
Number of Participants Who Repoorted a Suicide Event
|
8 participants
|
8 participants
|
Adverse Events
CLASP-A Intervention
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CLASP-A Intervention
n=19 participants at risk
Adolescent participants and parents will receive adjunctive psychosocial intervention.
CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan.
|
Treatment as Usual
n=23 participants at risk
Adolescent participants and parents will not receive study intervention
Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning.
|
|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
21.1%
4/19 • Number of events 4
|
13.0%
3/23 • Number of events 4
|
|
Psychiatric disorders
Hospitalization for suicidal ideation
|
15.8%
3/19 • Number of events 7
|
26.1%
6/23 • Number of events 9
|
|
Psychiatric disorders
ED visit for suicidal ideation
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Psychiatric disorders
ED for drug overdose
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
ED for medical evaluation (e.g. frostbite)
|
5.3%
1/19 • Number of events 2
|
0.00%
0/23
|
|
Social circumstances
Legal Issues
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place