Trial Outcomes & Findings for HEALTHY (Health Education Adolescent Leadership Training to Help Youth) Leaders (NCT NCT01708291)
NCT ID: NCT01708291
Last Updated: 2015-11-23
Results Overview
Self Administered questionnaire to assess level of stress at baseline and week 10. PSC-17 is a one page behavioral assessment tool that can be completed in \<5 minutes and can assess the sub-domains of attention, externalizing problem and internalizing problems. Attention, externalizing and Internalizing domains are each scored on a scale from 0 (best) to 10 (worst), where a score \>= 7 indicates stress.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Baseline and week 10
Results posted on
2015-11-23
Participant Flow
3 participants were not included in the study due to fighting.
Participant milestones
| Measure |
Mindfulness Based Stress Reduction
Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
|
No Mindfulness Based Stress Reduction
Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Mindfulness Based Stress Reduction
Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
|
No Mindfulness Based Stress Reduction
Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
|
|---|---|---|
|
Overall Study
fighting
|
2
|
1
|
Baseline Characteristics
HEALTHY (Health Education Adolescent Leadership Training to Help Youth) Leaders
Baseline characteristics by cohort
| Measure |
Mindfulness Based Stress Reduction
n=21 Participants
Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
|
No Mindfulness Based Stress Reduction
n=21 Participants
Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
14 to 17
|
17 participants
n=99 Participants
|
5 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Age, Customized
18 to 21
|
4 participants
n=99 Participants
|
16 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
21 participants
n=107 Participants
|
42 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 10Self Administered questionnaire to assess level of stress at baseline and week 10. PSC-17 is a one page behavioral assessment tool that can be completed in \<5 minutes and can assess the sub-domains of attention, externalizing problem and internalizing problems. Attention, externalizing and Internalizing domains are each scored on a scale from 0 (best) to 10 (worst), where a score \>= 7 indicates stress.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=21 Participants
Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
|
No Mindfulness Based Stress Reduction
n=21 Participants
Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
|
|---|---|---|
|
Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)
week 0-attention
|
3 participants
|
2 participants
|
|
Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)
week 0-external
|
4 participants
|
3 participants
|
|
Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)
week 0-internal
|
4 participants
|
8 participants
|
|
Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)
week 10-attention
|
3 participants
|
4 participants
|
|
Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)
week 10-external
|
3 participants
|
3 participants
|
|
Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)
week 10-internal
|
6 participants
|
11 participants
|
Adverse Events
Mindfulness Based Stress Reduction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Mindfulness Based Stress Reduction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place