Stress
Conditions
Keywords
youth, Stress, mindfulness, foster care, stress reduction, high risk teens
Brief summary
This project will measure baseline stress among a group of youth in foster and kinship care. The investigators will implement a pilot program to target stress reduction by using an evidence-based group therapy technique teaching mindfulness skills. The investigators hypothesize that the mindfulness skills will help youth to reduce stress, which will be measured using psychological and physiological techniques.
Interventions
BEHAVIORALMindfulness based stress reduction
an 8 week group intervention to teach mindfulness skills
BEHAVIORALonly pre and post evaluation measures
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* ages 14-21 years at time of intervention being offered, offered to youth in out of home care (e.g. foster and kinship care)
Exclusion criteria
* severe developmental delay * non English speaking, not in age range
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | Baseline and week 10 | 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. |
Countries
United States
Participant flow
Pre-assignment details
3 participants were not included in the study due to fighting.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | fighting | 2 | 1 |
Baseline characteristics
| Characteristic | Mindfulness Based Stress Reduction | No Mindfulness Based Stress Reduction | Total |
|---|---|---|---|
| Age, Customized 14 to 17 | 17 participants | 5 participants | 22 participants |
| Age, Customized 18 to 21 | 4 participants | 16 participants | 20 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 15 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 5 Participants | 2 Participants | 7 Participants |
| Region of Enrollment United States | 21 participants | 21 participants | 42 participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)
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.
Time frame: Baseline and week 10
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | week 0-attention | 3 participants |
| Mindfulness Based Stress Reduction | Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | week 0-external | 4 participants |
| Mindfulness Based Stress Reduction | Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | week 0-internal | 4 participants |
| Mindfulness Based Stress Reduction | Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | week 10-attention | 3 participants |
| Mindfulness Based Stress Reduction | Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | week 10-external | 3 participants |
| Mindfulness Based Stress Reduction | Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | week 10-internal | 6 participants |
| No Mindfulness Based Stress Reduction | Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | week 10-external | 3 participants |
| No Mindfulness Based Stress Reduction | Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | week 0-attention | 2 participants |
| No Mindfulness Based Stress Reduction | Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | week 10-attention | 4 participants |
| No Mindfulness Based Stress Reduction | Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | week 0-external | 3 participants |
| No Mindfulness Based Stress Reduction | Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | week 10-internal | 11 participants |
| No Mindfulness Based Stress Reduction | Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | week 0-internal | 8 participants |