Stress-exposed Urban Male YouthNCT01650233
Improving Wellness for Young Men
A study testing Mindfulness-based stress reduction in people with Stress-exposed Urban Male Youth, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study assesses the impact of a mindfulness-based stress reduction program compared with a health education program for urban middle-school male youth on outcomes of psychological symptoms, coping, stress, sleep, and behavior. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress-exposed Urban Male Youth
- What is being tested?
- Mindfulness-based stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 7th or 8th graders at St. Ignatius Loyola Academy in 2009-2010 academic year.
- Parent/guardian consents
- Student assents
Who cannot join
- significant psychopathology
- significant developmental delay
- significant substance abuse with behavioral consequences
- significant behavioral problems
- foster care due to consent restrictions)
Trial locations and contacts
1 site in 1 country.
About this study
This study assesses the impact of a mindfulness-based stress reduction program compared with a health education program for urban middle-school male youth on outcomes of psychological symptoms, coping, stress, sleep, and behavior.
- Conditions
- Stress-exposed Urban Male Youth
- Being tested
- Mindfulness-based stress reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reductionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based stress reduction | Experimental | The mindfulness-based stress reduction (MBSR) program was previously adapted for urban youth and here further adapted to 12 weekly 50-minute classes for use in school. Receives: Behavioral: Mindfulness-based stress reduction |
| Healthy Topics | Placebo comparator | An age-appropriate health education curriculum was used as a non-specific group comparison for the MBSR program to control for the effects of: positive adult instruction, interactive peer group instruction, learning new material, group size and location, time, and attention. Receives: Behavioral: Mindfulness-based stress reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychological symptoms
Psychological symptoms assessed include anxiety, hostility, and depression.
Measured: 6 months
coping
Coping assessed includes rumination and typically positive and negative coping approaches.
Measured: 6 months
Secondary outcomes (2)
Sleep
Sleep was measured using diary and actigraphy.
Measured: 6 months
stress
Stress was measured using self-report and salivary cortisol.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startAug 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress-exposed Urban Male YouthStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650233
- Sponsor's protocol ID
- NA_00028889
- Status last verified
- Jan 2018
- First submitted
- 20 Jul 2012
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Sibinga EM, Perry-Parrish C, Chung SE, Johnson SB, Smith M, Ellen JM. School-based mindfulness instruction for urban male youth: a small randomized controlled trial. Prev Med. 2013 Dec;57(6):799-801. doi: 10.1016/j.ypmed.2013.08.027. Epub 2013 Sep 9.
PubMed 24029559
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Wellness for Young Men
- ClinicalTrials.gov ID
- NCT01650233
- Acronym / sponsor ID
- NA_00028889
- Conditions
- Stress-exposed Urban Male Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assesses the impact of a mindfulness-based stress reduction program compared with a health education program for urban middle-school male youth on outcomes of psychological symptoms, coping, stress, sleep, and behavior.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based stress reduction | Experimental | Behavioral: Mindfulness-based stress reductionThe mindfulness-based stress reduction (MBSR) program was previously adapted for urban youth and here further adapted to 12 weekly 50-minute classes for use in school. |
| Healthy Topics | Placebo comparator | Behavioral: Mindfulness-based stress reductionAn age-appropriate health education curriculum was used as a non-specific group comparison for the MBSR program to control for the effects of: positive adult instruction, interactive peer group instruction, learning new material, group size and location, time, and attention. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 7th or 8th graders at St. Ignatius Loyola Academy in 2009-2010 academic year.
- Parent/guardian consents
- Student assents
Key exclusion criteria (5 listed)
- significant psychopathology
- significant developmental delay
- significant substance abuse with behavioral consequences
- significant behavioral problems
- foster care due to consent restrictions)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based stress reduction | Behavioural | Healthy Topics, Mindfulness-based stress reduction |
Primary outcome
psychological symptoms
Time frame: 6 months
Psychological symptoms assessed include anxiety, hostility, and depression.
coping
Time frame: 6 months
Coping assessed includes rumination and typically positive and negative coping approaches.
2 secondary outcomes
Sleep
Time frame: 6 months
stress
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Derived from this study: PubMed 24029559Sibinga EM, Perry-Parrish C, Chung SE, Johnson SB, Smith M, Ellen JM. School-based mindfulness instruction for urban male youth: a small randomized controlled trial. Prev Med. 2013 Dec;57(6):799-801. doi: 10.1016/j.ypmed.2013.08.027. Epub 2013 Sep 9.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction in people with Stress-exposed Urban Male Youth, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological symptoms (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01650233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.