Ignite Creation Date:
2024-05-06 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03404349
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2017-12-18
Brief Title:
Tailored Mindfulness Intervention in Adolescence
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Gender-specific Effect of a Tailored Adolescent Developed Mindfulness Intervention
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Approximately 13-20 of children living in the United States experience a mental health problem in any given year Youth with mental illness have difficulty in social settings and have poor academic performance that place them at risk for increased stress and poor mental health outcomes Stress typically manifests as depression anxiety or behavioral issues that lead to increasingly complex treatment with psychotropic medication It would follow that reducing stress may be a way to improve psychological well being prevent poor mental health outcomes and hopefully avoid the need for psychotropic medication Mindfulness teaching is a potentially powerful tool for adolescents because it focuses on reducing stress Thus far studies have not engaged adolescents in developing a patient-centered approach to mindfulness Interventions The current project would be a significant contribution to clinical practice and the scientific evidence for mindfulness interventions This research targets psychological well-being within a vulnerable adolescent population that is generally underrepresented in research The research outcomes will be useful to healthcare providers educators and parentsfamilies in encouraging optimal outcomes for adolescents The overall goals of this proposed research project are to develop and assess the feasibility of an adolescent-developed mindfulness intervention
Detailed Description:
At-risk behaviors are related to poor outcomes among adolescents Increasing evidence supports adolescence as a vital time to introduce stress reduction techniques to reduce risk and improve mental health The proposed study will develop and test a mindfulness intervention for adolescents in a quasi-experimental pre-test post-test design
Mindfulness teaching is a potentially powerful tool for adolescents because it focuses on reducing stress which can manifest as depression anxiety or behavioral problems that often are managed with complex psychotropic medication regimens Thus far studies have not engaged adolescents in developing mindfulness interventions Such interventions are critical given that in the United States 13-20 of children experience a mental health problem in any given year Moreover youth with a mental illness have difficulty in social settings and have poor academic performance that place them at risk for increased stress and poor mental health outcomes It would follow that reducing stress may be a way to improve psychological well-being prevent poor mental health outcomes and hopefully avoid the need for complex psychotropic medication The overall goals of this proposed research are to develop and to assess the feasibility of an adolescent-developed mindfulness intervention
The proposed pilot will build from the PIs prior and current research Earlier research determined that a mindfulness curriculum can have a notable positive impact on affect coping and mindfulness in at-risk adolescent girls This work was expanded by engaging the perspectives of adolescents from Southwest Baltimore in planning a mindfulness intervention Earlier research was funded by a pilot grant through an Agency for Healthcare Research and Quality AHRQ R24 infrastructure grant to promote patient- centered outcomes research PCOR at the University of Maryland Baltimore The preliminary data for the current proposal is based on these prior studies The current proposed study conducted under the Deans Research Scholar program will test the impact of a mindfulness intervention on decreasing stress and increasing well-being in adolescents The specific aims of the pilot study are to
1 To develop a tailored mindfulness program for adolescents in Southwest Baltimore
2 To pilot implementation of a tailored a mindfulness program for adolescents residing in Southwest Baltimore
The proposed study will develop and test a mindfulness intervention for adolescents in a non-randomized convenience sampling quasi-experimental pre-test post-test designRecruitment will occur among middle school students attending public school in Southwest Baltimore After informed consent and assent participants will attend mindfulness classes MC once per week for 12 weeks The class content will come from previous pilot work and focus groups both conducted by the researcher MC classes will be led by the Holistic Life Foundation Baseline evaluation will analyze demographics coping Response to Stress Questionnaire RSQ positive affect 10 item Positive and Negative Affect Scale for Children PANAS-C and mindfulness Mindfulness Attention Awareness Scale MAAS In addition possible gender differences in outcomes will be analyzed Participants will be contacted 3 months after study completion and again 1 year after study completion to re-evaluate study outcomes via self-reported tools used earlier in the study
Mindfulness teaching is a potentially powerful tool for adolescents because it focuses on reducing stress which can manifest as depression anxiety or behavioral problems that often are managed with complex psychotropic medication regimens Thus far studies have not engaged adolescents in developing mindfulness interventions Such interventions are critical given that in the United States 13-20 of children experience a mental health problem in any given year Moreover youth with a mental illness have difficulty in social settings and have poor academic performance that place them at risk for increased stress and poor mental health outcomes It would follow that reducing stress may be a way to improve psychological well-being prevent poor mental health outcomes and hopefully avoid the need for complex psychotropic medication The overall goals of this proposed research are to develop and to assess the feasibility of an adolescent-developed mindfulness intervention
The proposed pilot will build from the PIs prior and current research Earlier research determined that a mindfulness curriculum can have a notable positive impact on affect coping and mindfulness in at-risk adolescent girls This work was expanded by engaging the perspectives of adolescents from Southwest Baltimore in planning a mindfulness intervention Earlier research was funded by a pilot grant through an Agency for Healthcare Research and Quality AHRQ R24 infrastructure grant to promote patient- centered outcomes research PCOR at the University of Maryland Baltimore The preliminary data for the current proposal is based on these prior studies The current proposed study conducted under the Deans Research Scholar program will test the impact of a mindfulness intervention on decreasing stress and increasing well-being in adolescents The specific aims of the pilot study are to
1 To develop a tailored mindfulness program for adolescents in Southwest Baltimore
2 To pilot implementation of a tailored a mindfulness program for adolescents residing in Southwest Baltimore
The proposed study will develop and test a mindfulness intervention for adolescents in a non-randomized convenience sampling quasi-experimental pre-test post-test designRecruitment will occur among middle school students attending public school in Southwest Baltimore After informed consent and assent participants will attend mindfulness classes MC once per week for 12 weeks The class content will come from previous pilot work and focus groups both conducted by the researcher MC classes will be led by the Holistic Life Foundation Baseline evaluation will analyze demographics coping Response to Stress Questionnaire RSQ positive affect 10 item Positive and Negative Affect Scale for Children PANAS-C and mindfulness Mindfulness Attention Awareness Scale MAAS In addition possible gender differences in outcomes will be analyzed Participants will be contacted 3 months after study completion and again 1 year after study completion to re-evaluate study outcomes via self-reported tools used earlier in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None