Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03404349
Other study ID # HP-00077414
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date December 31, 2018

Study information

Verified date September 2019
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 parents/families 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.


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 PI's 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 Dean's 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 design.Recruitment 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 13 Years
Eligibility Inclusion Criteria:

1. Student at Pinderhughes Middle School

2. In 6-8 grade

3. Parent or legal guardian, confirmed by school records, is 18 years or older

4. Ages 11-13 years old at time of enrollment

Exclusion Criteria:

1. Lack of English fluency in participant or parent/guardian

2. Inability to complete measurement tools

3. Inability to attend the intervention meetings due to school or personal conflicts

4. self-reported pregnancy

5. No wards of the state or emancipated minors

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness for Adolescence Course
There are 6 topics that will each be presented over 2 weeks for the 12 week intervention. Individuals will participate in a one to 1.5 hours, once a week intervention for 12weeks. Mindfulness is the practice of becoming aware of one's present-moment experience with compassion and openness as a basis for wise action. This curriculum is intended to strengthen attention and emotion regulation, cultivate wholesome emotions like gratitude and compassion, expand the repertoire of stress management skills, and help participants integrate mindfulness into daily life. Each lesson includes age-appropriate discussion, activities, and opportunities to practice mindfulness in a group setting.

Locations

Country Name City State
United States Pinderhughes School Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from Baseline Mindful Attention Awareness Scale at 12 weeks, 6 months & 1 year Self-reported state mindfulness: . It places a focus on present time attention and awareness, leaving out dimensions of mindfulness, such as non-judgmental accepting. Statements characterize ideas or actions that are not congruent with mindfulness such as being on automatic pilot, preoccupation and being distracted.
The 15-item measure uses a 6-point Likert response scale (1= Almost Always to 6= Almost Never) and higher scores indicate higher levels of mindfulness with a possible range of 15-90. Specifically, MAAS demonstrated excellent reliability (-.82- .87) and was validated with multiple studies that demonstrate validity as the correlation between the MAAS and an alternate scale was .70.
12 weeks, 6 months, 1 year
Primary Change from Baseline Response to Stress Questionnaire at 12 weeks, 6 months & 1 year. Self-Reported primary & secondary coping: The 57-item RSQ instrument was used to evaluate voluntary and involuntary reactions to stressors and was formulated according to varied responses specific to children and adolescents. The measure uses a 4-point Likert response scale (1= No stress or problem coping to 4= A lot of stress or problem coping). Higher scores represent increased use of coping mechanisms. It is recommended that the total score for primary coping be calculated and divided by the total RSQ score to control for response bias and individual differences in base-rates of item endorsement. 12 weeks, 6 months, 1 year
Secondary Change from Baseline Positive and Negative Affect Schedule for Children at 12 weeks, 6 months & 1 year Self-reported positive and negative emotions such as happy, joyful, sad & angry: The 10-item PANAS-C was used to measure positive affect (PA).
The shortened tool was adapted from the 20-item PANAS-C (Laurent et al, 1999). The 10-item PANAS-C provides information regarding affect and can be used in the school or clinic setting. The PA questions (M=16.9, SD=5.5) focus on joyful, cheerful, happy, lively and proud. The measure uses a 5-point Likert response scale (1= Very Slightly or Not at All to 5= Extremely) and the range for each scale is 5-25. The newly formulated 10-item tool shows good reliability and validity with higher scores representing higher levels of positive affect.
12 weeks, 6 months, 1 year
See also
  Status Clinical Trial Phase
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Recruiting NCT04038190 - A Behavioral Activation Intervention Administered in a College Freshman Orientation Course Phase 2
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Active, not recruiting NCT05998161 - Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout N/A
Completed NCT03728062 - Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT06405789 - The Effect of Yoga on Mindfulness and Perceived Stress N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Completed NCT05245409 - Stress, EEG, ECG, and Chiropractic N/A
Completed NCT04722367 - Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Completed NCT06057883 - Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females Phase 2
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Completed NCT05312749 - The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students N/A
Completed NCT05623826 - Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager N/A
Completed NCT04013451 - The Kiss of Kindness Study II N/A