Clinical trial NCT03404349: Tailored Mindfulness Intervention in Adolescence
Official title: Gender-specific Effect of a Tailored, Adolescent Developed Mindfulness Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Mindfulness
Affect
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Response to Stress Questionnaire at 12 weeks, 6 months & 1 year.
timeFrame: 12 weeks, 6 months, 1 year
Secondary outcomes:
measure: Change from Baseline Positive and Negative Affect Schedule for Children at 12 weeks, 6 months & 1 year
timeFrame: 12 weeks, 6 months, 1 year
Other outcomes:
measure: Change from Baseline Mindful Attention Awareness Scale at 12 weeks, 6 months & 1 year
timeFrame: 12 weeks, 6 months, 1 year
Locations:
city: Baltimore
country: United States
facility: Pinderhughes School
state: Maryland
Study officials:
References: