Tailored Mindfulness Intervention in Adolescence

NCT03404349 | Completed

• 1 other identifier: HP-00077414
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Mindfulness; Affect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from Baseline Positive and Negative Affect Schedule for Children at 12 weeks, 6 months & 1 year

  12 weeks, 6 months, 1 year

Other Outcomes (1)

• Change from Baseline Mindful Attention Awareness Scale at 12 weeks, 6 months & 1 year

  12 weeks, 6 months, 1 year

Study Arms (1)

Mindfulness for Adolescence Course

EXPERIMENTAL

Participants will attend mindfulness classes to include deep breathing, yoga, listening to music and meditation.

Behavioral: Mindfulness for Adolescence Course

Interventions

Mindfulness for Adolescence Course BEHAVIORAL

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.

Mindfulness for Adolescence Course

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Student at Pinderhughes Middle School
• In 6-8 grade
• Parent or legal guardian, confirmed by school records, is 18 years or older
• Ages 11-13 years old at time of enrollment

You may not qualify if:

• Lack of English fluency in participant or parent/guardian
• Inability to complete measurement tools
• Inability to attend the intervention meetings due to school or personal conflicts
• self-reported pregnancy
• No wards of the state or emancipated minors

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Pinderhughes School

Baltimore, Maryland, 21217, United States

Location

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 19, 2018
• Study Start: February 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)