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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02544412
Other study ID # 2014-1263
Secondary ID A487400L&S/PSYCH
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2015
Est. completion date December 11, 2020

Study information

Verified date January 2021
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this project is to study whether a mindfulness-based training program supports self-regulation, resiliency, effective classroom behaviors, and persistence in teaching.


Description:

Participants in this study will be undergraduate pre-service teachers already enrolled in the Early Elementary Certification Program (EECP) in the School of Education. This competitive admission program is four semesters long and consists of 4 certificate granting areas. Over the course of 2 years (i.e., 4 semesters), the investigators will recruit a total of 8 cohorts; 2 from each certificate granting area. Participants will be recruited during their second semester in the program for enrollment during the third semester (i.e., enrollment first semester of senior year). Cohorts will be match randomized by cohort type, ensuring that 4 cohorts are randomized to treatment and 4 cohorts are randomized to teacher education as usual, and that one of each type of cohort is randomized to treatment and control, respectively. All participants will complete a battery of self-report and behavioral tasks, as well as undergo a standardized classroom observation prior to the start of the intervention, immediately after the intervention, and at follow-up (5-8 months post intervention). Follow-up testing will occur during the final month of the final semester in the EECP program, a time during which participants will be full-time student teaching, training that best approximates in-service teaching. The qualitative component of this study will involve participants partaking in approximately four-hours of interviews (either group or individual based on a hierarchal sampling criterion), before and after the intervention period. In addition, all student EECP records will be qualitatively analyzed (i.e., supervisor notes, state certification portfolios). Each September for three years post-graduation, participants will be contacted and instructed to complete an online survey consisting of self-report inventories and information about whether they are continuing to teach and if so, the name and district of the school they currently work. Participants randomized to treatment will receive 1.5 hours of mindfulness training for 8 to 10 weeks during their third semester. Thirty minutes of this will occur during mandatory cohort seminar time, with the remaining one-hour after the end of cohort seminar time. In addition, during the intervention period they will participate in two 4-hour "Days of Mindfulness." In total, intervention participants will receive about 21 hours of instruction in mindfulness over the intervention period. During the following semester (4th semester), intervention participants will receive 15 minutes of mindfulness "booster" practice each week as part of their mandatory cohort seminar. This novel mindfulness based intervention is incorporates elements of Mindfulness Based Stress Reduction (Kabat-Zinn, 1982), as well as contemplative practices that might be defined as social connectedness practices or constructivist practices (Dahl, Lutz, & Davidson, 2015). The curriculum has been developed by experienced mindfulness teachers (>10 years teaching experience, on average), all of whom have extensive meditation histories and most of whom have long-term experience as classroom teachers. The training will consist of formal and informal mindfulness meditation practices.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date December 11, 2020
Est. primary completion date December 14, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Undergraduate students in good academic standing entering their third semester of one of the following teacher education certificate programs (Early Education ESL, Middle Education SPED, Middle Education Content, Middle Education ESL). Note that good academic standing is a requirement for continuation in the certification program. Exclusion Criteria: - A history of schizophrenia-spectrum, bipolar disorder, or other psychotic disorders

Study Design


Intervention

Behavioral:
novel mindfulness-based well-being training


Locations

Country Name City State
United States UW Madison Department of Curriculum and Instruction Madison Wisconsin

Sponsors (3)

Lead Sponsor Collaborator
University of Wisconsin, Madison Mind and Life Institute, Hadley, Massachusetts, The Trust for the Meditation Process

Country where clinical trial is conducted

United States, 

References & Publications (14)

Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29. — View Citation

Baron AS, Banaji MR. The development of implicit attitudes. Evidence of race evaluations from ages 6 and 10 and adulthood. Psychol Sci. 2006 Jan;17(1):53-8. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

Dahl CJ, Lutz A, Davidson RJ. Reconstructing and deconstructing the self: cognitive mechanisms in meditation practice. Trends Cogn Sci. 2015 Sep;19(9):515-23. doi: 10.1016/j.tics.2015.07.001. Epub 2015 Jul 28. Review. — View Citation

Derogatis, L. R. (1994). SCL-90-R Symptom Checklist-90-R administration, scoring and procedures manual. Minneapolis, MN: National Computer Systems.

Hare TA, Tottenham N, Galvan A, Voss HU, Glover GH, Casey BJ. Biological substrates of emotional reactivity and regulation in adolescence during an emotional go-nogo task. Biol Psychiatry. 2008 May 15;63(10):927-34. doi: 10.1016/j.biopsych.2008.03.015. — View Citation

Jerusalem, M., & Schwarzer, R. (1992). Self-efficacy as a resource factor in stress appraisal processes. Self-efficacy: Thought control of action, 195-213.

Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. — View Citation

La Paro, K. M., Pianta, R. C., & Stuhlman, M. (2004). The Classroom Assessment Scoring System: Findings from the prekindergarten year. The Elementary School Journal, 104(5), 409-426. http://doi.org/10.1086/499760

Levinson DB, Stoll EL, Kindy SD, Merry HL, Davidson RJ. A mind you can count on: validating breath counting as a behavioral measure of mindfulness. Front Psychol. 2014 Oct 24;5:1202. doi: 10.3389/fpsyg.2014.01202. eCollection 2014. — View Citation

Maslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach burnout inventory manual . Mountain View, CA: CPP. Inc., and Davies-Black.

Quirin M, Kazén M, Kuhl J. When nonsense sounds happy or helpless: The Implicit Positive and Negative Affect Test (IPANAT). J Pers Soc Psychol. 2009 Sep;97(3):500-16. doi: 10.1037/a0016063. — View Citation

Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995 Oct;69(4):719-27. — View Citation

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline on CLASS assessment tool (La Paro, Pianta, & Stuhlman, 2004) A standardized classroom observation tool assessing teacher classroom behaviors. 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Primary Change from baseline on Symptoms Checklist 90 Revised (Derogatis, 1994) a 90-item self-report of psychological symptoms comprised of 9 symptom axes (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism). An aggregated score across all 9 domains provides a Global Severity Index score of psychological health. 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Primary Change from baseline on Maslach Burnout Inventory - Education Survey (Maslach, Jackson, & Leiter, 1996) a 22-item self-report of teaching related burnout 1-2 weeks before intervention (i.e., baseline), 11-12 weeks after baseline (1-2 weeks post-intervention), 8-11 months after baseline (5-8 months post-intervention): ~14 months after baseline, ~26 months after baseline, and ~38 months after baseline
Primary Change from baseline on Emotional go/nogo (Hare et al., 2008) An emotional inhibition paradigm. 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Primary Persistence in teaching: Current profession and role (if teaching, name of school) Self-report on employment status following graduation and teacher licensure. ~ 14 months after baseline, ~ 26 months after baseline, and ~ 38 months after baseline.
Secondary Change from baseline on Implicit Positive and Negative Affect Test (Quirin, Kazen, & Kuhl, 2009) A computer-based behavioral measure of implicit affective bias in which participants are provided with 5 nonsense words and asked to rate the words on a scale of emotional valence. 1-2 weeks before intervention (i.e., baseline), 11-12 weeks after baseline (1-2 weeks post-intervention), 8-11 months after baseline (5-8 months post-intervention): ~14 months after baseline, ~26 months after baseline, and ~38 months after baseline
Secondary Change from baseline on General Self-efficacy Scale (Jerusalem & Schwarzer, 1992) A 10-item self-report of general self-efficacy 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Secondary Change from baseline on Psychological Well-Being Scale (Ryff & Keyes, 1995) A 54-item self-report inventory assessing psychological well-being. 1-2 weeks before intervention (i.e., baseline), 11-12 weeks after baseline (1-2 weeks post-intervention), 8-11 months after baseline (5-8 months post-intervention): ~14 months after baseline, ~26 months after baseline, and ~38 months after baseline
Secondary Change from baseline on Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988) A self-report survey of general positive and negative affect. 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Secondary Change from baseline on Emotional Styles Questionnaire (under development) A self-report designed to assess styles of emotional responding. 1-2 weeks before intervention (i.e., baseline), 11-12 weeks after baseline (1-2 weeks post-intervention), 8-11 months after baseline (5-8 months post-intervention): ~14 months after baseline, ~26 months after baseline, and ~38 months after baseline
Secondary Change from baseline on Open response on difficulties in teaching A one-item open response on difficulty in teaching. 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Secondary Change from baseline on Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983) A 10-item self-report on perceived stress in the last month. 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Secondary Change from baseline on Implicit Association Task (Race, child and adult versions; Baron & Banaji, 2006) A behavioral task designed to assess implicit biases related to race. 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Secondary Change from baseline on Five Facet Mindfulness Questionnaire (Baer et al., 2008) A 39-item self-report of mindfulness 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Secondary Change from baseline on Breath Count Task (Levinson et al., 2014) 15 minute behavioral measure of mindfulness 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
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