Clinical trial NCT02637908: Mindfulness Training for Head Start Parents
Official title: Head Start Parenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Physiological
Keywords: Mindfulness
Parents
Families
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A training module has been developed for parents to effectively address stressors and demands of parenting and promote positive and supportive parent-child interactions. The purpose of this study is to implement the parent training program and evaluate the effectiveness of the program. Depending on the results, investigators expect core aspects of this module to be adaptable and modified or extended for parents of older children in the future to meet the needs of families across the stages of childhood development.

Detailed description: Parents of children enrolled in the Head Start program will be recruited to take part in a training module to learn and practice mindfulness techniques. Recruited participants will be randomly assigned to an intervention group or a wait-list control group. Parents in the intervention group will attend the training, which involves 6 weekly, group sessions. Data will be collected from both the intervention and wait-list control groups 1-3 weeks prior to the intervention period and 1-3 weeks following the end of the intervention period. This data will be collected through self-report questionnaires, in-home observations, hair sample from parents, an activity tracker for parents, and records on developmental assessments and attendance of the target child from Head Start. The wait-list control group will be offered a training after measures are completed. Intervention group participants may be invited to take part in focus groups after the training is complete. At these focus groups, they will engage in a discussion of their experiences and opinions about the class. Some participants may be invited to individual interviews to share their experiences and aid further revision of the program.

Eligibility criteria: Inclusion Criteria:

* Parents of children ages 0 - 5 who are enrolled in Head Start

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Parent Relationship Questionnaire 2-5 (PRQ2-5) scores (Kamphaus & Reynolds, 2006)
timeFrame: 1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)
measure: Change in HOME Infant / Toddler / Early Childhood Record Form scores (Totsika & Sylva, 2004)
timeFrame: 1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)
measure: Change in Symptom Checklist 90 Revised (SCL-90 R) scores (Derogatis, 1994)
timeFrame: 1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)
measure: Change in Psychological Well-Being Scales scores (Ryff & Keyes, 1995)
timeFrame: 1-3 weeks prior to intervention, 10 - 13 weeks after baseline (1-3 weeks post-intervention)
Secondary outcomes:
measure: Change in physical activities and characteristics measured using FitBit Activity Tracker (Bai et al., 2015)
timeFrame: Worn for 5 days at 1-3 weeks prior to intervention; worn for 5 days at 10 - 13 weeks after baseline (1-3 weeks post-intervention)
measure: Change in Prescription medication use
timeFrame: 1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)
measure: Adverse Childhood Experiences (Edwards, et al., 2003)
timeFrame: 1-3 weeks prior to intervention
measure: Family Instability Questionnaire (Ackerman et al., 1999)
timeFrame: 1-3 weeks prior to intervention
measure: Family Instability Questionnaire (Ackerman et al., 1999)
timeFrame: 10 - 13 weeks after baseline (1-3 weeks post-intervention)
measure: Change in Pittsburgh Sleep Quality Index scores (Buysse et al., 1989)
timeFrame: 1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)
measure: Change in Five Facet Mindfulness Questionnaire scores (Baer et al., 2008)
timeFrame: 1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)
measure: Hair cortisol (Russell et al., 2012)
timeFrame: 10 - 13 weeks after baseline (1-3 weeks post-intervention)
measure: Change in Behavior Assessment System for Children scores (Reynolds & Kamphaus, 2004)
timeFrame: 1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)
Other outcomes:
Locations:
city: Madison
country: United States
facility: Dane County Parent Council Inc
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Lisa Flook, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reynolds, C. R., & Kamphaus, R. W. (2004). BASC-2. Behavioral Assessment System for Children (2nd ed.). Circle Pines, MN: AGS.
citation: Kamphaus, R. W., & Reynolds, C. R. (2006). Parenting relationship questionnaire (PRQ). Bloomington, MN: Pearson Assessments.
citation: Bai Y, Welk GJ, Nam YH, Lee JA, Lee JM, Kim Y, Meier NF, Dixon PM. Comparison of Consumer and Research Monitors under Semistructured Settings. Med Sci Sports Exerc. 2016 Jan;48(1):151-8. doi: 10.1249/MSS.0000000000000727.
citation: Totsika V, Sylva K. The Home Observation for Measurement of the Environment Revisited. Child Adolesc Ment Health. 2004 Feb;9(1):25-35. doi: 10.1046/j.1475-357X.2003.00073.x.
citation: Ackerman BP, Kogos J, Youngstrom E, Schoff K, Izard C. Family instability and the problem behaviors of children from economically disadvantaged families. Dev Psychol. 1999 Jan;35(1):258-68. doi: 10.1037//0012-1649.35.1.258.
citation: Derogatis, L. R. (1994). SCL-90-R Symptom Checklist-90-R administration, scoring and procedures manual. Minneapolis, MN: National Computer Systems.
citation: Edwards VJ, Holden GW, Felitti VJ, Anda RF. Relationship between multiple forms of childhood maltreatment and adult mental health in community respondents: results from the adverse childhood experiences study. Am J Psychiatry. 2003 Aug;160(8):1453-60. doi: 10.1176/appi.ajp.160.8.1453.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
citation: Russell E, Koren G, Rieder M, Van Uum S. Hair cortisol as a biological marker of chronic stress: current status, future directions and unanswered questions. Psychoneuroendocrinology. 2012 May;37(5):589-601. doi: 10.1016/j.psyneuen.2011.09.009. Epub 2011 Oct 4.
citation: 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.
citation: Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995 Oct;69(4):719-27. doi: 10.1037//0022-3514.69.4.719.