Mindfulness Training for Head Start Parents

Stress, Physiological Clinical Trial

Official title:

Head Start Parenting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637908
• Other study ID #: 2014-1287
• Status: Completed
• Phase: N/A
• First received: September 3, 2015
• Last updated: August 9, 2016
• Start date: September 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stress, Physiological

Intervention

Behavioral:
• Mindfulness training
6-weeks of group-based mindfulness training for parents

Locations

Country	Name	City	State
United States	Dane County Parent Council Inc	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View Citation

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

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. — View Citation

Kamphaus, R. W., & Reynolds, C. R. (2006). Parenting relationship questionnaire (PRQ). Bloomington, MN: Pearson Assessments.

Reynolds, C. R., & Kamphaus, R. W. (2004). BASC-2. Behavioral Assessment System for Children (2nd ed.). Circle Pines, MN: AGS.

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. Review. — 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

Totsika, V., & Sylva, K. (2004). The home observation for measurement of the environment revisited. Child and Adolescent Mental Health, 9(1), 25-35.

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Parent Relationship Questionnaire 2-5 (PRQ2-5) scores (Kamphaus & Reynolds, 2006)	The PRQ2-5 will be completed by the parent participant prior to the intervention period and directly following the end of the intervention period in order to assess any change in the parent-child relationship.	1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)	No
Primary	Change in HOME Infant / Toddler / Early Childhood Record Form scores (Totsika & Sylva, 2004)	Observations of parents and children will be completed in parents' homes prior to the intervention and directly following the intervention period. Observations will involve completion of the HOME Record Form by trained observers. The observations completed at each time point will be used to assess change in the home environment of the child.	1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)	No
Primary	Change in Symptom Checklist 90 Revised (SCL-90 R) scores (Derogatis, 1994)	Parents will complete a self-report questionnaire assessing their own psychological symptoms prior to the intervention period and directly following the end of the intervention. Scores acquired at each time point will be used to assess change in the parent participant's psychological symptoms.	1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)	No
Primary	Change in Psychological Well-Being Scales scores (Ryff & Keyes, 1995)	Parents will complete a self-report questionnaire assessing their level of psychological well-being prior to the intervention period and directly following the end of the intervention. Scores acquired at each time point will be used to assess change in the parent participant's psychological well-being.	1-3 weeks prior to intervention, 10 - 13 weeks after baseline (1-3 weeks post-intervention)	No
Secondary	Change in physical activities and characteristics measured using FitBit Activity Tracker (Bai et al., 2015)	Data will be collected on the parent's physical activity, including steps, sleep and heart rate, using a FitBit Activity Tracker device. The data collected at each time point will be used to assess change in the parent participant's physical activity.	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)	No
Secondary	Change in Prescription medication use	Parents' self-report of their prescription medication use will be collected prior to the intervention and directly following the end of the intervention period. Information collected at each time point will be used to assess any change in the parent participant's prescription medication use.	1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)	No
Secondary	Adverse Childhood Experiences (Edwards, et al., 2003)	The Adverse Childhood Experiences questionnaire will be completed by parents to assess the parents' childhood experiences prior to the intervention.	1-3 weeks prior to intervention	No
Secondary	Family Instability Questionnaire (Ackerman et al., 1999)	Parents will complete a self-report questionnaire assessing events related to family instability that may have taken place prior to the intervention period.	1-3 weeks prior to intervention	No
Secondary	Family Instability Questionnaire (Ackerman et al., 1999)	Parents will complete a self-report questionnaire assessing events related to family instability that may have taken place during the time of the intervention period.	10 - 13 weeks after baseline (1-3 weeks post-intervention)	No
Secondary	Change in Pittsburgh Sleep Quality Index scores (Buysse et al., 1989)	Parents will complete a self-report questionnaire assessing their own sleep quality prior to the intervention period and directly following the end of the intervention period. Data collected at each time point will be used to assess changes in the parent participant's sleep quality.	1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)	No
Secondary	Change in Five Facet Mindfulness Questionnaire scores (Baer et al., 2008)	Parents will complete a self-report questionnaire assessing their level of mindfulness prior to the intervention period and directly following the end of the intervention. Scored collected at each time point will be used to assess changes in the parent's level of mindfulness.	1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)	No
Secondary	Hair cortisol (Russell et al., 2012)	Cortisol will be assessed in the hair of consenting parents directly following the end of the intervention period.	10 - 13 weeks after baseline (1-3 weeks post-intervention)	No
Secondary	Change in Behavior Assessment System for Children scores (Reynolds & Kamphaus, 2004)	Parents will complete a questionnaire concerning observed behaviors of their child prior to the intervention period and directly following the end of the intervention. Scores collected at each time point will be used to assess any change in the parent participant's perception of the target child's behavior.	1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)	No