Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02637908
Other study ID # 2014-1287
Secondary ID
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


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 allClick 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
See also
  Status Clinical Trial Phase
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Not yet recruiting NCT05491122 - The Influence of Fluid Intake on Daily Biological Rhythm and Mental Performance in Healthy Young Adults N/A
Completed NCT02844478 - Stress-Busting Program and QoL, Bio-markers of Immunity/Stress and Cellular Aging N/A
Withdrawn NCT04797546 - Adductor Canal Block Versus Patient Controlled Analgesia, in the Surgical Stress Response for Anterior Cruciate Ligament Repair Phase 1
Completed NCT05198414 - SER+ Against COVID-19 - Interventions to Strengthen the Resilience of HCWs in Ecuador
Completed NCT04815252 - Mindfulness Intervention for Early Childhood Educators N/A
Completed NCT04786496 - Wise Interventions and Responses to Stress N/A
Completed NCT04465240 - Adolescent Responses to Varying Environments in Virtual Reality Simulations N/A
Recruiting NCT05094115 - Enhancing Resiliency and Optimizing Readiness in Military Personnel N/A
Active, not recruiting NCT03904979 - Therapeutic Writing to Reduce Stress N/A
Completed NCT04637607 - Immediate Effect of Non-invasive Auricular Acupoint Stimulation for the Performance and the Meridian Activities of Archery Athletes N/A
Completed NCT04944264 - A Mind-Body Intervention for Diabetes Management: A Pilot Study N/A
Completed NCT05172804 - Mind-Body Modalities for Nursing Students N/A
Recruiting NCT04488757 - Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain N/A
Recruiting NCT05830435 - Trier Social Stress Test in Virtual Reality N/A
Recruiting NCT04910724 - Effects of Varying Energy Deficits on Protein Turnover at Rest and Carbohydrate Oxidation During Steady-state Exercise N/A
Completed NCT01464398 - Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS) N/A
Completed NCT06008236 - The Effect of Progressive Relaxation and Breathing Exercises Accompanied by Music on the Stress Levels of Nursing Students and Their Bio-psycho-social Responses N/A
Recruiting NCT06091189 - Internalized Stress in Relation to Alcohol Consumption Early Phase 1
Recruiting NCT04100213 - Real-Time Assessment of Stress and Stress Response N/A