NCT02637908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

10 months

First QC Date

September 3, 2015

Last Update Submit

August 9, 2016

Conditions

Keywords

MindfulnessParentsFamilies

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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)

Secondary Outcomes (9)

  • Change in physical activities and characteristics measured using FitBit Activity Tracker (Bai et al., 2015)

    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)

  • Change in Prescription medication use

    1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)

  • Adverse Childhood Experiences (Edwards, et al., 2003)

    1-3 weeks prior to intervention

  • Family Instability Questionnaire (Ackerman et al., 1999)

    1-3 weeks prior to intervention

  • Family Instability Questionnaire (Ackerman et al., 1999)

    10 - 13 weeks after baseline (1-3 weeks post-intervention)

  • +4 more secondary outcomes

Study Arms (2)

Mindfulness training

EXPERIMENTAL

The mindfulness training (experimental condition) will receive 6-weeks of mindfulness training for parents provided in a group setting.

Behavioral: Mindfulness training

Wait-list control

NO INTERVENTION

The wait-list control group will receive no intervention during the course of the study. The control group will be offered training following the completion of the study.

Interventions

6-weeks of group-based mindfulness training for parents

Mindfulness training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dane County Parent Council Inc

Madison, Wisconsin, 53704, United States

Location

Related Publications (11)

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

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

    BACKGROUND
  • 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.

    PMID: 26154336BACKGROUND
  • 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.

    PMID: 32797621BACKGROUND
  • 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.

    PMID: 9923480BACKGROUND
  • Derogatis, L. R. (1994). SCL-90-R Symptom Checklist-90-R administration, scoring and procedures manual. Minneapolis, MN: National Computer Systems.

    BACKGROUND
  • 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.

    PMID: 12900308BACKGROUND
  • 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.

    PMID: 2748771BACKGROUND
  • 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.

    PMID: 21974976BACKGROUND
  • 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.

    PMID: 18310597BACKGROUND
  • 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.

    PMID: 7473027BACKGROUND

Study Officials

  • Lisa Flook, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2015

First Posted

December 22, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations