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Clinical Trials/NCT02637908
NCT02637908
Completed
Not Applicable

Head Start Parenting

University of Wisconsin, Madison1 site in 1 country42 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress, Physiological
Sponsor
University of Wisconsin, Madison
Enrollment
42
Locations
1
Primary Endpoint
Change in Symptom Checklist 90 Revised (SCL-90 R) scores (Derogatis, 1994)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Symptom Checklist 90 Revised (SCL-90 R) scores (Derogatis, 1994)

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

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.

Change in Parent Relationship Questionnaire 2-5 (PRQ2-5) scores (Kamphaus & Reynolds, 2006)

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

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.

Change in HOME Infant / Toddler / Early Childhood Record Form scores (Totsika & Sylva, 2004)

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

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.

Change in Psychological Well-Being Scales scores (Ryff & Keyes, 1995)

Time Frame: 1-3 weeks prior to intervention, 10 - 13 weeks after baseline (1-3 weeks post-intervention)

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.

Secondary Outcomes

  • 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)
  • Hair cortisol (Russell et al., 2012)(10 - 13 weeks after baseline (1-3 weeks post-intervention))
  • Change in Behavior Assessment System for Children scores (Reynolds & Kamphaus, 2004)(1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention))
  • Change in Pittsburgh Sleep Quality Index scores (Buysse et al., 1989)(1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention))
  • Family Instability Questionnaire (Ackerman et al., 1999)(10 - 13 weeks after baseline (1-3 weeks post-intervention))
  • Change in Five Facet Mindfulness Questionnaire scores (Baer et al., 2008)(1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention))

Study Sites (1)

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