Mindfulness Training for Head Start Parents

August 9, 2016 updated by: University of Wisconsin, Madison

Head Start Parenting

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Dane County Parent Council Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness training
The mindfulness training (experimental condition) will receive 6-weeks of mindfulness training for parents provided in a group setting.
Behavioral: Mindfulness training
6-weeks of group-based mindfulness training for parents
No Intervention: Wait-list control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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)
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.
1-3 weeks prior to intervention, 10 - 13 weeks after baseline (1-3 weeks post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physical activities and characteristics measured using FitBit Activity Tracker (Bai et al., 2015)
Time Frame: 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)
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)
Change in Prescription medication use
Time Frame: 1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)
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)
Adverse Childhood Experiences (Edwards, et al., 2003)
Time Frame: 1-3 weeks prior to intervention
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
Family Instability Questionnaire (Ackerman et al., 1999)
Time Frame: 1-3 weeks prior to intervention
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
Family Instability Questionnaire (Ackerman et al., 1999)
Time Frame: 10 - 13 weeks after baseline (1-3 weeks post-intervention)
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)
Change in Pittsburgh Sleep Quality Index scores (Buysse et al., 1989)
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 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)
Change in Five Facet Mindfulness Questionnaire scores (Baer et al., 2008)
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 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)
Hair cortisol (Russell et al., 2012)
Time Frame: 10 - 13 weeks after baseline (1-3 weeks post-intervention)
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)
Change in Behavior Assessment System for Children scores (Reynolds & Kamphaus, 2004)
Time Frame: 1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Lisa Flook, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

December 17, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-1287

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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