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Completed

NCT Number: NCT02637908

Mindfulness Training for Head Start Parents

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.

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Key information

Conditions

Stress, Physiological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dane County Parent Council Inc

Madison, Wisconsin, 53704, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Mindfulness Training

Behavioral

6-weeks of group-based mindfulness training for parents

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Head Start Parenting

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2015
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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