Mindfulness Training for Head Start Parents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Head Start Parenting

Conditions
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Stress, Physiological

Intervention / Treatment
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* Behavioral: Mindfulness training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents of children ages 0 - 5 who are enrolled in Head Start Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Parents, Families