Stress, PhysiologicalNCT02637908
Mindfulness Training for Head Start Parents
A study testing Mindfulness training in people with Stress, Physiological, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Physiological
- What is being tested?
- Mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents of children ages 0 - 5 who are enrolled in Head Start
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Dane County Parent Council Inc
Madison, Wisconsin, 53704
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Physiological
- Being tested
- Mindfulness training
- Keywords
- Mindfulness, Parents, Families
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness trainingBehavioural
6-weeks of group-based mindfulness training for parents
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness training | Experimental | The mindfulness training (experimental condition) will receive 6-weeks of mindfulness training for parents provided in a group setting. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-3 weeks prior to intervention; 10 - 13 weeks after baseline (1-3 weeks post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Stress, PhysiologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Flook, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637908
- Sponsor's protocol ID
- 2014-1287
- Status last verified
- Aug 2016
- First submitted
- 3 Sep 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Reynolds, C. R., & Kamphaus, R. W. (2004). BASC-2. Behavioral Assessment System for Children (2nd ed.). Circle Pines, MN: AGS.
Kamphaus, R. W., & Reynolds, C. R. (2006). Parenting relationship questionnaire (PRQ). Bloomington, MN: Pearson Assessments.
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.
PubMed 26154336Totsika 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.
PubMed 32797621Ackerman 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.
PubMed 9923480Derogatis, L. R. (1994). SCL-90-R Symptom Checklist-90-R administration, scoring and procedures manual. Minneapolis, MN: National Computer Systems.
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.
PubMed 12900308Buysse 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.
PubMed 2748771Russell 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.
PubMed 21974976Baer 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.
PubMed 18310597Ryff 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.
PubMed 7473027
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head Start Parenting
- ClinicalTrials.gov ID
- NCT02637908
- Acronym / sponsor ID
- 2014-1287
- Conditions
- Stress, Physiological
- Keywords
- Mindfulness, Parents, Families
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness training | Experimental | Behavioral: Mindfulness trainingThe mindfulness training (experimental condition) will receive 6-weeks of mindfulness training for parents provided in a group setting. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents of children ages 0 - 5 who are enrolled in Head Start
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness training6-weeks of group-based mindfulness training for parents | Behavioural | Mindfulness training |
Primary outcome
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 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 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.
9 secondary outcomes
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)
Change in Prescription medication use
Time frame: 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
Family Instability Questionnaire (Ackerman et al., 1999)
Time frame: 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)
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)
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)
Hair cortisol (Russell et al., 2012)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- BackgroundReynolds, C. R., & Kamphaus, R. W. (2004). BASC-2. Behavioral Assessment System for Children (2nd ed.). Circle Pines, MN: AGS.
- BackgroundKamphaus, R. W., & Reynolds, C. R. (2006). Parenting relationship questionnaire (PRQ). Bloomington, MN: Pearson Assessments.
- Background: PubMed 26154336Bai 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.
- Background: PubMed 32797621Totsika 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.
- Background: PubMed 9923480Ackerman 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.
- BackgroundDerogatis, L. R. (1994). SCL-90-R Symptom Checklist-90-R administration, scoring and procedures manual. Minneapolis, MN: National Computer Systems.
- Background: PubMed 12900308Edwards 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.
- Background: PubMed 2748771Buysse 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.
- Background: PubMed 21974976Russell 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.
- Background: PubMed 18310597Baer 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.
- Background: PubMed 7473027Ryff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Flook, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness training in people with Stress, Physiological, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02637908, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.