Mindfulness Training for Head Start Parents

NCT ID: NCT02637908

Last Updated: 2016-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stress, Physiological

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mindfulness training

The mindfulness training (experimental condition) will receive 6-weeks of mindfulness training for parents provided in a group setting.

Group Type EXPERIMENTAL

Mindfulness training

Intervention Type BEHAVIORAL

6-weeks of group-based mindfulness training for parents

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindfulness training

6-weeks of group-based mindfulness training for parents

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lisa Flook, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dane County Parent Council Inc

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Reynolds, C. R., & Kamphaus, R. W. (2004). BASC-2. Behavioral Assessment System for Children (2nd ed.). Circle Pines, MN: AGS.

Reference Type BACKGROUND

Kamphaus, R. W., & Reynolds, C. R. (2006). Parenting relationship questionnaire (PRQ). Bloomington, MN: Pearson Assessments.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 26154336 (View on PubMed)

Totsika 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.

Reference Type BACKGROUND
PMID: 32797621 (View on PubMed)

Ackerman 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.

Reference Type BACKGROUND
PMID: 9923480 (View on PubMed)

Derogatis, L. R. (1994). SCL-90-R Symptom Checklist-90-R administration, scoring and procedures manual. Minneapolis, MN: National Computer Systems.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 12900308 (View on PubMed)

Buysse 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.

Reference Type BACKGROUND
PMID: 2748771 (View on PubMed)

Russell 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.

Reference Type BACKGROUND
PMID: 21974976 (View on PubMed)

Baer 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.

Reference Type BACKGROUND
PMID: 18310597 (View on PubMed)

Ryff 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.

Reference Type BACKGROUND
PMID: 7473027 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-1287

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nonviolent Communication for Parents
NCT06943105 RECRUITING NA