- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02158338
Do Bonding Disruptions Occur More Often in Children With Asthma Than in Non-asthmatic Populations?
Six studies have preceded this project. Three studies suggested that there is a significant connection between pediatric asthma and disruptions in maternal-infant bonding (Feinberg, 1988; Schwartz, 1988; Pennington, 1991). Three studies suggested that children with asthma benefit from a type of therapy that improves bonding with their mothers (Madrid, Ames, Skolek, & Brown, 2000; Madrid, Ames, Horner, Brown, & Navarrette, 2004; Madrid, Pennington, Brown & Wolfe, 2011).
This study proposes to study in a more thorough fashion the question of the incidence of bonding disruptions with between mothers and their children with asthma. This time there will be a larger sample, and more stringent criteria will used in assigning children to the asthma cohort. Through questions answered by mothers whose children have been said to have asthma, we will be able to decide if the children's respiratory conditions are likely to be attributable to asthma or more likely reflective of another respiratory condition such as vocal cord dysfunction or anxiety related hyperventilation (Anbar, 2014).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Biological mothers of male and female children between 2 and 12 years of age who live with or have contact with their children
- English is the primary language of the biological mother
Exclusion Criteria:
- Mothers of children only below 2 or above 12 years of age
- Mothers of children thought to have a chronic health condition other than asthma
- Mothers who have already completed a questionnaire with another child
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Asthma
Mothers of children thought to have asthma
|
mothers who have children that have been diagnosed with respiratory issues
|
|
Non-asthma
Mothers of children without diagnosed respiratory problems
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mothers who have children that do not have a diagnosis of respiratory problems
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of subjects with asthma and/or maternal infant bonding issues
Time Frame: Day 1
|
A questionnaire will be scored by a pediatric pulmonologist and a psychologist
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ran D Anbar, MD, State University of New York - Upstate Medical University
Publications and helpful links
General Publications
- Roduit C, Scholtens S, de Jongste JC, Wijga AH, Gerritsen J, Postma DS, Brunekreef B, Hoekstra MO, Aalberse R, Smit HA. Asthma at 8 years of age in children born by caesarean section. Thorax. 2009 Feb;64(2):107-13. doi: 10.1136/thx.2008.100875. Epub 2008 Dec 3.
- Anbar, R.D. Functional symptoms in pulmonology: taking your breath away. In: Ran D. Anbar (ed), Functional Symptoms in Pediatric Disease: A Clinical Guide. New York, NY: Springer, 2014; 47-58.
- Anbar RD, Geisler SC. Identification of children who may benefit from self-hypnosis at a pediatric pulmonary center. BMC Pediatr. 2005 Apr 25;5(1):6. doi: 10.1186/1471-2431-5-6.
- Annesi-Maesano I, Moreau D, Strachan D. In utero and perinatal complications preceding asthma. Allergy. 2001 Jun;56(6):491-7. doi: 10.1034/j.1398-9995.2001.056006491.x.
- Feinberg, Steven. Degree of maternal infant bonding and its relationship to pediatric asthma and family environments. Unpublished doctoral dissertation, Professional School of Psychology, San Francisco, 1988.
- Kero J, Gissler M, Gronlund MM, Kero P, Koskinen P, Hemminki E, Isolauri E. Mode of delivery and asthma -- is there a connection? Pediatr Res. 2002 Jul;52(1):6-11. doi: 10.1203/00006450-200207000-00004.
- Klaus, M. H., & Kennen, J. H. Maternal-infant bonding. St. Louis, MO: C. V. Mosby, 1976.
- Klinnert MD, Nelson HS, Price MR, Adinoff AD, Leung DY, Mrazek DA. Onset and persistence of childhood asthma: predictors from infancy. Pediatrics. 2001 Oct;108(4):E69. doi: 10.1542/peds.108.4.e69.
- Kozyrskyj AL, Mai XM, McGrath P, Hayglass KT, Becker AB, Macneil B. Continued exposure to maternal distress in early life is associated with an increased risk of childhood asthma. Am J Respir Crit Care Med. 2008 Jan 15;177(2):142-7. doi: 10.1164/rccm.200703-381OC. Epub 2007 Oct 11.
- Madrid A. Helping children with asthma by repairing maternal-infant bonding problems. Am J Clin Hypn. 2005 Oct-2006 Jan;48(2-3):199-211. doi: 10.1080/00029157.2005.10401517.
- Mantymaa M, Puura K, Luoma I, Salmelin R, Davis H, Tsiantis J, Ispanovic-Radojkovic V, Paradisiotou A, Tamminen T. Infant-mother interaction as a predictor of child's chronic health problems. Child Care Health Dev. 2003 May;29(3):181-91. doi: 10.1046/j.1365-2214.2003.00330.x.
- Nafstad P, Samuelsen SO, Irgens LM, Bjerkedal T. Pregnancy complications and the risk of asthma among Norwegians born between 1967 and 1993. Eur J Epidemiol. 2003;18(8):755-61. doi: 10.1023/a:1025395405101.
- Pennington, D. Events associated with maternal-infant bonding deficits and severity of pediatric asthma. Unpublished doctoral dissertation, Professional School of Psychology, San Francisco, 1991.
- Schwartz, M.P. Incidence of events associated with maternal-infant bonding disturbance in a pediatric population. Unpublished doctoral dissertation, Rosebridge Graduate School, Walnut Creek, 1988.
- Wright RJ, Cohen S, Carey V, Weiss ST, Gold DR. Parental stress as a predictor of wheezing in infancy: a prospective birth-cohort study. Am J Respir Crit Care Med. 2002 Feb 1;165(3):358-65. doi: 10.1164/ajrccm.165.3.2102016.
- Wright RJ, Visness CM, Calatroni A, Grayson MH, Gold DR, Sandel MT, Lee-Parritz A, Wood RA, Kattan M, Bloomberg GR, Burger M, Togias A, Witter FR, Sperling RS, Sadovsky Y, Gern JE. Prenatal maternal stress and cord blood innate and adaptive cytokine responses in an inner-city cohort. Am J Respir Crit Care Med. 2010 Jul 1;182(1):25-33. doi: 10.1164/rccm.200904-0637OC. Epub 2010 Mar 1.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 389127
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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