Asthma in ChildrenNCT02158338
Do Bonding Disruptions Occur More Often in Children With Asthma Than in Non-asthmatic Populations?
An observational study of Asthma in Children and Anxiety, run by Ran Anbar at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children, Anxiety
- What is being tested?
- Asthma and Non-asthma
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Mar 2015
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
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).
- Conditions
- Asthma in Children, Anxiety
- Being tested
- Asthma, Non-asthma
- Keywords
- asthma, maternal bonding, maternal bonding disruptions, mother-infant interaction
- Medical subject headings
- Anxiety Disorders, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsthmaOther
mothers who have children that have been diagnosed with respiratory issues
Non-asthmaOther
mothers who have children that do not have a diagnosis of respiratory problems
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Mothers of children thought to have asthma Receives: Other: Asthma | |
| Non-asthma | Mothers of children without diagnosed respiratory problems Receives: Other: Non-asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with asthma and/or maternal infant bonding issues
A questionnaire will be scored by a pediatric pulmonologist and a psychologist
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ran Anbar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ran Anbar, State University of New York - Upstate Medical University
- Investigators
- Ran D Anbar, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158338
- Sponsor's protocol ID
- 389127
- Status last verified
- May 2015
- First submitted
- 4 Jun 2014
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15850484Annesi-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.
PubMed 11421892Feinberg, 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.
PubMed 12084840Klaus, 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.
PubMed 11581477Kozyrskyj 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.
PubMed 17932381Madrid 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.
PubMed 16482847Mantymaa 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.
PubMed 12752609Nafstad 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.
PubMed 12974550Pennington, 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.
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.
PubMed 19052046Wright 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.
PubMed 11818321
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Bonding Disruptions Occur More Often in Children With Asthma Than in Non-asthmatic Populations?
- ClinicalTrials.gov ID
- NCT02158338
- Acronym / sponsor ID
- 389127
- Conditions
- Asthma in Children, Anxiety
- Keywords
- asthma, maternal bonding, maternal bonding disruptions, mother-infant interaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ran AnbarUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Jun 2014 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Other: AsthmaMothers of children thought to have asthma |
| Non-asthma | – | Other: Non-asthmaMothers of children without diagnosed respiratory problems |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Asthmamothers who have children that have been diagnosed with respiratory issues | Other | Asthma |
| Non-asthmamothers who have children that do not have a diagnosis of respiratory problems | Other | Non-asthma |
Primary outcome
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
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 2 Jun 2015.
- BackgroundAnbar, 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.
- Background: PubMed 15850484Anbar 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.
- Background: PubMed 11421892Annesi-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.
- BackgroundFeinberg, 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.
- Background: PubMed 12084840Kero 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.
- BackgroundKlaus, M. H., & Kennen, J. H. Maternal-infant bonding. St. Louis, MO: C. V. Mosby, 1976.
- Background: PubMed 11581477Klinnert 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.
- Background: PubMed 17932381Kozyrskyj 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.
- Background: PubMed 16482847Madrid 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.
- Background: PubMed 12752609Mantymaa 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.
- Background: PubMed 12974550Nafstad 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.
- BackgroundPennington, D. Events associated with maternal-infant bonding deficits and severity of pediatric asthma. Unpublished doctoral dissertation, Professional School of Psychology, San Francisco, 1991.
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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.
Ran D Anbar, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children and Anxiety, run by Ran Anbar 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 2 inclusion and 3 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 2 Jun 2015. 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?
Number of subjects with asthma and/or maternal infant bonding issues (time frame: Day 1). 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 NCT02158338, which also lists 16 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 2 Jun 2015.