Family Process, Adherence, and Child Asthma Outcome

Tracking Information
First Submitted Date	May 25, 2000
First Posted Date	May 26, 2000
Last Update Posted Date	February 18, 2016
Study Start Date	August 1996
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00005390 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Family Process, Adherence, and Child Asthma Outcome
Official Title	Not Provided
Brief Summary	To examine the role of family processes in asthma regulation in three groups of children with mild to moderate asthma.
Detailed Description	DESIGN NARRATIVE: The study, which was ancillary to the Childhood Asthma Management Program (CAMP), clarified the extent to which and the mechanisms whereby specific family processes might be protective or deleterious in the adherence behaviors and treatment outcome in three groups of children with mild to moderate asthma: 80 children participating in the Denver site of the CAMP, 80 children receiving asthma-related care in a large, nationally recognized health maintenance organization, and 60 children recruited by using school records to identify children with asthma receiving their care in a variety of different health care systems across the Denver metropolitan area. The study examined the extent to which family process variables were cross-sectionally associated with and longitudinally influenced adherence to asthma treatment and asthma treatment outcome as well as the consistency of this relationship across the three sites. The study also determined whether adherence with treatment mediated the relationship between specific family processes and asthma treatment outcome, as well as the consistency of this relationship across the three sites. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study Type	Observational
Study Design	Not Provided
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition	Asthma; Lung Diseases
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Cohen SY, Wamboldt FS. The parent-physician relationship in pediatric asthma care. J Pediatr Psychol. 2000 Mar;25(2):69-77.; Wamboldt FS, Spahn JD, Klinnert MD, Wamboldt MZ, Gavin LA, Szefler SJ, Leung DY. Clinical outcomes of steroid-insensitive asthma. Ann Allergy Asthma Immunol. 1999 Jul;83(1):55-60.; Gavin LA, Wamboldt MZ, Sorokin N, Levy SY, Wamboldt FS. Treatment alliance and its association with family functioning, adherence, and medical outcome in adolescents with severe, chronic asthma. J Pediatr Psychol. 1999 Aug;24(4):355-65.; Gabriels RL, Wamboldt MZ, McCormick DR, Adams TL, McTaggart SR. Children's illness drawings and asthma symptom awareness. J Asthma. 2000;37(7):565-74.; Wamboldt MZ, Wamboldt FS. Role of the family in the onset and outcome of childhood disorders: selected research findings. J Am Acad Child Adolesc Psychiatry. 2000 Oct;39(10):1212-9. Review.; Wamboldt FS, Bender BG, O'Connor SL, Gavin LA, Wamboldt MZ, Milgrom H, Szefler SJ, Iklé D, Rand C. Reliability of the model MC-311 MDI chronolog. J Allergy Clin Immunol. 1999 Jul;104(1):53-7.; Frankel K, Wamboldt MZ. Chronic childhood illness and maternal mental health--why should we care? J Asthma. 1998;35(8):621-30.; Wamboldt MZ, Schmitz S, Mrazek D. Genetic association between atopy and behavioral symptoms in middle childhood. J Child Psychol Psychiatry. 1998 Oct;39(7):1007-16. Erratum in: J Child Psychol Psychiatry 2000 Jul;41(5):674.; Wamboldt MZ, Fritz G, Mansell A, McQuaid EL, Klein RB. Relationship of asthma severity and psychological problems in children. J Am Acad Child Adolesc Psychiatry. 1998 Sep;37(9):943-50.; Wamboldt MZ, Wamboldt FS, Gavin L, McTaggart AS. A parent-child relationship scale derived from the child and adolescent psychiatric assessment (CAPA). J Am Acad Child Adolesc Psychiatry. 2001 Aug;40(8):945-53.; Wenzel SE, Morgan K, Griffin R, Stanford R, Edwards L, Wamboldt FS, Rogenes P. Improvement in health care utilization and pulmonary function with fluticasone propionate in patients with steroid-dependent asthma at a National Asthma Referral Center. J Asthma. 2001 Aug;38(5):405-12.; Millikan E, Wamboldt MZ, Bihun JT. Perceptions of the family, personality characteristics, and adolescent internalizing symptoms. J Am Acad Child Adolesc Psychiatry. 2002 Dec;41(12):1486-94.; Ho J, Bender BG, Gavin LA, O'Connor SL, Wamboldt MZ, Wamboldt FS. Relations among asthma knowledge, treatment adherence, and outcome. J Allergy Clin Immunol. 2003 Mar;111(3):498-502.; Fiese BH, Wamboldt FS. Tales of pediatric asthma management: family-based strategies related to medical adherence and health care utilization. J Pediatr. 2003 Oct;143(4):457-62.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Enrollment	Not Provided
Original Enrollment	Not Provided
Actual Study Completion Date	July 2001
Primary Completion Date	Not Provided
Eligibility Criteria	No eligibility criteria
Sex/Gender	Sexes Eligible for Study: Male
Ages	up to 100 Years (Child, Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Not Provided
Removed Location Countries
Administrative Information
NCT Number	NCT00005390
Other Study ID Numbers	4296; R01HL053391 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators	Not Provided
Investigators	Investigator: Frederick Wamboldt National Jewish Center for Immunology & Respiratory Medicine
PRS Account	National Heart, Lung, and Blood Institute (NHLBI)
Verification Date	August 2004