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Klinnert, M. D., Liu, A. H., Pearson, M. R., Ellison, M. C., Budhiraja, N., & Robinson, J. L. (2005). Short-term impact of a randomized multifaceted intervention for wheezing infants in low-income families. Archives of Pediatrics & Adolescent Medicine, 159(1), 75-82.

Model(s) Reviewed: Childhood Asthma Prevention Study (CAPS)
Manuscript screening details
Screening decision Screening conclusion
Passes screens Eligible for review
Study design details
Rating Design Attrition Baseline equivalence Reassignment Confounding factors
High Randomized controlled trial Low Not applicable None None
Notes:

footnote129

Submitted by user on Fri, 03/15/2019 - 14:29

High rating applies to most outcomes. Medical record outcomes receive a low rating because of high attrition and failure to demonstrate baseline equivalence.

Study characteristics
Study participants Participants (infants and their families) were recruited from local hospitals and clinics in the Denver, Colorado, area and assigned randomly to either the intervention or the comparison group. Initially 181 infants were randomly assigned, 90 to the treatment group and 91 to the comparison group. At baseline, the study groups were split among European Americans (22 percent treatment, 21 percent control), African American (23 percent treatment, 22 percent control), U.S.-born Hispanic (33 percent treatment, 31 percent control) and foreign-born Hispanic (22 percent treatment, 20 percent control). Approximately half of each group had incomes less than $12,000 per year. Participants were followed for one year after baseline data were collected.
Setting The study was conducted in Denver, Colorado.
Intervention services The intervention included home visits conducted by specially trained nurses. The intervention began when infants were from 9 to 24 months old and continued for 12 months. Participants received approximately 15 visits (or telephone calls) by a public health nurse. Each visit lasted an average of 53 minutes.
Comparison conditions Comparison group members received an educational video at the baseline interview that described risk factors for developing asthma and actions that caregivers can take to mediate the risks.
Staff characteristics and training The nurses in this study had bachelor’s of science degrees in nursing and had experience in community outreach.
Funding sources National Institute of Allergy and Infectious Diseases; National Institute of Health/National Center for Research Resources.
Author affiliation Mary D. Klinnert, a study author, is a developer of this model.

Findings details

Child health
Rating Outcome measure Effect Sample Timing of follow-up Sample size Intervention group Comparison group Group difference Effect size Statistical significance Notes
High Cotinine level
FavorableUnfavorable or ambiguousNo Effect
Denver, Colorado sample 12 months 130 children = 0.66 = 0.56 Mean difference = 0.10 HomeVEE calculated = 0.25 Not statistically significant, p = 0.28

footnote127

Submitted by user on Fri, 03/15/2019 - 14:29

Cotinine level outcome based on logistic regression model. Outcome from logrnormal regression model had high attrition and is not included in this report.

High Functional Severity Score
FavorableUnfavorable or ambiguousNo Effect
Denver, Colorado sample 12 months 150 children Mean = 1.03 Mean = 1.04 Mean difference = -0.01 Not available Not Statistically significant, p = 0.60
Maternal health
Rating Outcome measure Effect Sample Timing of follow-up Sample size Intervention group Comparison group Group difference Effect size Statistical significance Notes
High Caregiver quality of life score
FavorableUnfavorable or ambiguousNo Effect
Denver, Colorado sample 12 months 143 parents Mean = 6.47 Mean = 6.34 Mean difference = 0.13 Not available Not statistically significant, p = 0.72
Positive parenting practices
Rating Outcome measure Effect Sample Timing of follow-up Sample size Intervention group Comparison group Group difference Effect size Statistical significance Notes
High HOME score
FavorableUnfavorable or ambiguousNo Effect
Denver, Colorado sample 12 months 137 parents Mean = 36.66 Mean = 36.64 Mean difference = 0.02 Not available Not statistically significant, p = 0.94
High Asthma knowledge score
FavorableUnfavorable or ambiguousNo Effect
Denver, Colorado sample 12 months 150 parents Mean = 5.20 Mean = 4.84 Mean difference = 0.36 Not available Statistically significant, p = 0.04
High Cat dander
FavorableUnfavorable or ambiguousNo Effect
Denver, Colorado sample 12 months 140 parents = 0.33 = 0.26 Mean difference = 0.07 HomeVEE calculated = 0.20 Not statistically significant, p = 0.25
High Cockroach allergen
FavorableUnfavorable or ambiguousNo Effect
Denver, Colorado sample 12 months 140 parents = 0.01 = 0.13 Mean difference = -0.12 HomeVEE calculated = -1.62 Statistically significant, p = 0.03
High Collaborative relationship score
FavorableUnfavorable or ambiguousNo Effect
Denver, Colorado sample 12 months 146 parents Mean = 6.13 Mean = 5.81 Mean difference = 0.33 Not available Statistically significant, p = 0.04
High Dog dander
FavorableUnfavorable or ambiguousNo Effect
Denver, Colorado sample 12 months 141 parents = 0.13 = 0.24 Mean difference = -0.11 HomeVEE calculated = -0.45 Not statistically significant, p = -.07

Outcome measure summary

Child health
Outcome measure Description of measure Data collection method Properties of measure

Cotinine level

The authors measured cotinine levels to detect environmental tobacco smoke exposure. The measure indicates the percentage of infants in whom cotinine levels, a metabolite of nicotine, were greater than 5 nanograms of cotinine per gram of creatinine. Infant urine samples

Not applicable

Functional Severity Score

Incidence and severity of infant respiratory symptoms over the past six months. Parent/caregiver report

Not applicable

Maternal health
Outcome measure Description of measure Data collection method Properties of measure

Caregiver quality of life score

The Pediatric Asthma Caregiver's Quality of Life scale assesses the effects of a child's illness on the parent. The term "asthma" was replaced with words describing symptoms of wheezing illness. Items were coded on a 7-point scale. Parent/caregiver report

Not reported by author

Positive parenting practices
Outcome measure Description of measure Data collection method Properties of measure

HOME score

The Home Observation for Measurement of the Environment inventory (0-3 years) assesses parent-child interactions. Observational assessment

Interrater reliability was 93.2%

Cat dander

Percentage of homes in which the presence of cat dander was higher than the standard cut-off levels. House dust collection

Not applicable

Cockroach allergen

Percentage of homes in which the presence of cockroach allergen was higher than the standard cut-off levels. House dust collection

Not applicable

Dog dander

Percentage of homes in which the presence of dog dander was higher than the standard cut-off levels. House dust collection

Not applicable

Family Asthma Management System Scale--asthma knowledge and collaborative relationship subscales

The scale was adapted to assesses the caregiver's illness management practices with a wheezing infant. The authors used the asthma knowledge and collaborative relationship with medical care provider subscales. Items were coded on a 9-point scale. Parent/caregiver report

Interrater reliability ranged from 0.82-0.96 for the asthma knowledge subscale and from 0.79-0.96 for the collaborative relationship subscale