Keefe, M. R., Lobo, M., Froese-Fretz, A., Kotzer, A. M., Barbosa, G., & Dudley, W. (2006). Effectiveness of an intervention for colic. Clinical Pediatrics, 45(2), 123-134.
|Screening decision||Screening conclusion||HomVEE procedures and standards version|
|Passes screens||Eligible for review||Version 1|
|Rating||Design||Attrition||Baseline equivalence||Compromised randomization||Confounding factors||Valid, reliable measure(s)|
|High||Randomized controlled trial||Low||Not applicable||None||None||Not assessed in manuscripts reviewed before 2021|
In 2020, HomVEE updated this review to move the measures of the child's fussiness and crying Child Health domain to the Child Development and School Readiness domain because ACF determined that all measures of child behavioral health, including fussiness and crying, belong in HomVEE's Child Development and School Readiness domain.
Keefe, M. R., Lobo, M., Froese-Fretz, A., Kotzer, A. M., Barbosa, G., & Dudley, W. (2006) and Keefe M. R., Karlsen, K. A., Lobo, M. L., Kotzer, A. M., & Dudley, W. N. (2006) used the same sample.
High rating applies to treatment versus control comparison. Comparisons of these groups with the post-test-only group receive a low rating because of failure to establish baseline equivalence on socioeconomic status for that group.
|Study participants||Participants (infants and their parents) were either referred by their pediatrician or nurse or recruited through local advertisements. Infants were all full-term, healthy, and low-risk births between the ages of 2 and 6 weeks and lived within a 2-hour radius of the metropolitan area. Researchers randomly assigned 137 infants and their caregivers: 71 to the treatment group and 66 to the comparison group. A third group of 48 infants and their caregivers were assigned to receive limited exposure to treatment and comprised a post-test-only group. These 48 infants exceeded the authors’ 2- to 6-week age cutoff and could not be included in the randomization. Baseline equivalence on socioeconomic status could not be established on this group and their results are excluded from the HomVEE review. Participants were followed for 8 weeks.|
|Setting||The study was conducted in Charleston, South Carolina, and Denver, Colorado.|
|Intervention services||The intervention included four home visits conducted by specially trained pediatric nurse specialists. The intervention began at enrollment and continued through a four-week period. The intervention had two components: the first included activities to help colicky infants and the second component assisted parents. The principles guiding infant interventions were (1) regulation, (2) entrainment, (3) structure, and (4) touch. The parent component covered four main content areas: (1) reassurance, (2) empathy, (3) support, and (4) time-out.|
|Comparison conditions||Comparison group members received a standard well-child care for a four-week period.|
This field lists subgroups examined in the manuscript (even if they were not replicated in other samples and not reported on the summary page for this model’s report).
Subgroups are not listed for manuscripts reviewed before 2021.
|Staff characteristics and training||The pediatric nurses in this study had a minimum education level of a master’s degree in nursing. They received special training and used written protocols as guides in implementing the intervention.|
|Funding sources||National Institutes of Nursing Research, Grants R0-1 NR04661.|
|Author affiliation||Maureen R. Keefe, a study author, is a developer of this model.|
|Rating||Outcome measure||Effect||Sample||Timing of follow-up||Sample size||Intervention group||Comparison group||Group difference||Effect size||Statistical significance||Notes|
|High||Parent Report on Hours of Crying||
FavorableUnfavorable or ambiguousNo Effect
|Full sample||4 weeks||121 mother/child dyads||Unadjusted mean = 1.29||Unadjusted mean = 2.94||Mean difference = -1.65||Study reported = 0.70||Statistically significant, p = 0|
|High||Parent Report on Intensity of Fussiness||
FavorableUnfavorable or ambiguousNo Effect
|Full sample||4 weeks||121 mother/child dyads||Unadjusted mean = 1.97||Unadjusted mean = 2.79||Mean difference = -0.82||Study reported = -0.52||Statistically significant, p = 0.01|
Outcome measure summary
|Outcome measure||Description of measure||Data collection method||Properties of measure|
Parent report on hours of crying
The Fussiness Rating Scale assesses the following dimensions of unexplained infant irritability: hours of unexplained crying per day, intensity of fussiness, and amount of fussiness per day. Parents were asked to estimate the average number of hours per day over the past week that the infant engaged in unexplained crying. The intensity and amount of fussiness were measured on a 7-point scale from no fussiness to constant fussiness.
Not reported by author