Manuscript Details

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.

High rating
Study reviewed under: Handbook of Procedures and Standards, Version 1
Model(s) Reviewed
Author Affiliation

Maureen R. Keefe, a study author, is a developer of this model.

Funding Sources

National Institutes of Nursing Research, Grants R0-1 NR04661.

Study Design
Design Attrition Baseline equivalence Confounding factors Valid, reliable measures?
Randomized controlled trial Low

Not applicable

None

Not assessed in manuscripts reviewed under Handbook of Procedures and Standards, Version 1

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.

Findings that rate moderate or high in this manuscript

Child development and school readiness
Outcome measure Timing of follow-up Rating Direction of Effect Effect size (absolute value) Stastical significance Sample size Sample description
Parent Report on Hours of Crying 4 weeks High
0.70 Statistically significant, p = 0 121 mother/child dyads Full sample
Parent Report on Intensity of Fussiness 4 weeks High
0.52 Statistically significant, p = 0.01 121 mother/child dyads Full sample
Effect rating key
Favorable finding / Statistically significant
Unfavorable finding / Statistically significant
Ambiguous finding / Statistically significant
No effect / Not statistically significant
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.

Home Visiting 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.

Model(s) Reviewed
Comparison Conditions

Comparison group members received a standard well-child care for a four-week period.

Were any subgroups examined?
No

This study included participants with the following characteristics at enrollment:

Race/Ethnicity

The race and ethnicity categories may sum to more than 100 percent if Hispanic ethnicity was reported separately or respondents could select two or more race or ethnicity categories.

Black or African American
7%
Hispanic or Latino
11%
White
76%
Unknown
7%

Maternal Education

Data not available

Other Characteristics

Data not available