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Study Detail

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.

Program(s) Reviewed: REST Routine

Additional Sources:

Keefe, M. R., Barbosa, G. A., Froese-Fretz, A., Kotzer, A. M., & Lobo, M. (2005). An intervention program for families with irritable infants. The American Journal of Maternal Child Nursing, 30(4), 230-236.

Study Screening Details

Screening DecisionScreening Conclusion
Study Passes ScreensEligible for Review

Study Design Details

RatingDesignAttritionBaseline EquivalenceReassignmentConfounding Factors
HighRandomized controlled trialLowNot applicableNoneNone
Notes:

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.

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.

Study Characteristics

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.

Comparison Condition

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

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 Source

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

Author Affiliation

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


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