Random assignment in clinical trials: Issues in planning (Infant Health and Development Program)

Kraemer, Helena C.; Fendt, Kaye

doi:10.1016/0895-4356(90)90017-j

Cited by 35 publications

(20 citation statements)

References 15 publications

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“…Managed Health Care Organization: "In God we trust, from everybody else we demand outcome data." Fortunately, over the last 25 years substantial evidence for the effectiveness of early preventive intervention has been accumulated (e.g., Brooks-Gunn, Klebanov, Liaw, & Spiker, 1993;Field et al, 1986;Horacek, Ramey, Campbell, Hoffman, & Fletcher, 1987;Kraemer & Fendt, 1990).…”

Section: Overview Of Past Evaluations and Follow-upmentioning

confidence: 99%

Prevention, the appropriate target of infant psychotherapy

Fonagy

1998

Infant Ment. Health J.

110

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The main advantage of being asked to present a plenary address at a Congress (other than the obvious honor) is not having to submit an abstract. This is just as well, because had I submitted one, I have no doubt that my esteemed colleagues, Drs. de Cha ˆteau and Guedeney, the Cochairs of the Program Committee, would have rejected it, and appropriately so. This is because in this presentation I have decided to focus the evaluator's microscope not on early interventions

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Section: Overview Of Past Evaluations and Follow-upmentioning

confidence: 99%

Prevention, the appropriate target of infant psychotherapy

Fonagy

1998

Infant Ment. Health J.

110

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“…In summary, the intervention includes individual components (pedometer-based self-monitoring, educational materials, and tailored bi-weekly counseling calls); interpersonal components (bi-weekly group sessions and peer mentoring); environmental components (walking signage prompts, tailored community walking maps, posted step counts of different corridors and classes); and policy components (improvement of onsite activity opportunities and walking environments through peer led advocacy). Up to sixteen retirement community sites in San Diego County are being randomized to the intervention or control condition using an Efron-type procedure [23]. Ethical approval for the study was obtained from the University of California, San Diego (#091028).…”

Section: Methodsmentioning

confidence: 99%

Applying the ecological model of behavior change to a physical activity trial in retirement communities: Description of the study protocol

Kerr¹,

Rosenberg

Nathan

et al. 2012

Contemporary Clinical Trials

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OBJECTIVES To describe the intervention protocol for the first multilevel ecological intervention for physical activity in retirement communities that addresses individual, interpersonal and community influences on behavior change. DESIGN A cluster randomized controlled trial design was employed with two study arms: a physical activity intervention and an attention control successful aging condition. SETTING Sixteen continuing care retirement communities in San Diego County. PARTICIPANTS Three hundred twenty older adults, aged 65 years and older, are being recruited to participate in the trial. In addition, peer leaders are being recruited to lead some study activities, especially to sustain the intervention after study activities ceased. INTERVENTION Participants in the physical activity trial receive individual, interpersonal and community intervention components. The individual level components include pedometers, goal setting and individual phone counseling. The interpersonal level components include group education sessions and peer-led activities. The community level components include resource audits and enumeration, tailored walking maps, and community improvement projects. The successful aging group receives individual and group attention about successful aging topics. MEASUREMENTS The main outcome is light to moderate physical activity, measured objectively by accelerometry. Other objective outcomes included physical functioning, blood pressure, physical fitness, and cognitive functioning. Self report measures include depressive symptoms and health related quality of life. RESULTS The intervention is being delivered successfully in the communities and compliance rates are high. CONCLUSION Ecological Models call for interventions that address multiple levels of the model. Previous studies have not included components at each level and retirement communities provide a model environment to demonstrate how to implement such an intervention.

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“…The randomization procedure also matched on gender, maternal education, maternal race, primary language in the home, and infant participation in another study. (For further details of the recruitment and randomization process, see Gross et al, 1992; Infant Health and Development Program, 1990; Kraemer & Fendt, 1990). This resulted in 377 intervention infants and 608 follow-up infants (see Table 1 for a description of the two groups by site).…”

Section: Samplementioning

confidence: 99%

“…The infants were randomized immediately after hospital discharge using an adaptive randomization method (Efron, 1971;Kraemer & Fendt, 1990;Pocock & Simon, 1975) that maintained a 2:1 balance in each birthweight group within each site. The randomization procedure also matched on gender, maternal education, maternal race, primary language in the home, and infant participation in another study.…”

Section: Samplementioning

confidence: 99%

Enhancing the Development of Low-Birthweight, Premature Infants: Changes in Cognition and Behavior over the First Three Years

Brooks‐Gunn¹,

Klebanov²,

Liaw³

et al. 1993

Child Development

165

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The Infant Health and Development Program is a randomized clinical trial to test the efficacy of educational and family support services and pediatric follow-up offered in the first 3 years of life on reducing the incidence of developmental delay in low-birthweight (LBW), preterm infants in 8 clinical sites (N = 985). Effects of the intervention on cognitive and behavior problem scores over the 3 years are examined. Significant intervention effects were seen on cognitive scores at 24 and 36 but not 12 months of age; effect sizes were similar at both ages. These effects persist when controlling for earlier cognitive scores. At 24 and 36 months, behavior problem scores for the intervention group were significantly lower than for the follow-up group; the intervention was more efficacious for children with higher initial behavior problem scores. Results are discussed in terms of timing and targeting of services for LBW and disadvantaged children.

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Random assignment in clinical trials: Issues in planning (Infant Health and Development Program)

Cited by 35 publications

References 15 publications

Prevention, the appropriate target of infant psychotherapy

Prevention, the appropriate target of infant psychotherapy

Applying the ecological model of behavior change to a physical activity trial in retirement communities: Description of the study protocol

Enhancing the Development of Low-Birthweight, Premature Infants: Changes in Cognition and Behavior over the First Three Years

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