NCT00820677

Brief Summary

This is a randomized, controlled trial to test the use of an educational video during the newborn well-child visit. Parents who watch the video during their medical visit will be compared to those parents who receive traditional paper handouts. Measures obtained at baseline and 2-week follow-up include knowledge of infant development, self-efficacy with infant care, and problem-solving skills.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

December 14, 2009

Status Verified

January 1, 2009

Enrollment Period

8 months

First QC Date

January 8, 2009

Last Update Submit

December 11, 2009

Conditions

Infant, Newborn

Outcome Measures

Primary Outcomes (1)

  • Knowledge of Infant Development

    2 weeks

Study Arms (1)

DVD/Video

EXPERIMENTAL

Parents of newborns in the experimental group attending their first baby visit will be shown a video about newborn care.

Behavioral: DVD/Video

Interventions

DVD/VideoBEHAVIORAL

One DVD or Video will be watched by all parents of newborns enrolled into the experimental group.

DVD/Video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Baby's first visit to the pediatric office

You may not qualify if:

  • Baby \> 1 month old
  • Parent/Caregiver \< 18yrs old
  • Inability to understand English
  • No access to a working telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • Paradis HA, Conn KM, Gewirtz JR, Halterman JS. Innovative delivery of newborn anticipatory guidance: a randomized, controlled trial incorporating media-based learning into primary care. Acad Pediatr. 2011 Jan-Feb;11(1):27-33. doi: 10.1016/j.acap.2010.12.005.

    PMID: 21272821DERIVED

Study Officials

  • Heather A Paradis, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

  • Jill S Halterman, MD, MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 12, 2009

Study Start

November 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

December 14, 2009

Record last verified: 2009-01

Locations

US(1)