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Trial record 13 of 35 for:    "sudden infant death"

Study of the Impact of Parental Note Taking on the Effectiveness of Anticipatory Guidance

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ClinicalTrials.gov Identifier: NCT01014169
Recruitment Status : Completed
First Posted : November 16, 2009
Results First Posted : October 19, 2012
Last Update Posted : October 19, 2012
Sponsor:
Collaborator:
The Joel and Barbara Alpert Endowment For The Children of The City
Information provided by (Responsible Party):
Boston Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions: Health Education
Sudden Infant Death
Intervention: Behavioral: Note taking

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Mothers on the postpartum ward of an urban safety-net hospital were recruited. Inclusion criteria included gestational age > 35 weeks, fluency in English or Spanish, and access to a telephone. Mothers were excluded if there was prolonged hospitalization of the mother or the infant or if they were not expected to retain custody of the infant.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Usual Care Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
Note Taking The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.

Participant Flow:   Overall Study
    Usual Care   Note Taking
STARTED   65   61 
COMPLETED   58   48 
NOT COMPLETED   7   13 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Usual Care Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
Note Taking The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
Total Total of all reporting groups

Baseline Measures
   Usual Care   Note Taking   Total 
Overall Participants Analyzed 
[Units: Participants]
 65   61   126 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.8  (6.5)   28.9  (6.4)   28.3  (6.4) 
Gender 
[Units: Participants]
     
Female   65   61   126 
Male   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   31   32   63 
Not Hispanic or Latino   34   29   63 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   6   2   8 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   22   20   42 
White   7   9   16 
More than one race   30   30   60 
Unknown or Not Reported   0   0   0 
Language 
[Units: Participants]
     
English   37   36   73 
Spanish   28   25   53 
Number of pregnancies 
[Units: Pregnancies]
Median (Inter-Quartile Range)
 2 
 (2 to 2) 
 2 
 (2 to 2) 
 2 
 (2 to 2) 
Number of Children 
[Units: Children]
Median (Inter-Quartile Range)
 2 
 (2 to 2) 
 2 
 (1 to 2) 
 2 
 (2 to 2) 
Type of delivery 
[Units: Participants]
     
Vaginal   46   46   92 
Cesarean section   19   15   34 
Type of Insurance 
[Units: Participants]
     
Medicaid   52   46   98 
Free Care   5   3   8 
Private   7   11   18 
None   1   1   2 
Highest Education Level 
[Units: Participants]
     
Less than/some high school   24   14   38 
High school graduate   15   21   36 
Vocational/trade school   1   2   3 
Some college   9   11   20 
Associates degree   5   1   6 
Bachelors degree   7   7   14 
Graduate/professional degree   4   5   9 
Received prenatal care 
[Units: Participants]
     
Yes   65   61   126 
No   0   0   0 
Attended Childbirth Classes 
[Units: Participants]
     
Yes   10   12   22 
No   55   49   104 
Other Adults in the Home 
[Units: Participants]
     
No other adult in home   9   8   17 
Spouse/partner   43   44   87 
Baby's grandmother   10   12   22 
Baby's grandfather   6   4   10 
Baby's uncles or aunts   17   11   28 
Other adult   2   2   4 
Nurse Practitioner 
[Units: Participants]
     
Patients Seen By Nurse Practitioner # 1   37   34   71 
Patients Seen By Nurse Practitioner # 2   21   22   43 
Patients Seen By Nurse Practitioner # 3   7   5   12 


  Outcome Measures

1.  Primary:   The Primary Outcome of Interest is Maternal Practice Related to Supine Infant Sleep Position.   [ Time Frame: two days after discharge ]

2.  Secondary:   Maternal Practice Related to Breastfeeding Initiation   [ Time Frame: two days after discharge ]

3.  Secondary:   Maternal Practice Related to Correct Car Seat Use   [ Time Frame: two days after discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Conducted as a pilot study and not powered to demonstrate a significant difference between the two groups; subjects and NPs were aware of the group assignment; outcomes were determined using maternal self report.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Caroline Kistin
Organization: Boston University School of Medicine/Boston Medical Center
phone: 617-414-3642
e-mail: caroline.kistin@bmc.org


Publications:
Kendall J. Suzuki's Mother Tongue Method. Music Educators Journal. 1986;72:47-50
Creech A and Hallam S. Parent-teacher-pupil interactions in instrumental music tuition: a literature review. B.J. Music Ed. 2003;20:29-44.
Grilli S. An interview with Dr. Shin'ichi Suzuki at the Talent Education Institute. International Review of Education. 1992; 38: 547-551.
Intons-Peterson MJ, Fournier J. External and Internal Memory Aids: When and How Often Do We Use Them? Journal of Experimental Psychology: General. 1986;115:267-280.
Kiewra KA DuBois NF, McShane CD, et al. Note-taking functions and techniques. Journal of Educational Psychology. 1991;83:240-245.
Andrade J. What Does Doodling Do? Appl Cognit Psychol.2009;23:1-7.
2008. Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Third Edition. Elk Grove Village, IL: American Academy of Pediatrics.
United States Preventative Services Task Force: Recommendations of Breastfeeding Counseling. www.ahrq.gov/clinic/uspstf/uspsbrfd.htm. Accessed on 11/25/08.


Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01014169     History of Changes
Other Study ID Numbers: H-28356
First Submitted: November 13, 2009
First Posted: November 16, 2009
Results First Submitted: August 20, 2012
Results First Posted: October 19, 2012
Last Update Posted: October 19, 2012