23.5 Survey

Continuation of National Children's Study Vanguard (Pilot) Study Data Collection: Study Visits through 60-Months and Sibling Birth Enrollment

60M_ChildTeethInstrument

Child-Focused Biospecimen Collection (Postnatal)

OMB: 0925-0593

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OMB #: 0925-0593

OMB Expiration Date: 8/31/2014

Child Teeth Instrument, Phase 2g

OMB Specification


Child Teeth Instrument


Event Category:

Time-Based

Event:

60M

Administration:

N/A

Instrument Target:

Child

Instrument Respondent:

Primary Caregiver

Domain:

Biospecimen

Document Category:

Sample Collection

Method:

Data Collector Administered

Mode (for this instrument*):

In-Person, CAI

OMB Approved Modes:

In-Person, CAI

Estimated Administration Time:

3 minutes

Multiple Child/Sibling Consideration:

Per Child

Special Considerations:

N/A

Version:

1.0

MDES Release:

4.0


*This instrument is OMB-approved for multi-mode administration but this version of the instrument is designed for administration in this/these mode(s) only.


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Child Teeth Instrument



TABLE OF CONTENTS





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Child Teeth Instrument



GENERAL PROGRAMMER INSTRUCTIONS:

WHEN PROGRAMMING INSTRUMENTS, VALIDATE FIELD LENGTHS AND TYPES AGAINST THE MDES TO ENSURE DATA COLLECTION RESPONSES DO NOT EXCEED THOSE OF THE MDES. SOME GENERAL ITEM LIMITS USED ARE AS FOLLOWS:


DATA ELEMENT FIELDS

MAXIMUM CHARACTERS PERMITTED

DATA TYPE

PROGRAMMER INSTRUCTIONS

ADDRESS AND EMAIL FIELDS

100

CHARACTER


UNIT AND PHONE FIELDS

10

CHARACTER


_OTH AND COMMENT FIELDS

255

CHARACTER

  • Limit text to 255 characters

FIRST NAME AND LAST NAME

30

CHARACTER

  • Limit text to 30 characters

ALL ID FIELDS

36

CHARACTER


ZIP CODE

5

NUMERIC


ZIP CODE LAST FOUR

4

NUMERIC


CITY

50

CHARACTER


DOB AND ALL OTHER DATE FIELDS (E.G., DT, DATE, ETC.)

10

NUMERIC


CHARACTER



  • DISPLAY AS MM/DD/YYYY

  • STORE AS YYYY-MM-DD

  • HARD EDITS:

MM MUST EQUAL 01 TO 12

DD MUST EQUAL 01 TO 31

YYYY MUST BE BETWEEN 1900 AND CURRENT YEAR.

TIME VARIABLES

TWO-DIGIT HOUR AND TWO-DIGIT MINUTE, AM/PM DESIGNATION

NUMERIC

  • HARD EDITS:

HOURS MUST BE BETWEEN 00 AND 12;

MINUTES MUST BE BETWEEN 00 AND 59


Instrument Guidelines for Participant and Respondent IDs:

PRENATALLY, THE P_ID IN THE MDES HEADER IS THAT OF THE PARTICIPANT (E.G. THE NON-PREGNANT WOMAN, PREGNANT WOMAN, OR THE FATHER).


POSTNATALLY, A RESPONDENT ID WILL BE USED IN ADDITION TO THE PARTICIPANT ID BECAUSE SOMEBODY OTHER THAN THE PARTICIPANT MAY BE COMPLETING THE INTERVIEW. FOR EXAMPLE, THE PARTICIPANT MAY BE THE CHILD AND THE RESPONDENT MAY BE THE MOTHER, FATHER, OR ANOTHER CAREGIVER. THEREFORE, MDES VERSION 2.2 AND ALL FUTURE VERSIONS CONTAIN A R_P_ID (RESPONDENT PARTICIPANT ID) HEADER FIELD FOR EACH POST-BIRTH INSTRUMENT. THIS WILL ALLOW ROCs TO INDICATE WHETHER THE RESPONDENT IS SOMEBODY OTHER THAN THE PARTICIPANT ABOUT WHOM THE QUESTIONS ARE BEING ASKED.



A REMINDER:

ALL RESPONDENTS MUST BE CONSENTED AND HAVE RECORDS IN THE PERSON, PARTICIPANT, PARTICIPANT_CONSENT AND LINK_PERSON_PARTICIPANT TABLES, WHICH CAN BE PRELOADED INTO EACH INSTRUMENT. ADDITIONALLY, IN POST-BIRTH QUESTIONNAIRES WHERE THERE IS THE ABILITY TO LOOP THROUGH A SET OF QUESTIONS FOR MULTIPLE CHILDREN, IT IS IMPORTANT TO CAPTURE AND STORE THE CORRECT CHILD P_ID ALONG WITH THE LOOP INFORMATION. IN THE MDES VARIABLE LABEL/DEFINITION COLUMN, THIS IS INDICATED AS FOLLOWS: EXTERNAL IDENTIFIER: PARTICIPANT ID FOR CHILD DETAIL.





BIOSPECIMEN CHILD TEETH COLLECTION


(TIME_STAMP_BCT_ST).


PROGRAMMER INSTRUCTIONS

  • INSERT DATE/TIME STAMP

  • PRELOAD PARTICIPANT ID (P_ID) FOR CHILD AND RESPONDENT ID (R_P_ID) FOR ADULT CAREGIVER

  • PRELOAD CHILD'S FIRST NAME (C_FNAME) FROM THE PARTICIPANT VERIFICATION AND TRACING QUESTIONNAIRE.

  • IF C_FNAME ≠ -1 OR -2, DISPLAY C_FNAME AS APPROPRIATE THROUGHOUT THE INSTRUMENT.

  • IF C_FNAME = -1 OR -2, DISPLAY "the child" AS APPROPRIATE THROUGHOUT THE INSTRUMENT.


BCT01000/(TEETH_COLLECT_INTRO). We would like to collect {C_FNAME/the child}’s teeth.  To do this we will provide you with materials to mail us any baby teeth {C_FNAME/the child} loses after today.


DATA COLLECTOR INSTRUCTIONS

  • IF THE ADULT CAREGIVER REFUSES THIS COLLECTION, SELECT REFUSED.

  • OTHERWISE, SELECT CONTINUE AND REVIEW THE COLLECTION MATERIALS, COLLECTION INSTRUCTIONS, AND DATA COLLECTION FORM WITH THE ADULT CAREGIVER.


Label

Code

Go To

CONTINUE

1

DISTRIBUTE_METHOD

REFUSED

-1



BCT02000/(REFUSE_REASON). I am sorry that you have chosen not to participate in this collection.  Can you tell me why?


DATA COLLECTOR INSTRUCTIONS

  • ENTER REASON FOR REFUSAL. 


Label

Code

Go To

TOO COMPLICATED

1

BCT04000

PHYSICAL LIMITATION

2

BCT04000

PARTICIPANT ILL/EMERGENCY

3

BCT04000

LANGUAGE ISSUE

4

BCT04000

NO TIME

5

BCT04000

UNCOMFORTABLE WITH COLLECTION PROCEDURES

6

BCT04000

OTHER

-5


REFUSED

-1

BCT04000

DON'T KNOW

-2

BCT04000


SOURCE

National Children’s Study, Legacy Phase (6M Child)


BCT03000/(REFUSE_REASON_OTH). SPECIFY: ____________________________________


Label

Code

Go To

REFUSED

-1


DON'T KNOW

-2



SOURCE

National Children’s Study, Legacy Phase (6M Child)


BCT04000. That’s fine.  Thank you for your time.  


PROGRAMMER INSTRUCTIONS

  • GO TO COLLECTION_COMMENT.


BCT05000/(DISTRIBUTE_METHOD). HOW WAS THE KIT DISTRIBUTED TO THE ADULT CAREGIVER?


Label

Code

Go To

IN PERSON

1


BY MAIL

2


DID NOT DISTRIBUTE

-7

N_DISTRIB_REAS


BCT06000/(SPECIMEN_ID). RECORD THE SPECIMEN ID

 

 

|__|__|__|__|__|__|__|__|__|- |__|__|__|__| 


DATA COLLECTOR INSTRUCTIONS

  • IF THE ADULT CAREGIVER AGREES TO COLLECT TEETH, RECORD THE SPECIMEN ID OF THE KIT PROVIDED TO HIM/HER.


PROGRAMMER INSTRUCTIONS

  • CANNOT BE NULL.

  • HARD EDIT: INCLUDE HARD EDIT IF FORMAT IS NOT TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH TWO ALPHA, TWO NUMERIC CHARACTERS (AA # # # # # # #-AA##). 


BCT07000. Thank you for agreeing to send us your child’s baby teeth. 


PROGRAMMER INSTRUCTIONS

  • GO TO COLLECTION_COMMENT.


BCT08000/(N_DISTRIB_REAS). WHY COULDN’T YOU GIVE THE KIT TO THE ADULT CAREGIVER?


Label

Code

Go To

ADULT CAREGIVER REFUSED

1

COLLECTION_COMMENT

NO TIME TO DISTRIBUTE KIT

2

COLLECTION_COMMENT

KIT UNAVAILABLE

3

COLLECTION_COMMENT

OTHER

-5



BCT09000/(N_DISTRIB_REAS_OTH). SPECIFY: _____________________________


BCT10000/(COLLECTION_COMMENT). RECORD ANY COMMENTS ABOUT THE CHILD TEETH COLLECTION KIT DISTRIBUTION PROCEDURE.


DATA COLLECTOR INSTRUCTIONS

  • DOCUMENT ANY PROBLEMS OR CONCERNS ABOUT THE CHILD TEETH COLLECTION KIT DISTRIBUTION PROCEDURE.


Label

Code

Go To

NO COMMENTS

1

TIME_STAMP_BCT_ET

COMMENT

2



BCT11000/(COLLECTION_COMMENT_OTH). SPECIFY:  ________________________


(TIME_STAMP_BCT_ET).


PROGRAMMER INSTRUCTIONS

  • INSERT DATE/TIME STAMP


Public reporting burden for this collection of information is estimated to average 3 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.  An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.  Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0593*).  Do not return the completed form to this address.

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