23.3 Survey

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

ChildSalivaInstrument

Child-Focused Biospecimen Collection (Postnatal)

OMB: 0925-0593

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OMB #: 0925-0593

OMB Expiration Date: 8/31/2014

Child Saliva Instrument, Phase 2g

OMB Specification


Child Saliva Instrument


Event Category:

Time-Based

Event:

12M, 36M, 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:

10 minutes

Multiple Child/Sibling Consideration:

Per Child

Special Considerations:

N/A

Version:

2.0

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 Saliva Instrument



TABLE OF CONTENTS





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Child Saliva 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 SALIVA COLLECTION INSTRUMENT


(TIME_STAMP_BCS_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 AND DISPLAY NAME IN C_FNAME THROUGHOUT INSTRUMENT

  • OTHERWISE, IF C_FNAME = -1 OR -2, DISPLAY “the child” IN APPROPRIATE FIELDS THROUGHOUT THE INSTRUMENT.


BCS07000/(SALIVA_INTRO_COLLECTOR). I would like to collect a sample of {C_FNAME/the child}’s saliva.  Before I do so, I will explain this collection and ask you some questions.


DATA COLLECTOR INSTRUCTIONS

  • EXPLAIN THE CHILD SALIVA COLLECTION PROCEDURES TO THE ADULT CAREGIVER.

  • BE SURE TO INFORM THE ADULT CAREGIVER THAT SHE/HE NEEDS TO BE PRESENT WHILE THE PROCEDURE IS BEING PERFORMED

  • IF THE ADULT CAREGIVER REFUSES THE COLLECTION, SELECT REFUSED.  OTHERWISE, SELECT CONTINUE.


Label

Code

Go To

CONTINUE

1

BCS11000

REFUSED

-1



SOURCE

National Children’s Study, Vanguard Phase (BIO Child Saliva)


BCS08000/(COLL_REFUSAL_REASON). I am sorry that you have chosen not to participate in this collection.  Can you tell me why?


DATA COLLECTOR INSTRUCTIONS

  • SELECT REASON FOR REFUSAL.

 


Label

Code

Go To

CHILD IS SLEEPING/TIRED

1

BCS10000

REFUSED

-1

BCS10000

DON’T KNOW

-2

BCS10000

OTHER

-5



SOURCE

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


BCS09000/(COLL_REFUSAL_REASON_OTH). SPECIFY: ____________________        


Label

Code

Go To

REFUSED

-1


DON'T KNOW

-2



SOURCE

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


BCS10000. That’s fine.  Thank you for your time. 


PROGRAMMER INSTRUCTIONS

  • GO TO COLLECTION_COMMENT.


BCS11000. When was the last time {C_FNAME/the child} had anything to eat or drink?


DATA COLLECTOR INSTRUCTIONS

  • RECORD THE LAST TIME CHILD ATE OR DRANK ANYTHING.

  • RECORD THE TIME AS HH:MM, BE SURE TO FILL THE SPACE WITH A ZERO WHEN NECESSARY AND TO MARK THE BOX TO CHOOSE “AM” OR “PM”.  FOR EXAMPLE, IF THE LAST TIME CHILD ATE OR DRANK WAS AT 2:05PM, RECORD “02:05” AND CHOOSE “PM”.

  • RECORD THE DATE AS A TWO-DIGIT MONTH, TWO-DIGIT DAY, AND FOUR-DIGIT YEAR.


SOURCE

National Children’s Study, Vanguard Phase (BIO Child Saliva)


(LAST_EAT_TIME) LAST TIME ATE OR DRANK – TIME

 

|___|___|:|___|___|

    H    H       M    M


Label

Code

Go To

REFUSED

-1


DON'T KNOW

-2



(LAST_EAT_TIME_UNIT) LAST TIME ATE OR DRANK – AM/PM


Label

Code

Go To

AM

1


PM

2



(LAST_EAT_MM) LAST TIME ATE OR DRANK – DATE: MONTH

 

|___|___|

   M    M      


Label

Code

Go To

REFUSED

-1


DON'T KNOW

-2



(LAST_EAT_DD) LAST TIME ATE OR DRANK – DATE: DAY

 

|___|___|

   D    D   


Label

Code

Go To

REFUSED

-1


DON'T KNOW

-2



(LAST_EAT_YYYY) LAST TIME ATE OR DRANK – DATE: YEAR

 

|___|___|___|___|

   Y    Y     Y    Y


Label

Code

Go To

REFUSED

-1


DON'T KNOW

-2



BCS15000/(SPECIMEN_STATUS). STATUS OF THE SALIVA COLLECTION


DATA COLLECTOR INSTRUCTIONS

  • ENTER THE STATUS OF THE SPECIMEN COLLECTION.


Label

Code

Go To

COLLECTED

1

SALIVA_COLLECTOR

NOT COLLECTED

2



BCS16000/(NO_SPECIMEN_REAS).


DATA COLLECTOR INSTRUCTIONS

  • ENTER THE PRIMARY REASON WHY THE SPECIMEN WAS NOT COLLECTED.

  • SELECT ONLY ONE RESPONSE.


Label

Code

Go To

CHILD UNHAPPY

1

COLLECTION_COMMENT

CHILD SLEEPY

2

COLLECTION_COMMENT

PHYSICAL LIMITATION

3

COLLECTION_COMMENT

ADULT CAREGIVER ILL/EMERGENCY

4

COLLECTION_COMMENT

CHILD ILL/EMERGENCY

5

COLLECTION_COMMENT

COLLECTION SUPPLIES MALFUNCTIONED

6

COLLECTION_COMMENT

NO TIME

7

COLLECTION_COMMENT

OTHER

-5


REFUSED

-1

COLLECTION_COMMENT

DON'T KNOW

-2

COLLECTION_COMMENT


BCS17000/(NO_SPECIMEN_REAS_OTH). SPECIFY: ________________________ 


DATA COLLECTOR INSTRUCTIONS

  • GO TO COLLECTION_COMMENT.


BCS18000/(SALIVA_COLLECTOR). WHO COLLECTED CHILD SALIVA SPECIMEN?


DATA COLLECTOR INSTRUCTIONS

  • RECORD WHO COLLECTED THE CHILD SALIVA SPECIMEN.


Label

Code

Go To

DATA COLLECTOR

1

SPECIMEN_ID

MOTHER

2

SPECIMEN_ID

FATHER

3

SPECIMEN_ID

OTHER

-5



BCS19000/(SALIVA_COLLECTOR _OTH). SPECIFY:  ____________________________


BCS20000/(SPECIMEN_ID).  

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


DATA COLLECTOR INSTRUCTIONS

  • RECORD SALIVA COLLECTION SPECIMEN ID.


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##).


BCS21000.


DATA COLLECTOR INSTRUCTIONS

  • RECORD DATE AND TIME THE CHILD SALIVA SPECIMEN WAS COLLECTED.

  • RECORD THE DATE AS TWO DIGIT MONTH, TWO DIGIT DAY, AND FOUR DIGIT YEAR.

  • RECORD THE TIME AS HH:MM, BE SURE TO FILL THE SPACE WITH A ZERO WHEN NECESSARY AND CHOOSE “AM” OR “PM”. FOR EXAMPLE, IF THE CHILD SALIVA SAMPLE WAS COLLECTED AT 2:05PM RECORD “02:05” AND CHOOSE “PM”.


(C_SALIVA_COLL_MM) DATE CHILD SALIVA SPECIMEN WAS COLLECTED - MONTH

 

|___|___| 

    M    M        


(C_SALIVA_COLL_DD) DATE CHILD SALIVA SPECIMEN WAS COLLECTED - DAY

 

|___|___| 

    D    D       


(C_SALIVA_COLL_YYYY) DATE CHILD SALIVA SPECIMEN WAS COLLECTED - YEAR

 

|___|___|___|___|

    Y    Y   Y      Y


(C_SALIVA_COLL_TIME) TIME CHILD SALIVA SPECIMEN COLLECTED

 

|___|___|:|___|___|

 H    H        M   M


(C_SALIVA_COLL_TIME_UNIT) AM/PM CHILD SALIVA SPECIMEN COLLECTED 


Label

Code

Go To

AM

1


PM

2



BCS24000. Thank you for providing the child’s saliva sample.


BCS25000/(COLLECTION_COMMENT). RECORD ANY COMMENTS ABOUT THE CHILD SALIVA COLLECTION PROCEDURE.


DATA COLLECTOR INSTRUCTIONS

  • RECORD ANY COMMENTS ABOUT THE CHILD SALIVA COLLECTION PROCEDURE.


Label

Code

Go To

NO COMMENTS

1

TIME_STAMP_BCS_ET

COMMENTS

2



BCS26000/(COLLECTION_COMMENT_OTH). SPECIFY: ________________________


(TIME_STAMP_BCS_ET).


PROGRAMMER INSTRUCTIONS

  • INSERT DATE/TIME STAMP


Public reporting burden for this collection of information is estimated to average 10 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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