Validation_20110103_Regulatory_Final_V1 b

Recruitment Strategy Substudy

Event Name(s):

Validation Instrument (EH, PB, HI, LI)

Instrument Name(s) and Versions:

Validation Instrument (EH, PB, HI, LI)-1.0

Recruitment Groups:

Enhanced Household, Provider-Based, High Intensity,

and Low Intensity

Validation Instrument (EH, PB, HI, LI)

Date	Version	Summary of Change/Milestone
8/2/2010	VALIDATION_08022010	Initial draft of validation instrument with skips for multiple reference interviews
9/17/2010	VALIDATION_091710	Addition of sources to individual measures.
10/28/10	VALIDATION_20102810	IRB Team Review – no changes made
12/09/10	VALIDATION_20101207	OMB Team edited sourcing; checked skip patterns; added placeholders for 3- and 9-month instrument validation questions and inserted / edited timestamps where necessary Need validation questions specific to 3- and 9-month visits
12/9/10	VALIDATION_20101209	Validation questions specific to 3 and 9 month instruments inserted
12/10/10	VALIDATION_20101210	Paymon fixed = time stamps
12/15/10	VALIDATION_20101215	J. Park corrected burden blurb
12/17/10	VALIDATION_20101227	Graber revised based on SH comments
1/3/11	VALIDATION_20110103	Track changes accepted for review
1/10/11	VALIDATION_20110103_Regulatory Final_V1a	Copy edits made by Circle were reviewed and accepted. Saved as Regulatory Final version
1/25/11	VALIDATION_20110103_Regulatory Final_V1b	Changes made by S3 noted in track changes accepted; additional comments from Dr. Hirschfeld added (see CS003-5).

NOTE: Italics denote anticipated development stages.

Validation Instrument (EH, PB, HI, LI)

TABLE OF CONTENTS

INTERVIEWER INTRODUCTION 4

Respondent Identification 5

PRIVACY STATEMENT 7

VISIT-SPECIFIC ITEMS 7

HOUSEHOLD ENUMERATION 7

PREGNANCY SCREENER 8

INFORMED CONSENT 8

PPG CALLS 9

PRE-PREGNANCY VISIT 9

PREGNANCY VISIT 1 9

PREGNANCY VISIT 2 10

BIRTH VISIT 10

3-MONTH PHONE CALL 10

6-MONTH VISIT 11

9-MONTH PHONE CALL 11

12-MONTH VISIT 12

INTERVIEWER QUALITY 13

CLOSING STATEMENTS 13

Validation Instrument (EH, PB, HI, LI)

Interviewer Introduction

(TIME_STAMP_1) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

IN001 (INTRO_1) Hello, my name is [INTERVIEWER’S NAME] and I am calling on behalf of the National Children’s Study. May I please speak with [NAME OF RESPONDENT]?

YES 1 (TIME_STAMP_2)

NO 2 (BEST_TTC1)

NO SUCH PERSON AT ADDRESS/PHONE 3 (VER_NUMBER))

REFUSED -1 (BEST_TTC1)

DON’T KNOW -2 (BEST_TTC1)

PROGRAMMER INSTRUCTION: PRELOAD NAME OF RESPONDENT

IN002 (VER_NUMBER) Just to verify, is this {TELEPHONE NUMBER FOR PARTICIPANT}?

YES 1(TIME_STAMP_17)

NO 2(TIME_STAMP_17)

REFUSED -1(TIME_STAMP_17)

DON’T KNOW 2(TIME_STAMP_17)

PROGRAMMER INSTRUCTION: INSERT PARTICIPANT BEST TELEPHONE NUMBER.

IN003 (BEST_TTC_1) What would be a good time to reach her?

INTERVIEWER INSTRUCTION: ENTER IN HOUR AND MINUTE VALUES AND/OR DAY(S) OF WEEK; AND SELECT AM OR PM

|___|___| : |___|___| _____________________

H H M M DAY_WEEK_1

REFUSED -1

DON’T KNOW -2

IN005 (BEST_TTC_2)

AM 1

PM 2

REFUSED -1

DON’T KNOW -2

N007 (BEST_TTC_3)

AFTER TIME REPORTED 1

BEFORE TIME REPORTED 2

REFUSED -1

DON’T KNOW -2

IN009 (PHONE) Is this a good phone number to reach [RESPONDENT’S NAME]?

YES 1 (TIME_STAMP17)

NO 2 (PHONE_NBR)

REFUSED -1 (PHONE_NBR)

DON’T KNOW -2 (PHONE_NBR)

PROGRAMMER INSTRUCTION: PRELOAD NAME OF RESPONDENT

IN011 (PHONE_NBR) Would you please tell me a telephone number where she can be reached?

|___|___|___| - |___|___|___| - |___|___|___|___| (TIME_STAMP17)

REFUSED -1 (TIME_STAMP17) DON’T KNOW -2 (TIME_STAMP17)

(TIME_STAMP_2) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

Respondent Identification

[WHEN SPEAKING TO RESPONDENT]

INTERVIEWER INSTRUCTION: REPEAT AS NEEDED. [Hello, my name is [INTERVIEWER’S NAME] and I am calling on behalf of the National Children’s Study.]

RI001 (INTRO_2) You recently spoke with one of our staff members. We routinely re-contact some people to see if circumstances have changed.

CONTINUE 1 (INTRO_3)

R STATES THAT NO INTERVIEW TOOK PLACE 2 (SCHEDULE)

RI002 (SCHEDULE) I’m sorry for the misunderstanding. May I schedule a time with you to complete that interview?

YES 1…………… (RI003)

NO 2 (TIME_STAMP17)

RI003 INTERVIEWER INSTRUCTION: SCHEDULE INTERVIEW WITH RESPONDENT, THEN SKIP TO (TIME_STAMP17)

RI004 (INTRO_3) Is this a good time to talk?

YES 1 (TIME_STAMP_3)

NO 2 (R_BEST_TTC_1)

REFUSED -1 (TIME_STAMP_3) DON’T KNOW -2 (TIME_STAMP_3)

RI005 (R_BEST_TTC_1) What would be a better time for you?

INTERVIEWER INSTRUCTION: ENTER IN HOUR AND MINUTE VALUES AND/OR DAY(S) OF WEEK; AND SELECT AM OR PM

|___|___| : |___|___| _____________________________

H H M M DAY_WEEK_2

REFUSED -1

DON’T KNOW -2

RI006 (R_BEST_TTC_2)

AM 1

PM 2

REFUSED -1

DON’T KNOW -2

RI007 (R_BEST_TTC_3)

AFTER TIME REPORTED 1 (TIME_STAMP17)

BEFORE TIME REPORTED 2 (TIME_STAMP17)

REFUSED -1 (TIME_STAMP17)

DON’T KNOW -2 (TIME_STAMP17)

Privacy Statement

(TIME_STAMP_3) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

All information will be kept private and used for Study purposes only. You may refuse to answer any question or stop at any time.

PS001 (INT_CONFIRM) According to our records, [INTERVIEWER’S NAME] spoke with you on [DAY AND DATE OF INTERVIEW]. Do you remember speaking with our staff member?

YES 1

NO 2

REFUSED -1 DON’T KNOW -2

PROGRAMMER INSTRUCTION: PRELOAD NAME OF INTERVIEWER AND DAY/DATE OF INTERVIEW

PROGRAMMER INSTRUCTION: SKIP TO NEXT QUESTION BASED ON WHICH INSTRUMENT WAS ADMINISTERED

• HOUSEHOLD ENUMERATION  SKIP TO (TIME_STAMP_4)

• PREGNANCY SCREENER  SKIP TO (TIME_STAMP_5)

• INFORMED CONSENT  SKIP TO (TIME_STAMP_6)

• PPG CALLS  SKIP TO (TIME_STAMP_7)

• PRE-PREGNANCY  SKIP TO (TIME_STAMP_8)

• FIRST PREGNANCY  SKIP TO (TIME_STAMP_9)

• SECOND PREGNANCY  SKIP TO (TIME_STAMP_10)

• BIRTH  SKIP TO (TIME_STAMP_11)

• 3-MONTH  SKIP TO (TIME_STAMP_12)

• 6-MONTH  SKIP TO (TIME_STAMP_13)

• 9-MONTH  SKIP TO (TIME_STAMP_14 )

• 12-MONTH SKIP TO (TIME_STAMP_15 )

Visit-Specific Items

(TIME_STAMP_4) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

VS001 (HH_ENUM) Were you asked questions about the number of people who live at this address?

YES 1

NO 2

REFUSED -1 DON’T KNOW -2

VS003 (NUM_FEMALE) In [MONTH OF INTERVIEW], how many women [LOCAL AGE OF MAJORITY] or older were living in your household? Please include anyone who usually stays there but was temporarily away on business, vacation, in the hospital, on full-time active military duty, or is a student temporarily living away from home. Do not include anyone who was in a nursing home or other institution.

|___|___| (POLITE)

NUMBER OF ADULT FEMALES

REFUSED -1 (TIME_STAMP_16)

DON’T KNOW -2 (TIME_STAMP_16)

(TIME_STAMP_5) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

VS005 (PREG_SCR) Were you asked if you or others in your household might be pregnant?

YES 1

NO 2

REFUSED -1 DON’T KNOW -2

VS007 (AGE) During [MONTH OF INTERVIEW] how old were you?

|___|___| (TIME_STAMP_16)

AGE

REFUSED -1 (TIME_STAMP_16)

DON’T KNOW -2 (TIME_STAMP_16)

(TIME_STAMP_6) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

VS009 (INF_CONSENT) Were you given information about the National Children’s Study and asked if you would like to participate?

YES 1

NO 2

REFUSED -1 DON’T KNOW -2

VS011 (INF_CONSENT2) Were you given an opportunity to ask all the questions you had about joining the Study before being asked to agree to join?

YES 1 (TIME_STAMP_16)

NO 2 (TIME_STAMP_16)

REFUSED -1 (TIME_STAMP_16) DON’T KNOW -2 (TIME_STAMP_16)

(TIME_STAMP_7) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

VS013 (PPG_CATI) Were you asked whether or not you were pregnant or trying to become pregnant?

YES 1

NO 2

REFUSED -1 DON’T KNOW -2

VS015 (PPG_CATI2) At that time were you pregnant or trying to become pregnant?

YES 1 (TIME_STAMP_16)

NO 2 (TIME_STAMP_16)

NO, RECENT PREGNANCY LOSS 3 (TIME_STAMP_16)

NO, RECENTLY GAVE BIRTH 4 (TIME_STAMP_16)

NO, UNABLE TO HAVE CHILDREN 5 (TIME_STAMP_16)

REFUSED -1 (TIME_STAMP_16) DON’T KNOW -2 (TIME_STAMP_16)

(TIME_STAMP_8) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

VS017 (PREPREG) Were you asked if you have ever been pregnant?

YES 1

NO 2

REFUSED -1 DON’T KNOW -2

VS019 (PREPREG2) At that time had you ever been pregnant? Please include live births, miscarriages, stillbirths, ectopic pregnancies, and pregnancy terminations.

YES 1 (TIME_STAMP_16)

NO 2 (TIME_STAMP_16)

REFUSED -1 (TIME_STAMP_16) DON’T KNOW -2 (TIME_STAMP_16)

(TIME_STAMP_9) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

VS021 (PREG1) During that interview were you asked about your baby’s due date?

YES 1

NO 2

REFUSED -1 DON’T KNOW -2

VS023(HOME_TEST). Did you use a home pregnancy test to help find out you were pregnant?

YES 1 (TIME_STAMP_16)

NO 2 (TIME_STAMP_16)

REFUSED -1 (TIME_STAMP_16) DON’T KNOW -2 (TIME_STAMP_16)

(TIME_STAMP_10) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

VS025 (PREG2) During that interview were you asked about where you planned to deliver your baby?

YES 1

NO 2

REFUSED -1 DON’T KNOW -2

VS027 (OWN_HOME) During [MONTH OF INTERVIEW] was the home you were living in:

Owned or being bought by you or someone in your household 1 (TIME_STAMP_16)

Rented by you or someone in your household, or 2 (TIME_STAMP_16) Occupied without payment of rent? 3 (TIME_STAMP_16) SOME OTHER ARRANGEMENT………………………….. -5 (TIME_STAMP_16) REFUSED……………………………………………………. -1 (TIME_STAMP_16)

DON’T KNOW -2 (TIME_STAMP_16)

(TIME_STAMP_11) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

VS029 (BIRTH) Were you asked about where in your home you planned for the baby to sleep?

YES 1

NO 2

REFUSED -1 DON’T KNOW -2

VS031 (VACCINE) At that time did you plan for your baby to have well-baby shots or vaccinations?

YES 1 (TIME_STAMP_16)

NO 2 (TIME_STAMP_16)

REFUSED -1 (TIME_STAMP_16) DON’T KNOW -2 (TIME_STAMP_16)

(TIME_STAMP_12) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

VS041 (CHILDSLP) Were you asked about your baby’s sleeping habits?

YES 1

NO 2

REFUSED -1 DON’T KNOW -2

VS043 (VCHILDCARE) Were you asked about your arrangements for child care?

YES 1 (TIME_STAMP_16)

NO 2 (TIME_STAMP_16)

REFUSED -1 (TIME_STAMP_16) DON’T KNOW -2 (TIME_STAMP_16)

(TIME_STAMP_13) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

VS033 (6MONTH) Were you asked about your baby’s health?

YES 1

NO 2

REFUSED -1 DON’T KNOW -2

VS035 (INSURE) During [MONTH OF INTERVIEW] was your baby covered by any kind of health insurance or some other health care plan?

YES 1 (TIME_STAMP_16)

NO 2 (TIME_STAMP_16)

REFUSED -1 (TIME_STAMP_16) DON’T KNOW -2 (TIME_STAMP_16)

(TIME_STAMP_14) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

VS045 (CHILDSKILL) Were you asked about things that your baby could do like following you with his or her eyes?

YES 1

NO 2

REFUSED -1 DON’T KNOW -2

VS047 (R_HCARE) At that time, what kind of place did your baby usually go to when your baby needed routine or well-child care, such as a check-up or well-baby shots (immunizations)?

Clinic or health center	……………………	1	(TIME_STAMP_16)
Doctor's office or Health Maintenance Organization (HMO)	……………………	2	(TIME_STAMP_16)
Hospital emergency room	……………………	3	(TIME_STAMP_16)
Hospital outpatient department	……………………	4	(TIME_STAMP_16)
Some other place	……………………	5	(TIME_STAMP_16)
DOESN'T GO TO ONE PLACE MOST OFTEN	……………………	6	(TIME_STAMP_16)
DOESN'T GET WELL-CHILD CARE ANYWHERE	……………………	7	(TIME_STAMP_16)
REFUSED	……………………	-1	(TIME_STAMP_16)
DON’T KNOW	……………………	-2	(TIME_STAMP_16)

(TIME_STAMP_15) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

VS037 (12MONTH) Were you asked about your baby’s personality?

YES 1

NO 2

REFUSED -1 DON’T KNOW -2

VS039 (CHILDCARE) During [MONTH OF INTERVIEW], did your baby receive any regularly scheduled care from someone other than a parent or guardian, for example, from relatives, friends, or other non-relatives, or a child care center or program?

YES 1 (TIME_STAMP_16)

NO 2 (TIME_STAMP_16)

REFUSED -1 (TIME_STAMP_16) DON’T KNOW -2 (TIME_STAMP_16)

(TIME_STAMP_16) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

Interviewer Quality

IQ003 (COMMENT) Would you like to tell me anything else about your experience, the interviewer, or the interview itself?

YES 1 (COMMENT_OTH)

NO 2

REFUSED -1

DON’T KNOW -2

(COMMENT_OTH) ENTER RESPONDENT COMMENTS AS TEXT FIELD

_________________________________________________________________________

(TIME_STAMP_17) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

PROGRAMMER INSTRUCTION: SKIP TO CLOSING STATEMENT BASED ON THE RESPONSES BELOW

IF (INTRO_1) = 3  SKIP TO (END_NOMATCH)

IF (PHONE) = 1, 2, -1, -2  SKIP TO (END_UNAVAIL)

IF (INTRO_2) = 2 and SCHEDULE=2 SKIP TO (END_SCHEDULE)

IF (SCHEDULE) = 1  SKIP TO (END_CB)

ELSE SKIP TO (END_COMPLETE)

Closing Statements

CS001 (END_NOMATCH) I apologize for bothering you. I have the wrong number. Thank you for your time. If you have any questions, please contact us at [LOCAL SC TOLL-FREE NUMBER].

CS002 (END_UNAVAIL) Thank you again for speaking with me today. Please ask her to call us at [LOCAL SC TOLL-FREE NUMBER].

CS003 (END_CB) Thank you for your time. I will call back again. [IF CALLBACK TIME OBTAINED: at the time you requested]. If you have any questions, please contact us at [LOCAL SC TOLL-FREE NUMBER]. Goodbye.

CS004 (END_COMPLETE) Those are all the questions I have. Thank you so much for your time and cooperation. If you have any questions, please contact us at [LOCAL SC TOLL-FREE NUMBER]. Goodbye.

CS005 (END_SCHEDULE) Thank you so much for your time. If you have any questions, please contact us at [LOCAL SC TOLL-FREE NUMBER]. Goodbye.

INTERVIEWER INSTRUCTION: END INTERVIEW AND DISPOSITION CASE AS APPROPRIATE

(TIME_STAMP_18) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

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