Form 5.1 Survey

OMB #: 0925-0593

Expiration Date: xx/xxxx

JULY LAUNCH VERSION

VERSION 6/7/2010

ASSUME PRE-PREGNANCY VISIT WAS

ADMINISTERED UNLESS NOTED

Recruitment Strategy Substudy

Pregnancy Probability Group Follow Up

CATI Instrument

TABLE OF CONTENTS

CATI

1. PREGNANCY SCREENER

2. TRACING QUESTIONS

DOCUMENT HISTORY

DATE	VERSION	SUMMARY OF CHANGE/MILESTONE
5/20/2010	CATI_v1	Schoendorf draft with Graber’s programming and operational content
5/20/2010	20100520	Formatted for IRB; modification of (STATUS) PPG_GROUP=5 language; yet to apply to all relevant instruments; add in tracing questions.
5/21/2010	20100520_jg_edits	Modified tracing items.
5/21/2010	20100521	Accepted Graber’s comments; tweak of phone number item.
5/24/2010	20100521	INFORMAL SUBMISSION TO OMB
5/26/2010	20100526	Additional comments from Jessica
5/26/2010	20100526	INCORPORATE COMMENTS FROM OMB (no changes)
5/27/2010	20100527	Revised closing scripts
5/28/2010	20100527	Comments from SDSU
6/3/2010	20100603	Incorporated changes from Program Office Staff and checked for eligibility-related language
6/7/2010	20100607	Accepted changes from previous version
6/7/2010	20100607a	Incorporate changes from J. Slutsman
		COMMENTS FROM HIRSCHFELD
		RECONCILE WITH DATA ELEMENTS TABLES
		FORMAL SUBMISSION TO OMB
		INCORPORATE COMMENTS FROM OMB
		SUBMIT TO NICHD IRB
		RECONCILE WITH DATA ELEMENTS TABLES

NOTE: Italics denote anticipated development stages

CATI

PG001

/

(TIME_STAMP_1)

PROGRAMMER INSTRUCTIONS: ENTER DATE/TIME STAMP

PG002

Hello. My name is [INTERVIEWER FIRST AND LAST NAME] from the National Children’s Study. It’s been a few months since we have spoken with you. We’re following up with women of childbearing age and our first questions are always about pregnancy. We first want to know…

PG003

/

(PREGNANT)

Are you pregnant now?

YES

……………………….

1

PG005

/

(PPG_DUE_DATE_1)

NO

……………………….

2

PG004

/

(TRYING)

RECENTLY LOST PREGNANCY (MISCARRIAGE OR ABORTION

……………………….

3

PG010

/

(MED_UNABLE)

RECENTLY GAVE BIRTH

……………………….

4

PG011

/

(STATUS)

UNABLE TO HAVE CHILDREN (E.G., HYSTERECTOMY, TUBAL LIGATION)

5

PG010

/

(MED_UNABLE)

REFUSED

……………………….

-1

PG004

/

(TRYING)

DON’T KNOW

……………………….

-2

PG004

/

(TRYING)

INTERVIEWER INSTRUCTIONS: ENTER “YES” EVEN IF R IS UNSURE THAT SHE IS PREGNANT

PROGRAMMER INSTRUCTIONS: IF (PREGNANT = 1); SET PPG_GROUP = 1 (PREGNANT AND ELIGIBLE) IF (PREGNANT = 3); SET PPG_GROUP = 3 (HIGH PROBABILITY-RECENT LOSS) IF (PREGNANT = 4); SET PPG_GROUP = 4 (OTHER PROBABILITY – NOT PREGNANT AND NOT TRYING) REFERENCE CODE LIST: PREGNANCY_TRYING_STATUS_CL1

PG004

/

(TRYING)

Are you currently trying to become pregnant?

YES

……………………….

1

PG010

/

(MED_UNABLE)

NO

……………………….

2

PG010

/

(MED_UNABLE)

RECENTLY LOST PREGNANCY (MISCARRIAGE OR ABORTION

……………………….

3

PG011

/

(STATUS)

RECENTLY GAVE BIRTH

……………………….

4

PG011

/

(STATUS)

UNABLE TO HAVE CHILDREN (E.G., HYSTERECTOMY, TUBAL LIGATION)

5

PG010

/

(MED_UNABLE)

REFUSED

……………………….

-1

PG010

/

(MED_UNABLE)

DON’T KNOW

……………………….

-2

PG010

/

(MED_UNABLE)

INTERVIEWER INSTRUCTIONS: DO NOT DEFINE “TRYING TO BECOME PREGNANT”

PROGRAMMER INSTRUCTIONS: IF (TRYING = 1); SET PPG_GROUP = 2 (HIGH PROBABILITY - TRYING TO CONCEIVE) IF (TRYING = 3); SET PPG_GROUP = 3 (HIGH PROBABILITY-RECENT LOSS) IF (TRYING = 4); SET PPG_GROUP = 4 (OTHER PROBABILITY – NOT PREGNANT AND NOT TRYING) REFERENCE CODE LIST: PREGNANCY_TRYING_STATUS_CL1

PG005

/

(PPG_DUE_DATE_1)

[Congratulations.] When is your baby due?

__ __ / __ __/ __ __ __ __

……………………….

PG011

/

(STATUS)

M M D D Y Y Y Y

REFUSED

……………………….

-1

PG006

/

(DATE_PERIOD)

DON’T KNOW

……………………….

-2

PG006

/

(DATE_PERIOD)

INTERVIEWER INSTRUCTIONS: ENTER A TWO DIGIT MONTH, TWO DIGIT DAY, AND A FOUR DIGIT YEAR.

PROGRAMMER INSTRUCTIONS: SO SOFT EDIT: IF DATE IS MORE THAN NINE MONTHS AFTER CURRENT DATE, DISPLAY, “You have entered a date that is more than nine months from today. Confirm date and re-enter it.” HARD EDIT: IF DATE IS MORE THAN TEN MONTHS AFTER CURRENT DATE, DISPLAY, “You have entered a date that is more than ten months from today. Re-enter date.” IF DATE IS MORE THAN 1 MONTH BEFORE CURRENT DATE, DISPLAY, “You have entered a date that occurred more than a month before today. Re-enter date.” IF DATE IS COMPLETE, SET (PPG_DUE_DATE_2) TO DATE PROVIDED; ELSE GO TO (DATE_PERIOD)

PG006

/

(DATE_PERIOD)

What was the first day of your last menstrual period?

__ __ / __ __/ __ __ __ __

……………………….

PG011

/

(STATUS)

M M D D Y Y Y Y

REFUSED

……………………….

-1

PG007

/

(WEEKS_PREG)

DON’T KNOW

……………………….

-2

PG007

/

(WEEKS_PREG)

INTERVIEWER INSTRUCTIONS: ENTER A TWO DIGIT MONTH, TWO DIGIT DAY, AND A FOUR DIGIT YEAR.

PROGRAMMER INSTRUCTIONS: SO HARD EDIT: IF DATE IS MORE THAN TEN MONTHS BEFORE CURRENT DATE, DISPLAY, “You have entered a date that was more than ten months before today. Confirm date. If this date is correct, enter ‘Don’t Know’ to continue with duration questions.” IF DATE IS AFTER TODAY’S DATE, DISPLAY “You have entered a date that has not occurred yet. Re-enter date.” IF DATE IS COMPLETE, CALCULATE DUE DATE FROM FIRST DATE OF LAST MENSTRUAL PERIOD, WHERE (PPG_DUE_DATE_2) = (DATE_PERIOD) + 280 DAYS)) ; ELSE GO TO (WEEKS_PREG)

PG007

(WEEKS_PREG)

How many weeks pregnant are you now? If you’re not sure, please make your best guess.

__ __

……………………….

PG011

/

(STATUS)

NUMBER OF WEEKS

REFUSED

……………………….

-1

PG008

/

(MONTHS_PREG)

DON’T KNOW

……………………….

-2

PG008

/

(MONTHS_PREG)

PROGRAMMER INSTRUCTIONS: SO SOFT EDIT: IF >43 HARD EDIT: IF <1 OR >44 IF DATE IS COMPLETE, CALCULATE DUE DATE FROM NUMBER OF WEEKS PREGNANT, WHERE (PPG_DUE_DATE_2) = TODAY’S DATE + (280 DAYS – (WEEKS_PREG)*7); ELSE GO TO (MONTHS_PREG)

PG008

/

(MONTHS_PREG)

About how many months pregnant are you? If you’re not sure, please make your best guess.

__ __

……………………….

PG011

/

(STATUS)

NUMBER OF MONTHS

REFUSED

……………………….

-1

PG009

/

(TRIMESTER)

DON’T KNOW

……………………….

-2

PG009

/

(TRIMESTER)

PROGRAMMER INSTRUCTIONS: SO SOFT EDIT: IF >10 HARD EDIT: IF <1 OR >12 IF DATE IS COMPLETE, CALCULATE DUE DATE FROM NUMBER OF MONTHS PREGNANT, WHERE (PPG_DUE_DATE_2) = TODAY’S DATE + (280 DAYS – (MONTHS_PREG)*30 - 15) ; ELSE GO TO (TRIMESTER)

PG009

/

(TRIMESTER)

Are you currently in your First, Second, or Third trimester?

1ST (1 to 3 months pregnant)

……………………….

1

PG011

/

(STATUS)

2ND (4 to 6 months pregnant)

……………………….

2

PG011

/

(STATUS)

3RD (7 to 9 months pregnant)

……………………….

3

PG011

/

(STATUS)

REFUSED

……………………….

-1

PG011

/

(STATUS)

DON’T KNOW

……………………….

-2

PG011

/

(STATUS)

PROGRAMMER INSTRUCTIONS: REFERENCE CODE LIST: TRIMESTER_CL1 SO CALCULATE DUE DATE FROM (TRIMESTER), IF (TRIMESTER = 1) THEN: (PPG_DUE_DATE_2) = TODAY’S DATE + (280 DAYS – 46 DAYS)) IF (TRIMESTER = 2) THEN: (PPG_DUE_DATE_2) = TODAY’S DATE + (280 DAYS – 140 DAYS)) IF (TRIMESTER = 3) THEN: (PPG_DUE_DATE_2) = TODAY’S DATE + (280 DAYS – 235 DAYS)) IF (TRIMESTER = -1 OR -2) THEN: (PPG_DUE_DATE_2) = TODAY’S DATE + (280 DAYS – 140 DAYS))

PG010

/

(MED_UNABLE)

Do any of the following apply to you? Have you had: A hysterectomy, Both ovaries removed, Your tubes tied, Gone through menopause or Any other medical reason why you cannot become pregnant?

YES

……………………….

1

PG011

/

(STATUS)

NO

……………………….

2

PG011

/

(STATUS)

REFUSED

……………………….

-1

PG011

/

(STATUS)

DON’T KNOW

……………………….

-2

PG011

/

(STATUS)

PROGRAMMER INSTRUCTIONS: IF (UNABLE = 1); SET PPG_GROUP = 5 (INELIGIBLE- UNABLE TO CONCEIVE) REFERENCE CODE LIST: CONFIRM_TYPE_CL1

PG011

/

(STATUS)

Are yo

IF PPG_GROUP =1

[Congratulations again on your pregnancy.] We would like to set up a time to talk about the National Children’s Study. If you have any other questions before that time, please call xxx-xxx-xxxx, which is XXX’s local toll free National Children’s Study office. Thank you for taking time to answer these questions.

PG012

/

(TIME_STAMP_2)

IF PPG_GROUP =2

We will call you again in a couple of months to ask a few quick questions. If you find out that you’re pregnant before our next call, please call xxx-xxx-xxxx, which is XXX’s local toll free National Children’s Study office. Thank you for taking time to answer these questions. .

PG012

/

(TIME_STAMP_2)

IF PPG_GROUP =3

[I’m so sorry to hear that you’ve lost your baby. I know this can be a hard time.] Because your address is in the study area, we may be back in touch at a later time to update your household information. If you have any other questions before that time, please call xxx-xxx-xxxx, which is XXX’s local toll free National Children’s Study office. Thank you for taking time to answer these questions.

PG012

/

(TIME_STAMP_2)

IF PPG_GROUP =4

We will call you again in a couple of months to ask a few quick questions. If you have any other questions before that time, please call xxx-xxx-xxxx, which is XXX’s local toll free National Children’s Study office. Thank you for taking time to answer these questions.

PG012

/

(TIME_STAMP_2)

IF PPG_GROUP =5

Based on what you’ve told me, we will not ask you to take part in the study at this time. We may be back in touch at a later time to update your household information. If you have any other questions before that time, please call xxx-xxx-xxxx, which is XXX’s local toll free National Children’s Study office. Thank you for taking time to answer these questions.

PG012

/

(TIME_STAMP_2)

INTERVIEWER INSTRUCTIONS: READ APPROPRIATE PPG SCRIPT

PROGRAMMER INSTRUCTIONS: DISPLAY SCRIPT BASED ON ASSIGNED PPG STATUS DISPLAY CORRECT SITE OFFICE TOLL-FREE NUMBER REFERENCE CODE LIST: PPG_STATUS_CL1

PG012

/

(TIME_STAMP_2)

PROGRAMMER INSTRUCTIONS: ENTER DATE/TIME STAMP

TR001

/

(BST_NMBR)

TR001.

/

(BST_NMBR)

Just to confirm, is this the best phone number to reach you?

YES

……………………….

1

TR004.

/

(TIME_STAMP_3)

NO

……………………….

2

TR002

/

(PHONE_NBR)

REFUSED

……………………….

-1

TR004.

/

(TIME_STAMP_3)

DON’T KNOW

……………………….

-2

TR004.

/

(TIME_STAMP_3)

TR002.

/

(PHONE_NBR)

What is the best phone number to reach you? ENTER PHONE NUMBER AND CONFIRM. |___|___|___| - |___|___|___| - |___|___|___|___|

RESPONDENT PROVIDED TELEPHONE NUMBER

……………………….

1

TR003

(PHONE_TYPE)

RESPONDENT HAS NO TELEPHONE

……………………….

-8

TR004

/

(TIME_STAMP_3)

REFUSED

……………………….

-1

TR004.

/

(TIME_STAMP_3)

DON’T KNOW

……………………….

-2

TR004.

/

(TIME_STAMP_3)

TR003.

/

(PHONE_TYPE)

Is that your home, work, cell, or another phone number? CONFIRM IF KNOWN.

HOME

……………………….

1

TR004.

/

(TIME_STAMP_3)

WORK

……………………….

2

TR004.

/

(TIME_STAMP_3)

CELL

……………………….

3

TR004.

/

(TIME_STAMP_3)

FRIEND/RELATIVE

4

TR004.

/

(TIME_STAMP_3)

OTHER

5

TR004.

/

(TIME_STAMP_3)

REFUSED

-1

TR004.

/

(TIME_STAMP_3)

DON’T KNOW

-2

TR004.

/

(TIME_STAMP_3)

TR004.

/

(TIME_STAMP_3)

PROGRAMMER INSTRUCTIONS: ENTER DATE/TIME STAMP

TR005. Thank you for participating in the National Children’s Study and for taking the time to answer our questions.

Public reporting burden for this collection of information is estimated to average 5 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.