ENROLLMENT Packet (Mother)

The Study to Explore Early Development (SEED) - Phase 3 (Modified for COVID-19 Impact Assessment)

Attachment 18. Participant Flow Chart_revised

ENROLLMENT Packet (Mother)

OMB: 0920-1171

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Attachment 18

Data Collection Flow Outline



Abbreviations:

CASE – Autism Spectrum Disorder - Case Group,

DD – Developmental Delay or Disability

POP - Randomly sampled population Comparison Group

The following study flow charts will be included in the Enrollment Packets sent to the mothers of children in the ASD, DD, and POP workflows as determined during the Invitation Call

All study participants will be assigned to one of three workflows that will determine the data collection study protocol:

  1. ASD workflow (also known as POSSIBLE ASD workflow):

    1. All children who are identified from data sources as having a previous ASD diagnosis and/or autism special education eligibility;

    2. All children identified as having a previous ASD diagnosis during the invitation call (including children originally ascertained from lists of potential DD or POP participants);

    3. All children who screen “positive” on the SCQ screen – defined as SCQ score =>11 (including children originally ascertained from lists of potential DD or POP participants).


  1. DD workflow: children identified from sources as having one of the DD diagnoses or special education eligibilities included in the “broad net” list who:

    1. Do NOT have a positive ASD screen: SCQ score <11; and

    2. Do NOT have a maternal report of a previous ASD diagnosis.


  1. POP workflow: children randomly sampled from birth records who:

    1. Do NOT have a positive ASD screen: SCQ score <11; and

    2. Do NOT have a maternal report of a previous ASD diagnosis.



All families will be sent the study flow charts at two different points in the study:

  • Enrollment Packet (mailed after the Invitation Call and in advance of the Maternal Interview)

  • Forms Packet (mailed after the Maternal Interview).

Different sections of the form will be highlighted in the two mailings to indicate to the participant what study step she is currently completing and what the next step will be.

Different sites may use slight variations of this form. For example, these forms have been developed to include the possibility of a home visit in addition to a visit at the study site clinical location. Not all sites will offer home visits and the study flow chart verbiage will be adjusted accordingly.




ASD Workflow Study Flow Chart (first mailing)



GROUP: ASD


Data Collection Step*

Time to Complete

Time Incentives

1

Invitation Letter



2

Screening and Invitation Phone Call (with the SCQ)

30 min.



3.

Enrollment Packet (includes incentive for the eligibility screening)


$10

4.

Follow Up Phone Call 1 (includes completing Pregnancy Reference Form)

15 min

$20

5.

Maternal Interview Call

60 min

$45

6.

Clinic Visit Preparation, Medical History and Child Development Forms Packet

95 min

$50

7.

Follow Up Phone Call 2 (includes answering questions, help with self-administered forms as needed, and preparation for clinic visit)

20 min


11.

Clinic/Home Visit

330 min

$200


TOTAL

9 hours, 10 minutes

$325

*refer to study flow diagram for details






What Study Step Are You At?

Keep this sheet handy. It outlines the steps in SEED and you can fill in your appointment times.

Each step builds on each other and is voluntary.

Shape1

STEP 1 – Review the information in the enrollment and maternal interview prep packets.

  • The $10 <cash card> for the previous phone call is in your enrollment packet.

  • Review booklet and pregnancy calendar in the maternal interview prep packet to help you during the next telephone interview.

  • The $20 <cash card > for completing the pregnancy calendar is in this packet.








Shape2

$10





Shape3 Shape4



STEP 2 – Maternal Interview on: ­__________________________________

  • To discuss your health during your pregnancy and your child’s early years.


After the interview, we will also:

  • Discuss the next packet of information we will send you and your preference for how to complete family history and child development forms.

  • Schedule phone call to help you complete these forms.

  • Schedule the in-person visit at our clinic or in your home.

$20





Shape5

45 min







Shape6

15 min



Shape7

STEP 3 – Clinic visit prep information and forms to fill out - Look for our mail to you!


  • Guide for how to prepare for the clinic visit

  • Frequently asked questions and answers about biologic samples (saliva and blood)

  • Child-friendly story about the clinic visit

  • 6 forms to fill out about your family’s health and your child’s development either – you can fill out on your own or with our staff on the phone (STEP 4)

  • The $45 <cash card> for the previous phone call will be in this packet.







Shape8

$45





Shape16 Shape9 Shape10 Shape14 Shape15 Shape11 Shape13 Shape12

STEP 5 – Developmental and physical exam on:

  • Developmental exam (playing with your child)

  • Asking you questions about your child’s development

  • Have you sign medical record release forms

  • Finish filling out the forms about your family’s health and child’s development (if needed).

  • Take measurements (height, weight, and head size) of your child

  • Take your measurements (height and head size)

  • Collect saliva samples and draw blood from you and your child

  • Collect saliva sample from the father (if available)

  • You will get the $50 <cash card> for the previous phone call and the $200 <cash card> for the visit at this appointment.


STEP 6 – Results Letter and Newsletters - Look for our mail to you!


  • Summary letter of the results of the developmental evaluation

  • Newsletters about SEED and about child development in general (2 times a year)

You’ve finished the steps in our study!

< 5.5 hrs

$50

$200

STEP 4 – Form completion appointment on:

­

  • If needed, we will schedule a call to work with you to collect the information on the forms mailed to you in STEP 3 about your family’s health and your child’s development.

  • We will also schedule the in-person visit at our clinic or in your home.



< 2 hrs

Conduct Clinic or Home Visit for CASE (305 min)

  1. Consent family and give incentive for visit

(10 min)

  1. Administer Mullen Scales of Early Learning (40 min)

  2. Administer Vineland Adaptive Behavior Scales (45 min)

  3. Administer Autism Diagnostic Observation Schedule (40 min)

  4. Administer Autism Diagnostic Interview – Revised (120 min)

  5. Administer Services and Treatments Questionnaire (10 min)

  6. Collect and review SAP forms

  7. Complete SAP pending forms (if needed)

  8. Obtain anthropometric measures (10 min)

  9. Obtain blood and cheek samples (30 min)







POP Workflow Study Flow Chart (first mailing)



GROUP: POP


Data Collection Step*

Time to Complete

Time Incentives

1

Invitation Letter



2

Screening and Invitation Phone Call (with the SCQ)

30 min.



3.

Enrollment Packet (includes incentive for the eligibility screening)


$10

4.

Follow Up Phone Call 1(includes completing the Pregnancy Reference Form)

15 min

$20

5.

Maternal Interview Call

60 min

$45

6.

Clinic Visit Preparation, Medical History and Child Development Forms Packet

95 min

$50

7.

Follow Up Phone Call 2 (includes answering questions, help with self-administered forms as needed, and preparation for clinic visit)

20 min


11.

Clinic/Home Visit

110 min

$75


TOTAL

5 hours, 30 minutes

$200

*refer to study flow diagram








What Study Step Are You At?

Keep this sheet handy. It outlines the steps in SEED and you can fill in your appointment times.

Each step builds on each other and is voluntary.

Shape17

STEP 1 – Review the information in the enrollment and maternal interview prep packets.

  • The $10 <cash card> for the previous phone call is in your enrollment packet.

  • Review booklet and pregnancy calendar in the maternal interview prep packet to help you during the next telephone interview.

  • The $20 <cash card > for completing the pregnancy calendar is in this packet.








Shape18

$10





Shape19 Shape20



STEP 2 – Maternal Interview on: ­__________________________________

  • To discuss your health during your pregnancy and your child’s early years.


After the interview, we will also:

  • Discuss the next packet of information we will send you and your preference for how to complete family history and child development forms.

  • Schedule phone call to help you complete these forms.

$20





Shape21

45 min







Shape22

15 min



Shape23

STEP 3 – Clinic visit prep information and forms to fill out - Look for our mail to you!


  • Guide for how to prepare for the clinic visit

  • Frequently asked questions and answers about biologic samples (saliva and blood)

  • Child-friendly story about the clinic visit

  • 6 forms to fill out about your family’s health and your child’s development either – you can fill out on your own or with our staff on the phone (STEP 4)

  • The $45 <cash card> for the previous phone call will be in this packet.







Shape24

$45





Shape32 Shape25 Shape26 Shape30 Shape31 Shape27 Shape29 Shape28

STEP 5 – Developmental and physical exam on:


  • Developmental exam (playing with your child)

  • Have you sign medical record release forms

  • Finish filling out the forms about your family’s health and child’s development (if needed).

  • Take measurements (height, weight, and head size) of your child

  • Take your measurements (height and head size)

  • Collect saliva samples and draw blood from you and your child

  • Collect saliva sample from the father (if available)

  • You will get the $50 <cash card> for the previous phone call and the $75 <cash card> for the visit at this appointment.


STEP 6 – Results Letter and Newsletters - Look for our mail to you!


  • Summary letter of the results of the developmental evaluation

  • Newsletters about SEED and about child development in general (2 times a year)

You’ve finished the steps in our study!

< 2 hrs

$50

$75

STEP 4 – Form completion appointment on: ­

  • If needed, we will schedule a call to work with you to collect the information on the forms mailed to you in STEP 3 about your family’s health and your child’s development.

  • We will also schedule the in-person visit at our clinic or in your home.




< 2 hrs

Conduct Clinic or Home Visit for CASE (305 min)

  1. Consent family and give incentive for visit

(10 min)

  1. Administer Mullen Scales of Early Learning (40 min)

  2. Administer Vineland Adaptive Behavior Scales (45 min)

  3. Administer Autism Diagnostic Observation Schedule (40 min)

  4. Administer Autism Diagnostic Interview – Revised (120 min)

  5. Administer Services and Treatments Questionnaire (10 min)

  6. Collect and review SAP forms

  7. Complete SAP pending forms (if needed)

  8. Obtain anthropometric measures (10 min)

  9. Obtain blood and cheek samples (30 min)







DD Workflow Study Flow Chart (first mailing)



GROUP: DD


Data Collection Step*

Time to Complete

Time Incentives

1

Invitation Letter



2

Screening and Invitation Phone Call (with the SCQ)

30 min.



3.

Enrollment Packet (includes incentive for the eligibility screening)


$10

4.

Follow Up Phone Call 1 (includes completing the Pregnancy Reference Form)

15 min

$20

5.

Maternal Interview Call

60 min

$45

6.

Medical History Forms Packet (4 forms only)

60 min

$50


TOTAL

2 hours, 45 minutes

$125

*refer to Appendix H. for detailed study flow diagram




What Study Step Are You At?

Keep this sheet handy. It outlines the steps in SEED and you can fill in your appointment times.

Each step builds on each other and is voluntary.

Shape33

STEP 1 – Review the information in the enrollment and maternal interview prep packets.

  • The $10 <cash card> for the previous phone call is in your enrollment packet.

  • Review booklet and pregnancy calendar in the maternal interview prep packet to help you during the next telephone interview.

  • The $20 <cash card > for completing the pregnancy calendar is in this packet.








Shape34

$10





Shape35 Shape36



STEP 2 – Maternal Interview on: ­__________________________________

  • To discuss your health during your pregnancy and your child’s early years.


After the interview, we will also:

  • Discuss the next packet of information we will send you and your preference for how to complete family history and child development forms.

  • Schedule phone call to help you complete these forms.

  • Schedule the in-person visit at our clinic or in your home.

$20





Shape37

45 min







Shape38

15 min



Shape39

STEP 3 –Forms to fill out - Look for our mail to you!


  • 4 forms to fill out about your family’s health – you can fill out on your own or with our staff on the phone (STEP 4)

  • The $45 <cash card> for the previous phone call will be in this packet.







Shape40

$45





Shape45 Shape41 Shape43 Shape44 Shape42

STEP 6 – Thank you Letter and Newsletters - Look for our mail to you!


  • Thank you letter

  • The $50 <cash card> for completing the health history forms will also be included.


  • Newsletters about SEED and about child development in general (2 times a year)


You’ve finished the steps in our study!

$50

STEP 4 – Form completion appointment on:

­


  • If needed, we will schedule a call to work with you to collect the information on the forms mailed to you in STEP 3 about your family’s health and your child’s development.



< 2 hrs

Conduct Clinic or Home Visit for CASE (305 min)

  1. Consent family and give incentive for visit

(10 min)

  1. Administer Mullen Scales of Early Learning (40 min)

  2. Administer Vineland Adaptive Behavior Scales (45 min)

  3. Administer Autism Diagnostic Observation Schedule (40 min)

  4. Administer Autism Diagnostic Interview – Revised (120 min)

  5. Administer Services and Treatments Questionnaire (10 min)

  6. Collect and review SAP forms

  7. Complete SAP pending forms (if needed)

  8. Obtain anthropometric measures (10 min)

  9. Obtain blood and cheek samples (30 min)





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