Appendix_D

Data Collection Flow: Project Coordinators/Researchers Version

Tracing Procedures

Follow Up Call
1. Schedule Clinic Visits
2. Schedule Second Questionnaire
Packet

Questionnaire Packet II (interview or self-administered)
1. CBCL (15)
2. Carey Temperament Scale (10)
3. Sleep Habits Questionnaire (10)
4. Child Social Responsiveness Scale (15)
5. Parent Social Responsiveness Scale (30)

20 min.

1 week

Follow Up Call
1. Answer questions about clinic visits.
2. Remind about clinic visits.

1 week

Invitation Letter
1. Letter
2. Study brochure
3. Response card
4. $1.00 incentive (beach ball,
magnet, etc)

No response card received

Response
Card
Received

Invitation Letter 2nd mailing (if
required)

Questionnaire Packet I (interview or selfadministered)
1. Paternal Medical Hx (10)
55-80
2. Maternal Medical Hx (10)
min.
3. Autoimmune History Worksheet (20)
4. GI questionnaire (10)
5. Paternal Occupational Exposure
Questionnaire (5)
6. Services & Treatments Q (Cases Only) (5)
7. Early Development Questionnaire (Cases
Only) (20)

Caregiver Interview**
Verbal consent for interview obtained by
interviewer

60
min

2 hrs, 5 min –
5 hrs. 30 min.

Invitation Phone Call/Screener
(may consist of 2 separate phone
calls)
20 min.
1. Introduction to study
2. Eligibility screen (10)
3. Verbal consent for the SCQ
4. SCQ (10)
5. Overall verbal consent to
participate in the study
6. Inform participant of
enrollment packet

Follow Up Call
30
1. Q & A on the study
2. Schedule Caregiver Interview.
3. Complete Pregnancy Reference Form.
4. Explain Questionnaire Packets.
Schedule First Questionnaire Packet.

15 min.

CLINIC VISIT
Initial Clinic Visit (Clinic or Home)
30 min
1. Review & sign written informed consent (10)
2. Obtain signed medical records release forms (10)
3. Review completed questionnaires & assist with buccal collection if necessary
4. Complete other data collection components if scheduled

Subcohort/NIC Child Clinic
(Clinic or Home)
1. Mullen * (45)
2. Dysmorphology exam (15)
3. Biosamples (20)
- blood, hair (buccal if needed)
1 hr.
20 min

Up to 2 or 3 weeks

80 min.

min.

Case Child Clinic
Administered to Child (Clinic or Home):
1. Mullen (45)
2. Dysmorphology exam (15)
3. Child biosamples (20)
2
- blood, hair ( buccal if needed)
hours
4. ADOS (40)***
Administered to Parent (clinic, home, or
telephone)
2 hours,
1. ADI-R (120)
45 min
2. Vineland (45) *

1 week

Enrollment Packet (mailed)
1. Introductory Letter
2. Copy of consent to review
3. Study bill of rights
4. Study flow sheet
5. Prep Guides for data collection
6. Picture Story
7. Questionnaire Checklist
8. HIPAA checklist & medical records
release forms
9. Buccal Swab Kit
a. Buccal Instructions
b Buccal Consent Forms
c. Buccal Collection Materials

Parent Biosamples (Clinic or Home)
1. Blood (Buccal if needed) (15)

Third Questionnaire Packet
1. 3 day diet diary (20)
2. 7 day stool diary (40)

10. medical
record
abstraction

15
min

1 hour

Key

TOTAL TIME:
CASE: 11 hours
NIC/Subcohort: 7 hours
(X)

Time
Case only

Figure 9. Study Flow Diagram

* Vineland will be administered to subcohort and NIC members who score
<1.5 std. dev. Below average on the Mullen. This outcome is expected to be
rare, but if it occurs, the vineland will be administered AFTER the mullen as a
follow up telephone call.
*** ADOS will be administered to subcohort children who score positively on
SCQ

Subcohort/NIC
All Participants
Study Staff