Appendix_D

Appendix_D.3 DC Instrument Summary Table.doc

The Study to Explore Early Development (SEED)

Appendix_D

OMB: 0920-0741

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Data Collection Instrument Summary Table


Instrument

Time (min)

Respondent

Subject

Item#

Administration Mode(s)

Instrument

Origin

Purpose

Screener








Social Communication Questionnaire (SCQ)

10

Caregiver1

Child

1- 2

Phone or Self-Administer

Standardized

To screen children for ASD. Captures information on child’s reciprocal social interaction, language, communication, reciprocal conversation, and repetitive and stereotyped patterns of behavior.

Self-Administered Questionnaires








Paternal Medical History

10

Father

Father

3

Self-Administer

CADDRE

To obtain information on medical and psychiatric conditions of father other than autoimmune disorders.

Maternal Medical History

10

Mother

Mother

3

Self-Administer

CADDRE

To obtain information on medical and psychiatric conditions of mother other than autoimmune disorders.

Child Behavior Checklist (CBCL)

15

Caregiver1

Child

3

Self-Administer

Standardized

To assess behavior problems and social competencies of the child.


Carey Temperament Scale (Carey)

10

Caregiver1

Child

3

Self-Administer

Standardized

To assess child’s temperament.

Sleep Habits Questionnaire

10

Caregiver1

Child

3

Self-Administer

Standardized

To assess child’s behaviors and medical disorders of sleep.

Stool & Diet Diary

60 (40 min Stool, 20 min Diet)

Caregiver1

Child

9

Self-Administer

CO:GI-Study

To assess child’s stool and corresponding dietary patterns.

Autoimmune Worksheet

20

Mother

Nuclear family

3

Self-Administer

CADDRE

To obtain information on nuclear family’s autoimmune history.

Social Responsiveness Scale

45 min. (15 min per form)

Caregiver1


Nuclear Family

3

Self-Administer

Standardized

To obtain information on behaviors related to the nuclear family.

GI Questionnaire

10

Caregiver1

Child

3

Self administered

CADDRE

To obtain information on GI disturbances in the child.

Paternal Occupational Exposure Questionnaire

5

Father

Father

3

Self administered

CADDRE

To obtain information on paternal occupational exposure.

Clinical Intake Form

3

Caregiver1

Child

3

Self administered

CADDRE

To obtain information on child to assist with the clinical evaluation.

Caregiver Interview

3

* 50 minutes for alternative interview

0*

Caregiver1

Mother & Child



5

Phone


CADDRE


To obtain etiologic information related to the mother’s medical & reproductive history & child’s postnatal medical experiences.

Vineland Adaptive Behavior Scales

45

Caregiver1

Child2

7

Phone

Standardized

To assess child’s adaptive behavioral information (i.e., socialization, daily living skills) and language skills.

Early Development Questionnaire

20

Caregiver1

Child2

7

Self-administered

Ozonoff, Williams, Landa

To assess regression of language skills, social skills, and functional behavior of child.

Services & Treatment

5

Caregiver1

Child2

7

Phone

CADDRE

To assess the types and frequency of any services and treatments the child is currently receiving

Autism Diagnostic Interview-Rev (ADI-R)

120

Caregiver1

Child2

7

In-Person

home/clinic

Standardized

To assess whether a child has behaviors consistent with ASD based on social and communicative behaviors

Parent Clinical








Biologic Samples

15

Mother & Father

Mother & Father

8

In-Person

home/clinic

CADDRE use of Standard procedures

To study genetic components related to autism (including gene-environment interactions), and altered immune function and dysfunction (autoimmunity).

Child Clinical: Child Evaluation








Autism Diagnostic Observation Schedule (ADOS)

40

Child

Child2

7

In-Person home/clinic

Standardized

To assess whether a child has ASD based on observation of the child’s social interaction and communication skills and through the use of structured play activities.

Mullen Scales of Early Learning

45

Child

Child

7

In-Person home/clinic

Standardized

To assess the child’s level of cognition in five domains: gross motor, visual reception, fine motor, receptive language, and expressive language.

Dysmorphology Exam

15

Child

Child

7

In-Person home/clinic

CADDRE use of Standard procedures

To collect anthropometric measurements & any dysmorphic characteristics (i.e, digit ratios)

Biosampling

20

Child

Child

7

In-Person home/clinic

CADDRE use of Standard procedures

To examine genetic components (e.g. gene-environment interactions), immune function and dysfunction (autoimmunity), metabolism of xenobiotics, and hormone function possibly related to autism

Medical Record Abstraction








Maternal Primary Physician (PP) and Labor & Delivery (LD) Forms

N/A

N/A

Mother

10

Medical Record Abstraction

CADDRE/

CHARGE

To obtain information on maternal medical and reproductive history, as well as obstetric and delivery complications and events.

Child Neonatal (N) and Pediatric (P) Forms

N/A

N/A

Child

10

Medical Record Abstraction

CADDRE/ CHARGE

To obtain neonatal and postnatal medical experiences of the child.

1A Caregiver is defined as a parent or relative of legal age who has resided with and been caring for the child since the child was 6 months of age or younger.

2Case– indicates these instruments will only be administered to CASE group.

CADDRE Study –revised 30 AUG 2005

Appendix H.1 DC Instrument Summary.doc

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