Table 2.
Study to Explore Early Development data collection
| Data collection | Reference; version | Collection mode (time to complete) | Participanta | Primary purpose for SEED | Analytic domainsb |
|---|---|---|---|---|---|
| Autism-related assessments | |||||
| Social Communication Questionnaire (SCQ) | Rutter et al. 2003; 2003 WPS Current Version | Telephone (10 min) | C | Screen for autism spectrum disorders | B |
| Autism Diagnostic Observation Scale (ADOS) | Lord et al. 1999; Lord et al. 2000; Gotham et al, 2007; 2001 WPS Version | Clinic (40 min) | C (ASD) | Assess ASD symptoms; determine final ASD status | B |
| Autism Diagnostic Interview-Revised (ADI-R) | Lord et al. 1994; Rutter et al. 2003; 2003 WPS Version | Clinic (120 min) | C (ASD) | Assess ASD symptoms; determine final ASD status | B |
| Ohio State University (OSU) Autism Rating Scale (OARS) | OSU Research Unit, 2005; adapted for SEED | Staff review (n/a) | C (ASD) | Assess ASD symptoms and comprehensive clinical impression | B |
| Early Development Questionnaire (EDQ) | Ozonoff et al. 2005; Version 3 | Filled out by parent (20 min) | C (ASD) | Assess regression of language and social skills, and functional behavior | B |
| Social Responsiveness Scale (SRS) | Constantino 2002; 2006 WPS Preschool Version & 2005 WPS Adult Version | Filled out by parent (15–30 min) | C, M, F | Assess social behavior | B |
| Other behavioral and developmental assessments | |||||
| Mullen Scales of Early Learning | Mullen, 1995; 1995 AGS/Pearson Version | Clinic (45 min) | C | Assess cognitive function | B |
| Vineland Adaptive Behavior Scales | Sparrow et al. 1984; 2005 AGS/Pearson Version | Clinic (45 min) | C | Assess adaptive behavior | B |
| Child Behavior Checklist (CBCL) | Achenbach, 1992; 2000 ASBE Version | Filled out by parent (15 min) | C | Assess behavior problems and social competencies | B |
| Carey Temperament Scale | Carey and McDevitt, 1995; 1995 Behavioral /Developmental Initiatives Version, | Filled out by parent (10 min) | C | Assess temperament | B |
| Health and medical information | |||||
| Physical examination | CADDRE-derived | Clinic (15 min) | C | Anthropometry and dysmorphology exam | D |
| Services and treatments questionnaire | CADDRE-derived | Filled out by parent (5 min) | C (ASD) | Assess types and frequency of current services and treatments | B |
| Child Sleep Habits Questionnaire | Owens 2000 | Filled out by parent (10 min) | C | Assess behaviors and medical disorders of sleep | B |
| Gastrointestinal questionnaire | CADDRE-derived | Filled out by parent (10 min) | C | Assess past and current gastrointestinal disturbances | GI |
| Paternal medical history form | CADDRE-derived | Self-administered (10 min) | F | Assess medical and psychiatric conditions | B |
| Maternal medical history form | CADDRE-derived | Self-administered (10 min) | M | Assess medical and psychiatric conditions | B, H, I |
| Autoimmune disease survey | CADDRE-derived | Self-administered (20 min) | Nuclear family | Assess history of autoimmune disease | I |
| Medical records for the preconceptionc, prenatal, and labor/delivery periods | CADDRE-derived | Staff review (n/a) | M | Prenatal, perinatal, and postnatal medical information related to risk factors of interest | S,H,I,GI,O |
| Medical records for the neonatal and pediatric3 periods | CADDRE-derived | Staff review (n/a) | C | Prenatal, perinatal-, and postnatal medical information related to risk factors of interest | S,H,I,GI,O |
| 7-day stool diary | Bristol Stool Form Scale (Lewis, 1997) | Filled out by parent (40 min) | C | Assess bowel movement and stool patterns | GI |
| 3-day diet diary | CADDRE-derived | Filled out by parent (20 min) | C | Assess diet patterns during stool diary period | GI |
| Biologic specimens | |||||
| Buccal cells (cheek swab) | Kit mailed to family (15 min) | C, M, F | For analysis of genetic biomarkers | G | |
| Blood | Clinic (15 min) | C, M, F | For analysis of genetic and non-genetic biomarkers | H,I,G,E | |
| Hair | Clinic (1 min) | C | For analysis of environmental exposures | E | |
| Guthrie card bloodspots | Clinic (4 min) | C | For analysis of genetic and non-genetic biomarkers | H,I,G,E | |
| Other data | |||||
| Paternal occupational history form | CADDRE-derived | Self-administered (5 min) | F | Paternal occupational history during index pregnancy | E |
| Multidimensional | |||||
| Birth certificate | Data linkage | C | S | ||
| Caregiver interview | CADDRE-derived | Telephone (60 min) | M | Biologic mother as informant: biologic mother’s full reproductive and pregnancy history and diagnosed developmental outcomes in all children; medical, therapeutic, obstetric and lifestyle characteristics of pregnancy (considered 3 months before conception through breastfeeding) with index child (including infertility treatments of either biological parent); maternal occupational history during index pregnancy | B,GI,H,I,O,E, S |
| Biologic mother or other primary caregiver as informant: index child’s postnatal developmental and medical history; parent/caregiver demographics; | |||||
a
C = Child M = Mother F = Father
b
B = Behavioral Phenotype; D = Dysmorphology; GI = Gastrointestinal disorders; H = Hormonal; I = Infection and immune function; O = Obstetric; G = Genetic; E = Environmental; S = Sociodemographic
c
Preconception records consist of specialists for infertility, immune, and psychiatric conditions in 3 years before conception; Pediatric records consist of pediatrician and specialists records in 3 years after birth (pediatric genetics clinic records consist of all evaluations prior to the date of the Study to Explore Early Development physical examination)