DATA SHARING

Accessing CIFASD Research Data

The CIFASD encourages investigators who are not part of CIFASD to use CIFASD data in an effort to pursue a cross-cultural assessment of fetal alcohol spectrum disorders (FASD), with the ultimate goal of improving diagnoses and treatment of FASD.

CIFASD was established in September 2003, as a multisite, multidisciplinary consortium to improve the identification of individuals affected by prenatal alcohol exposure or Fetal Alcohol Spectrum Disorders (FASD) and to inform and develop effective interventions and treatment approaches for this population. Thus far, the consortium has collected data in three phases; each phase is described below. We are currently accepting data sharing access requests for available data from Phase I.

Investigators who are interested in using CIFASD data must adhere to the CIFASD Data Sharing Policy and complete the online CIFASD Data Access Request Form. Additionally, the CIFASD Data Use Agreement must be signed by the investigator responsible for the research and data management.

The Informatics Core presentation on how to access CIFASD data. | The Informatics Core Visualization of CIFASD Clinical Data.

CIFASD Phases, Data Descriptions, Dictionaries and Definitions:

Phase I

Phase II

Phase III

Dysmorphology

Neurobehavioral Assessment

Alcohol Exposure

For a description of current and past CIFASD projects, please see Research Projects. Data dictionary files and data tools are maintained by the Informatics Core of CIFASD; if you have any questions or would like more information, please contact them at cifasdic@iu.edu.

 


 

Phase I

Phase I took place between 2003 and 2007 and included seven sites: (1) Center for Behavioral Teratology, San Diego State University, San Diego, CA; (2) Seven Northern Plains communities, including six Indian reservations; (3) University of Cape Town, South Africa, and a town in the Western Cape Province; (4) Institute of Psychiatry, Moscow, Russia; (5) Folkhälsan Research Center, Helsinki, Finland, (6) Moscow Region Institute of Obstetrics and Gynecology, Moscow, Russia, and 7) Omni-Net sites at the Rivne Diagnostic Center, and the Kherson Children’s Hospital, Rivne and Kherson, Ukraine. Subject recruitment varied between the sites. For more details and a description of the sample, please see Mattson et al. 2010 (CIFASD: Methodology of Clinical Projects).

The subject population in Phase I is racially and ethnically diverse. All subjects in sites 1-5 were children between the ages of 5 and 18, although the majority were ages 7-18 years. Data were collected across multiple domains including: dysmorphology, neurobehavior, and facial imaging. A total of 1206 subjects were assessed, although all subjects do not have complete data in all domains. A standard dysmorphology assessment was performed and the variables collected are provided in the Dysmorphology data dictionary. Neurobehavior assessed the following domains: general intelligence (Leiter International Performance Scale-Revised), executive function (Delis-Kaplan Executive Function System, CANTAB), attention (NES-3), spatial learning/memory (CANTAB, Virtual Water Maze), and parent ratings of behavior and psychopathology (e.g., CBCL). A complete list of all tests and variables collected are listed in the Neurobehavior I data dictionary. Facial imaging was performed using the Minolta Vivid 910fw camera in a subset of the Phase I subjects. A summary of the measurements obtained from these images are provided in the 3D Facial Imaging data dictionary. A limited number of subjects with learning disabilities but not prenatal alcohol exposure were included as a comparison group.

The subject population in Phase I for sites 6 and 7 included pregnant women. At sites 6 & 7 in the Moscow Region and in Ukraine, pregnant women were the subjects enrolled and data was collected on current and recent alcohol consumption, demographics and pregnancy history. Variables are provided in the Screener data dictionary. In addition, in the Ukraine site, prenatal ultrasound measures were collected for a subset of those screened, maternal interview data, and infant dysmorphology outcomes were also collected. The variables collected are provided in the Ultrasound data dictionary, the EEAC data dictionary and the Dysmorphology data dictionary.

 


 

Phase II

Phase II began in 2007 and continued through 2012. The subject population in Phase II is racially and ethnically diverse and were recruited at seven sites: (1) Center for Behavioral Teratology, San Diego State University, San Diego, CA; (2) Emory University, Atlanta, GA; (3) University of New Mexico, Albuquerque, NM; (4) Seven Northern Plains communities, including six Indian reservations; (5) University of Cape Town, South Africa, and a town in the Western Cape Province; (6) the University of California, Los Angeles, Los Angeles, CA; and (7) Omni-Net locations in Ukraine: the Rivne Diagnostic Center and the Khmelnytsky Perinatal Center in Rivne and Khmelnytsky, Ukraine. For more details see Mattson et al. 2010 CIFASD: Methodology of Clinical Projects) and Mattson et al. 2013 (Further Development of a Neurobehavioral Profile of FASD, which includes a description of the sample).

Two primary cohorts were recruited and evaluated. Subjects recruited at sites 1-6 listed above, who were between the ages of 8 and 16 years, completed a protocol that obtained data across multiple domains including: dysmorphology, neurobehavior, brain and facial imaging. A total of 1624 subjects were assessed, although all subjects do not have complete data in all domains. A standard dysmorphology assessment was performed and was identical to that used in Phase I. The variables are provided in the Dysmorphology data dictionary. Neurobehavior assessed the following domains: general intelligence (WISC-IV), executive function (Delis-Kaplan Executive Function System, CANTAB), and parent ratings of behavior and psychopathology (e.g., CBCL). A complete list of all tests and variables collected are listed in the Neurobehavior II data dictionary. Facial imaging was performed using the 3dMD system and a summary of the measurements obtained from these images are provided in the 3D Facial Imaging data dictionary. Brain imaging (MRI) was added in Phase II and the variables are provided in the Brain Imaging data dictionary. For the Neurobehavior and Facial Imaging projects, subjects without prenatal alcohol exposure but with attention-deficit/hyperactivity or low IQ scores were included as a comparison group.

At the site 7 in Ukraine, 11,909 pregnant women were screened for alcohol use. Variables are provided in the Screener data dictionary. From those women approximately 350 moderately to heavily alcohol-exposed pregnant women and approximately 350 low or unexposed women were enrolled in a longitudinal study. Pregnancies were followed with serial ultrasounds. Variables are provided in the Ultrasound data dictionary and are identical to those in Phase I. Maternal interviews were conducted at enrollment and in the last trimester. Variables are provided in the EEAC data dictionary and Follow-up Interview data dictionary. Maternal blood samples were collected at enrollment and in the third trimester and analyzed for various nutrients and markers of oxidative stress and inflammation. Live born infants received at least one dysmorphological examination. Variables were identical to those in Phase I and are provided in the Dysmorphology data dictionary. Children were evaluated with the Bayley Scales of Infant Development (version II) at 6 months and 12 months of age. Variables for the Bayley neurobehavioral assessment are provided in the Infant Neurobehavioral data dictionary. At one site an experimental cardiac orienting response paradigm was also administered at 6 and 12 months of age. Variables for this evaluation are provided in the infant neurobehavioral data dictionary referenced above. Facial images were collected on a subset of infants at 6 and 12 months of age at one of the locations. Measurements obtained from these images are provided in the 3D facial imaging data dictionary.

 


 

Phase III

Phase III began in 2012 and is currently ongoing. The subject population in Phase III is racially and ethnically diverse and are being recruited at five sites: 1) San Diego State University, 2) Emory University, 3) USC-CHLA, 4) University of Minnesota; 5) Omni-Net locations in Ukraine: the Rivne Diagnostic Center and the Khmelnytsky Perinatal Center in Rivne and Khmelnytsky, Ukraine.

Two primary cohorts were recruited and evaluated. In the first cohort, subjects recruited at sites 1-4 listed above were recruited into 2 age-based protocols (ages 5-7 years and 10-16 years). All subjects are assessed with the same protocol that obtained data across multiple domains including: dysmorphology, neurobehavior, brain and facial imaging, although not all subjects participated in all domains of testing. A total of 880 subjects are planned.

A standard dysmorphology assessment was performed and was identical to that used in Phase I. The variables are provided in the Dysmorphology data dictionary. Neurobehavior assessed the following domains: general intelligence (DAS-II), broad neuropsychological function (NEPSY-II), memory (CVLT-C), and parent ratings of behavior and psychopathology (e.g., CBCL). A complete list of all tests and variables collected are listed in the Neurobehavior III data dictionary. Facial imaging was performed using the 3dMD system and a summary of the measurements obtained from these images are provided in the 3D Facial Imaging data dictionary. Brain imaging (MRI, DTI) continued in Phase III and the variables are provided in the Brain Imaging data dictionary. For the Neurobehavior and Facial Imaging projects, subjects without prenatal alcohol exposure but with other relevant developmental conditions or concerns were included as a comparison group.

At site 5 (Ukraine), an additional 200 pregnant women are planned to be enrolled and followed through delivery and their children through preschool age. All of the data collected for pregnant women and infants through 12 months of age are identical to that collected in Phase II and the associated data dictionaries apply (Screener, EEAC, Follow-up, Ultrasound, Dysmorphology, and Infant Neurobehavior). A subset of 240 children from the Phase II cohort are also planned to be followed through 5 years of age with growth measures, measures of sleep disturbances, illness, and eating behaviors collected at 2 years of age and again at 3.5-4.5 years of age. Variables are provided in the Eating Behaviors data dictionary. Cardiac orienting response data is being collected at both time points and at both locations, identical to that collected in Phase II except for the specific visual and auditory stimuli. A standard neurobehavioral testing battery (comparable to the 5-7 year old assessment at sites 1-4) at the 3.5-4.5 years of age visit is being administered. Variables are provided in the Preschool Neurobehavioral data dictionary. Collection of blood, urine, and cheek cell samples is taking place for children at one or both visits. 3D facial imaging is performed for a subset at one or more study visits. Variables are provided in the 3D Facial Imaging data dictionary.

 


 

Dysmorphology

The same dysmorphology assessment was used in all phases of CIFASD. The dysmorphology form is available for download. As a result of the exam, each child is assigned a diagnosis of FAS, not FAS or Deferred (see Table 1). The Deferred category is a temporary label to be updated with additional information at the end of the study. One of the primary goals of CIFASD is to delineate the full range of structural anomalies in children prenatally exposed to alcohol in order to determine the boundaries that encompass FASD. A further goal is to determine a profile of neurobehavioral features that are useful diagnostically and this information will be used to further clarify diagnoses of alcohol-exposed children categorized as Deferred.

 

Table 1. Diagnostic Criteria used by the CIFASD Dysmorphology Core
Criterion Definition
Growth Deficiency Weight and/or Height <10th percentile
Microcephaly Head circumference <10th percentile
Structural Abnormality1 At least two of the following KEY facial features:
Palpebral fissure length <10th percentile
Smooth Philtrum (score of 4 or 5 on Lipometer 2)
Thin Vermillion Border (score of 4 or 5 on Lipometer)
Category Required Criteria
FAS Structural Abnormality and Growth Deficiency OR
Structural Abnormality and Microcephaly OR
Structural Abnormality and Microcephaly and Growth Deficiency
Deferred At least one KEY facial feature (listed above) OR
Microcephaly and Growth Deficiency OR
Microcephaly or Growth Deficiency AND at least one of the following additional features:
Railroad track configuration ears2
Ptosis
Heart murmur
Decreased pronation/supination at elbows
Camptodactyly
Other joint contractures
Hockey stick upper palmar crease1
Not FAS Does not meet criteria for either FAS or Deferred category

1 See (Hoyme et al., 2005)
2 See (Astley, 2004)

 


 

Neurobehavioral Assessment

Although measures differed between the phases of data collection in CIFASD (see Table 2), the test battery was administered in one day by a trained examiner. Data were scored by the examiner and rechecked by a second person. When possible, testing and scoring were conducted by examiners blind to subject group membership.

Table 2. Neurobehavioral assessments used in the CIFASD projects
Functional Domain Measure Subtests Phase
General Intellectual Ability Leiter International Performance Scale-Revised (Leiter-R) Phase I
Wechsler Intelligence Scale for Children – fourth edition (WISC-IV) Integrated Phase II
Differential Ability Scales – second edition (DAS-II) Phase III
Attention & Concentration NES3 – Continuous Performance Test Animals Phase I
NEPSY-II Speeded Naming
Arrows
Phase III
Executive Function Delis-Kaplan Executive Function System Verbal Fluency, Trail Making Phase I & Phase II
Color-Word Interference, Tower, 20 Questions, Design Fluency Phase II
Progressive Planning Test Phase I
Visual Discrimination Reversal Learning Phase I
CANTAB Intra/Extradimensional Shift Phase II
CANTAB Stockings of Cambridge Phase III
NEPSY-II Word Generation
Inhibition
Phase III
BRIEF Parent version Phase II & III
BRIEF Child version Phase II
Working Memory/Memory CANTAB Spatial Working Memory Phase I & Phase II
Spatial Span, Pattern Recognition Memory, Spatial Recognition Memory Phase I
CANTAB Delayed Matching to Sample Phase II
Virtual Water Maze Phase I
California Verbal Learning Test – children’s version (CVLT-C) Phase III
NEPSY-II Memory for Names (immediate & delayed)
Memory for Designs (immediate & delayed)
Memory for Faces (immediate & delayed)
Narrative Memory
Phase III
Visual-Motor Visual-Motor Integration Test Phase I
Motor/Reaction Time CANTAB Motor Screening, Big/Little Circle, Phase I & Phase II
Simple Reaction Time, Choice Reaction Time Phase II
Grooved Pegboard Test Phase I
Interhemispheric Transfer Finger Localization Test Phase I
Psychological Symptomatology ASEBA Child Behavior Checklist, Teacher Report Form, Youth Self Report Phase I, II, III
Disruptive Behavior Rating Scale Phase I, Phase II, & Phase III
Sluggish Cognitive Tempo Scale Phase I, Phase II, & Phase III
Vineland Adaptive Behavior Scales, Second Edition Parent/Caregiver Rating Form, Teacher Rating Form Phase II & Phase III
Pictorial Depression Scale Phase I
Conners 3rd Edition Phase III
C-DISC Psychiatric Interview Demographics, GAD, MDD, ADHD, ODD, CD modules Phase II & Phase III

 


 

Alcohol Exposure

Alcohol exposure histories are obtained from maternal report and review of medical, legal, and social service records. In studies where identification is retrospective, subjects are recruited if they are reported to be heavily exposed, defined as >4 drinks/occasion at least once/week or >13 drinks/week during pregnancy. Controls are screened for prenatal alcohol exposure and excluded for evidence of greater than minimal alcohol exposure. Minimal exposure is defined <1 drink per week on average and never >2 drinks on any one occasion during pregnancy.

In studies where identification is prospective, mothers are asked about the quantity and frequency of alcohol exposure in the month around conception and in the most recent month at the Screening visit. Mothers who enroll in the longitudinal study are asked about daily amounts of alcohol, type of alcohol, quantity and frequency, period of hours over which alcohol is consumed in a typical week around conception and in the most recent two weeks. In the third trimester, mothers are asked if their alcohol consumption has changed since enrollment, and if it has, they complete another timeline follow-back questionnaire for the previous week. Additional questions are asked comprising the TWEAK, T-ACE, and CAGE, age at onset of drinking, and questions about paternal alcohol exposure.

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