5. Participant Selection

Participants were recruited with the assistance of the clinical trials office at CCHMC. Because of the necessary sample size of 150 participants, we plan to have successful completions of our scan protocol in each of the following 5 age ranges: 0-3 years, 4-6 years, 7-9 years, 10-14 years, and 15-18 years.  We plan to have 20 0 - 3 year olds, 20 4 - 6 year olds, 30 7 - 9 year olds, 25 10 - 14 year olds, and 25 15 - 18 year olds.  Due to the relative difficulty of completing non-sedated MRI scan in infants and young children, we plan to recruit 60 participants in the 0-3 years age group and 40 participants in the 4-6 years age group.

Success Flow Chart

 

5.1 Initial participant screening

Inclusion Criteria

  • Children between the ages of 0 and 18 years
  • Body Mass Index within the 5th to the 95th percentile for age and gender
  • Negative history for neurologic or psychiatric disease in the infant or pre-schooler
  • Maintenance of at least a C- average in school (ages 6 and up)
  • Negative family history for neurologic or psychiatric disease (in first degree relatives only) to include genetic disorders
  • Assent of children between 5 and 17 and informed consent of 18-year-olds
  • Informed consent of parent or guardian of children between 0 and 17 years of age
  • Conforms to expected population distribution based on gender, race, and SES.

Exclusion Criteria

  • Standard MRI exclusion criteria
  • Orthodontic braces or other metallic implants which obscure or interfere with the MRI
  • Special education placement of the child based on ability or behavior
  • Previous history of head trauma that is not included in the medical record
  • Gestational age less than 37 weeks or greater than 42 weeks.
  • A birth weight less than the 10th percentile, which corresponds to approximately 6.25lbs for boys and 6.0lbs for girls.
  • Any chronic illness

Exit Criteria

  • Gross neurological examination abnormal
  • Head circumference less than the 5th or greater than the 95th percentile
  • Abnormal MRI findings
  • Full Scale IQ of less than 75
     

5.2 Screening of subjects

All participants/families who express interest will be contacted initially by phone, and at the time of the initial phone call, the inclusion and exclusion criteria will be reviewed with the parents (or the participant him/herself for 18-year-olds). The standard MRI screening checklist and the neurological screening checklist will also be reviewed. Any potential participants who do not meet the inclusion/exclusion criteria will not be included in the study.

After enrollment in the study and consent of the participant, a participant may meet certain exit criteria.  These are not considered to be inclusion / exclusion criteria sine study staff will have no knowledge of items until the partcipant has been enrolled and consented to the study.

Upon one of their study visits, participants will be administered a gross neurological examination by a study neurologist, and any abnormalities on this exam will cause the participant to be exited from the study. Neuropsychological testing will also be conducted at the second or third study visit. Participants whose IQ scores are lower than 85 or who show other evidence of neurological disorder will also be excluded from data analysis.  The MRI anatomical images will be reviewed by a study neuroradiologist, and any abnormalities in these images will cause the participant to be exited from the study.

 

5.3 MRI safety screening

Potential participants will be screened with the following chart to determine their inclusion in the study based on standard MRI contraindications.  Should a participant have any of these contraindications, s/he will be excluded from any further study participation.

In conjunction with the above poster, the following questionnaire will be administered during screening: MRI Screening Form

 

5.4 IRB protocol and consent form templates

The original IRB protocols and consent/assent forms for each segment of the C-MIND recruitment are available for download here.

Protocol
Consent
Assent

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