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. Author manuscript; available in PMC: 2016 Nov 1.
Published in final edited form as: Contemp Clin Trials. 2015 Oct 20;45(0 0):177–183. doi: 10.1016/j.cct.2015.10.006

Table 2.

Summary of study measures and timeline in the FADS trial

Variable Type Measure Timeline1
Intervention Study Arms

  • CSM referral letter alone

  • CSM referral letter + DIG

  • Reduced CSM referral letter alone

  • Reduced CSM referral letter + DIG

  • Modified Standard letter

 At randomization
Primary Outcome Dental exams

  • Child’s receipt of dental care

 Beginning and end of school year
Secondary Outcomes (Mediators) IPQ-RD

  • Caregiver illness perception


Caregiver Questionnaire

  • Behavioral intention

 Baseline, Two-week, and Exit
Moderators Caregiver Questionnaire

  • Caregiver literacy

  • Caregiver self-efficacy 2

  • Caregiver dental fear

  • Caregiver perceived stress

  • Subjective norm 2

  • Dental insurance status


Site (urban/rural)		 Baseline
Confounders Child’s age, race, dental visit Caregiver socio-demographics (age, race, SES, education, marital status) Baseline
1

Baseline: prior to screening dental exam; At randomization: after baseline dental screening exam; Two-weeks: Two weeks after randomization; Exit: two weeks before end of school year dental exam

2

Caregiver self-efficacy and subjective norms will also be considered as potential mediators in the additional mediational analyses, and will be measured at the Exit in addition to Baseline.