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Sampling, recruitment, and administration guidelines

LEVANTE is designed to enable coordinated data collection around measuring children’s variability within and across individuals, groups, and cultures. Data collection will be distributed across groups and populations via a call for proposals, resulting in an interrelated set of accelerated, longitudinal studies that use the same sampling plan and core measure set to explore developmental variability across diverse populations. Sites applying for funding to use the LEVANTE framework are required to follow a set of broad guidelines around sampling, recruitment, and administration. 

Sampling planning

• LEVANTE projects should follow an accelerated longitudinal design. 
• Target age range is 2:0 – 12:0 years (ages 2:0-10:0 years at time of enrollment). Proposals may target specific ages or recruit more broadly.
• Participants should be re-evaluated annually for a minimum of 2 follow-up evaluations per child (3 total time points) and up to 12:0 years of age. 
• Sites with feasible proposals for denser measurement (e.g. every 6 months for children ages 2-6) may apply for additional funding. 
• Sample size justification
  • Anticipated number of participants per one-year age group at study entry.
  • Anticipated number of follow-up visits per participant.
  • Power calculation or other sample size justification for any planned inferential hypothesis test (e.g., in proposals with random assignment). 
  • Description of how sampling and recruitment strategy relates to a broader population of interest.

Recruitment

The recruitment strategy may follow one of two primary paths or a combination of the two with a justification of feasibility: school-based – where families in the same school are recruited – and family-based – where families are recruited individually (e.g., via online advertising, a clinic, or other recruitment method). 

For school-based recruitment, provide justification and/or documentation for the following considerations:

• Intended inclusion and exclusion criteria for the target sample.
• Strategy for inviting schools to participate and/or known commitments from schools for participation in the project.
• Site by site requirements for permission from schools for on-site assessment administration and records obtainment.
• Site by site strategy for obtaining caregiver consent and questionnaire completion.  
• Retention strategy for follow-up visits and corresponding plan for documenting participant attrition throughout study duration.

For family-based recruitment, provide justification and/or documentation for the following considerations: 

• Intended inclusion and exclusion criteria for the target sample.
• Strategy for inviting individual families to participate in the study.
• Retention strategy for follow-up visits and corresponding plan for documenting participant attrition throughout study duration.
• Indication as to whether school records and/or teacher responses will be obtained.

Administration

Sites have substantial flexibility around administration, but should follow these guidelines: 

• Consistent administration across children so as to avoid confounding of contextual factors and administration details; when this is not possible, explicit justification should be given. 
• For ages 2:0 – 4:11, participants should have an appropriate adult overseeing individual administration (e.g. teacher, research assistant, caregiver). Adults should receive a briefing on helping the child to access the platform, stay on task, and move through the assessment queue while refraining from assisting the child with the tasks.
• For ages 5:0 – 11:11, individual administration as described above OR group based administration can be employed. Group-based administration is discouraged for the youngest children in this age band (5:0 – 6:11) without a strong justification. For group administration (e.g. in a classroom setting), participants should receive an introductory description of the process, information on how to ask for help, and an emphasis on the importance of staying on task. 
• School-based administration
  • Must have access to primary caregivers for questionnaire completion, a plan for questionnaire administration, and follow-up for missing forms.
  • Preference for the inclusion of administrative records per student and teacher survey regarding classroom setting (to be applied to all participants from a particular classroom and/or school as appropriate).
• Family-based administration (in-person)
  • Must have access to primary caregivers for questionnaire completion, a plan for caregiver form completion, and follow-up for missing forms.
  • School administration records and/or teacher survey desired but not required.
  • Location could include participants’ homes, a clinic setting, library, or other appropriate location convenient to participants (include plan for ensuring families have access to a device and internet connection). 
  • Plan for who will monitor participants during individual assessment (e.g. caregiver, research assistant, etc).
• Family-based administration (remote)
  • Must have access to primary caregivers for questionnaire completion, a plan for caregiver form completion, and follow-up for missing forms.
  • School administration records and/or teacher form desired but not required.
  • Plan for infrastructure around remote data collection (e.g. internet access, devices, monitoring, etc.)

Timing for administration of core measures is as follows:

• Child assessment: 60 minutes (can be broken into 2-3 sessions)
• Caregiver survey: 30-45 minutes
• Teacher survey (if school-based): 15 minutes