119 Short-term outcomes and six-month follow-up of BEAR 6 Screened infants and toddlers* (n= 57) *by our knowledge Excluded (n= 8) - Decided not to participate (n= 6) - No contact (n=2) Participant allocation to BEAR (n= 40) Participant allocation to CAU (n= 15) Intervention phase (8 weeks) Discontinued study (n=1) Intervention phase (8 weeks) Participating well-baby clinics 19 WBC total Cluster randomization 10 WBC allocated to BEAR 9 WBC allocated to CAU Individual enrollments (n=11 ) Endpoint assessment (T2) Discontinued study (n=2 ) Endpoint assessment (T2) Discontinued study (n= 2) Follow-up assessment (T3) Discontinued study (n= 8) Follow-up assessment (T3) Discontinued study (n=2) Analyzed under intention-to-treat (n= 26) Analyzed under intention-to-treat (n= 10) Baseline assesment (T1) Discontinued study before baseline measures were completed (n= 1) Baseline assesment (T1) Discontinued study before baseline measures were completed (n=0) Randomization Excluded (n= 5) - Decided not to participate (n=2 ) - No contact (n=3) Total n=55 Figure 1. Consort Participant Flow Diagram Figure 1. Consort Participant Flow Diagram
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