Bright by Three (BB3) Effectiveness Study
Stopped early · Not applicable
Conditions studied: Developmental Delay
In brief
The Investigators propose to conduct a pragmatic randomized controlled trial of 350 one to four year old children and their caregivers to study the effectiveness of 1) the Bright By Three (BB3) intervention for promoting children's language and socio-emotional development and 2) a modified version of the Safe 'N Sound (SNS) intervention for reducing safety hazards and injuries. The SNS intervention will serve as a control for the BB3 group and vice versa so that all study participants will receive a clinically meaningful intervention. In collaboration with primary care clinics that serve low-income and minority children, the Investigators will recruit and randomize 350 twelve to fifteen month olds and their parents/caregivers to one of the two intervention arms and deliver the interventions over a 2 year period.
Key facts
- Study ID
- NCT02717390
- Run by
- University of Colorado, Denver
- People needed
- 100
- Starts
- 2017-08-01
- Expected to finish
- 2019-03-30
- Last updated by the study team
- 2020-11-04
Who can join
Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Low-income (based on insurance status of child being Medicaid or CHIP),
- Lower educational level (less than college level education) parents of 12 to 15 month old children from the Rocky Mountain Youth Clinic and the Child Health Clinic who speak either English or Spanish or both and their 12-15 month old toddlers.
You may not qualify if…
- Parents with children born prior to 36 weeks gestation (premature infants)
- Children with chronic conditions known to affect neuro-development, such as trisomy 21, or
- Children who have a positive screen on the Children with Special Health Care Needs screener 57
- Parents who have already participated in the BB3 program
- Parents without access to a smart phone
- Parents who cannot read or converse in either English or Spanish
Where it is running
- University of Colorado AMC — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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