Bright by Three (BB3) Effectiveness Study

Summary

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.

Conditions

• Developmental Delay

Interventions

BEHAVIORAL

Bright By Three (BB3)

The purpose of the BB3 intervention (annual home visit, written materials, and BB3 mobile application 'app') is to increase parental talking, reading, playing, and praise (TRPP) behaviors and improves children's social-emotional and language development at ages 2, 3, and 4 years.

BEHAVIORAL

Texts for Child Safety (TCS)

The purpose of the injury prevention arm is to reduce the prevalence of safety hazards in the home and car environments, decrease the number of self-reported and medically-attended injuries among children, and increase caregiver's self-reported safety behaviors and knowledge of child safety. The Investigators will compare the results of our tailored child safety intervention (Texts for Child Safety \[TCS\]) among participants in the injury prevention arm with those randomized to the BB3 arm.

Sponsors & Collaborators

• Bright by 3

  collaborator UNKNOWN

• Children's Hospital Colorado

  collaborator OTHER

• Daniels Fund

  collaborator UNKNOWN

• Piton Foundation

  collaborator UNKNOWN

• Gantz Family Foundation

  collaborator OTHER

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Mandy Allison, MD, MSPH · University of Colorado, Denver

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

15 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-01

Primary Completion

2019-03-30

Completion

2019-03-30

Countries

• United States

Study Locations