Bright by Three (BB3) Effectiveness Study

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.

Study Overview

• Status: Terminated
• Conditions: Developmental Delay
• Intervention / Treatment: Behavioral: Bright By Three (BB3); Behavioral: Texts for Child Safety (TCS)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado AMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bright By Three (BB3) Intervention; 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: 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.
Active Comparator: Texts for Child Safety (TCS) Intervention; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in parental behavior based on the Stim-Q	The Stim-Q assessment tool is a reliable and valid of the cognitive stimulation provided in the home for children between 5 months and 6 years old. It can be completed by a parent in English or Spanish in about 20 minutes and has been used in several studies of interventions to support early childhood development	Child ages 1, 2, 3 and 4
Change in children's language development based on the CDI	The MacArthur-Bates Communicative Development Inventories (CDI)-Words and Gestures, Words and Sentences, and CDI-III forms are norm- referenced measures of children's language development that can be completed by a parent in English or Spanish in about 20 minutes for children 8 through 37 months of age.	Child ages 1 and 2.
Change in children's language development based on the E/ROWPVT-4	The Receptive and Expressive One- Word Picture Vocabulary Tests (E/ROWPVT-4) are norm-referenced assessments used to assess receptive and expressive vocabulary skills in children ages 2 years and older who speak English or Spanish. These tests can be administered in-person by a trained research assistant and each take about 20 minutes to complete. Both the CDI and the E/ROWPVT have been used in studies of interventions for language development.	Child age 3.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental attitudes, norms, self-efficacy, and intentions toward talking, reading, playing, praising (TRPP) behaviors	Measured by a survey similar to the one used in the pilot study - Survey developed by the study team based on the Theories of Planned Behavior and Social Cognitive Theory using measures on attitudes, norms, self-efficacy and intentions validated from other research as a template.	Child ages 1, 2 and 3
Parental positive regard for the children measured by the Parenting Stress Index	The Parenting Stress Index has been validated with diverse populations to identify dysfunctional parent-child systems in families with infants to 10 year old children, can be completed by a parent in English or Spanish in about 20 minutes, and has been used in hundreds of studies related to early childhood development	Child ages 1, 2 and 3
Children's socio-emotional development based on the Child Behavior Checklist	The Child Behavior Checklist, Preschool is a validated, commonly used, parent completed tool to identify children ages 1.5 to 5 with emotional and behavioral problems	Child ages 2 and 3

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Children's Hospital Colorado; Bright by 3; Daniels Fund; Piton Foundation; Gantz Family Foundation
• Investigators: Principal Investigator: Mandy Allison, MD, MSPH, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Safety; Reading; Injury prevention; Early Childhood development; Talking; Playing; Praising
• Other Study ID Numbers: 15-2164

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No