Clinical trial NCT02717390: Bright by Three (BB3) Effectiveness Study
Official title: Bright by Three (BB3) Effectiveness Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Developmental Delay
Keywords: Reading
Early Childhood development
Talking
Playing
Praising
Safety
Injury prevention
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Bright by 3
name: Children's Hospital Colorado
name: Daniels Fund
name: Piton Foundation
name: Gantz Family Foundation
First posted: 2016-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in parental behavior based on the Stim-Q
timeFrame: Child ages 1, 2, 3 and 4
measure: Change in children's language development based on the CDI
timeFrame: Child ages 1 and 2.
measure: Change in children's language development based on the E/ROWPVT-4
timeFrame: Child age 3.
Secondary outcomes:
measure: Parental attitudes, norms, self-efficacy, and intentions toward talking, reading, playing, praising (TRPP) behaviors
timeFrame: Child ages 1, 2 and 3
measure: Parental positive regard for the children measured by the Parenting Stress Index
timeFrame: Child ages 1, 2 and 3
measure: Children's socio-emotional development based on the Child Behavior Checklist
timeFrame: Child ages 2 and 3
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado AMC
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Mandy Allison, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: