Bright by Three (BB3) Effectiveness Study

University of Colorado Denver (CU Denver)

Status: Terminated

Conditions: Developmental Delay

Treatments: Behavioral: Texts for Child Safety (TCS); Behavioral: Bright By Three (BB3)

Study type: Interventional

Funder types: Other

Identifiers

NCT02717390

15-2164

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 12 to 15 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Bright By Three (BB3) Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Bright By Three (BB3)

Texts for Child Safety (TCS) Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Texts for Child Safety (TCS)