Study Stopped
Lack of funding to recruit target sample size
Bright by Three (BB3) Effectiveness Study
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2016
CompletedFirst Posted
Study publicly available on registry
March 23, 2016
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedNovember 4, 2020
November 1, 2020
1.7 years
March 15, 2016
November 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Parental attitudes, norms, self-efficacy, and intentions toward talking, reading, playing, praising (TRPP) behaviors
Child ages 1, 2 and 3
Parental positive regard for the children measured by the Parenting Stress Index
Child ages 1, 2 and 3
Children's socio-emotional development based on the Child Behavior Checklist
Child ages 2 and 3
Study Arms (2)
Bright By Three (BB3) Intervention
EXPERIMENTALThe 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
Texts for Child Safety (TCS) Intervention
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Bright by 3collaborator
- Children's Hospital Coloradocollaborator
- Daniels Fundcollaborator
- Piton Foundationcollaborator
- Gantz Family Foundationcollaborator
Study Sites (1)
University of Colorado AMC
Aurora, Colorado, 80045, United States
Related Publications (1)
Cunningham MA, Gorman C, McNulty MC, Chavez C, Luna-Asturias C, Dixon CA, Bull S, Berman S, Allison MA. Engage, Develop, Learn: a pilot randomized clinical trial to test if a mobile application can enhance home support for early cognitive development among children living in poverty. Mhealth. 2023 Jan 28;9:4. doi: 10.21037/mhealth-22-13. eCollection 2023.
PMID: 36760785DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mandy Allison, MD, MSPH
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2016
First Posted
March 23, 2016
Study Start
August 1, 2017
Primary Completion
March 30, 2019
Study Completion
March 30, 2019
Last Updated
November 4, 2020
Record last verified: 2020-11