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Bright by Three (BB3) Effectiveness Study

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ClinicalTrials.gov Identifier: NCT02717390
Recruitment Status : Terminated (Lack of funding to recruit target sample size)
First Posted : March 23, 2016
Last Update Posted : November 4, 2020
Sponsor:
Collaborators:
Bright by 3
Children's Hospital Colorado
Daniels Fund
Piton Foundation
Gantz Family Foundation
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Developmental Delay Behavioral: Bright By Three (BB3) Behavioral: Texts for Child Safety (TCS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Bright by Three (BB3) Effectiveness Study
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : March 30, 2019

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.




Primary Outcome Measures :
  1. Change in parental behavior based on the Stim-Q [ Time Frame: Child ages 1, 2, 3 and 4 ]
    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

  2. Change in children's language development based on the CDI [ Time Frame: Child ages 1 and 2. ]
    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.

  3. Change in children's language development based on the E/ROWPVT-4 [ Time Frame: Child age 3. ]
    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.


Secondary Outcome Measures :
  1. Parental attitudes, norms, self-efficacy, and intentions toward talking, reading, playing, praising (TRPP) behaviors [ Time Frame: Child ages 1, 2 and 3 ]
    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.

  2. Parental positive regard for the children measured by the Parenting Stress Index [ Time Frame: Child ages 1, 2 and 3 ]
    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

  3. Children's socio-emotional development based on the Child Behavior Checklist [ Time Frame: Child ages 2 and 3 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717390


Locations
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United States, Colorado
University of Colorado AMC
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Bright by 3
Children's Hospital Colorado
Daniels Fund
Piton Foundation
Gantz Family Foundation
Investigators
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Principal Investigator: Mandy Allison, MD, MSPH University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02717390    
Other Study ID Numbers: 15-2164
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Reading
Early Childhood development
Talking
Playing
Praising
Safety
Injury prevention