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NCT02717390

Bright by Three (BB3) Effectiveness Study

Terminated NA Last updated 4 November 2020
What this trial tests

NA trial testing Bright By Three (BB3) in Developmental Delay in 100 participants. Terminated before completion.

Timeline
1 August 2017
Primary endpoint
30 March 2019
30 March 2019

Quick facts

Lead sponsorUniversity of Colorado, Denver
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment100
Start date1 August 2017
Primary completion30 March 2019
Estimated completion30 March 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Colorado, Denver

Who can join

Adults 12 Months to 15 Months, any sex, with Developmental Delay. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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.
    Cunningham MA, Gorman C, McNulty MC, Chavez C, et al · · 2023 · cited 3× · PMID 36760785 · DOI 10.21037/mhealth-22-13

Verify or expand the search:

Other recruiting trials for Developmental Delay

Currently open trials in the same condition.

Other University of Colorado, Denver trials

Trials by the same sponsor.

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Data sources for this page

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