Developmental DelayNCT02717390
Bright by Three (BB3) Effectiveness Study
A study testing Bright By Three (BB3) and Texts for Child Safety (TCS) in people with Developmental Delay, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Delay
- What is being tested?
- Bright By Three (BB3) and Texts for Child Safety (TCS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Developmental Delay
- Being tested
- Bright By Three (BB3), Texts for Child Safety (TCS)
- Keywords
- Reading, Early Childhood development, Talking, Playing, Praising, Safety, Injury prevention
- Medical subject headings
- Learning Disabilities, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright By Three (BB3)Behavioural
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.
Texts for Child Safety (TCS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Bright By Three (BB3) Intervention | Experimental | 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 Receives: Behavioral: Bright By Three (BB3) |
| Texts for Child Safety (TCS) Intervention | Active comparator | 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. Receives: Behavioral: Texts for Child Safety (TCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Child age 3.
Secondary outcomes (3)
Parental attitudes, norms, self-efficacy, and intentions toward talking, reading, playing, praising (TRPP) behaviors
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.
Measured: Child ages 1, 2 and 3
Parental positive regard for the children measured by the Parenting Stress Index
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
Measured: Child ages 1, 2 and 3
Children's socio-emotional development based on the Child Behavior Checklist
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
Measured: Child ages 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study start1 Aug 2017
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Why it stopped: Lack of funding to recruit target sample size
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental DelayStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Bright by 3, Children's Hospital Colorado, Daniels Fund, Piton Foundation, Gantz Family Foundation
- Responsible party
- Sponsor
- Investigators
- Mandy Allison, MD, MSPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717390
- Sponsor's protocol ID
- 15-2164
- Status last verified
- Nov 2020
- First submitted
- 15 Mar 2016
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36760785
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright by Three (BB3) Effectiveness Study
- ClinicalTrials.gov ID
- NCT02717390
- Acronym / sponsor ID
- 15-2164
- Conditions
- Developmental Delay
- Keywords
- Reading, Early Childhood development, Talking, Playing, Praising, Safety, Injury prevention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding to recruit target sample size
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Bright by 3, Children's Hospital Colorado, Daniels Fund, Piton Foundation, Gantz Family Foundation
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright By Three (BB3) Intervention | Experimental | 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 |
| Texts for Child Safety (TCS) Intervention | Active comparator | 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. |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Bright By Three (BB3) Intervention |
| 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. | Behavioural | Texts for Child Safety (TCS) Intervention |
Primary outcome
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
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.
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.
3 secondary outcomes
Parental attitudes, norms, self-efficacy, and intentions toward talking, reading, playing, praising (TRPP) behaviors
Time frame: Child ages 1, 2 and 3
Parental positive regard for the children measured by the Parenting Stress Index
Time frame: Child ages 1, 2 and 3
Children's socio-emotional development based on the Child Behavior Checklist
Time frame: Child ages 2 and 3
Results and safety
The study was stopped early (reason given: Lack of funding to recruit target sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 36760785Cunningham 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mandy Allison, MD, MSPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright By Three (BB3) and Texts for Child Safety (TCS) in people with Developmental Delay, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding to recruit target sample size). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parental behavior based on the Stim-Q (time frame: Child ages 1, 2, 3 and 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.