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Lack of funding to recruit target sample size
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| Name | Class |
|---|---|
| Bright by 3 | UNKNOWN |
| Children's Hospital Colorado | OTHER |
| Daniels Fund | UNKNOWN |
| Piton Foundation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright By Three (BB3) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Child ages 1, 2 and 3 |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mandy Allison, MD, MSPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado AMC | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36760785 | Derived | 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. |
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| ID | Term |
|---|---|
| D007859 | Learning Disabilities |
| D013060 | Speech |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C107120 | bombesin receptor subtype 3 |
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| UNKNOWN |
| Gantz Family Foundation | OTHER |
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| Texts for Child Safety (TCS) | Behavioral | 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. |
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| 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 | 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 | Child ages 2 and 3 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |