Promoting Optimal Parenting (Bright Start)

Study Overview
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Brief Summary
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The purpose of this study is to determine if providing parenting education materials delivered in different ways during the first 30 months of a child's life will increase child-parent attachment and promote mother-child interaction, if certain types of strategies improve cognitive, language, and emotional development in infants and toddlers, and if our way of delivering these materials is cost-effective.

Official Title
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Promoting Optimal Parenting

Conditions
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Cognitive Development, Emotional Development

Intervention / Treatment
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* Behavioral: Parenting Education
* Behavioral: Control Group - Safety Materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking 18-23 year-old first-time mother of a healthy newborn Exclusion Criteria: Anything other than above

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 23 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Will receive parenting educational materials hypothesized to enhance emotional and cognitive development | Behavioral: Parenting Education<br>* Will receive parenting educational materials hypothesized to enhance emotional and cognitive development<br>|
| Sham Comparator: Control<br>Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development | Behavioral: Control Group - Safety Materials<br>* Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Language ENvironment Analysis System (LENA) |  | 6/18/30 months - tracking changes throughout study | 
| Adaptive Behavior Assessment System, Second Edition (ABAS-II) |  | Month 12/24/36/42 - tracking changes throughout study | 
| Brief Infant Sleep Questionnaire(BISQ) |  | Month 12/24 - tracking changes throughout study | 
| Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) |  | Month 24/42 - tracking changes throughout study | 
| MacArthur Communicative Development Inventory- Short Form (CDI) |  | Month 24/42 - tracking changes throughout study | 
| Children's Sleep Habits Questionnaire (CSHQ) |  | Month 36/42 - tracking changes throughout study | 
| Devereux Early Childhood Assessment-Clinical Form (DECA-C) |  | Month 24/36/42 - tracking changes throughout study | 
| Devereux Early Childhood Assessment- Infant/Toddler (DECA-I/T) |  | Month 12 | 
| Family Resource Scale (FRS) |  | Baseline | 
| MARLOWE-CROWNE |  | Baseline | 
| Maternal Emotional Styles Questionnaire (MESQ) |  | Month 36 | 
| Patient Health Questionnaire 2 (PHQ-2) |  | Baseline and Month 12/24/36/42 - tracking changes throughout study | 
| Preschool Language Scale-5 (PLS-5) |  | Month 36 | 
| Parenting Sense of Competence-Efficacy(PSOC) |  | Baseline and Months 12/24/36/42 - tracking changes throughout study | 
| Social competence subscale of the Social Competence and Behavior Evaluation(SCBE) |  | Months 36/42 - tracking changes throughout study | 
| (Strange Situation Procedure) SSP |  | Month 15 | 
| Nursing Child Assessment Teaching Scale (NCATS) |  | Months 15/36 - tracking changes throughout study |