Promoting Optimal Parenting
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Seattle Children's Hospital
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Language ENvironment Analysis System (LENA)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 23 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •English-speaking
- •18-23 year-old first-time mother of a healthy newborn
Exclusion Criteria
- •Anything other than above
Arms & Interventions
Intervention
Will receive parenting educational materials hypothesized to enhance emotional and cognitive development
Intervention: Parenting Education (Behavioral)
Control
Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development
Intervention: Control Group - Safety Materials (Behavioral)
Outcomes
Primary Outcomes
Language ENvironment Analysis System (LENA)
Time Frame: 6/18/30 months - tracking changes throughout study
Adaptive Behavior Assessment System, Second Edition (ABAS-II)
Time Frame: Month 12/24/36/42 - tracking changes throughout study
Brief Infant Sleep Questionnaire(BISQ)
Time Frame: Month 12/24 - tracking changes throughout study
Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
Time Frame: Month 24/42 - tracking changes throughout study
MacArthur Communicative Development Inventory- Short Form (CDI)
Time Frame: Month 24/42 - tracking changes throughout study
Children's Sleep Habits Questionnaire (CSHQ)
Time Frame: Month 36/42 - tracking changes throughout study
Devereux Early Childhood Assessment-Clinical Form (DECA-C)
Time Frame: Month 24/36/42 - tracking changes throughout study
Devereux Early Childhood Assessment- Infant/Toddler (DECA-I/T)
Time Frame: Month 12
Family Resource Scale (FRS)
Time Frame: Baseline
MARLOWE-CROWNE
Time Frame: Baseline
Maternal Emotional Styles Questionnaire (MESQ)
Time Frame: Month 36
Patient Health Questionnaire 2 (PHQ-2)
Time Frame: Baseline and Month 12/24/36/42 - tracking changes throughout study
Preschool Language Scale-5 (PLS-5)
Time Frame: Month 36
Parenting Sense of Competence-Efficacy(PSOC)
Time Frame: Baseline and Months 12/24/36/42 - tracking changes throughout study
Social competence subscale of the Social Competence and Behavior Evaluation(SCBE)
Time Frame: Months 36/42 - tracking changes throughout study
(Strange Situation Procedure) SSP
Time Frame: Month 15
Nursing Child Assessment Teaching Scale (NCATS)
Time Frame: Months 15/36 - tracking changes throughout study
Secondary Outcomes
No secondary outcomes reported
Investigators
Dimitri Christakis
Investigator
Seattle Children's Hospital