Promoting Optimal Parenting (Bright Start)

Not Applicable

• Conditions: Cognitive Development; Emotional Development
• Interventions: Behavioral: Parenting Education; Behavioral: Control Group - Safety Materials

• Registration Number: NCT01573793
• Lead Sponsor: Seattle Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-30
• Study Start: 2012-04
• Study First Submitted QC: 2012-04-05
• Study First Posted: 2012-04-10
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-24
• Last Update Posted: 2014-03-26
• Primary Completion: 2016-05
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• English-speaking
• 18-23 year-old first-time mother of a healthy newborn

Exclusion Criteria

• Anything other than above

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Parenting Education	Will receive parenting educational materials hypothesized to enhance emotional and cognitive development
Control	Control Group - Safety Materials	Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development

Primary Outcome Measures

Name	Time	Method
Brief Infant Sleep Questionnaire(BISQ)	Month 12/24 - tracking changes throughout study
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
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

Trial Locations

Locations (1)

Seattle Children's Research Institute; 🇺🇸 Seattle, Washington, United States