Promoting Optimal Parenting (Bright Start)

Cognitive Development Clinical Trial

Official title:

Promoting Optimal Parenting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01573793
• Other study ID #: 13852
• Secondary ID: 1R01HD068478-01A
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2012
• Last updated: March 24, 2014
• Start date: April 2012
• Est. completion date: December 2016

Study information

• Verified date: March 2014
• Source: Seattle Children's Hospital
• Contact: Heather D Violette, Ph.D.
• Phone: 206-884-8259
• Email: heather.violette[@]seattlechildrens.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 23 Years

Eligibility

Inclusion Criteria:

• English-speaking

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

Exclusion Criteria:

• Anything other than above

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Cognitive Development
• Emotional Development

Intervention

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

Locations

Country	Name	City	State
United States	Seattle Children's Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Language ENvironment Analysis System (LENA)		6/18/30 months - tracking changes throughout study	No
Primary	Adaptive Behavior Assessment System, Second Edition (ABAS-II)		Month 12/24/36/42 - tracking changes throughout study	No
Primary	Brief Infant Sleep Questionnaire(BISQ)		Month 12/24 - tracking changes throughout study	No
Primary	Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)		Month 24/42 - tracking changes throughout study	No
Primary	MacArthur Communicative Development Inventory- Short Form (CDI)		Month 24/42 - tracking changes throughout study	No
Primary	Children's Sleep Habits Questionnaire (CSHQ)		Month 36/42 - tracking changes throughout study	No
Primary	Devereux Early Childhood Assessment-Clinical Form (DECA-C)		Month 24/36/42 - tracking changes throughout study	No
Primary	Devereux Early Childhood Assessment- Infant/Toddler (DECA-I/T)		Month 12	No
Primary	Family Resource Scale (FRS)		Baseline	No
Primary	MARLOWE-CROWNE		Baseline	No
Primary	Maternal Emotional Styles Questionnaire (MESQ)		Month 36	No
Primary	Patient Health Questionnaire 2 (PHQ-2)		Baseline and Month 12/24/36/42 - tracking changes throughout study	No
Primary	Preschool Language Scale-5 (PLS-5)		Month 36	No
Primary	Parenting Sense of Competence-Efficacy(PSOC)		Baseline and Months 12/24/36/42 - tracking changes throughout study	No
Primary	Social competence subscale of the Social Competence and Behavior Evaluation(SCBE)		Months 36/42 - tracking changes throughout study	No
Primary	(Strange Situation Procedure) SSP		Month 15	No
Primary	Nursing Child Assessment Teaching Scale (NCATS)		Months 15/36 - tracking changes throughout study	No