Promoting Optimal Parenting (Bright Start)

Promoting Optimal Parenting

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 Overview

• Status: Unknown
• Conditions: Cognitive Development; Emotional Development
• Intervention / Treatment: Behavioral: Parenting Education; Behavioral: Control Group - Safety Materials

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather D Violette, Ph.D.; Phone Number: 206-884-8259; Email: heather.violette@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98121
      • Recruiting
      • Seattle Children's Research Institute
      • Contact: Heather D Violette, Ph.D.; Phone Number: 206-884-8259; Email: heather.violette@seattlechildrens.org
      • Principal Investigator: Dimitri A Christakis, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 23 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Anything other than above

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Dimitri A Christakis, MD, MPH, Seattle Children's Research Institute, University of Washington

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: March 30, 2012
• First Submitted That Met QC Criteria: April 5, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 24, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 13852; 1R01HD068478-01A1 (U.S. NIH Grant/Contract)