Promoting Optimal Parenting (Bright Start)

This study is currently recruiting participants. (see Contacts and Locations)

Verified March 2014 by Seattle Children's Hospital

Sponsor:

Collaborator:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party):

Dimitri Christakis, Seattle Children's Hospital

ClinicalTrials.gov Identifier:

NCT01573793

First received: March 30, 2012

Last updated: March 24, 2014

Last verified: March 2014

History of Changes

Purpose

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.

Condition	Intervention
Cognitive Development Emotional Development	Behavioral: Parenting Education Behavioral: Control Group - Safety Materials


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
Official Title:	Promoting Optimal Parenting

Resource links provided by NLM:

MedlinePlus related topics: Parenting

U.S. FDA Resources

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:

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


Estimated Enrollment:	500
Study Start Date:	April 2012
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	May 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Anything other than above

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573793

Contacts


Contact: Heather D Violette, Ph.D.	206-884-8259	heather.violette@seattlechildrens.org

Locations


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

Sponsors and Collaborators

Seattle Children's Hospital

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

More Information


Responsible Party:	Dimitri Christakis, Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier:	NCT01573793 History of Changes
Other Study ID Numbers:	13852 1R01HD068478-01A1
Study First Received:	March 30, 2012
Last Updated:	March 24, 2014
Health Authority:	United States: Institutional Review Board United States: Federal Government

ClinicalTrials.gov processed this record on September 23, 2016

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