Promoting Optimal Parenting (Bright Start)

This study is currently recruiting participants.

Verified January 2013 by Seattle Children's Hospital

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

Seattle Children's Hospital

ClinicalTrials.gov Identifier:

NCT01573793

First received: March 30, 2012

Last updated: January 10, 2013

Last verified: January 2013

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 24 ] [ 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 15/24 - tracking changes throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
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
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

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

Contacts

Contact: Melanie G Biehle, M.S.

206-884-8265

melanie.biehle@seattlechildrens.org

Locations

United States, Washington
Seattle Children's Research Institute	Recruiting
Seattle, Washington, United States, 98121
Contact: Melanie G Biehle, MS 206-884-8265 melanie.biehle@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

No publications provided

Responsible Party:	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:	January 10, 2013
Health Authority:	United States: Institutional Review Board United States: Federal Government

ClinicalTrials.gov processed this record on May 21, 2013

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