Promoting Optimal Parenting (Bright Start)

NCT ID: NCT01573793

Last Updated: 2014-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Cognitive Development Emotional Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Will receive parenting educational materials hypothesized to enhance emotional and cognitive development

Group Type ACTIVE_COMPARATOR

Parenting Education

Intervention Type BEHAVIORAL

Will receive parenting educational materials hypothesized to enhance emotional and cognitive development

Control

Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development

Group Type SHAM_COMPARATOR

Control Group - Safety Materials

Intervention Type BEHAVIORAL

Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development

Interventions

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Parenting Education

Will receive parenting educational materials hypothesized to enhance emotional and cognitive development

Intervention Type BEHAVIORAL

Control Group - Safety Materials

Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Anything other than above
Minimum Eligible Age

18 Years

Maximum Eligible Age

23 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dimitri Christakis

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dimitri A Christakis, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Research Institute, University of Washington

Locations

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Seattle Children's Research Institute

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Heather D Violette, Ph.D.

Role: CONTACT

206-884-8259

Facility Contacts

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Heather D Violette, Ph.D.

Role: primary

206-884-8259

Other Identifiers

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1R01HD068478-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13852

Identifier Type: -

Identifier Source: org_study_id

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