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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

March 30, 2012
January 10, 2013
April 2012
May 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01573793 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
  • Cognitive Development
  • Emotional Development
  • Behavioral: Parenting Education
    Will receive parenting educational materials hypothesized to enhance 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
  • Active Comparator: Intervention
    Will receive parenting educational materials hypothesized to enhance emotional and cognitive development
    Intervention: Behavioral: Parenting Education
  • Sham Comparator: Control
    Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development
    Intervention: Behavioral: Control Group - Safety Materials
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
December 2016
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Anything other than above
Female
18 Years to 23 Years
No
Contact: Melanie G Biehle, M.S. 206-884-8265 melanie.biehle@seattlechildrens.org
United States
 
NCT01573793
13852, 1R01HD068478-01A1
Yes
Seattle Children's Hospital
Seattle Children's Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Dimitri A Christakis, MD, MPH Seattle Children's Research Institute, University of Washington
Seattle Children's Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP