Trial record 5 of 82 for:    Open Studies | "Parenting"

Promoting Optimal Parenting (Bright Start)

This study is currently recruiting participants.
Verified March 2014 by Seattle Children's Hospital
Sponsor:
Collaborator:
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
  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:


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
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: 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
Investigators
Principal Investigator: Dimitri A Christakis, MD, MPH Seattle Children's Research Institute, University of Washington
  More Information

No publications provided

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 April 20, 2014