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Promoting Optimal Parenting (Bright Start)

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ClinicalTrials.gov Identifier: NCT01573793
Recruitment Status : Unknown
Verified March 2014 by Dimitri Christakis, Seattle Children's Hospital.
Recruitment status was:  Recruiting
First Posted : April 10, 2012
Last Update Posted : March 26, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cognitive Development Emotional Development Behavioral: Parenting Education Behavioral: Control Group - Safety Materials

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Promoting Optimal Parenting
Study Start Date : April 2012
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Language ENvironment Analysis System (LENA) [ Time Frame: 6/18/30 months - tracking changes throughout study ]
  2. Adaptive Behavior Assessment System, Second Edition (ABAS-II) [ Time Frame: Month 12/24/36/42 - tracking changes throughout study ]
  3. Brief Infant Sleep Questionnaire(BISQ) [ Time Frame: Month 12/24 - tracking changes throughout study ]
  4. Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) [ Time Frame: Month 24/42 - tracking changes throughout study ]
  5. MacArthur Communicative Development Inventory- Short Form (CDI) [ Time Frame: Month 24/42 - tracking changes throughout study ]
  6. Children's Sleep Habits Questionnaire (CSHQ) [ Time Frame: Month 36/42 - tracking changes throughout study ]
  7. Devereux Early Childhood Assessment-Clinical Form (DECA-C) [ Time Frame: Month 24/36/42 - tracking changes throughout study ]
  8. Devereux Early Childhood Assessment- Infant/Toddler (DECA-I/T) [ Time Frame: Month 12 ]
  9. Family Resource Scale (FRS) [ Time Frame: Baseline ]
  10. MARLOWE-CROWNE [ Time Frame: Baseline ]
  11. Maternal Emotional Styles Questionnaire (MESQ) [ Time Frame: Month 36 ]
  12. Patient Health Questionnaire 2 (PHQ-2) [ Time Frame: Baseline and Month 12/24/36/42 - tracking changes throughout study ]
  13. Preschool Language Scale-5 (PLS-5) [ Time Frame: Month 36 ]
  14. Parenting Sense of Competence-Efficacy(PSOC) [ Time Frame: Baseline and Months 12/24/36/42 - tracking changes throughout study ]
  15. Social competence subscale of the Social Competence and Behavior Evaluation(SCBE) [ Time Frame: Months 36/42 - tracking changes throughout study ]
  16. (Strange Situation Procedure) SSP [ Time Frame: Month 15 ]
  17. Nursing Child Assessment Teaching Scale (NCATS) [ Time Frame: Months 15/36 - tracking changes throughout study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 23 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014