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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cognitive Development Emotional Development | Behavioral: Parenting Education Behavioral: Control Group - Safety Materials | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Intervention
Will receive parenting educational materials hypothesized to enhance emotional and cognitive development
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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
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Behavioral: Control Group - Safety Materials
Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development |
- Language ENvironment Analysis System (LENA) [ Time Frame: 6/18/30 months - tracking changes throughout study ]
- Adaptive Behavior Assessment System, Second Edition (ABAS-II) [ Time Frame: Month 12/24/36/42 - tracking changes throughout study ]
- Brief Infant Sleep Questionnaire(BISQ) [ Time Frame: Month 12/24 - tracking changes throughout study ]
- Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) [ Time Frame: Month 24/42 - tracking changes throughout study ]
- MacArthur Communicative Development Inventory- Short Form (CDI) [ Time Frame: Month 24/42 - tracking changes throughout study ]
- Children's Sleep Habits Questionnaire (CSHQ) [ Time Frame: Month 36/42 - tracking changes throughout study ]
- Devereux Early Childhood Assessment-Clinical Form (DECA-C) [ Time Frame: Month 24/36/42 - tracking changes throughout study ]
- Devereux Early Childhood Assessment- Infant/Toddler (DECA-I/T) [ Time Frame: Month 12 ]
- Family Resource Scale (FRS) [ Time Frame: Baseline ]
- MARLOWE-CROWNE [ Time Frame: Baseline ]
- Maternal Emotional Styles Questionnaire (MESQ) [ Time Frame: Month 36 ]
- Patient Health Questionnaire 2 (PHQ-2) [ Time Frame: Baseline and Month 12/24/36/42 - tracking changes throughout study ]
- Preschool Language Scale-5 (PLS-5) [ Time Frame: Month 36 ]
- Parenting Sense of Competence-Efficacy(PSOC) [ Time Frame: Baseline and Months 12/24/36/42 - tracking changes throughout study ]
- Social competence subscale of the Social Competence and Behavior Evaluation(SCBE) [ Time Frame: Months 36/42 - tracking changes throughout study ]
- (Strange Situation Procedure) SSP [ Time Frame: Month 15 ]
- Nursing Child Assessment Teaching Scale (NCATS) [ Time Frame: Months 15/36 - tracking changes throughout study ]

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Ages Eligible for Study: | 18 Years to 23 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- English-speaking
- 18-23 year-old first-time mother of a healthy newborn
Exclusion Criteria:
- Anything other than above

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
Contact: Heather D Violette, Ph.D. | 206-884-8259 | heather.violette@seattlechildrens.org |
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 |
Principal Investigator: | Dimitri A Christakis, MD, MPH | Seattle Children's Research Institute, University of Washington |
Responsible Party: | Dimitri Christakis, Investigator, Seattle Children's Hospital |
ClinicalTrials.gov Identifier: | NCT01573793 |
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 |