Clinical trial NCT01573793: Promoting Optimal Parenting (Bright Start)
Official title: Promoting Optimal Parenting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Development
Emotional Development
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-04-10
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Anything other than above

Primary outcomes:
measure: Language ENvironment Analysis System (LENA)
timeFrame: 6/18/30 months - tracking changes throughout study
measure: Adaptive Behavior Assessment System, Second Edition (ABAS-II)
timeFrame: Month 12/24/36/42 - tracking changes throughout study
measure: Brief Infant Sleep Questionnaire(BISQ)
timeFrame: Month 12/24 - tracking changes throughout study
measure: Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
timeFrame: Month 24/42 - tracking changes throughout study
measure: MacArthur Communicative Development Inventory- Short Form (CDI)
timeFrame: Month 24/42 - tracking changes throughout study
measure: Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: Month 36/42 - tracking changes throughout study
measure: Devereux Early Childhood Assessment-Clinical Form (DECA-C)
timeFrame: Month 24/36/42 - tracking changes throughout study
measure: Devereux Early Childhood Assessment- Infant/Toddler (DECA-I/T)
timeFrame: Month 12
measure: Family Resource Scale (FRS)
timeFrame: Baseline
measure: MARLOWE-CROWNE
timeFrame: Baseline
measure: Maternal Emotional Styles Questionnaire (MESQ)
timeFrame: Month 36
measure: Patient Health Questionnaire 2 (PHQ-2)
timeFrame: Baseline and Month 12/24/36/42 - tracking changes throughout study
measure: Preschool Language Scale-5 (PLS-5)
timeFrame: Month 36
measure: Parenting Sense of Competence-Efficacy(PSOC)
timeFrame: Baseline and Months 12/24/36/42 - tracking changes throughout study
measure: Social competence subscale of the Social Competence and Behavior Evaluation(SCBE)
timeFrame: Months 36/42 - tracking changes throughout study
measure: (Strange Situation Procedure) SSP
timeFrame: Month 15
measure: Nursing Child Assessment Teaching Scale (NCATS)
timeFrame: Months 15/36 - tracking changes throughout study
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
affiliation: Seattle Children's Research Institute, University of Washington
name: Dimitri A Christakis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: