Recruiting

Bright Start

Sponsor:

Seattle Children's Hospital

Code:

NCT01573793

Conditions

Cognitive Development

Emotional Development

Eligibility Criteria

Sex: Female

Age: 18 - 23

Healthy Volunteers: Not accepted

Interventions

Parenting Education

Control Group - Safety Materials

Study Details

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.

Conditions

Cognitive Development

Emotional Development

Study ID

NCT01573793

Start date

Apr, 2012

Status verified date

Mar, 2014

Completion date

Dec, 2016

Anticipated

Primary completion date

May, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 23

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Anything other than above

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Arms

active comparator: Intervention

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

Interventions

Parenting Education

Will receive parenting educational materials hypothesized to enhance emotional and cognitive development

Control Group - Safety Materials

Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Heather D Violette, Ph.D.

206-884-8259heather.violette@seattlechildrens.org

Locations

Seattle Children's Research Institute

Recruiting

Seattle, Washington, United States, 98121

Contacts

Heather D Violette, Ph.D.

206-884-8259heather.violette@seattlechildrens.org

Principal Investigator:

Dimitri A Christakis, MD, MPH

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Mar 26, 2014

Last verified

Mar, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2014-03-26.