CClinicalTrials.gg
Status unknownNCT01573793Updated Mar 26, 2014

Promoting Optimal Parenting (Bright Start)

An interventional study of Parenting Education and Control Group - Safety Materials in Cognitive Development and Emotional Development, sponsored by Seattle Children's Hospital. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 23 Years. Per ClinicalTrials.gov, last updated 2014-03-26.

Sponsored by Seattle Children's Hospital · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Mar 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years to 23 Years
Sex
Female
01

Study 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.

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Conditions studied

  • Cognitive Development
  • Emotional Development
03

In context

Lead sponsor

Seattle Children's Hospital is the lead sponsor of 210 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 23 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Anything other than above
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
500 participants (estimated)

Study arms

  • Active comparator
    Intervention

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

    Behavioral: Parenting Education

  • Sham comparator
    Control

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

    Behavioral: Control Group - Safety Materials

Interventions

  • BehavioralParenting Education

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

  • BehavioralControl Group - Safety Materials

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

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Seattle Children's Research Institute
    Seattle, Washington 98121, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01573793
Lead sponsor
Seattle Children's Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Dimitri Christakis (Investigator, Seattle Children's Hospital) — Principal investigator
First posted
Apr 10, 2012
Start date
Apr 2012
Primary completion
May 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Mar 26, 2014

Study contacts

Heather D Violette, Ph.D.
Contact
heather.violette@seattlechildrens.org
206-884-8259
Dimitri A Christakis, MD, MPH
principal investigator · Seattle Children's Research Institute, University of Washington

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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