NCT01573793

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

4.1 years

First QC Date

March 30, 2012

Last Update Submit

March 24, 2014

Conditions

Cognitive DevelopmentEmotional Development

Outcome Measures

Primary Outcomes (17)

  • Language ENvironment Analysis System (LENA)

    6/18/30 months - tracking changes throughout study

  • Adaptive Behavior Assessment System, Second Edition (ABAS-II)

    Month 12/24/36/42 - tracking changes throughout study

  • Brief Infant Sleep Questionnaire(BISQ)

    Month 12/24 - tracking changes throughout study

  • Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)

    Month 24/42 - tracking changes throughout study

  • MacArthur Communicative Development Inventory- Short Form (CDI)

    Month 24/42 - tracking changes throughout study

  • Children's Sleep Habits Questionnaire (CSHQ)

    Month 36/42 - tracking changes throughout study

  • Devereux Early Childhood Assessment-Clinical Form (DECA-C)

    Month 24/36/42 - tracking changes throughout study

  • Devereux Early Childhood Assessment- Infant/Toddler (DECA-I/T)

    Month 12

  • Family Resource Scale (FRS)

    Baseline

  • MARLOWE-CROWNE

    Baseline

  • Maternal Emotional Styles Questionnaire (MESQ)

    Month 36

  • Patient Health Questionnaire 2 (PHQ-2)

    Baseline and Month 12/24/36/42 - tracking changes throughout study

  • Preschool Language Scale-5 (PLS-5)

    Month 36

  • Parenting Sense of Competence-Efficacy(PSOC)

    Baseline and Months 12/24/36/42 - tracking changes throughout study

  • Social competence subscale of the Social Competence and Behavior Evaluation(SCBE)

    Months 36/42 - tracking changes throughout study

  • (Strange Situation Procedure) SSP

    Month 15

  • Nursing Child Assessment Teaching Scale (NCATS)

    Months 15/36 - tracking changes throughout study

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Behavioral: Parenting Education

Control

SHAM COMPARATOR

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

Behavioral: Control Group - Safety Materials

Interventions

Parenting EducationBEHAVIORAL

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

Intervention
Control Group - Safety MaterialsBEHAVIORAL

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

Control

Eligibility Criteria

Age18 Years - 23 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Anything other than above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98121, United States

RECRUITING

Study Officials

  • Dimitri A Christakis, MD, MPH

    Seattle Children's Research Institute, University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather D Violette, Ph.D.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 10, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2016

Study Completion

December 1, 2016

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

US(1)