Cognitive DevelopmentNCT01573793
Promoting Optimal Parenting (Bright Start)
A study testing Parenting Education in people with Cognitive Development and Emotional Development, run by Seattle Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 23 years, women only
- Conditions the study is for
- Cognitive Development, Emotional Development
- What is being tested?
- Parenting Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 23 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- English-speaking
- 18-23 year-old first-time mother of a healthy newborn
Who cannot join
- Anything other than above
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Research Institute
Seattle, Washington, 98121
Heather D Violette, Ph.D., 206-884-8259, heather.violette@seattlechildrens.org
Dimitri A Christakis, MD, MPH
About this study
Official title: Promoting Optimal Parenting
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
- Being tested
- Parenting Education, Control Group - Safety Materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting EducationBehavioural
Will receive parenting educational materials hypothesized to enhance emotional and cognitive development
Control Group - Safety MaterialsBehavioural
Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Will receive parenting educational materials hypothesized to enhance emotional and cognitive development Receives: Behavioral: Parenting Education |
| Control | Sham comparator | Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development Receives: Behavioral: Control Group - Safety Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language ENvironment Analysis System (LENA)
Measured: 6/18/30 months - tracking changes throughout study
Adaptive Behavior Assessment System, Second Edition (ABAS-II)
Measured: Month 12/24/36/42 - tracking changes throughout study
Brief Infant Sleep Questionnaire(BISQ)
Measured: Month 12/24 - tracking changes throughout study
Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
Measured: Month 24/42 - tracking changes throughout study
MacArthur Communicative Development Inventory- Short Form (CDI)
Measured: Month 24/42 - tracking changes throughout study
Children's Sleep Habits Questionnaire (CSHQ)
Measured: Month 36/42 - tracking changes throughout study
Devereux Early Childhood Assessment-Clinical Form (DECA-C)
Measured: Month 24/36/42 - tracking changes throughout study
Devereux Early Childhood Assessment- Infant/Toddler (DECA-I/T)
Measured: Month 12
Family Resource Scale (FRS)
Measured: Baseline
MARLOWE-CROWNE
Measured: Baseline
Maternal Emotional Styles Questionnaire (MESQ)
Measured: Month 36
Patient Health Questionnaire 2 (PHQ-2)
Measured: Baseline and Month 12/24/36/42 - tracking changes throughout study
Preschool Language Scale-5 (PLS-5)
Measured: Month 36
Parenting Sense of Competence-Efficacy(PSOC)
Measured: Baseline and Months 12/24/36/42 - tracking changes throughout study
Social competence subscale of the Social Competence and Behavior Evaluation(SCBE)
Measured: Months 36/42 - tracking changes throughout study
(Strange Situation Procedure) SSP
Measured: Month 15
Nursing Child Assessment Teaching Scale (NCATS)
Measured: Months 15/36 - tracking changes throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Dimitri Christakis, Seattle Children's Hospital
- Investigators
- Dimitri A Christakis, MD, MPH, Principal investigator, Seattle Children's Research Institute, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573793
- Sponsor's protocol ID
- 13852
- Other IDs
- 1R01HD068478-01A1
- Status last verified
- Mar 2014
- First submitted
- 30 Mar 2012
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Optimal Parenting
- ClinicalTrials.gov ID
- NCT01573793
- Acronym / sponsor ID
- 13852
- Conditions
- Cognitive Development, Emotional Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2012
- Primary completion
- May 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Parenting EducationWill receive parenting educational materials hypothesized to enhance emotional and cognitive development |
| Control | Sham comparator | Behavioral: Control Group - Safety MaterialsWill receive safety and dental hygiene materials that have no bearing on emotional and cognitive development |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- English-speaking
- 18-23 year-old first-time mother of a healthy newborn
Key exclusion criteria (1 listed)
- Anything other than above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenting EducationWill receive parenting educational materials hypothesized to enhance emotional and cognitive development | Behavioural | Intervention |
| Control Group - Safety MaterialsWill receive safety and dental hygiene materials that have no bearing on emotional and cognitive development | Behavioural | Control |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri A Christakis, MD, MPH principal investigator
Seattle Children's Research Institute, University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Education in people with Cognitive Development and Emotional Development, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather D Violette, Ph.D. (206-884-8259, heather.violette@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language ENvironment Analysis System (LENA) (time frame: 6/18/30 months - tracking changes throughout study). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014; AzTrials last refreshed its copy on 28 Oct 2026.