Parenting Videos In Primary Care | NCT00558987

Studies
Parenting Videos In Primary Care

NCT00558987

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Jan 29, 2009Estimated

Enrollment

122Actual

Phase

Not Applicable

Conditions

Discipline Attitudes
Discipline Practices

Interventions

Discipline Video
Nutrition Video

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NA_00012021

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Nov 15, 2007

First Submission Date that Met QC Criteria

Nov 15, 2007

First Posted Date

Nov 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2009

Last Update Posted Date

Jan 29, 2009Estimated

Name	Class
The Thomas Wilson Sanitarium for Children of Baltimore City	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to test the effectiveness of a video-based parent education intervention delivered in the primary care setting on parents and other caregivers discipline attitudes and practices.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Behavioral: Discipline Video
2	Sham Comparator		Behavioral: Nutrition Video

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Discipline Video	Behavioral	The discipline video will be shown to the caregiver before the visit while they are waiting to see the doctor. The video gives specific guidance on avoiding physical discipline, setting consistent, safe and age appropriate limits. A copy of the discipline video and the handout reinforcing the messages presented in the video will be given to the caregiver by the research staff to share with other caregivers.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of spanking		baseline and 6 week follow-up

Secondary Outcomes

Measure	Description	Time Frame
Attitudes about Discipline		baseline and 6 week follow-up
Type of discipline practices used		baseline and 6 week follow-up
Discussion with pediatric provider

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult caregivers of children ages 12 to 36 months with a scheduled well-child visit.
Caregivers must be older than 18 years of age, must be considered a consistent caregiver for the child, must be the primary caregiver at least 2 days per week, and must live with the child.

Exclusion Criteria:

Caregivers previously enrolled in the study.
Caregivers who do not speak or read English,
Caregivers not able to give contact information for follow-up,
Caregivers of a child who has a severe behavioral problem or developmental delay as reported by the parent during the initial recruitment phone call.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachel A Dodge, MD, MPH	Johns Hopkins University	Study Director
Anne K Duggan, ScD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Harriet Lane Primary Care Clinic		Baltimore	Maryland	21287	United States