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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00558987
Other study ID # TW-101251
Secondary ID NA_00012021
Status Completed
Phase N/A
First received November 15, 2007
Last updated January 28, 2009
Start date February 2008
Est. completion date January 2009

Study information

Verified date January 2009
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Discipline Video
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.
Nutrition Video
A brief educational video on nutrition information, a topic not related to discipline.

Locations

Country Name City State
United States Harriet Lane Primary Care Clinic Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University The Thomas Wilson Sanitarium for Children of Baltimore City

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of spanking baseline and 6 week follow-up No
Secondary Attitudes about Discipline baseline and 6 week follow-up No
Secondary Type of discipline practices used baseline and 6 week follow-up No
Secondary Discussion with pediatric provider immediately post visit No
See also
  Status Clinical Trial Phase
Terminated NCT04067804 - Implementing Restorative Practices for Youth N/A