NCT00558987

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

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

November 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

11 months

First QC Date

November 15, 2007

Last Update Submit

January 28, 2009

Conditions

Keywords

DisciplineParentingPrimary CareVideos

Outcome Measures

Primary Outcomes (1)

  • Frequency of spanking

    baseline and 6 week follow-up

Secondary Outcomes (3)

  • Attitudes about Discipline

    baseline and 6 week follow-up

  • Type of discipline practices used

    baseline and 6 week follow-up

  • Discussion with pediatric provider

    immediately post visit

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Discipline Video

2

SHAM COMPARATOR
Behavioral: Nutrition Video

Interventions

1. 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. 2. 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.

Also known as: "Positive discipline: Vol. 2" by Injoy Videos
1
Nutrition VideoBEHAVIORAL

A brief educational video on nutrition information, a topic not related to discipline.

Also known as: "Childhood Nutrition: Vol. 2" by Injoy Videos
2

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harriet Lane Primary Care Clinic

Baltimore, Maryland, 21287, United States

Location

Study Officials

  • Rachel A Dodge, MD, MPH

    Johns Hopkins University

    STUDY DIRECTOR
  • Anne K Duggan, ScD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 16, 2007

Study Start

February 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations