- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01304719
A Computer-based Intervention to Augment Home Visitation Services: The E-Parenting Project
May 13, 2013 updated by: Centers for Disease Control and Prevention
The current protocol aims to examine the effects of a computer-based intervention used in conjunction with existing Healthy Families America (HFA) home visitation programs on the challenges related to participant enrollment, retention, and motivation as well as parent and child outcomes.
Study Overview
Status
Completed
Conditions
Detailed Description
The present study aims to determine whether a computer-based intervention can provide augmentation of home visiting services to decrease the risk of child maltreatment.
The computer-based software includes modules on motivation, Cognitive Retraining, and elements of the ecobehavioral SafeCare approach.
A total of 420 mother-infant dyads from four Healthy Families America (HFA) sites will be randomly assigned to either treatment as usual, software-supplemented home visitation, or community control conditions.
For families in the software-supplemented condition, home visitors will present the software to parents via a Tablet PC during regular home visits.
All parents will be followed-up at 6, 12, and 18 months by independent and blinded research assistants.
Parents are evaluated for maltreatment and maltreatment risks as measured by self-report, home visitor report, blinded independent observers, and statewide CPS data.
If validated, the proposed intervention can provide augmentation of home visiting services with unprecedented ease of dissemination, at negligible additional cost, and with limitless potential for further development.
Study Type
Interventional
Enrollment (Actual)
413
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Pregnant or post-partum mothers who are eligible (i.e., score 25 or greater on the Kempe Family Stress Checklist and are not involved in CPS open case investigation at the time of HFA participation) and willing to participate in the HFA program are eligible to participate in the current study, with the following restrictions:
- Mothers must be 18 years or older and able to complete the baseline assessment within 4 weeks of delivery.
- Mothers have not completed any prior post-partum treatment plan.
- Participants must have functional cognitive abilities.
- Premature infants have to be released from hospital care within 6 weeks of birth.
- Participants must be able to communicate in English.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computer Assisted home visitation
Home visitation with computer modules added
|
Computer modules added to home visitation protocol for Healthy Families America
|
Experimental: Home Visitation TAU
Home Visitation Treatment as Usual
|
Healthy Families America Home Visitation Treatment as Usual
|
No Intervention: Community Referral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Child maltreatment reports
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Steven Ondersma, Ph.D., Wayne State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
February 10, 2011
First Submitted That Met QC Criteria
February 24, 2011
First Posted (Estimate)
February 25, 2011
Study Record Updates
Last Update Posted (Estimate)
May 15, 2013
Last Update Submitted That Met QC Criteria
May 13, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 092506B3F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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