Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Indianapolis, Indiana 46202


Purpose:

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 summary:

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.


Criteria:

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: 1. Mothers must be 18 years or older and able to complete the baseline assessment within 4 weeks of delivery. 2. Mothers have not completed any prior post-partum treatment plan. 3. Participants must have functional cognitive abilities. 4. Premature infants have to be released from hospital care within 6 weeks of birth. 5. Participants must be able to communicate in English.


Study is Available At:


Original ID:

092506B3F


NCT ID:

NCT01304719


Secondary ID:


Study Acronym:


Brief Title:

A Computer-based Intervention to Augment Home Visitation Services: The E-Parenting Project


Official Title:

A Computer-based Intervention to Augment Home Visitation Services: The E-Parenting Project


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Centers for Disease Control and Prevention


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

413


Enrollment Type:

Actual


Overall Contact Information

Official Name:Steven Ondersma, Ph.D.
Principal Investigator
Wayne State University

Study Dates

Start Date:October 2007
Completion Date:August 2011
Completion Type:Actual
Primary Completion Date:August 2011
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:May 13, 2013
First Received Date:February 10, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Child maltreatment reports
Time Frame:18 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Computer Assisted Healthy Families America Home Vi
Description:Computer modules added to home visitation protocol for Healthy Families America
Arm Name:Computer Assisted home visitation
Intervention Type:Behavioral
Name:Healthy Families America Home Visitation
Description:Healthy Families America Home Visitation Treatment as Usual
Arm Name:Home Visitation TAU

Study Arms

Study Arm Type:Experimental
Arm Name:Computer Assisted home visitation
Description:Home visitation with computer modules added
Study Arm Type:Experimental
Arm Name:Home Visitation TAU
Description:Home Visitation Treatment as Usual
Study Arm Type:No Intervention
Arm Name:Community Referral
Description:Community Referral

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Centers for Disease Control and Prevention

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.