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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT01304719

First received: February 10, 2011

Last updated: May 13, 2013

Last verified: May 2013

History of Changes

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.

Condition	Intervention
Child Maltreatment	Behavioral: Computer Assisted Healthy Families America Home Visitation Behavioral: Healthy Families America Home Visitation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Computer-based Intervention to Augment Home Visitation Services: The E-Parenting Project

Resource links provided by NLM:

MedlinePlus related topics: Parenting

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

Child maltreatment reports [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment:	413
Study Start Date:	October 2007
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Computer Assisted home visitation Home visitation with computer modules added	Behavioral: Computer Assisted Healthy Families America Home Visitation Computer modules added to home visitation protocol for Healthy Families America
Experimental: Home Visitation TAU Home Visitation Treatment as Usual	Behavioral: Healthy Families America Home Visitation Healthy Families America Home Visitation Treatment as Usual
No Intervention: Community Referral Community Referral

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304719

Locations

United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Steven Ondersma, Ph.D.

Wayne State University

More Information

No publications provided

Responsible Party:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT01304719 History of Changes
Other Study ID Numbers:	092506B3F
Study First Received:	February 10, 2011
Last Updated:	May 13, 2013
Health Authority:	United States: Federal Government

ClinicalTrials.gov processed this record on May 21, 2013

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